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Purpose of the study: The aim of the present study is to evaluate the strategies performed to decrease the loss to follow up in recently diagnosed HIV patients. Method: We reviewed the clinical charts of the recently diagnosed adult (>18 y/o) HIV patients who presented for the first time in our HIV clinic between 1/Jan/2009 and 30/Nov/2010. Among the patients who were newly diagnosed with HIV infection, we identified those who attended our clinic only once. Since January 2009, we implemented new strategies: those patients who were diagnosed with HIV infection were assigned an early appointment with an attending; those patients who did not attend the appointment were called to reassign another appointment; clinic hours were increased, another attending joined the team and the matters the patients had to deal with were reduced. The results obtained with regard to loss to follow up in these patients were compared with previous results, before January 2009, to assess the effectiveness of these measures. Summary of the results: 247 patients attended the clinic for the first time, 43 (17.4%) of them attended the clinic only once. Comparing with the 45-month period before the implementation of these strategies in which 256 patients attend the clinic and 135 (52.7%) attended the clinic only once, loss to follow up was improved (P=0.0000 [OR 0.19, 95% CI 0.12-0.29]). No statistically significant differences were found between both groups regarding age, gender, nationality, employment status, presence of family/partner at home or access to health insurance. Conclusions: Although the small sample size, the implemented measures decreased the lost to follow up in our clinic. This study emphasises the need to continue reinforcing engagement with clinical care in the newly diagnosed HIV patients. (Published: 11 November 2012) Citation: Abstracts of the Eleventh International Congress on Drug Therapy in HIV Infection Fridman V et al. Journal of the International AIDS Society 2012, 15 (Suppl 4):18147 http://www.jiasociety.org/index.php/jias/article/view/18147 | http://dx.doi.org/10.7448/IAS.15.6.18147

Background: Tuberculous meningitis (TBM) has a substantial mortality even with anti-tuberculous treatment, in HIV-non-infected patients. Purpose of the study. The objectives were to describe clinical and laboratory differences of TBM in HIV-infected versus HIV non-infected patients and to assess risk factors of death in HIV-infected patients. Methods: We retrospectively analyzed patients admitted to four infectious diseases hospitals in Romania, between 2001 and 2011, with TBM. Patients were defined as having TBM according to a consensus definition published by Marais et al. [1] and further divided into three categories of TBM (definite, probable and possible). Results: We identified 162 patients with TBM of which 47 (29%) tested positive for HIV infection. Sixty-six patients had definite, 53 probable and 43 possible TBM. Out of the 47 HIV-infected patients 25 had definite, 17 probable and 5 possible TBM. TBM in HIV-infected patients vs. HIV non-infected patients was significantly associated in multivariable analysis with younger age (p=0.01), in-hospital mortality (p

Despite the potential for pre-exposure prophylaxis (PrEP) and treatment as prevention (TasP) to have a significant impact on HIV transmission, there is broad agreement that a safe and effective preventive vaccine remains an essential tool for ending the AIDS epidemic. To date, progress towards a vaccine has been painstaking. Nevertheless, recent progress has opened up promising new leads. Results of the STEP and RV-144 trials provide novel insights that may lead to improved design of candidate vaccines. In addition, the identification of highly potent, broadly neutralizing monoclonal antibodies from some infected patients suggests novel approaches to generating protective immunity. Refinements in our understanding of the gp120 structure and its interaction with CD4 also provide opportunities for improving immunogen design. Although the challenges remain daunting, these advances have instilled a renewed sense of optimism into the field. (Published: 11 November 2012) Citation: Abstracts of the Eleventh International Congress on Drug Therapy in HIV Infection Kuritzkes D. Journal of the International AIDS Society 2012, 15 (Suppl 4):18190 http://www.jiasociety.org/index.php/jias/article/view/18190 | http://dx.doi.org/10.7448/IAS.15.6.18190

