541 results on '"Venter, Willem"'
Search Results
202. MOESM2 of Lipid levels, insulin resistance and cardiovascular risk over 96Â weeks of antiretroviral therapy: a randomised controlled trial comparing low-dose stavudine and tenofovir
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Vos, Alinda, Chersich, Matthew, Klipstein-Grobusch, Kerstin, Zuithoff, Peter, Moorhouse, Michelle, Lalla-Edward, Samanta, Kambugu, Andrew, N. Kumarasamy, Grobbee, Diederick, Barth, Roos, and Venter, Willem
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3. Good health - Abstract
Additional file 2: Table S2. Title: Estimated means with 95% confidence intervals per outcome. Description of data: This table presents estimates of the means for each treatment group at 4 follow-up measurements based on a linear mixed model with correction for age, sex, site of inclusion (South-Africa, Uganda or India), body mass index and viral load at baseline (see â Methodsâ for details).
203. MOESM1 of Lipid levels, insulin resistance and cardiovascular risk over 96Â weeks of antiretroviral therapy: a randomised controlled trial comparing low-dose stavudine and tenofovir
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Vos, Alinda, Chersich, Matthew, Klipstein-Grobusch, Kerstin, Zuithoff, Peter, Moorhouse, Michelle, Lalla-Edward, Samanta, Kambugu, Andrew, N. Kumarasamy, Grobbee, Diederick, Barth, Roos, and Venter, Willem
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3. Good health - Abstract
Additional file 1: Table S1. Title: Laboratory methods. Description of data: this table includes details on the measurement methods of lipids, glucose, insulin, HIV viral load and CD4+ cell count.
204. MOESM3 of Lipid levels, insulin resistance and cardiovascular risk over 96Â weeks of antiretroviral therapy: a randomised controlled trial comparing low-dose stavudine and tenofovir
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Vos, Alinda, Chersich, Matthew, Klipstein-Grobusch, Kerstin, Zuithoff, Peter, Moorhouse, Michelle, Lalla-Edward, Samanta, Kambugu, Andrew, N. Kumarasamy, Grobbee, Diederick, Barth, Roos, and Venter, Willem
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lipids (amino acids, peptides, and proteins) ,3. Good health - Abstract
Additional file 3: Table S3. Title: Generalized linear mixed models. Description of data: generalized linear mixed models for the outcomes total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, glucose, insulin, HOMA-IR and Framingham risk score.
205. Randomized clinical trial of nitazoxanide or sofosbuvir/daclatasvir for the prevention of SARS-CoV-2 infection
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Sokhela, Simiso, Bosch, Bronwyn, Hill, Andrew, Simmons, Bryony, Woods, Joana, Johnstone, Hilary, Akpomiemie, Godspower, Ellis, Leah, Owen, Andrew, Casas, Carmen Perez, Venter, Willem Daniel Francois, Sokhela, Simiso, Bosch, Bronwyn, Hill, Andrew, Simmons, Bryony, Woods, Joana, Johnstone, Hilary, Akpomiemie, Godspower, Ellis, Leah, Owen, Andrew, Casas, Carmen Perez, and Venter, Willem Daniel Francois
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BACKGROUND: The COVER trial evaluated whether nitazoxanide or sofosbuvir/daclatasvir could lower the risk of SARS-CoV-2 infection. Nitazoxanide was selected given its favourable pharmacokinetics and in vitro antiviral effects against SARS-CoV-2. Sofosbuvir/daclatasvir had shown favourable results in early clinical trials. METHODS: In this clinical trial in Johannesburg, South Africa, healthcare workers and others at high risk of infection were randomized to 24 weeks of either nitazoxanide or sofosbuvir/daclatasvir as prevention, or standard prevention advice only. Participants were evaluated every 4 weeks for COVID-19 symptoms and had antibody and PCR testing. The primary endpoint was positive SARS-CoV-2 PCR and/or serology ≥7 days after randomization, regardless of symptoms. A Poisson regression model was used to estimate the incidence rate ratios of confirmed SARS-CoV-2 between each experimental arm and control. RESULTS: Between December 2020 and January 2022, 828 participants were enrolled. COVID-19 infections were confirmed in 100 participants on nitazoxanide (2234 per 1000 person-years; 95% CI 1837-2718), 87 on sofosbuvir/daclatasvir (2125 per 1000 person-years; 95% CI 1722-2622) and 111 in the control arm (1849 per 1000 person-years; 95% CI 1535-2227). There were no significant differences in the primary endpoint between the treatment arms, and the results met the criteria for futility. In the safety analysis, the frequency of grade 3 or 4 adverse events was low and similar across arms. CONCLUSIONS: In this randomized trial, nitazoxanide and sofosbuvir/daclatasvir had no significant preventative effect on infection with SARS-CoV-2 among healthcare workers and others at high risk of infection.
206. Comparing prospective incident severe acute respiratory syndrome Coronavirus 2 infection rates during successive waves of Delta and Omicron in Johannesburg, South Africa
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Sokhela, Simiso, Bosch, Bronwyn, Hill, Andrew, Simmons, Bryony, Woods, Joana, Johnstone, Hilary, Madhi, Shabir, Qavi, Ambar, Ellis, Leah, Akpomiemie, Godspower, Bhaskar, Esther, Levi, Jacob, Falconer, Jonathan, Mirchandani, Manya, Perez Casas, Carmen, Moller, Karlien, Pilkington, Victoria, Pepperrell, Toby, Venter, Willem Daniel Francois, Sokhela, Simiso, Bosch, Bronwyn, Hill, Andrew, Simmons, Bryony, Woods, Joana, Johnstone, Hilary, Madhi, Shabir, Qavi, Ambar, Ellis, Leah, Akpomiemie, Godspower, Bhaskar, Esther, Levi, Jacob, Falconer, Jonathan, Mirchandani, Manya, Perez Casas, Carmen, Moller, Karlien, Pilkington, Victoria, Pepperrell, Toby, and Venter, Willem Daniel Francois
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In high-risk individuals in Johannesburg, during the Delta coronavirus disease 2019 wave, 22% (125/561) were positive, with 33% symptomatic (2 hospitalizations; 1 death). During Omicron, 56% (232/411) were infected, with 24% symptomatic (no hospitalizations or deaths). The remarkable speed of infection of Omicron over Delta poses challenges to conventional severe acute respiratory syndrome coronavirus 2 control measures.
207. Final 192-week efficacy and safety results of the ADVANCE trial, comparing 3 first-line antiretroviral regimens
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Sokhela, Simiso, Venter, Willem D.F., Bosch, Bronwyn, Woods, Joana, McCann, Kaitlyn, Akpomiemie, Godspower, Chandiwana, Nomathemba, Mashabane, Nkuli, Tembo, Angela, Simmons, Bryony, Lalla-Edward, Samanta, Siedner, Mark J., Sinxadi, Phumla, Hermans, Lucas, Fairlie, Lee, Vos, Alinda, Abrams, Elaine, Manne-Goehler, Jennifer M., Moorhouse, Michelle, Clayden, Polly, Norris, Shane, Qavi, Ambar, Chersich, Matthew, Masenya, Masebole, Arulappan, Natasha, Hill, Andrew, Sokhela, Simiso, Venter, Willem D.F., Bosch, Bronwyn, Woods, Joana, McCann, Kaitlyn, Akpomiemie, Godspower, Chandiwana, Nomathemba, Mashabane, Nkuli, Tembo, Angela, Simmons, Bryony, Lalla-Edward, Samanta, Siedner, Mark J., Sinxadi, Phumla, Hermans, Lucas, Fairlie, Lee, Vos, Alinda, Abrams, Elaine, Manne-Goehler, Jennifer M., Moorhouse, Michelle, Clayden, Polly, Norris, Shane, Qavi, Ambar, Chersich, Matthew, Masenya, Masebole, Arulappan, Natasha, and Hill, Andrew
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BACKGROUND: ADVANCE compared 3 World Health Organization-recommended first-line regimens in participants with HIV who were antiretroviral naive. METHODS: This randomized, open-label, noninferiority trial enrolled participants living with HIV with no antiretroviral exposure in the previous 6 months to 1 of the following arms: tenofovir alafenamide (TAF) / emtricitabine (FTC) + dolutegravir (DTG) (2 tablets), tenofovir disoproxil fumarate (TDF) / FTC + DTG (2 tablets), or a fixed-dose combination of TDF / FTC / efavirenz (EFV) (1 tablet). We report the final safety and efficacy data up to 192 weeks. RESULTS: Repeat consent from the original 351 participants randomized to each arm was obtained from 230 participants (66%) in the TAF/FTC + DTG arm, 209 (60%) in the TDF/FTC + DTG arm, and 183 (52%) in the TDF/FTC/EFV arm. At 192 weeks, 213 (61%) of the original 351 participants in the TAF/FTC + DTG arm, 195 (56%) in the TDF/FTC + DTG arm, and 172 (49%) in the TDF/FTC/EFV arm had confirmed RNA <50 copies/mL, with low virologic failure in all groups and no significant integrase inhibitor mutations in any arm. Mean weight gain was 8.9 kg (SD, 7.1) in the TAF/FTC + DTG arm, 5.9 kg (SD, 7.1) in the TDF/FTC + DTG arm, and 3.2 kg (SD, 8.1) in the TDF/FTC/EFV arm at 192 weeks from baseline and was greatest among women, those taking TAF, and those with lower baseline CD4 counts. The weight trajectory slowed after week 96. There were few clinical events and minor laboratory changes and differences among arms after 96 weeks. There were no significant differences in treatment-emergent hypertension or pregnancy outcomes by arm. CONCLUSIONS: High viral suppression was seen across arms, with no resistance to DTG. Weight gain continued but slowed after 96 weeks, with few clinical events or laboratory changes.
208. Integration of point-of-care screening for type 2 diabetes mellitus and hypertension into the COVID-19 vaccine programme in Johannesburg, South Africa.
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Brennan, Alana T, Vetter, Beatrice, Masuku, Sithabiso D, Mtshazo, Bukelwa, Mashabane, Nkuli, Sokhela, Simiso, Venter, Willem DF, Kao, Kekeletso, and Meyer-Rath, Gesine
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TYPE 2 diabetes , *MEDICAL screening , *COVID-19 vaccines , *HEALTH facilities , *BLOOD sugar , *DIABETIC retinopathy - Abstract
Background: South Africa grapples with a substantial burden of non-communicable diseases (NCDs), particularly type 2 diabetes (diabetes) and hypertension. However, these conditions are often underdiagnosed and poorly managed, further exacerbated by the strained primary healthcare (PHC) system and the disruptive impact of the COVID-19 pandemic. Integrating NCD screening with large-scale healthcare initiatives, such as COVID-19 vaccination campaigns, offers a potential solution, especially in low- and middle-income countries (LMICs). We investigated the feasibility and effectiveness of this integration. Methods: A prospective cohort study was conducted at four government health facilities in Johannesburg, South Africa. NCD screening was incorporated into the COVID-19 vaccination campaign. Participants underwent COVID-19 rapid tests, blood glucose checks, blood pressure assessments, and anthropometric measurements. Those with elevated blood glucose or blood pressure values received referrals for diagnostic confirmation at local PHC centers. Results: Among 1,376 participants screened, the overall diabetes prevalence was 4.1%, combining previously diagnosed cases and newly identified elevated blood glucose levels. Similarly, the hypertension prevalence was 19.4%, comprising pre-existing diagnoses and newly detected elevated blood pressure cases. Notably, 46.1% of participants displayed waist circumferences indicative of metabolic syndrome, more prevalent among females. Impressively, 7.8% of all participants screened were potentially newly diagnosed with diabetes or hypertension. Approximately 50% of individuals with elevated blood glucose or blood pressure successfully linked to follow-up care within four weeks. Conclusion: Our study underscores the value of utilizing even brief healthcare interactions as opportunities for screening additional health conditions, thereby aiding the identification of previously undiagnosed cases. Integrating NCD screenings into routine healthcare visits holds promise, especially in resource-constrained settings. Nonetheless, concerted efforts to strengthen care linkage are crucial for holistic NCD management and control. These findings provide actionable insights for addressing the NCD challenge and improving healthcare delivery in LMICs. [ABSTRACT FROM AUTHOR]
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- 2023
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209. Third-Line Antiretroviral Therapy Program in the South African Public Sector: Cohort Description and Virological Outcomes.
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Moorhouse, Michelle, Maartens, Gary, Venter, Willem Daniel Francois, Moosa, Mahomed-Yunus, Steegen, Kim, Jamaloodien, Khadija, Fox, Matthew P., and Conradie, Francesca
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Background: The World Health Organization recommends that antiretroviral therapy (ART) programs in resource-limited settings develop third-line ART policies. South Africa developed a national third-line ART program for patients who have failed both first-line non-nucleoside reverse transcriptase inhibitor–based ART and second-line protease inhibitor (PI)-based ART. We report on this program. Methods: Third-line ART in South Africa is accessed through a national committee that assesses eligibility and makes individual regimen recommendations. Criteria for third-line include the following: ≥1 year on PI-based ART with virologic failure, despite adherence optimization, and genotypic antiretroviral resistance test showing PI resistance. We describe baseline characteristics and resistance patterns of this cohort and present longitudinal data on virological suppression rates. Results: Between August 2013 and July 2014, 144 patients were approved for third-line ART. Median age was 41 years [interquartile range (IQR): 19–47]; 60% were women (N = 85). Median CD4+ count and viral load were 172 (IQR: 128–351) and 14,759 (IQR: 314–90,378), respectively. About 2.8% started PI-based ART before 2004; 11.1% from 2004 to 2007; 31.3% from 2008 to 2011; and 6.3% from 2012 to 2014 (48.6% unknown start date). Of the 144 patients, 97% and 98% had resistance to lopinavir and atazanavir, respectively; 57% had resistance to darunavir. All were initiated on a regimen containing darunavir, with raltegravir in 101, and etravirine in 33. Among those with at least 1 viral load at least 6 months after third-line approval (n = 118), a large proportion (83%, n = 98) suppressed to <1000 copies per milliliter, and 79% (n = 93) to <400 copies per milliliter. Conclusion: A high proportion of third-line patients with follow-up viral loads are virologically suppressed. [ABSTRACT FROM AUTHOR]
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- 2019
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210. Community-based management of a five-arm randomised clinical trial in COVID-19 outpatients in South Africa: challenges and opportunities.
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Chandiwana, Nomathemba, Kruger, Chelsea, Richardson, Naomi, Nxumalo, Sibongiseni, Mashilo, Nkoleleng, Dineka, Yengiwe, Mudau, Ntanganedzeni, Johnstone, Hilary, Kim, Wookyung, Ju, Chung, Arbe-Barnes, Sarah, Marrast, Anne Claire, Flynn, Julia, and Venter, Willem D. Francois
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COVID-19 pandemic , *CLINICAL trials , *COVID-19 , *COMMUNITY health workers , *LABOR demand - Abstract
Background: Repeated COVID-19 waves and corresponding mitigation measures have impacted health systems globally with exceptional challenges. In response to the pandemic, researchers, regulators, and funders rapidly pivoted to COVID-19 research activities. However, many clinical drug studies were not completed, due to often complex and rapidly evolving research conditions. Methods: We outline our experience of planning and managing a randomised, adaptive, open-label, phase 2 clinical trial to evaluate the safety and efficacy of four repurposed drug regimens versus standard-of-care (SOC) in outpatients with 'mild to moderate' COVID-19 in Johannesburg, South Africa, in the context of a partnership with multiple stakeholders. The study was conducted between 3 September 2020 and 23 August 2021 during changing COVID-19 restrictions, significant morbidity and mortality waves, and allied supply line, economic, and political instability. Results: Our clinical study design was pragmatic, including low-risk patients who were treated open label. There was built-in flexibility, including provision for some sample size adjustment and a range of secondary efficacy outcomes. Barriers to recruitment included the timing of waves, staff shortages due to illness, late presentation of patients, COVID-19 misinformation, and political unrest. Mitigations were the use of community health workers, deployment of mobile clinical units, and simplification of screening. Trial management required a radical reorganisation of logistics and processes to accommodate COVID-19 restrictions. These included the delivery of staff training and monitoring remotely, electronic consent, patient training and support to collect samples and report data at home, and the introduction of tele-medicine. These measures were successful for data collection, safe, and well received by patients. Conclusion: Completing a COVID-19 trial in outpatients during the height of the pandemic required multiple innovations in nearly every aspect of clinical trial management, a high commitment level from study staff and patients, and support from study sponsors. Our experience has generated a more robust clinical research infrastructure, building in efficiencies to clinical trial management beyond the pandemic. [ABSTRACT FROM AUTHOR]
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- 2023
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211. Socio-demographic Characteristics of Female Sex Worker's in the Inner-city Johannesburg Hillbrow.
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Sibanyoni, Jabhile Maria, Mutanha, Nyaradzo, Motsamai, Petros Jacob, and Venter, Willem D. Francois
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An abstract of the article "Socio-demographic Characteristics of Female Sex Worker's in the Inner-city Johannesburg Hillbrow" by Kathryn T. Mngadi, Nomzamo Mvandaba, Nonhlanhla Langa and colleagues is presented.
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- 2014
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212. Population pharmacokinetics of tenofovir given as either tenofovir disoproxil fumarate or tenofovir alafenamide in an African population.
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Kawuma, Aida N., Wasmann, Roeland E., Sinxadi, Phumla, Sokhela, Simiso M., Chandiwana, Nomathemba, Venter, Willem D. F., Wiesner, Lubbe, Maartens, Gary, and Denti, Paolo
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AFRICANS , *SOUTH Africans , *PHARMACOKINETICS , *TENOFOVIR , *NEPHROTOXICOLOGY - Abstract
Tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF) are prodrugs of the nucleotide analogue tenofovir, which acts intracellularly to inhibit HIV replication. Whereas TDF converts to tenofovir in plasma and may cause kidney and bone toxicity, TAF mostly converts to tenofovir intracellularly, so it can be administered at lower doses. TAF leads to lower tenofovir plasma concentrations and lower toxicity, but there are limited data on its use in Africa. We used data from 41 South African adults living with HIV from the ADVANCE trial and described, with a joint model, the population pharmacokinetics of tenofovir given as TAF or TDF. The TDF was modeled to appear in plasma as tenofovir with a simple first‐order process. Instead, two parallel pathways were used for a TAF dose: an estimated 32.4% quickly appeared as tenofovir into the systemic circulation with first‐order absorption, whereas the rest was sequestered intracellularly and released into the systemic circulation as tenofovir slowly. Once in plasma (from either TAF or TDF), tenofovir disposition followed two‐compartment kinetics and had a clearance of 44.7 L/h (40.2–49.5), for a typical 70‐kg individual. This semimechanistic model describes the population pharmacokinetics of tenofovir when dosed as either TDF or TAF in an African population living with HIV and can be used as a tool for exposure prediction in patients, and to simulate alternative regimes to inform further clinical trials. [ABSTRACT FROM AUTHOR]
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- 2023
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213. Weight and Metabolic Changes After Switching From Tenofovir Alafenamide/Emtricitabine (FTC)+Dolutegravir (DTG), Tenofovir Disoproxil Fumarate (TDF)/FTC + DTG, and TDF/FTC/Efavirenz to TDF/Lamivudine/DTG.
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Bosch, Bronwyn, Akpomiemie, Godspower, Chandiwana, Nomathemba, Sokhela, Simiso, Hill, Andrew, McCann, Kaitlyn, Qavi, Ambar, Mirchandani, Manya, and Venter, Willem Daniel Francois
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LIPID analysis , *ENERGY metabolism , *HIV infections , *GLYCOSYLATED hemoglobin , *BLOOD pressure , *BODY weight , *COMBINATION drug therapy , *GENERIC drug substitution , *TENOFOVIR , *DESCRIPTIVE statistics , *HIGH density lipoproteins , *BODY mass index , *STATISTICAL sampling , *EMTRICITABINE - Abstract
Participants randomized to first-line tenofovir alafenamide (TAF)/emtricitabine (FTC)+dolutegravir (DTG), tenofovir disoproxil fumarate (TDF)/FTC + DTG, or TDF/FTC/efavirenz (EFV) for 192 weeks were then switched to TDF/lamivudine (3TC)/DTG for 52 weeks. Participants switching either TAF/FTC + DTG or TDF/FTC/EFV to TDF/3TC/DTG showed statistically significant reductions in weight, low-density lipoprotein, triglycerides, glucose and glycated hemoglobin. [ABSTRACT FROM AUTHOR]
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- 2023
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214. Impact and cost‐effectiveness of the national scale‐up of HIV pre‐exposure prophylaxis among female sex workers in South Africa: a modelling analysis.
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Stone, Jack, Bothma, Rutendo, Gomez, Gabriela B., Eakle, Robyn, Mukandavire, Christinah, Subedar, Hasina, Fraser, Hannah, Boily, Marie‐Claude, Schwartz, Sheree, Coetzee, Jenny, Otwombe, Kennedy, Milovanovic, Minja, Baral, Stefan, Johnson, Leigh F., Venter, Willem Daniel Francois, Rees, Helen, and Vickerman, Peter
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PRE-exposure prophylaxis , *SEX workers , *MEDICAL personnel , *HIV infection transmission , *COST effectiveness , *HIV infections - Abstract
Introduction: In 2016, South Africa (SA) initiated a national programme to scale‐up pre‐exposure prophylaxis (PrEP) among female sex workers (FSWs), with ∼20,000 PrEP initiations among FSWs (∼14% of FSW) by 2020. We evaluated the impact and cost‐effectiveness of this programme, including future scale‐up scenarios and the potential detrimental impact of the COVID‐19 pandemic. Methods: A compartmental HIV transmission model for SA was adapted to include PrEP. Using estimates on self‐reported PrEP adherence from a national study of FSW (67.7%) and the Treatment and Prevention for FSWs (TAPS) PrEP demonstration study in SA (80.8%), we down‐adjusted TAPS estimates for the proportion of FSWs with detectable drug levels (adjusted range: 38.0–70.4%). The model stratified FSW by low (undetectable drug; 0% efficacy) and high adherence (detectable drug; 79.9%; 95% CI: 67.2–87.6% efficacy). FSWs can transition between adherence levels, with lower loss‐to‐follow‐up among highly adherent FSWs (aHR: 0.58; 95% CI: 0.40–0.85; TAPS data). The model was calibrated to monthly data on the national scale‐up of PrEP among FSWs over 2016–2020, including reductions in PrEP initiations during 2020. The model projected the impact of the current programme (2016–2020) and the future impact (2021–2040) at current coverage or if initiation and/or retention are doubled. Using published cost data, we assessed the cost‐effectiveness (healthcare provider perspective; 3% discount rate; time horizon 2016–2040) of the current PrEP provision. Results: Calibrated to national data, model projections suggest that 2.1% of HIV‐negative FSWs were currently on PrEP in 2020, with PrEP preventing 0.45% (95% credibility interval, 0.35–0.57%) of HIV infections among FSWs over 2016–2020 or 605 (444–840) infections overall. Reductions in PrEP initiations in 2020 possibly reduced infections averted by 18.57% (13.99–23.29). PrEP is cost‐saving, with $1.42 (1.03–1.99) of ART costs saved per dollar spent on PrEP. Going forward, existing coverage of PrEP will avert 5,635 (3,572–9,036) infections by 2040. However, if PrEP initiation and retention doubles, then PrEP coverage increases to 9.9% (8.7–11.6%) and impact increases 4.3 times with 24,114 (15,308–38,107) infections averted by 2040. Conclusions: Our findings advocate for the expansion of PrEP to FSWs throughout SA to maximize its impact. This should include strategies to optimize retention and should target women in contact with FSW services. [ABSTRACT FROM AUTHOR]
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- 2023
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215. Point-of-Care Tenofovir Urine Testing for the Prediction of Treatment Failure and Drug Resistance During Initial Treatment for Human Immunodeficiency Virus Type 1 (HIV-1) Infection.