Background: In Argentina, antiretroviral treatment (ART) is covered by the State for all the persons who do not have health insurances, who represent 70% of all HIV infected patients in the country. Since 1992, the Direction of Aids (Ministry of Health) buys and delivers ART, treatments for opportunistic infections and reagents to diagnose and follow-up HIV infection. Nevertheless, until now, an analysis of the evolution of the costs of the drugs acquired by the Direction of Aids has not been performed. The aim of this study was to analyze the direct costs of ART for the Direction of Aids in Argentina since 2006, and evaluate progression over time. Methods: The expenditure on ART and drugs for opportunistic infections was obtained. All values (in pesos) were converted to dollars. The cost of ART per patient per year was calculated. Changes in cost were determined for the total and per patient expenditures, and the reasons for the changes analyzed. Results: Total expenditure for ART (in uS dollars) went from 33.7 million in 2006 to 75 million in 2011 (123% increase). The number of patients on ART covered by the Aids Direction increased from 23228 in 2006 to 33279 (43%) by the end of 2011. The cost (u$s) of ART per person per year was: *06*: 1449; *07*: 1645; *08*: 1516; *09*: 1543; *10*: 1968; *11*: 2255. This represents a 56% increase from 2006 to 2011, though this change was uneven through the years. This was driven mainly by a decrease from 07 to 08, due to lack of acquisition of ART for political reasons; and a very steep increase in 09-10 due to incorporation of more expensive drugs such as tenofovir/emtricitabine, raltegravir and maraviroc. Conclusions: Annual cost of ART per person in Argentina has been increasing considerably in the last years. Even though this cost is much lower than those informed by some European countries (Italy: u$ 7500[1]; UK: u$ 9000[2], Germany: u$ 18000); it is one of the highest in Latin-America, where median cost is u$1200 (range: 200-3300). According to PAHO, the delivered ART in Argentina should cost u$ 1200 per person per year, or less. In view of the policy for treatment expansion (new Ministry of Health guidelines recommend ART with CD4 ≤ 500/mm 3 ), it is important to seek ways of lowering the cost of ART. Some of the strategies might be the incorporation of generics (Argentina has a young patents law, barriers to generic use seem not to be very strong but this might change in the future) and buying via strategic funds. (Published: 11 November 2012) Citation: Abstracts of the Eleventh International Congress on Drug Therapy in HIV Infection Bissio E et al. Journal of the International AIDS Society 2012, 15 (Suppl 4):18390 http://www.jiasociety.org/index.php/jias/article/view/18390 | http://dx.doi.org/10.7448/IAS.15.6.18390

Background: In virologically suppressed patients, simplifying to darunavir/ ritonavir (DRV/r) monotherapy maintains HIV RNA suppression and could lower treatment costs. Monotherapy is mentioned as an alternative treatment option in the Greek therapeutic guidelines (posted in the Greek Health Authority website), even though it is not included in the label of darunavir or any other PI. Methods: In the MONET trial 256 patients with HIV RNA

Purpose of the study : In Germany, older age is described as a risk factor for late presentation of HIV disease (defined as 60 y and 31%-49% in the younger age groups (see Table 1). Across age groups, 43%-60% of pts had pretreatment HIV1-RNA levels >100,000 c/mL. Median times to virologic response (Figure 1) and response rates at week 48 did not differ across age groups in either analysis, nor did immunologic outcomes. Median times to +100/μL CD4 increase were between 11.1 and 15.3 weeks. CD4 increase at week 48 was lower in pts >60 y compared to patients of younger age categories (165/μL vs 211/μL; P=ns). However, these differences between age groups did not reach statistical significance, even when stratified by baseline CD4 count 60 y group (P=0.194). In addition, 11.3 % of pts ≤60 and 14.9% of pts >60 y discontinued therapy prior to week 48 due to treatment related AEs (P=0.427). Conclusions: In the STAR/STELLA cohorts, pts aged >60 y had high rates of late presentation, with two-thirds of patients with CD4 cell counts

Purpose of the study: Good penetration of antiretroviral drugs to the seminal plasma may be associated with a decrease in viral replication and play an important role in the prevention of sexual transmission of HIV. We present data from a series of HIV-infected ARV-experienced patients receiving etravirine-containing regimens, in whom etravirine concentrations and viral loads were determined in blood plasma and seminal plasma. The objective was to determine etravirine concentrations and HIV-1 viral load (VL) in blood plasma (BP) and seminal plasma (SP) of HIV-infected patients. Methods: Ten HIV-1 adult antiretroviral-experienced patients receiving an etravirine-containing regimen for at least 1 month were enrolled. Semen and blood samples were both collected around 12-24 h after the last etravirine dose, depending on once-daily or twice-daily dosing, respectively. HPLC/MS/MS was used to determine etravirine concentrations, and HIV-1 VL was determined by real-time PCR (limit of detection, VL 40 copies/mL). Results: Ten blood and twenty semen samples were collected. Median (range) CD4 count was 502 cells/mm 3 (252-817) and median (range) BP VL was