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Hermans, Lucas E, Umunnakwe, Chijioke N, Lalla-Edward, Samanta T, Hebel, Shane K, Tempelman, Hugo A, Nijhuis, Monique, Venter, Willem D F, and Wensing, Annemarie M J
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HIV infections , *ANTI-HIV agents , *EFAVIRENZ , *CONFIDENCE intervals , *SEQUENCE analysis , *POINT-of-care testing , *TENOFOVIR , *DRUG resistance , *ANTIRETROVIRAL agents , *CASE-control method , *TREATMENT failure , *PRE-exposure prophylaxis , *RESEARCH funding , *URINALYSIS , *PREDICTION models , *SENSITIVITY & specificity (Statistics) , *ODDS ratio , *EMTRICITABINE - Abstract
Background Viral rebound during antiretroviral treatment (ART) is most often driven by suboptimal adherence in the absence of drug resistance. We assessed the diagnostic performance of point-of-care (POC) tenofovir (TFV) detection in urine for the prediction of viral rebound and drug resistance during ART. Methods We performed a nested case-control study within the ADVANCE randomized clinical trial (NCT03122262) in Johannesburg, South Africa. Adults with human immunodeficiency virus (HIV) and newly initiating ART were randomized to receive either dolutegravir or efavirenz, tenofovir disoproxil fumarate or alafenamide, and emtricitabine. All participants with rebound ≥200 copies/mL between 24 and 96 weeks of follow-up were selected as cases and matched to controls with virological suppression <50 copies/mL. Rapid POC urine-TFV detection was performed retrospectively. Results We included 281 samples from 198 participants. Urine-TFV was detectable in 30.7% (70/228) of cases and in 100% (53/53) of controls. Undetectable urine-TFV predicted rebound with a sensitivity of 69% [95% confidence interval {CI}: 63–75] and specificity of 100% [93–100]. In cases with virological failure and sequencing data (n = 42), NRTI drug resistance was detected in 50% (10/20) of cases with detectable urine-TFV versus in 8.3% (2/24) of cases with undetectable urine-TFV. Detectable urine-TFV predicted NRTI resistance (odds ratio [OR] 10.4 [1.8–114.4] P =.005) with a sensitivity of 83% [52–98] and specificity of 69% [50–84]. Conclusions POC objective adherence testing using a urine-TFV test predicted viral rebound with high specificity. In participants with rebound, urine-TFV testing predicted the selection of drug resistance. Objective adherence testing may be used to rapidly provide insight into adherence, suppression, and drug resistance during ART. [ABSTRACT FROM AUTHOR]
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- 2023
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216. From Evidence to Effectiveness: Implications of the Randomized Trial to Prevent Vascular Events in HIV Study for People With HIV in Low- and Middle-Income Settings.
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Manne-Goehler, Jennifer, Ali, Mohammed K, Flood, David, Marconi, Vincent C, Venter, Willem D F, and Siedner, Mark J
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POLITICAL psychology , *DIABETES risk factors , *CARDIOVASCULAR disease prevention , *MIDDLE-income countries , *RISK assessment , *ANTILIPEMIC agents , *EVIDENCE gaps , *PREDICTION models , *HIV-positive persons , *MEDICAL care , *CARDIOVASCULAR diseases risk factors , *STATINS (Cardiovascular agents) , *PUBLIC health , *LOW-income countries , *OBESITY - Abstract
The Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) study found a 35% reduction in major adverse cardiovascular events for people with human immunodeficiency virus who received daily pitavastatin. However, how this evidence will change practice is far from certain. Here, we outline evidence gaps and political and healthcare delivery challenges that will need to be addressed for REPRIEVE to offer public health benefits in low- and middle-income countries. [ABSTRACT FROM AUTHOR]
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- 2024
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217. Roadmap for Achieving Universal Antiretroviral Treatment.
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Sokhela, Simiso, Lalla-Edward, Samanta, Siedner, Mark J., Majam, Mohammed, and Venter, Willem Daniel Francois
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AIDS prevention , *DIAGNOSIS of HIV infections , *HIV prevention , *HIV infections , *HEALTH services accessibility , *ANTIRETROVIRAL agents , *UNIVERSAL healthcare , *WORLD health , *DRUG development - Abstract
Modern antiretroviral therapy safely, potently, and durably suppresses human immunodeficiency virus (HIV) that, if left untreated, predictably causes acquired immunodeficiency syndrome (AIDS), which has been responsible for tens of millions of deaths globally since it was described in 1981. In one of the most extraordinary medical success stories in modern times, a combination of pioneering basic science, innovative drug development, and ambitious public health programming resulted in access to lifesaving, safe drugs, taken as an oral tablet daily, for most of the world. However, substantial challenges remain in the fields of prevention, timely access to diagnosis, and treatment, especially in pediatric and adolescent patients. As HIV-positive adults age, treating their comorbidities will require understanding the course of different chronic diseases complicated by HIV-related and antiretroviral toxicities and finding potential treatments. Finally, new long-acting antiretrovirals on the horizon promise exciting new options in both the prevention and treatment fields. [ABSTRACT FROM AUTHOR]
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- 2023
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218. Comparing Prospective Incident Severe Acute Respiratory Syndrome Coronavirus 2 Infection Rates During Successive Waves of Delta and Omicron in Johannesburg, South Africa.
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Sokhela, Simiso, Bosch, Bronwyn, Hill, Andrew, Simmons, Bryony, Woods, Joana, Johnstone, Hilary, Madhi, Shabir, Qavi, Ambar, Ellis, Leah, Akpomiemie, Godspower, Bhaskar, Esther, Levi, Jacob, Falconer, Jonathan, Mirchandani, Manya, Casas, Carmen Perez, Moller, Karlien, Pilkington, Victoria, Pepperrell, Toby, and Venter, Willem Daniel Francois
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COVID-19 , *SARS-CoV-2 , *SARS-CoV-2 Omicron variant - Abstract
In high-risk individuals in Johannesburg, during the Delta coronavirus disease 2019 wave, 22% (125/561) were positive, with 33% symptomatic (2 hospitalizations; 1 death). During Omicron, 56% (232/411) were infected, with 24% symptomatic (no hospitalizations or deaths). The remarkable speed of infection of Omicron over Delta poses challenges to conventional severe acute respiratory syndrome coronavirus 2 control measures. [ABSTRACT FROM AUTHOR]
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- 2022
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219. Randomized clinical trial of nitazoxanide or sofosbuvir/daclatasvir for the prevention of SARS-CoV-2 infection.
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Sokhela, Simiso, Bosch, Bronwyn, Hill, Andrew, Simmons, Bryony, Woods, Joana, Johnstone, Hilary, Akpomiemie, Godspower, Ellis, Leah, Owen, Andrew, Casas, Carmen Perez, and Venter, Willem Daniel Francois
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Background: The COVER trial evaluated whether nitazoxanide or sofosbuvir/daclatasvir could lower the risk of SARS-CoV-2 infection. Nitazoxanide was selected given its favourable pharmacokinetics and in vitro antiviral effects against SARS-CoV-2. Sofosbuvir/daclatasvir had shown favourable results in early clinical trials.Methods: In this clinical trial in Johannesburg, South Africa, healthcare workers and others at high risk of infection were randomized to 24 weeks of either nitazoxanide or sofosbuvir/daclatasvir as prevention, or standard prevention advice only. Participants were evaluated every 4 weeks for COVID-19 symptoms and had antibody and PCR testing. The primary endpoint was positive SARS-CoV-2 PCR and/or serology ≥7 days after randomization, regardless of symptoms. A Poisson regression model was used to estimate the incidence rate ratios of confirmed SARS-CoV-2 between each experimental arm and control.Results: Between December 2020 and January 2022, 828 participants were enrolled. COVID-19 infections were confirmed in 100 participants on nitazoxanide (2234 per 1000 person-years; 95% CI 1837-2718), 87 on sofosbuvir/daclatasvir (2125 per 1000 person-years; 95% CI 1722-2622) and 111 in the control arm (1849 per 1000 person-years; 95% CI 1535-2227). There were no significant differences in the primary endpoint between the treatment arms, and the results met the criteria for futility. In the safety analysis, the frequency of grade 3 or 4 adverse events was low and similar across arms.Conclusions: In this randomized trial, nitazoxanide and sofosbuvir/daclatasvir had no significant preventative effect on infection with SARS-CoV-2 among healthcare workers and others at high risk of infection. [ABSTRACT FROM AUTHOR]- Published
- 2022
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220. Comparative performance of cardiovascular risk prediction models in people living with HIV.
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Tahir, Irtiza S., Vos, Alinda G., Damen, Johanna A. A., Barth, Roos E., Tempelman, Hugo A., Grobbee, Diederick E., Scheuermaier, Karine, Venter, Willem D. F., and Klipstein-Grobusch, Kerstin
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HIV-positive persons , *CARDIOVASCULAR diseases risk factors , *PREDICTION models , *DISEASE risk factors , *AFRICANS - Abstract
Background: Current cardiovascular risk assessment in people living with HIV is based on general risk assessment tools; however, whether these tools can be applied in sub-Saharan African populations has been questioned. Objectives: The study aimed to assess cardiovascular risk classification of common cardiovascular disease (CVD) risk prediction models compared to the Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) 2010 and 2016 models in people living with HIV. Method: Cardiovascular disease risk was estimated by Framingham Cardiovascular and Heart Disease (FHS-CVD, FHS-CHD), Atherosclerotic Cardiovascular Disease (ASCVD) and D:A:D 2010 and 2016 risk prediction models for HIV-infected participants of the Ndlovu Cohort Study, Limpopo, rural South Africa. Participants were classified to be at low (< 10%), moderate (10% – 20%), or high-risk (> 20%) of CVD within 10 years for general CVD and five years for D:A:D models. Kappa statistics were used to determine agreement between CVD risk prediction models. Subgroup analysis was performed according to age. Results: The analysis comprised 735 HIV-infected individuals, predominantly women (56.7%), average age 43.9 (8.8) years. The median predicted CVD risk for D:A:D 2010 and FHS-CVD was 4% and for ASCVD and FHS-CHD models, 3%. For the D:A:D 2016 risk prediction model, the figure was 5%. High 10-year CVD risk was predicted for 2.9%, 0.5%, 0.7%, 3.1% and 6.6% of the study participants by FHS-CVD, FHS-CHD, ASCVD, and D:A:D 2010 and 2016. Kappa statistics ranged from 0.34 for ASCVD to 0.60 for FHS-CVD as compared to the D:A:D 2010 risk prediction model. Conclusion: Overall, predicted CVD risk is low in this population. Compared to D:A:D 2010, CVD risk estimated by the FHS-CVD model showed similar overall results for risk classification. With the exception of the D:A:D model, all other risk prediction models classified fewer people to be at high estimated CVD risk. Prospective studies are needed to develop and validate CVD risk algorithms in people living with HIV in sub-Saharan Africa. [ABSTRACT FROM AUTHOR]
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- 2022
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221. The influence of smoking and HIV infection on pulmonary function.
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Sussenbach, Annelotte E., van Gijzel, Sjors W. L., Lalla-Edward, Samanta T., Venter, Willem D. F., Shaddock, Erica, Feldman, Charles, Klipstein-Grobusch, Kerstin, and Vos, Alinda G.
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HIV infections , *LUNG infections , *FORCED expiratory volume , *VITAL capacity (Respiration) , *HIV status - Abstract
Background: Prevalence of HIV, smoking, and pulmonary infections in South Africa are high. Objectives: We investigated the role of smoking and HIV status on lung function. Methods: This is a secondary analysis of a cross-sectional study conducted in South Africa. Data included demographics, pulmonary risk factors and a spirometry test to obtain the forced expiratory volume in one second (FEV1) and the ratio of FEV1/forced vital capacity (FVC). In the initial multivariable regression analysis, the effect of smoking on pulmonary function in HIV-positive adults was assessed. The analysis was repeated, assessing the influence of HIV status on lung function in both HIV-negative and HIV-positive smokers. The models were adjusted for age, sex, body mass index (BMI), time since HIV diagnosis, antiretroviral treatment (ART) use, occupational hazards, history of tuberculosis or pneumonia, indoor smoking and the presence of an indoor fireplace during childhood. Results: This study included 524 people living with HIV (PLWH, 66.7% female, mean age 40.9 years [s.d.; 9.4]) and 79 HIV-negative smokers (77.2% male, mean age 34.4 years [s.d.: 12.1]). Of the PLWH, 118 (22.5%) were past or current smokers and 406 (77.5%) were non-smokers. Smoking was not associated with changes in the FEV1 or FEV1/FVC ratio in multivariable regression analysis. In the second analysis, HIV status was also not associated with reduced pulmonary function following adjustment for confounders. Conclusion: Neither smoking nor being HIV-positive was associated with decreased pulmonary function in this relatively young population. These findings should be confirmed in a longitudinal study, including an older population. [ABSTRACT FROM AUTHOR]
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- 2022
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222. Genetic Associations with Weight Gain among South Africans who Initiated Dolutegravir-Containing and Tenofovir-Containing Regimens.
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Cindi, Zinhle, Maartens, Gary, Bradford, Yuki, Venter, Willem D. F., Sokhela, Simiso, Chandiwana, Nomathemba C., Haas, David W., and Sinxadi, Phumla
- Abstract
Background: Excessive weight gain affects some HIV-positive individuals prescribed dolutegravir-containing regimens. Mechanisms underlying such weight gain are unknown. Setting: Data and DNA from antiretroviral therapy-naïve participants who were randomized to initiate dolutegravir with emtricitabine plus either tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF) in the ADVANCE study (NCT03122262) were used to characterize associations between human genetic polymorphisms and magnitude of weight gain. Methods: Associations with percent weight gain from baseline to week 48 were assessed using multivariable linear regression models. Primary analyses a priori considered 59 polymorphisms and 10 genes of potential relevance to dolutegravir, TAF, or TDF pharmacokinetics. We also explored genome-wide associations. Results: Among the 314 (92%) of 340 dolutegravir recipients who were successfully genotyped, 160 (47%) and 154 (45%) were randomized to TAF/emtricitabine and TDF/emtricitabine, respectively. In target gene analyses, the lowest P-values for the dolutegravir and tenofovir groups were ABCG2 rs4148149 (P = 7.0 · 1024) and ABCC10 rs67861980 (P = 1.0 · 1022), respectively, which were not significant after correction for multiple testing. In genome-wide analyses, the lowest P-values were rs7590091 in TMEM163 (P = 3.7 · 1028) for dolutegravir, rs17137701 in LOC105379130 (P = 6.4 · 1028) for TAF, and rs76771105 in LOC105371716 (P = 9.7 · 1028) for TDF. Conclusions: Among South African participants in a randomized clinical trial of dolutegravir plus either TAF/emtricitabine or TDF/emtricitabine, we identified several potential genetic associations with weight gain. Only TMEM163 rs7590091 withstood correction for multiple testing. These associations warrant replication in other cohorts. [ABSTRACT FROM AUTHOR]
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- 2021
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223. Is there a role for doravirine in African HIV treatment programmes? A large observational resistance study in South Africa.
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Steegen, Kim, Moorhouse, Michelle, Wensing, Annemarie MJ, Venter, Willem DF, and Hans, Lucia
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ANTIRETROVIRAL agents , *TREATMENT effectiveness , *GENOTYPES , *HIV , *MIDDLE-income countries - Abstract
Introduction: Dolutegravir has replaced efavirenz in most low‐ and middle‐income countries, due to better tolerability and formidable resistance profile, but dolutegravir side effects suggest alternatives are needed. We evaluated doravirine resistance in South Africa as a first step to assess whether doravirine may replace dolutegravir. Methods: A retrospective dataset was analysed for predicted doravirine susceptibility, including sequences obtained from three patient groups. First, data from 277 patients initiating antiretroviral treatment (ART) were collected between February 2013 and October 2014 as part of a national survey. Second, data from 788 patients experiencing NNRTI‐based ART failure were obtained between February 2013 and October 2014 as part of a national survey. Third, data derived from 584 patients who had genotypic drug resistance testing requested after NNRT‐based failure as part of individual patient management between January 2016 and December 2019. Pol sequences were generated using validated population‐based in‐house genotyping and submitted to Stanford HIVdb v8.9. Results and discussion: Less than 5% of patients initiating ART presented with genotypic doravirine resistance, whereas most patients experiencing NNRTI‐based ART failure presented with predicted intermediate (41.0%) or high‐level resistance (43.8%) to doravirine. High‐level resistance to doravirine was commonly predicted by the presence of at least three DRMs (79.7%). The predicted resistance profile to doravirine in ART‐naïve patients is promising, but less so in those experiencing failure to first‐generation NNRTIs. Accumulation of NNRTI DRMs seems to be an important factor in the poor resistance prediction for doravirine. Conclusions: Although doravirine is approved as initial therapy in patients who are ART‐naïve, it is currently recommended to obtain a genotype prior to the initiation of ART. Clinical studies are needed to ascertain whether predicted resistance profiles in ART naïve and NNRTI‐treated patients translate into poor clinical outcomes, especially in settings where genotypic resistance testing is not available. [ABSTRACT FROM AUTHOR]
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- 2021
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224. Enhanced and Timely Investigation of ARVs for Use in Pregnant Women.
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Abrams, Elaine J., Mofenson, Lynne M., Pozniak, Anton, Lockman, Shahin, Colbers, Angela, Belew, Yodit, Clayden, Polly, Mirochnick, Mark, Siberry, George K., Ford, Nathan, Khoo, Saye, Renaud, Francoise, Vitoria, Marco, Venter, Willem D. F., Doherty, Meg, and Penazzato, Martina
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Background: Concerns have been voiced that the exclusion of pregnant women from clinical trials results in a lack of safety and pharmacokinetic data for antiretroviral drugs (ARVs) in pregnancy, creating clear risks to pregnant women living with HIV (PWLHIV), and their infants. Setting: The World Health Organization convened a Paediatric Antiretroviral Drug Optimization group meeting, December 10-12, 2018, in Geneva, Switzerland. Methods: The group, comprised of clinicians, scientists, HIV program managers, regulators, and community representatives, were tasked to consider how ARVs are studied in PWLHIV, define alternative approaches to studying ARVs in PWLHIV, identify ways to shorten the timeline to determine safe use of new agents during pregnancy, and define strategies to collaborate with regulators and industry to change longstanding practices. Results: Most new ARVs are not studied in pregnant populations until after drug licensure, primarily opportunistically among women who become pregnant while taking the ARV of interest. Acceleration of the timeline will require earlier completion of preclinical studies and a new paradigm, namely-under certain conditions-allow women who become pregnant while participating in phase III ARV studies the option of remaining on study and enroll pregnant women into phase III trials of new agents to obtain preliminary safety and dosing and efficacy data. Conclusion: A revision of the current approach to the study of antiretrovirals in pregnant women is urgently needed to improve timely access and safe use of new agents during pregnancy. [ABSTRACT FROM AUTHOR]
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- 2021
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225. Virological suppression and clinical management in response to viremia in South African HIV treatment program: A multicenter cohort study.
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Hermans, Lucas E., Carmona, Sergio, Nijhuis, Monique, Tempelman, Hugo A., Richman, Douglas D., Moorhouse, Michelle, Grobbee, Diederick E., Venter, Willem D. F., and Wensing, Annemarie M. J.
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TREATMENT programs , *PROPORTIONAL hazards models , *BK virus , *HIV infections , *COHORT analysis - Abstract
Background: Uptake of antiretroviral treatment (ART) is expanding rapidly in low- and middle-income countries (LMIC). Monitoring of virological suppression is recommended at 6 months of treatment and annually thereafter. In case of confirmed virological failure, a switch to second-line ART is indicated. There is a paucity of data on virological suppression and clinical management of patients experiencing viremia in clinical practice in LMIC. We report a large-scale multicenter assessment of virological suppression over time and management of viremia under programmatic conditions.Methods and Findings: Linked medical record and laboratory source data from adult patients on first-line ART at 52 South African centers between 1 January 2007 and 1 May 2018 were studied. Virological suppression, switch to second-line ART, death, and loss to follow-up were analyzed. Multistate models and Cox proportional hazard models were used to assess suppression over time and predictors of treatment outcomes. A total of 104,719 patients were included. Patients were predominantly female (67.6%). Median age was 35.7 years (interquartile range [IQR]: 29.9-43.0). In on-treatment analysis, suppression below 1,000 copies/mL was 89.0% at month 12 and 90.4% at month 72. Suppression below 50 copies/mL was 73.1% at month 12 and 77.5% at month 72. Intention-to-treat suppression was 75.0% and 64.3% below 1,000 and 50 copies/mL at month 72, respectively. Viremia occurred in 19.8% (20,766/104,719) of patients during a median follow-up of 152 (IQR: 61-265) weeks. Being male and below 35 years of age and having a CD4 count below 200 cells/μL prior to start of ART were risk factors for viremia. After detection of viremia, confirmatory testing took 29 weeks (IQR: 16-54). Viral resuppression to below 1,000 copies/mL without switch of ART occurred frequently (45.6%; 6,030/13,210) but was associated with renewed viral rebound and switch. Of patients with confirmed failure who remained in care, only 41.5% (1,872/4,510) were switched. The median time to switch was 68 weeks (IQR: 35-127), resulting in 12,325 person-years spent with a viral load above 1,000 copies/mL. Limitations of this study include potential missing data, which is in part addressed by the use of cross-matched laboratory source data, and the possibility of unmeasured confounding.Conclusions: In this study, 90% virological suppression below the threshold of 1,000 copies/mL was observed in on-treatment analysis. However, this target was not met at the 50-copies/mL threshold or in intention-to-treat analysis. Clinical management in response to viremia was profoundly delayed, prolonging the duration of viremia and potential for transmission. Diagnostic tools to establish the cause of viremia are urgently needed to accelerate clinical decision-making. [ABSTRACT FROM AUTHOR]- Published
- 2020
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226. Simplified clinical algorithm for identifying patients eligible for same-day HIV treatment initiation (SLATE): Results from an individually randomized trial in South Africa and Kenya.
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Rosen, Sydney, Maskew, Mhairi, Larson, Bruce A., Brennan, Alana T., Tsikhutsu, Isaac, Fox, Matthew P., Vezi, Lungisile, Bii, Margaret, and Venter, Willem D. F.
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MEDICAL protocols , *MEDICAL history taking , *VIRAL load , *HIV , *HIV-positive persons - Abstract
Background: The World Health Organization recommends "same-day" initiation of antiretroviral therapy (ART) for HIV patients who are eligible and ready. Identifying efficient, safe, and feasible procedures for determining same-day eligibility and readiness is now a priority. The Simplified Algorithm for Treatment Eligibility (SLATE) study evaluated a clinical algorithm that allows healthcare workers to determine eligibility for same-day treatment and to initiate ART at the patient's first clinic visit.Methods and Findings: SLATE was an individually randomized trial at three outpatient clinics in urban settlements in Johannesburg, South Africa and three hospital clinics in western Kenya. Adult, nonpregnant, HIV-positive, ambulatory patients presenting for any HIV care, including HIV testing, but not yet on ART were enrolled and randomized to the SLATE algorithm arm or standard care. The SLATE algorithm used four screening tools-a symptom self-report, medical history questionnaire, physical examination, and readiness assessment-to ascertain eligibility for same-day initiation or refer for further care. Follow-up was by record review, and analysis was conducted by country. We report primary outcomes of 1) ART initiation ≤28 days and 2) initiation ≤28 days and retention in care ≤8 months of enrollment. From March 7, 2017 to April 17, 2018, we enrolled 600 patients (median [IQR] age 34 [29-40] and CD4 count 286 [128-490]; 63% female) in South Africa and 477 patients in Kenya (median [IQR] age 35 [29-43] and CD4 count 283 [117-541]; 58% female). In the intervention arm, 78% of patients initiated ≤28 days in South Africa, compared to 68% in the standard arm (risk difference [RD] [95% confidence interval (CI)] 10% [3%-17%]); in Kenya, 94% of intervention-arm patients initiated ≤28 days compared to 89% in the standard arm (6% [0.5%-11%]). By 8 months in South Africa, 161/298 (54%) intervention-arm patients had initiated and were retained, compared to 146/302 (48%) in the standard arm (6% [(2% to 14%]). By 8 months in Kenya, the corresponding retention outcomes were identical in both arms (137/240 [57%] of intervention-arm patients and 136/237 [57%] of standard-arm patients). Limitations of the trial included limited geographic representativeness, exclusion of patients too ill to participate, missing viral load data, greater study fidelity to the algorithm than might be achieved in standard care, and secular changes in standard care over the course of the study.Conclusions: In South Africa, the SLATE algorithm increased uptake of ART within 28 days by 10% and showed a numerical increase (6%) in retention at 8 months. In Kenya, the algorithm increased uptake of ART within 28 days by 6% but found no difference in retention at 8 months. Eight-month retention was poor in both arms and both countries. These results suggest that a simple structured algorithm for same-day treatment initiation procedures is feasible and can increase and accelerate ART uptake but that early retention on treatment remains problematic.Trial Registration: Clinicaltrials.gov NCT02891135, registered September 1, 2016. First participant enrolled March 6, 2017 in South Africa and July 13, 2017 in Kenya. [ABSTRACT FROM AUTHOR]- Published
- 2019
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227. Who is seeking antiretroviral treatment for HIV now? Characteristics of patients presenting in Kenya and South Africa in 2017‐2018.