Etravirine (ETR) is a next generation non-nucleoside reverse transcriptase inhibitor (NNRTI). The studies for ETR EMA approval were almost exclusively performed together with the protease inhibitor (PI) darunavir. However the fact that ETR can be active against NNRTI-pretreated HIV variants and that it is well tolerated suggests its application in PI-free antiretroviral combination therapies. Although approved only for PI-containing therapies, a number of ETR treatments without PIs are performed currently. To evaluate the performance of ETR in PI-free regimens, we analyzed the EURESIST database. We observed a total of 70 therapy switches to a PI-free, ETR containing antiretroviral combination with detectable baseline viral load. 50/70 switches were in male patients and 20/70 in females. The median of previous treatments was 10. The following combinations were detected in the EURESIST database: ETR+MVC+RAL (20.0%); ETR+FTC+TDF (18.6%); 3TC+ETR+RAL (7.1%); 3TC+ABC+ETR (5.7%); other combinations (31.4%). A switch was defined as successful when either ≤50 copies/mL or a decline of the viral load of 2 log 10 , both at week 24 (range 18-30) were achieved. The overall success rate (SR) was 77% (54/70), and for the different combinations: ETR+MVC+RAL =78.6% (11/14); ETR+FTC+TDF =92.3% (12/13); 3TC+ETR+RAL =80.0% (4/5), 3TC+ABC+ETR =100% (SR 4/4); and for other combinations =67.6% (23/34). These SR values are comparable to those for other therapy combinations in such pretreated patients. (Published: 11 November 2012) Citation: Abstracts of the Eleventh International Congress on Drug Therapy in HIV Infection Schuelter E et al. Journal of the International AIDS Society 2012, 15 (Suppl 4):18260 http://www.jiasociety.org/index.php/jias/article/view/18260 | http://dx.doi.org/10.7448/IAS.15.6.18260

Purpose of the study : DRV/r mx is proposed as a therapeutic option for patients with NNRTI toxicity. We aimed to evaluate the impact of switching to DRV/r mx in kidney function and lipid profile. Methods : From March 2009 to June 2012 we conducted an observational, retrospective multicenter study evaluating patients switching to DRV/r mx. Kidney function and lipid levels were measured at baseline and at 48 weeks of DRV/r mx. Renal function was estimated by MDRD GFR. Comparative analyzes were performed using Student's t test for paired samples. Summary of results : We identified 147 patients: women 30.6%, age 49±7yr, 45% IDU, 27.9% heterosexuals, AIDS 41.5%, Caucasian 58.5%, HCV-coinfected 48%, baseline HIV-RNA

Almost 1/3 of HIV-infected individuals enter health care late in the course of infection, worsening their prognosis and costs of care. According to the recent European consensus definitions, late presenters are persons presenting with CD4 counts

Objective : The aim of this study was to investigate clinical risk factors on survival among infected children born to HIV-positive mothers in the southern region of Thailand.: Methods : Data from routine prospective cohort studies from 1990-2010 were analyzed. In these studies, totally 1549 infected children born to HIV-positive mothers were enrolled at birth and followed longitudinally. Information on demographic, clinical manifestation, HIV infection status factors was collected. Survival analysis was used to determine risk factors associated with mortality. Results : The main result found that one-quarter of infected children died (434, 28.02%) during the follow-up period. A total of 135,295 person-months of follow up was available. The incident rate was 1.03 times per 100 person-months (95% CI: 0.97 to 1.08). The median survival time among infected children born to HIV-positive mothers from diagnosis to death was 87.34 months (95% CI: 87.32 to 87.36). Infected children born to HIV-infected mothers were diagnosed to confirm as AIDS (88.44%) and symptomatic HIV positive (11.56%), respectively. Regarding the clinical risk factor on survival among infected children born to HIV-positive mothers were found. Infected children born to HIV-positive mothers were more likely to die, who infected with candidiasis (HR: 1.47, 95% CI: 1.07 to 2.00), Mycobacterium tuberculosis (HR: 1.51, 95% CI: 1.26 to 1.81) and Pneumocystis carinii (HR: 1.50, 95% CI: 1.27 to 1.76), those compared to infected children without clinical manifestation. Conclusion : Mortality among infected children born to HIV-positive mothers contributed to high levels in the southern region of Thailand. Consequently, health service system related to prevent mother-to-child HIV transmission is needed to improve child survival by lowering HIV infection and mortality in children born to HIV-positive mothers. (Published: 11 November 2012) Citation: Abstracts of the Eleventh International Congress on Drug Therapy in HIV Infection Chaimay B et al. Journal of the International AIDS Society 2012, 15 (Suppl 4):18217 http://www.jiasociety.org/index.php/jias/article/view/18217 | http://dx.doi.org/10.7448/IAS.15.6.18217