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Brennan, Alana T, Maskew, Mhairi, Larson, Bruce A, Tsikhutsu, Isaac, Bii, Margaret, Vezi, Lungisile, Fox, Matthew P, Venter, Willem DF, Ehrenkranz, Peter, and Rosen, Sydney
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HIV , *WEIGHT loss , *PUBLIC sector - Abstract
Introduction: Many African countries have had at least two years' experience with universal treatment eligibility for HIV. The literature contains few descriptions, though, of populations starting treatment since adoption of universal eligibility. Using baseline data from a clinical trial of same‐day ART initiation, we describe the populations presenting for HIV testing or care at study clinics in Kenya and South Africa in 2017‐18, during the era of same‐day initiation. Methods: The Simplified Algorithm for Treatment Eligibility (SLATE) trials in Kenya (SLATE I) and South Africa (SLATE II) were multicenter, non‐blinded, individually randomized, pragmatic trials evaluating simple, standardized algorithms to determine eligibility for same‐day initiation of ART without relying on laboratory results, point of care tests or multiple clinic visits. In Kenya, enrolment occurred during July 2017 to April 2018. In South Africa, enrolment occurred during March to September 2018. We describe demographic, socioeconomic and clinical characteristics of patients randomized to the same‐day initiation arm for both studies. Results and Discussion: A total of 240 and 296 participants were enrolled in Kenya and South Africa. The majority were female (59% and 64% respectively), with a median age of 35 years. In both countries, most subjects were newly diagnosed with HIV on the day of enrolment (62%, 55%), believed they already had adequate knowledge to begin ART (78%, 68%), and preferred to start ART immediately (same‐day) (98% in both countries). About 40% of all patients had at least one symptom related to tuberculosis (cough, fever, night sweats, weight loss) and/or cryptococcal meningitis (continuous headache). More than a third of patients (37%, 36%) presented with advanced disease (CD4 <200 cells/mm3), a fifth presented with very advanced disease (CD4 < 100), and approximately 1 in 20 presented with very advanced disease and were asymptomatic. Conclusions: Despite >2 years of universal eligibility for ART in Kenya and South Africa, in 2017‐2018 more than half of HIV‐positive patients presenting at public sector clinics were not yet aware of their status, and more than a third presented for care with advanced HIV disease. These proportions remain similar to those observed before the introduction of universal eligibility. [ABSTRACT FROM AUTHOR]
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- 2019
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228. Lipid levels, insulin resistance and cardiovascular risk over 96 weeks of antiretroviral therapy: a randomised controlled trial comparing low-dose stavudine and tenofovir.
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Vos, Alinda G., Chersich, Matthew F., Klipstein-Grobusch, Kerstin, Zuithoff, Peter, Moorhouse, Michelle A., Lalla-Edward, Samanta T., Kambugu, Andrew, Kumarasamy, N., Grobbee, Diederick E., Barth, Roos E., and Venter, Willem D.
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COMBINATION drug therapy , *HIV infections , *ANTIRETROVIRAL agents , *LIPIDS , *INSULIN resistance , *CARDIOVASCULAR diseases risk factors , *STAVUDINE , *TENOFOVIR - Abstract
Background: HIV infection and antiretroviral treatment are associated with changes in lipid levels, insulin resistance and risk of cardiovascular disease (CVD). We investigated these changes in the first 96 weeks of treatment with low-dose stavudine or tenofovir regimens. Methods: This is a secondary analysis of a double blind, randomised controlled trial performed in South-Africa, Uganda and India comparing low-dose stavudine (20 mg twice daily) with tenofovir in combination with efavirenz and lamivudine in antiretroviral-naïve adults (n = 1067) (Clinicaltrials.gov, NCT02670772). Over 96 weeks, data were collected on fasting lipids, glucose and insulin. Insulin resistance was assessed with the HOMA-IR index and 10-year CVD risk with the Framingham risk score (FRS). A generalized linear mixed model was used to estimate trends over time. Results: Participants were on average 35.3 years old, 57.6% female and 91.8% Black African. All lipid levels increased following treatment initiation, with the sharpest increase in the first 24 weeks of treatment. The increase in all lipid subcomponents over 96 weeks was higher among those in the stavudine than the tenofovir group. Insulin resistance increased steadily with no difference detected between study groups. FRS rose from 1.90% (1.84–1.98%) at baseline to 2.06 (1.98–2.15%) at week 96 for the total group, with no difference between treatment arms (p = 0.144). Lipid changes were more marked in Indian than African participants. Conclusion: Lipid levels increased in both groups, with low-dose stavudine resulting in a worse lipid profile compared to tenofovir. Insulin resistance increased, with no difference between regimens. CVD risk increased over time and tended to increase more in the group on stavudine. The low CVD risk across both arms argues against routine lipid and glucose monitoring in the absence of other CVD risk factors. In high risk patients, monitoring may only be appropriate at least a year after treatment initiation. [ABSTRACT FROM AUTHOR]
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- 2018
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229. Effect of HIV-1 low-level viraemia during antiretroviral therapy on treatment outcomes in WHO-guided South African treatment programmes: a multicentre cohort study.
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Hermans, Lucas E, Moorhouse, Michelle, Carmona, Sergio, Grobbee, Diederick E, Hofstra, L Marije, Richman, Douglas D, Tempelman, Hugo A, Venter, Willem D F, and Wensing, Annemarie M J
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ANTIRETROVIRAL agents , *HIV infections , *THERAPEUTICS , *VIREMIA , *VIRAL replication , *COHORT analysis , *COMPARATIVE studies , *HIV , *LONGITUDINAL method , *RESEARCH methodology , *MEDICAL cooperation , *RESEARCH , *VIRAL load , *EVALUATION research , *HIGHLY active antiretroviral therapy , *TREATMENT effectiveness , *DISEASE incidence - Abstract
Background: Antiretroviral therapy (ART) that enables suppression of HIV replication has been successfully rolled out at large scale to HIV-positive patients in low-income and middle-income countries. WHO guidelines for these regions define failure of ART with a lenient threshold of viraemia (HIV RNA viral load ≥1000 copies per mL). We investigated the occurrence of detectable viraemia during ART below this threshold and its effect on treatment outcomes in a large South African cohort.Methods: In this observational cohort study, we included HIV-positive adults registered between Jan 1, 2007, and May 1, 2016, at 57 clinical sites in South Africa, who were receiving WHO-recommended ART regimens and viral load monitoring. Low-level viraemia was defined as the occurrence of at least one viral load measurement of 51-999 copies per mL during ART. Outcomes were WHO-defined virological failure (one or more viral load measurement of ≥1000 copies per mL) and switch to second-line ART. Risks were estimated with Cox proportional hazard models.Findings: 70 930 patients were included in the analysis, of whom 67 644 received first-line ART, 1476 received second-line ART, and 1810 received both. Median duration of follow-up was 124 weeks (IQR 56-221) for patients on first-line ART and 101 weeks (IQR 51-178) for patients on second-line ART. Low-level viraemia occurred in 16 013 (23%) of 69 454 patients, with an incidence of 11·5 per 100 person-years of follow-up (95% CI 11·4-11·7), during first-line ART. Virological failure during follow-up occurred in 14 380 (22%) of 69 454 patients on first-line ART. Low-level viraemia was associated with increased hazards of virological failure (hazard ratio [HR] 2·6, 95% CI 2·5-2·8; p<0·0001) and switch to second-line ART (HR 5·2, 4·4-6·1; p<0·0001]) compared with virological suppression of less than 50 copies per mL. Risk of virological failure increased further with higher ranges and persistence of low-level viraemia.Interpretation: In this large cohort, low-level viraemia occurred frequently and increased the risk of virological failure and switch to second-line ART. Strategies for management of low-level viraemia need to be incorporated into WHO guidelines to meet UNAIDS-defined targets aimed at halting the global HIV epidemic.Funding: None. [ABSTRACT FROM AUTHOR]- Published
- 2018
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230. Landskap as ervaarskap in die Site_Specific International Land Art Biennale (2011) – ʼn fenomenologiese benadering
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Van Rensburg, A.W., Venter, W.P., Goosen, M., 13061127 - Venter, Willem Pretorius (Supervisor), and 20216483 - Goosen, Moya (Supervisor)
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landskap-fenomenologie ,Site_Specific International Land Art Biennale (2011) ,ervaarskap ,landskap ,Merleau-Ponty ,enomenologie ,ervaring ,plek-spesifieke kuns ,kunstenaarsliggaam ,Agentskap ,wese-in-die-wêreld - Abstract
MA (Kunsgeskiedenis), North-West University, Potchefstroom Campus In hierdie verhandeling word die interaksie tussen kunstenaarsliggaam en die landskap as ervaarskap, tydens die skep van plekspesifieke landkuns, vanuit ’n fenomenologiese raamwerk ondersoek. Dit word gedoen aan die hand van geselekteerde landkunswerke in die Site_Specific International Land Art Biennale (2011). Die problematiek van die studie is geleë in die moontlike wisselwerking tussen die agentskap van die kunstenaarsliggaam en die landskap, wat ’n produktiewe spanning gedurende die proses van landkunsskepping moontlik maak. Die produktiewe spanning tussen die landskap en die kunstenaar is vir die doeleindes van die studie gesitueer in vyf landkunswerke, geskep deur die kunstenaars Andrew van der Merwe, Hannelie Coetzee, Gabriele Meneguzzi en Vincenzo Sponga, Angus Taylor en Strijdom van der Merwe. Die kunstenaars se liggaamlike agentskap in die landskap dien as ’n platform vir die ondersoek na mens-landskap interaksie, wat aansluit by navorsing oor landskap. Hierdie navorsing beklemtoon hoe die mens en landskap met mekaar vervleg is en nie van mekaar verwyderd is nie. ʼn Oorsig oor die mens-landskap interaksie tydens kunsskepping binne verskillende style dien as onderbou vir die kunstenaar se ervaring van, en interaksie met, die landskap. Myns insiens is daar nog nie genoegsaam ondersoek ingestel na die wyse waarop die landskap die kunstenaar beïnvloed tydens die skep van landkuns nie. Hierdie ondersoek word van stapel gestuur sodat die landskap se rol en agentskap tydens landkuns heroorweeg kan word en die dinamiese wisselwerking tussen die landskap en die kunstenaar verhelder. Die ervaring van die landskap, asook die agentskap van beide kunstenaarsliggaam en landskap, word ondersoek vanuit ’n fenomenologiese benadering tot agentskap. Daarom ondersoek hierdie studie die kunstenaar as ’n wese-in-die-wêreld en liggaam-subjek (soos geteoretiseer deur Merleau-Ponty), wat die landskap met die hele liggaam (deur middel van die sintuie) ervaar en hierdeur ook beïnvloedbaar is. Vanuit hierdie benadering word aangedui hoe die ervaring van die landskap ’n produktiewe spanning tussen agentskappe impliseer. Dié produktiewe spanning is geleë in die landskap se ervaarbaarheid (deur middel van die liggaam) daarom word die landskap eerder as ’n ervaarskap in hierdie studie gekontekstualiseer. Tydens die skep van landkuns skakel die liggaam van die kunstenaar direk met die ervaarskap en wanneer hierdie interaksie erken word, word die beskouing van twee wederkerige agente versterk – waar beide agente (liggaam en ervaarskap) deel het aan die skeppingsproses. Die ervaarskap se agentskap tydens landkuns is, onder andere, geleë in liggaamlike ervaarbaarheid, wat die besluite en aksies van die kunstenaar beïnvloed en ook die verloop van ’n landkunswerk affekteer. Die ervaarskap se rol in die skeppingsproses is, byvoorbeeld, te sien in die wyse waarop die see Coetzee se Familieportret omspoel, waarna sy dit weer herbou, net sodat dit weer omgespoel kan word. So ook in Strijdom van der Merwe se Circles washed up by the tide, waar die golwe sy agentskap beïnvloed en teëstaan, en sodoende die ervaarskap se rol in die landkunswerk duidelik maak. In hierdie konteks betwis die ervaarskap konnotasies van ’n suiwer visuele ver-beeld-ing, soos met landskapskildering, en bevorder dit die moontlikheid om die agentskap van die ervaarskap tydens die skep van landkuns te erken. Masters
- Published
- 2020
231. Corrigendum: The influence of HIV infection and antiretroviral treatment on pulmonary function in individuals in an urban setting in sub-Saharan Africa.
- Author
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van den Berg, Oda E., Shaddock, Erica J., Stacey, Sarah L., Feldman, Charles, Barth, Roos E., Grobbee, Diederick E., Venter, Willem D. F., Klipstein-Grobusch, Kerstin, and Vos, Alinda G.
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- *
HIV infections , *ANTIRETROVIRAL agents - Published
- 2022
- Full Text
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232. Power calculation accuracy as a function of wind data resolution
- Author
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Martinus Gerhardus De Klerk, W.C. Venter, 10063218 - Venter, Willem Christiaan, and 20555466 - De Klerk, Martinus Gerhardus
- Subjects
Engineering ,Polynomial ,General Computer Science ,020209 energy ,02 engineering and technology ,Turbine ,Statistics ,0202 electrical engineering, electronic engineering, information engineering ,Econometrics ,lcsh:TJ163.26-163.5 ,Representation (mathematics) ,Data resolution analysis ,lcsh:Environmental sciences ,Weibull distribution ,Statistical hypothesis testing ,lcsh:GE1-350 ,Wind power ,business.industry ,Function (mathematics) ,data resolution analysis ,wind power ,Power (physics) ,General Energy ,lcsh:Energy conservation ,Weibull ,business - Abstract
Wind power calculations are usually based on average wind data taken over one-hour intervals. The effect of the wind data resolution on the statistical techniques used to calculate the probable power output (PPO) is commonly overlooked. This effect is analysed in this paper by iteratively calculating and comparing the PPO of a wind turbine using data, averaged over different periods, obtained from Wind Association of South Africa. The power is calculated using both Weibull representation and direct polynomial substitution techniques in order to compare and verify the results. The results indicate a fairly linear relationship between the resolution used and the PPO error incurred. These results raise an interest to examine the effects of a fine resolution on the data in terms of data dependence, which may violate the criteria for the majority of statistical tests and procedures.
- Published
- 2017
233. SARS risk profile indicator model evaluation
- Author
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Theron, H.N., Venter, W.C., and 10063218 - Venter, Willem Christiaan (Supervisor)
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South African Revenue Service (SARS) ,Descriptive statistics ,South African Association of Freight Forwarders (SAAFF) ,Analyses ,Data visualizations ,Predictive modelling ,Customs risk models ,Web application ,Cross-border operations ,Customs procedures - Abstract
PhD (Computer and Electronic Engineering), North-West University, Potchefstroom Campus Managing trade efficiently and in a cost-effective manner can greatly benefit the economy of a country. In South Africa, customs processes lead to many unnecessary delays seemingly without any underlaying reason. This research report aims to show how this conclusion was made, along with a range of other statements about the efficiency and state of customs processing in this country. The first chapter gives some background information, as well as states the main problem to be addressed, namely developing an application that can analyse raw customs data provided by SAAFF in order to reach meaningful conclusions from the data. The objectives for the project as well as the methodology are discussed in detail. Furthermore, a literature study showing motivation for the research and background on the more important topics are provided. The conceptual design broadly explains the design phase for the complete project, including all of the functional units and a complete functional analysis of all the units and the interfaces. The detail design then zooms in on the unit responsible for creating the analyses and provides flowcharts to explain the design of the analyses. The next chapter provides results after the implementation of the design and evaluates the results in detail. There are two main categories for the analyses, namely the statistical and the modelling categories. The former uses descriptive statistics to process the data in a meaningful way and to ensure easy interpretation for users of the software. The results are displayed in the form of histograms. The second category, modelling, makes use of statistical principles to deliver ruling on the probability of future occurrences. This could be of great help to SAAFF members when making decisions about their trades and can help them make more informed decisions in regards to the commodities they trade. The last chapter draws conclusions about the results and gives further recommendations on how the project can be improved upon. The attached appendices give more detail about the statistical tables used as well as descriptions for some of the customs codes used in the analyses. The user manual for the software is also included, along with the source code and full digital archive. Masters
- Published
- 2019
234. Parameter analysis of the Jensen-Shannon divergence for shot boundary detection in streaming media applications
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M.G. De Klerk, W.C. Venter, A.J. Hoffman, 10063218 - Venter, Willem Christiaan, 10196978 - Hoffman, Alwyn Jakobus, and 20555466 - De Klerk, Martinus Gerhardus
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Boundary detection ,Computer science ,Shot (filmmaking) ,Video processing ,Jensen-Shannon Divergence ,Execution time ,Parameter analysis ,shot boundary detection ,Jensen–Shannon divergence ,threshold parameters ,Electrical and Electronic Engineering ,Precision and recall ,Divergence (statistics) ,Algorithm - Abstract
Shot boundary detection is an integral part of multimedia, be it video management or video processing. Multiple boundary detection techniques have been developed throughout the years, but are only applicable to very specific instances. The Jensen-Shannon divergence (JSD) is one such a technique that can be implemented to detect the shot boundaries in digital videos. This paper investigates the use of the JSD algorithm to detect shot boundaries in streaming media applications. Furthermore, the effects of the various parameters used by the JSD technique, on the accuracy of the detected boundaries, are quantified by the recall and precision metrics all the while keeping track of how they affect the execution time
- Published
- 2018
235. Optimisation of video detection algorithms for use in advertisement detection applications
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De Klerk, M.G., Venter, W.C., Prof, and 10063218 - Venter, Willem Christiaan (Supervisor)
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Jensen-Shannon divergence ,hash generation ,Video detection ,boundary detection ,video segmentation - Abstract
DPhil (Computer and Electronic Engineering), North-West University, Potchefstroom Campus The focus of this thesis is on the optimisation of the video detection process to detect advertisements in streaming digital media. While the process of video detection has been around for many years, it is very limited in its scope of application. These limitations pertain not only to the types of video, but in particular the execution time thereof. For a video detection technique to be effectively utilised in an advertisement detection environment, it must be able to perform real-time analysis. A proposed method was found in literature which addressed some of the core functionality required for such an application. This method was however still extremely limited with regard to its scope of application and devoid of scientific justification for the parameters used therein. The work presented in this thesis aim to address these limitations by not only expanding the scope of operation of the detection algorithm, but to provide scientific justification for the techniques and parameters utilised therein. One of these core components is the video segmentation algorithm, realised by employing the Jensen-Shannon divergence. While the Jensen-Shannon divergence is commonly seen as an information metric, it poses an uncanny ability to help detect video shot boundaries. By analysing the Jensen-Shannon divergence in this context, a profound insight into the technique and its associated parameters was derived. In doing so, a wider variety of videos can be detected with better accuracy and precision. Since the video segmentation aspect of the investigation provided a means to increase the speed by reliably reducing the data to be processed, the subsequent core module tasked with identifying the video was evaluated. The identification of an unknown video is done by extracting and comparing a unique, yet robust, digital video fingerprint against a known database. Due to the infinite variance in possible advertisements, a unique video fingerprinting algorithm was employed, consisting of unique hash descriptors derived from prominent keypoints found within each video. While each of these core modules have been individually optimised, the main contribution of this thesis is the integration of these modules to create a video detection ecosystem incorporating the unique underlying dependencies between these modules. Lastly, the optimisation of the integrated video detection ecosystem, provides a means of detecting a multitude of different videos, while adhering to the real-time processing requirements with scientific justification for the techniques and parameters employed to accomplish the task. Doctoral
- Published
- 2018
236. Raw coal ore classification using image segmentation methods
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Theunissen, M.W., Venter, W.C., Prof, and 10063218 - Venter, Willem Christiaan (Supervisor)
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Image segmentation ,Cluster analysis ,Machine learning ,Statistical classification - Abstract
MEng (Computer and Electronic Engineering), North-West University, Potchefstroom Campus The research done in order to complete this dissertation can be summarised as the investigation, implementation, analysis, and comparison of data analysis techniques with the intention to segment a digital image of a raw coal sample into its constituent materials. The goal is to obtain a per-pixel classification of the image with a sufficient level of accuracy, to be used to generate a viable washability curve. An extensive literature survey was done in order to investigate the current state of the applicable fields of image segmentation, data classification, clustering, and machine learning. The identified techniques that are both pertinent and suitable to the problem defined above were then implemented in a common development environment. In order to investigate, rate, and compare the techniques they were analysed using internal analysis techniques as well as compared to ground truth classifications obtained by expert geologists. The research is based on previous work [1], and the explicit goal is to improve an existing system of image classification. The existing system makes use of feature extraction and a clustering algorithm, called k-means, to identify similar groups of pixels and then assign them to model values that are selected by a user. The results of the research presented here makes use of a system using a similar high level topology with several alterations that were made to improve the accuracy of the image segmentation. The most prominent of these alterations is the use of a mean shift algorithm to "group" the pixels together and assign them to the models. This choice was, largely, made due to the higher level of spatial information about the image pixels that is incorporated in the mean shift algorithm. This is as opposed to the k-means algorithm that only makes use of range values. It was found that image segmentation techniques can, indeed, be used to achieve a sufficient level of accuracy towards raw coal ore classification under certain conditions. The success of each technique, and the constraints under which they achieve it, are identified and thoroughly motivated in this dissertation. The first half of the dissertation investigates the research problem, existing system, and possible alternatives in the literature. The second half presents the results of the research and discusses the knowledge obtained from it. Masters
- Published
- 2018
237. Application of data analytics to transport corridor diagnostics and performance benchmarking
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Alwyn J. Hoffman, W.C. Venter, 10063218 - Venter, Willem Christiaan, and 10196978 - Hoffman, Alwyn Jakobus
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Computer science ,ComputingMilieux_PERSONALCOMPUTING ,Efficiency ,02 engineering and technology ,Benchmarking ,010501 environmental sciences ,01 natural sciences ,Transport corridor ,Transport engineering ,Identification (information) ,Multinational corporation ,Multinational ,0202 electrical engineering, electronic engineering, information engineering ,Key (cryptography) ,020201 artificial intelligence & image processing ,Performance measurement ,Performance benchmarking ,0105 earth and related environmental sciences ,Block (data storage) - Abstract
Increase in exports is essential for economic growth in developing countries. In Southern Africa the development of effective multi-national trade corridors is the single biggest stumbling block to achieve this objective. Continuous performance measurement of all key trade corridor activities will facilitate the identification and elimination of bottle necks that currently restrict the free flow of trade. This article describes a methodology to implement continuous corridor performance measurement as necessary step to achieve the larger goal of improved corridor performance and hence increase in exports. It is described how performance benchmarks for road freight transport were established by leveraging data that is available from existing systems operated by corridor users. We also discuss the challenges to establish a permanent system of corridor performance measurement that will include not only physical cargo movements but also the detailed transactions to move cargo across national borders and through ports.
- Published
- 2017
238. Using visual texture analysis to classify raw coal components
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H. C. Dorland, P. Erasmus, W.C. Venter, Pieter A. Van Vuuren, M. I. Dorland, Q.P. Campbell, M. Le Roux, 10732926 - Van Vuuren, Pieter Andries, 10192247 - Campbell, Quentin Peter, 12413887 - Le Roux, Marco, and 10063218 - Venter, Willem Christiaan
- Subjects
Pixel ,business.industry ,Computer science ,Feature vector ,ComputingMethodologies_IMAGEPROCESSINGANDCOMPUTERVISION ,Coal ore classification ,ComputerApplications_COMPUTERSINOTHERSYSTEMS ,Pattern recognition ,Image processing ,Sample (graphics) ,Texture (geology) ,Image texture ,Pattern recognition (psychology) ,Coal ,Artificial intelligence ,business ,Visual texture - Abstract
Coal ore isn't a uniform material. In order to optimize the coal liberation process it is necessary to classify a coal ore sample into its constituent components as quickly and cheaply possible. This paper investigates whether it is feasible to employ image processing and pattern recognition to segment a photographic image of coal ore into its various mineral components prior to the sample being crushed. The key to solving this classification problem is to model the visual texture of the various coal components by means of a low-dimensional texture space consisting of two main dimensions, namely: roughness and regularity. The regularity of each texture is estimated by means of a novel model-based approach. The distribution of the various coal components in the resultant feature space is modelled by means of a mixtures model and a simple nearest-neighbour decision rule is used to classify each pixel in the image. The performance of the classification system is encouraging and shows the feasibility of our idea.
- Published
- 2015
239. Pebble Bed Micro Model system identification
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W.C. Venter, E.C. Lamprecht, and 10063218 - Venter, Willem Christiaan
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Mathematical model ,business.industry ,Computer science ,Nuclear engineering ,System identification ,Thermodynamics ,Nuclear reactor ,Modular design ,Solver ,Brayton cycle ,law.invention ,Electricity generation ,Nuclear Energy and Engineering ,law ,business ,Pebble ,system identification ,mathematical models - Abstract
Linear system identification techniques will be applied to obtain mathematical models of a simulation of the Pebble Bed Micro Model (PBMM). The PBMM is a conceptual model of the Pebble Bed Modular Reactor (PBMR), a new high temperature gas nuclear reactor. The basis of the PBMR and PBMM is a three-phase Brayton Power Generation Cycle. The Brayton cycle will in this paper be simulated by the use of Flownex, a general thermal-fluid network analysis code solver. A description of the Brayton Power Generation Cycle, as well as description of the Flownex modelling program, will also be given. http://dx.doi.org/10.1016/j.anucene.2012.02
- Published
- 2012
240. GLP-1 Receptor Agonists and the Path to Sustainable Obesity Care.
- Author
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Manne-Goehler J, Teufel F, and Venter WDF
- Published
- 2024
- Full Text
- View/download PDF
241. The long wait for long-acting HIV prevention and treatment formulations.
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Venter WDF, Gandhi M, Sokhela S, Sikwese K, Bygrave H, Gama LD, Mphothulo N, Jamieson L, Siedner MJ, Pozniak AL, Rojo P, Baptiste SL, Wambui J, Meyer-Rath G, Honermann B, Warren M, Bekker LG, Sinxadi P, Collins S, Burry J, Möller K, Clayden P, Owen A, and Hill A
- Subjects
- Humans, HIV Infections drug therapy, HIV Infections prevention & control, HIV Infections epidemiology, Anti-HIV Agents therapeutic use, Anti-HIV Agents administration & dosage
- Abstract
Large randomised studies of new long-acting medications for the prevention and treatment of HIV have shown high effectiveness and acceptability. Although modelling studies indicate these agents could be fundamental in HIV elimination, coordination of their entry into health-care markets is crucial, especially in low-income and middle-income countries with high HIV prevalence, where coordination is low despite UNAIDS flagging that global HIV targets will not be met. Research and implementation projects are tightly controlled by originator pharmaceutical companies, with only a small percentage of eligible people living with or affected by HIV benefiting from these projects. WHO, financial donors, manufacturers, and governments need to consider urgent coordinated action from stakeholders worldwide, akin to the successful introduction of dolutegravir into treatment programmes across low-income and middle-income countries. Without this immediate coordination, large-scale access to long-acting agents for HIV will be delayed, potentially extending into the 2030s. This delay is unacceptable considering the established global HIV targets., Competing Interests: Declaration of interests WDFV receives grants paid to University of the Witwatersrand from the Bill & Melinda Gates Foundation, South African Medical Research Council, National Institutes of Health (NIH), Unitaid, Foundation for Innovative New Diagnostics, Children's Investment Fund Foundation, United States Agency for International Development (USAID), ViiV Healthcare, and Merck; drug donations from Gilead Sciences, ViiV Healthcare, Merck, and Johnson and Johnson; honoraria for educational talks and advisory board membership from Gilead Sciences, ViiV Healthcare, Mylan-Viatris, Merck, Adcock-Ingram, Aspen, Abbott, Roche, Johnson and Johnson, Sanofi, and Virology Education; conducts commercial drug studies for Merck and Novo Nordisk; and is a member of the international NIH HIV data safety monitoring board and WHO and Southern African HIV Clinicians Society HIV guideline committees. MG is supported financially by NIH. SLB is a member of the AIDS Vaccine Advocacy Coalition board, a Global Coalition of Tuberculosis Activists fiscal sponsor, and is a member of the Global Public Investment Network and Global Fund Advocate Network steering committees. LJ is financially supported by USAID and the Bill & Melinda Gates Foundation. BH receives grant support from ViiV Healthcare to amFAR. MW's receives support from the Bill & Melinda Gates Foundation to the AIDS Vaccine Advocacy Coalition. KM has received honoraria from Johnson and Johnson. LG-B has received honoraria for advisories to Merck, ViiV Healthcare, and Gilead Sciences; is an unpaid board member for Access to Medicine Foundation, AIDS Vaccine Advocacy Coalition, and International AIDS Vaccine Initiative; and her unit (Desmond Tutu HIV Centre) has received a study drug from ViiV Healthcare and Johnson and Johnson for studies funded by the Bill & Melinda Gates Foundation. AO reports consulting fees for Gilead Sciences, ViiV Healthcare, and Assembly Biosciences; and is Director and Chief Science Officer for Tandem Nano, with patents issued and pending in drug delivery. AP receives grants paid to NEAT ID from NIH, National Heart, Lung, and Blood Institute, the EU (via the VERDI Consortium), Gilead Sciences, ViiV Healthcare, and Merck for commercial drug studies; receives honoraria for educational talks and advisory board membership from Gilead Sciences, ViiV Healthcare, Merck, and Virology Education; is on a data safety monitoring board for MRC–PENTA studies; is a member of the European AIDS Clinical Society and British HIV Association HIV treatment guidelines panels; is the President of NEAT ID; and is a board member of Doctor's with Africa CUAMM UK. PR has received grants from ViiV Healthcare and consulted for Gilead Sciences. All other authors declare no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.)
- Published
- 2024
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242. Trends in body mass index for people with and without HIV: Pooled analysis of nationally-representative health surveys from 10 countries and 173,800 adults in Africa.
- Author
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Carrillo-Larco RM, Bulstra CA, Manne-Goehler J, Siedner MJ, Johnson LCM, Marconi VC, Chung MH, Francois Venter WD, Kocher E, Lalla-Edward S, Chandiwana NC, Kariuki JK, and Ali MK
- Abstract
It remains unclear if and how body mass index (BMI) levels have changed over time in HIV endemic regions. We described trends in mean BMI and prevalence of overweight between 2003-2019 in 10 countries in Africa including people living with (PLWH) and without (PLWoH) HIV. We pooled Demographic and Health Surveys (DHS) from countries where ≥2 surveys >4 years apart were available with height/weight measurements and HIV tests. HIV status was ascertained with a finger-prick dried blood spot (DBS) specimen tested in a laboratory. The DBS is taken as part of the regular DHS procedures. We summarized age and socioeconomic status standardized sex-specific mean BMI (kg/m2) and prevalence of overweight (BMI ≥25 kg/m2) by HIV status. We fitted country-level meta-regressions to ascertain if changes in ART coverage were correlated with changes in BMI. Before 2011, women LWH (22.9 [95% CI: 22.2-23.6]) and LWoH (22.6 [95% CI: 22.3-22.8]) had similar mean BMI. Over time, mean BMI increased more in women LWH (+0.8 [95% CI: 0.7-0.8] BMI units) than LWoH (+0.2 [95% CI: 0.2-0.3]). Before 2013, the mean BMI was similar between men LWH (21.1 (95% CI: 20.3-21.9)) and LWoH (20.8 (95% CI: 20.6-21.1)). Over time, mean BMI increased more in men LWoH (+0.3 [95% CI: 0.3-0.3]) than LWH (+0.1 [95% CI: 0.1-0.1]). The same profile was observed for prevalence of overweight. ART coverage was not strongly associated with BMI changes. Mean BMI and prevalence of overweight were similar in PLWH and PLWoH, yet in some cases the estimates for PWLH were on track to catch up with those for PLWoH. BMI monitoring programs are warranted in PLWH to address the rising BMI trends., Competing Interests: VCM has received investigator-initiated research grants (to the institution) and consultation fees from Eli Lilly, Bayer, Gilead Sciences, Merck, and ViiV., (Copyright: © 2024 Carrillo-Larco et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
- Published
- 2024
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- View/download PDF
243. Novel anti-obesity drugs for people with HIV.
- Author
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Chandiwana N, Manne-Goehler J, Gaayeb L, Calmy A, and Venter WDF
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- Humans, HIV Infections drug therapy, Obesity drug therapy, Anti-Obesity Agents therapeutic use
- Abstract
Competing Interests: NC receives research funding from the Bill & Melinda Gates Foundation, Merck, Novo Nordisk, and Johnson & Johnson and receives speaker's honoraria from Johnson & Johnson and Novo Nordisk. AC receives grants from Gilead Sciences, MSD, and ViiV Healthcare. WDFV receives grants from the South African Medical Research Council, US National Institutes of Health, Bill & Melinda Gates Foundation, and ViiV Healthcare; personal fees and non-financial support from ViiV Healthcare and Gilead Sciences; and personal fees from Mylan, Merk, Adcock-Ingram, Aspen, Abbott, Roche, Johnson & Johnson, Sanofi, and Virology Education. All other authors declare no competing interests.
- Published
- 2024
- Full Text
- View/download PDF
244. Regional variation in weight change after the transition to dolutegravir in Uganda and South Africa.
- Author
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Migisha R, Chen G, Muyindike WR, Aung TN, Nanfuka V, Komukama N, Chandiwana N, Shazi G, Tien D, Moosa MS, Gupta RK, Pillay D, Marconi VC, Hedt-Gauthier B, Venter WDF, Siedner MJ, McCluskey SM, and Manne-Goehler J
- Subjects
- Humans, South Africa epidemiology, Uganda epidemiology, Male, Female, Prospective Studies, Adult, Middle Aged, HIV Integrase Inhibitors therapeutic use, Anti-HIV Agents therapeutic use, Lamivudine therapeutic use, Tenofovir therapeutic use, Drug Substitution, Young Adult, Pyridones therapeutic use, HIV Infections drug therapy, Heterocyclic Compounds, 3-Ring therapeutic use, Weight Gain drug effects, Oxazines therapeutic use, Piperazines therapeutic use
- Abstract
Background: People with HIV (PWH) on integrase inhibitor-based regimens may be at risk of excess weight gain, but it is unclear if this risk is consistent across settings. We assessed weight change over 48 weeks among PWH who were transitioned to tenofovir disoproxil fumarate/lamivudine/dolutegravir (TLD)., Design: We conducted a prospective cohort study at public-sector HIV clinics in Uganda and South Africa., Methods: Eligible participants were adults who were transitioned to TLD. Weight was measured at enrollment, 24-, and 48-weeks post TLD transition. Our outcomes were weight change, change in waist circumference, and clinically significant weight gain, defined as ≥10% increase in weight from baseline, over 48 weeks. We used linear mixed-effects regression models, adjusted for demographic factors, to estimate weight gain and identify risk factors., Results: Weight data were available for 428 participants in Uganda and 367 in South Africa. The mean weight change was 0.6 kg [95% CI: 0.1-1.0] in Uganda and 2.9 kg [2.3-3.4] in South Africa ( P < 0.001). The mean change in waist circumference was 0.8 cm [95% CI: 0.0-1.5]) in Uganda and 2.3 cm [95% CI: 1.4-3.2] in South Africa ( P = 0.012). Clinically significant weight gain occurred in 9.8% [7.0-12.6] of participants in Uganda and 18.0% [14.1-21.9] in South Africa ( P < 0.001). After adjustment, PWH gained significantly less weight in Uganda than in South Africa., Conclusions: PWH in South Africa experienced significantly greater weight gain and increases in waist circumference compared to Uganda. Strategies to address weight gain in PWH should be carefully considered and may vary by region., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)
- Published
- 2024
- Full Text
- View/download PDF
245. Intervention strategies to improve adherence to treatment for selected chronic conditions in sub-Saharan Africa: a systematic review.
- Author
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Gumede SB, de Wit JBF, Venter WDF, Wensing AMJ, and Lalla-Edward ST
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- Humans, Africa South of the Sahara, Chronic Disease drug therapy, HIV Infections drug therapy, Medication Adherence statistics & numerical data
- Abstract
Introduction: Evidence-based intervention strategies to improve adherence among individuals living with chronic conditions are critical in ensuring better outcomes. In this systematic review, we assessed the impact of interventions that aimed to promote adherence to treatment for chronic conditions., Methods: We systematically searched PubMed, Web of Science, Scopus, Google Scholar and CINAHL databases to identify relevant studies published between the years 2000 and 2023 and used the QUIPS assessment tool to assess the quality and risk of bias of each study. We extracted data from eligible studies for study characteristics and description of interventions for the study populations of interest., Results: Of the 32,698 total studies/records screened, 2814 were eligible for abstract screening and of those, 497 were eligible for full-text screening. A total of 82 studies were subsequently included, describing a total of 58,043 patients. Of the total included studies, 58 (70.7%) were related to antiretroviral therapy for HIV, 6 (7.3%) were anti-hypertensive medication-related, 12 (14.6%) were anti-diabetic medication-related and 6 (7.3%) focused on medication for more than one condition. A total of 54/82 (65.9%) reported improved adherence based on the described study outcomes, 13/82 (15.9%) did not have clear results or defined outcomes, while 15/82 (18.3%) reported no significant difference between studied groups. The 82 publications described 98 unique interventions (some studies described more than one intervention). Among these intervention strategies, 13 (13.3%) were multifaceted (4/13 [30.8%] multi-component health services- and community-based programmes, 6/13 [46.2%] included individual plus group counselling and 3/13 [23.1%] included SMS or alarm reminders plus individual counselling)., Discussion: The interventions described in this review ranged from adherence counselling to more complex interventions such as mobile health (mhealth) interventions. Combined interventions comprised of different components may be more effective than using a single component in isolation. However, the complexity involved in designing and implementing combined interventions often complicates the practicalities of such interventions., Conclusions: There is substantial evidence that community- and home-based interventions, digital health interventions and adherence counselling interventions can improve adherence to medication for chronic conditions. Future research should answer if existing interventions can be used to develop less complicated multifaceted adherence intervention strategies., (© 2024 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of International AIDS Society.)
- Published
- 2024
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246. Obesity is South Africa's new HIV epidemic.
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Chandiwana N, Venter W, Manne-Goehler J, Wade A, Le Roux C, Mbalati N, Grimbeek A, Kruger P, Montsho E, Zimela Z, Yawa A, Tshabalala S, Rambau N, Mpofu N, Stevenson S, McNulty B, Ntusi N, Pillay Y, Dave J, Murphy A, Goldstein S, Hfman K, Mahomedy S, Thomas E, Mrara B, Wing J, Lubbe J, Koto Z, Conradie-Smit M, Wharton S, May W, Marr I, Kaplan H, Forgan M, Alexander G, Turner J, Fourie VR, Hellig J, Banks M, Ragsdale K, Noeth M, Mohamed F, Myer L, Lebina L, Maswime S, Moosa Y, Thomas S, Mbelle M, Sinxadi P, Bekker LG, Bhana S, Fabian J, Decloedt E, Bayat Z, Daya R, Bobat B, Storie F, Goedecke J, Kahn K, Tollman S, Mansfield B, Siedner M, Marconi V, Mody A, Mtshali N, Geng E, Srinivasa S, Ali M, Lalla-Edwards S, Bentley A, Wolvaardt G, Hill A, and Nel J
- Subjects
- Humans, South Africa epidemiology, Obesity epidemiology, HIV Infections epidemiology, Epidemics
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- 2024
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247. Does Engagement in HIV Care Affect Screening, Diagnosis, and Control of Noncommunicable Diseases in Sub-Saharan Africa? A Systematic Review and Meta-analysis.
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Kileel EM, Zheng A, Bor J, Fox MP, Crowther NJ, George JA, Khoza S, Rosen S, Venter WDF, Raal F, Hibberd P, and Brennan AT
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- Humans, Africa South of the Sahara epidemiology, Anti-HIV Agents therapeutic use, Cardiovascular Diseases epidemiology, Cardiovascular Diseases prevention & control, Cardiovascular Diseases diagnosis, Diabetes Mellitus epidemiology, Diabetes Mellitus diagnosis, Hypertension drug therapy, Hypertension epidemiology, Hypertension diagnosis, HIV Infections drug therapy, HIV Infections diagnosis, HIV Infections epidemiology, Mass Screening, Noncommunicable Diseases epidemiology, Noncommunicable Diseases prevention & control
- Abstract
Low- and middle-income countries are facing a growing burden of noncommunicable diseases (NCDs). Providing HIV treatment may provide opportunities to increase access to NCD services in under-resourced environments. We conducted a systematic review and meta-analysis to evaluate whether use of antiretroviral therapy (ART) was associated with increased screening, diagnosis, treatment, and control of diabetes, hypertension, chronic kidney disease, or cardiovascular disease among people living with HIV in sub-Saharan Africa (SSA). A comprehensive search of electronic literature databases for studies published between 01 January 2011 and 31 December 2022 yielded 26 studies, describing 13,570 PLWH in SSA, 61% of whom were receiving ART. Random effects models were used to calculate summary odds ratios (ORs) of the risk of diagnosis by ART status and corresponding 95% confidence intervals (95% CIs), where appropriate. ART use was associated with a small but imprecise increase in the odds of diabetes diagnosis (OR 1.07; 95% CI 0.71, 1.60) and an increase in the odds of hypertension diagnosis (OR 2.10, 95% CI 1.42, 3.09). We found minimal data on the association between ART use and screening, treatment, or control of NCDs. Despite a potentially higher NCD risk among PLWH and regional efforts to integrate NCD and HIV care, evidence to support effective care integration models is lacking., (© 2024. The Author(s).)
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- 2024
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248. Final 192-Week Efficacy and Safety Results of the ADVANCE Trial, Comparing 3 First-line Antiretroviral Regimens.
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Sokhela S, Venter WDF, Bosch B, Woods J, McCann K, Akpomiemie G, Chandiwana N, Mashabane N, Tembo A, Simmons B, Lalla-Edward S, Siedner MJ, Sinxadi P, Hermans L, Fairlie L, Vos A, Abrams E, Manne-Goehler JM, Moorhouse M, Clayden P, Norris S, Qavi A, Chersich M, Masenya M, Arulappan N, and Hill A
- Abstract
Background: ADVANCE compared 3 World Health Organization-recommended first-line regimens in participants with HIV who were antiretroviral naive., Methods: This randomized, open-label, noninferiority trial enrolled participants living with HIV with no antiretroviral exposure in the previous 6 months to 1 of the following arms: tenofovir alafenamide (TAF) / emtricitabine (FTC) + dolutegravir (DTG) (2 tablets), tenofovir disoproxil fumarate (TDF) / FTC + DTG (2 tablets), or a fixed-dose combination of TDF / FTC / efavirenz (EFV) (1 tablet). We report the final safety and efficacy data up to 192 weeks., Results: Repeat consent from the original 351 participants randomized to each arm was obtained from 230 participants (66%) in the TAF/FTC + DTG arm, 209 (60%) in the TDF/FTC + DTG arm, and 183 (52%) in the TDF/FTC/EFV arm. At 192 weeks, 213 (61%) of the original 351 participants in the TAF/FTC + DTG arm, 195 (56%) in the TDF/FTC + DTG arm, and 172 (49%) in the TDF/FTC/EFV arm had confirmed RNA <50 copies/mL, with low virologic failure in all groups and no significant integrase inhibitor mutations in any arm. Mean weight gain was 8.9 kg (SD, 7.1) in the TAF/FTC + DTG arm, 5.9 kg (SD, 7.1) in the TDF/FTC + DTG arm, and 3.2 kg (SD, 8.1) in the TDF/FTC/EFV arm at 192 weeks from baseline and was greatest among women, those taking TAF, and those with lower baseline CD4 counts. The weight trajectory slowed after week 96. There were few clinical events and minor laboratory changes and differences among arms after 96 weeks. There were no significant differences in treatment-emergent hypertension or pregnancy outcomes by arm., Conclusions: High viral suppression was seen across arms, with no resistance to DTG. Weight gain continued but slowed after 96 weeks, with few clinical events or laboratory changes., (© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)
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- 2024
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249. Weight Gain After HIV Therapy Initiation: Pathophysiology and Implications.
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Chandiwana NC, Siedner MJ, Marconi VC, Hill A, Ali MK, Batterham RL, and Venter WDF
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- Humans, Female, Weight Gain, Anti-Retroviral Agents therapeutic use, Obesity complications, Weight Loss, HIV Infections complications, Anti-HIV Agents adverse effects
- Abstract
Rapid advances in the potency, safety, and availability of modern HIV antiretroviral therapy (ART) have yielded a near-normal life expectancy for most people living with HIV (PLWH). Ironically, considering the history of HIV/AIDS (initially called "slim disease" because of associated weight loss), the latest dilemma faced by many people starting HIV therapy is weight gain and obesity, particularly Black people, women, and those who commenced treatment with advanced immunodeficiency. We review the pathophysiology and implications of weight gain among PLWH on ART and discuss why this phenomenon was recognized only recently, despite the availability of effective therapy for nearly 30 years. We comprehensively explore the theories of the causes, from initial speculation that weight gain was simply a return to health for people recovering from wasting to comparative effects of newer regimens vs prior toxic agents, to direct effects of agents on mitochondrial function. We then discuss the implications of weight gain on modern ART, particularly concomitant effects on lipids, glucose metabolism, and inflammatory markers. Finally, we discuss intervention options for PLWH and obesity, from the limitations of switching ART regimens or specific agents within regimens, weight-gain mitigation strategies, and potential hope in access to emerging antiobesity agents, which are yet to be evaluated in this population., (© The Author(s) 2023. Published by Oxford University Press on behalf of the Endocrine Society.)
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- 2024
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250. Perceptions of Health, Body Size, and Nutritional Risk Factors for Obesity in People with HIV in South Africa.
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Manne-Goehler J, Rahim N, van Empel E, de Vlieg R, Chamberlin G, Ihama A, Castle A, Mabweazara S, Venter WDF, Chandiwana N, Levitt NS, and Siedner M
- Subjects
- Humans, South Africa epidemiology, Cross-Sectional Studies, Obesity epidemiology, Overweight epidemiology, Risk Factors, Body Mass Index, HIV Infections epidemiology, HIV Infections complications
- Abstract
Metabolic disease is increasing in people with HIV (PWH) in South Africa, but little is known about self-perceptions of body size, health, and nutritional behavior in this population. We performed a cross-sectional analysis of individual-level data from the 2016 South Africa Demographic and Health Survey. This survey measured HIV serostatus and body mass index (BMI). We categorized participants into six BMI groups: 18.5-22 kg/m
2 , 22-25 kg/m2 , 25-27.5 kg/m2 , 27.5-30 kg/m2 , 30-35 kg/m2 , and ≥ 35 kg/m2 and stratified them by HIV serostatus. Our outcomes were self-reported (1) body size and (2) health status among all participants, and intake of (3) chips and (4) sugar-sweetened beverages (SSB) in PWH. We described these metrics and used multivariable regression to evaluate the relationship between the nutritional behaviors and BMI ≥ 25 kg/m2 in PWH only, adjusting for age, sex, educational attainment, and household wealth quintile. Of 6138 participants, 1163 (19.7%) were PWH. Among PWH, < 10% with a BMI 25-30 kg/m2 , < 20% with a BMI 30-35 kg/m2 and < 50% with a BMI ≥ 35 kg/m2 self-reported as overweight or obese. PWH reported being in poor health at higher rates than those without HIV at each BMI category except ≥ 35 kg/m2 . In adjusted models, SSB consumption was associated with BMI ≥ 25 kg/m2 (1.13 [1.01-1.25], t-statistic = 2.14, p = 0.033) in PWH. Perceptions of body size may challenge efforts to prevent weight gain in PWH in South Africa. SSB intake reduction should be further explored as a modifiable risk factor for obesity., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)- Published
- 2024
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