Combining various antiretroviral agents into one single pill (STR, single-tablet regimen) is a strategy to reduce pill burden, enhance adherence and improve efficacy of HAART. We evaluated STR from a cost-effectiveness point of view in a large, unselected cohort of patients starting their first HAART. The incremental cost-effectiveness analysis was carried out by means of a Markov model simulating QoL and costs for a patient, according to the given regimen, through 1-year cycles. The considered outcome measure was quality-adjusted life years (QALYs) and all direct health costs were computed. From January 2006 to January 2012, 793 naive patients started their first regimen at our center and were included in the analysis. They were mostly males (74.5%) with a mean age of 39 years, a baseline mean HIV-RNA of 200K copies/ml and a mean baseline CD4 count of 292 cells/μL. We adopted several definitions to describe STR use trying to reflect the clinical indications of single-tablet regimens: a) any EFV-based regimen followed by STR treatment; b) TDF+FTC+EFV followed by STR; c) any HAART regimen followed by STR; d) use since the beginning of STR. We run the analysis for each of these different STR treatment definitions and compared the results with those of two different control groups: patients receiving a PI-based OD treatment or patients receiving a PI-based BID treatment. For the considered definitions of STR, the mean year-cost per patient ranged from 6,766 to 7,083€ with a mean per patient QALYs ranging from 0.955 to 0.973. In the case of OD PI-based regimens the cost range was from 8,484 to 8,532€ and the QALYs mean varied from 0.923 to 0.925. The same values for BID PI-based regimens were from 8,040 to 8,303€ and from 0.930 to 0.931. In all cases STR dominated (i.e. was more effective and less costly) any comparator HAART regimen. The incremental cost-effectiveness ratio (ICER) values comparing the different STR definitions are reported in the table. STR compared to boosted PI-based regimens either OD or BID resulted highly cost-effective showing in any case the lowest cost and the best efficacy as measured by QALYs. The comparison of different strategies including STR use revealed that starting with an STR regimen is cost-effective compared to simplification strategies, assuming a commonly internationally accepted threshold of 50.000€ to define cost-effectiveness. (Published: 11 November 2012) Citation: Abstracts of the Eleventh International Congress on Drug Therapy in HIV Infection Maggiolo F et al. Journal of the International AIDS Society 2012, 15 (Suppl 4):18377 http://www.jiasociety.org/index.php/jias/article/view/18377 | http://dx.doi.org/10.7448/IAS.15.6.18377

Background : Simplification of antiretroviral therapy (ART) may be an option for virologically suppressed patients for a variety of reasons. Etravirine (ETV) 400 mg qd has a good safety profile and retains activity against viruses resistant to nevirapine or efavirenz. Our objective was to evaluate the efficacy of ETV plus two nucleoside reverse transcriptase inhibitors (NRTIs) as a simplification strategy in treatment-experienced virologically suppressed individuals with prior episodes of virological failure (VF) and presence of genotypic resistance mutations (GRM). Methods : Eligible subjects were followed for ≥6 mo. Primary endpoint was proportion of patients remaining virologically suppressed using an ITT analysis. Genotypic sensitivity score (GSS) to new regimen was calculated according to Stanford resistance database. Results : Fourteen (10%) of 145 subjects switching to ETV+2NRTIs while virologically suppressed had a documented prior VF and presence of GRM and were included in the analysis. Median (range) number of previous episodes of VF to ART, NRTI-containing regimen, to a NNRTI-containing regimen and to a PI-containing regimen were 4 (1-6), 2 (1-5), 1 (0-2) and 1 (0-2) respectively. Median duration of virological suppression before switching therapy was 22.5 months (1-65). All patients switched from an effective PI-containing regimen (8 LPV/r, 5 ATV/r and 1 DRV/r) to a qd regimen with ETV 400 mg plus Truvada ® (n=12) or Kivexa ® (2). 11/14 patients (79%) remained virologically suppressed at ≥6 mo. All of them had a GSS >1.5 to the new regimen and none had resistance to etravirine. Conversely 3/14 (21%) developed a VF at 1, 3 and 6 months respectively. All these 3 patients had a GSS ≤1.5 to the new regimen and 2 of them intermediate resistance to ETV (Y181C). No side effects were reported. Conclusions : Our results suggest that ETV plus 2NRTI could be a good strategy for simplification in virologically suppressed patients despite previous episodes of VF if the GSS to the new regimen is ≥1.5 and ETV remains active. (Published: 11 November 2012) Citation: Abstracts of the Eleventh International Congress on Drug Therapy in HIV Infection Blanco J et al. Journal of the International AIDS Society 2012, 15 (Suppl 4):18379 http://www.jiasociety.org/index.php/jias/article/view/18379 | http://dx.doi.org/10.7448/IAS.15.6.18379

Non-AIDS events are the leading cause of death in HIV-positive patients (pts) on effective HAART. The VACS index, composed by HIV-RNA, CD4+, age, hemoglobin, FIB-4, eGFR and HCV co-infection, has been validated as 5-year mortality index in HIV- positive pts [1]. The aim of our study was to evaluate the prevalence and any possible predictive factors of medium-high VACS index in a cohort of HIV-positive pts; we also evaluated whether it relates with markers of systemic immune activation. 501 consecutive HIV-positive asymptomatic pts on effective HAART (HIV-RNA 30%). Groups (pts with low and medium-high VACS index) were comparable for CD4+ nadir, AIDS diagnosis, CD8+45RO%, CD8+38RO%, CD127+%. Females, active or previous IDU, pts with shorter HAART exposure showed more frequently medium-high VACS index (table 1). In the multivariable model, female sex (AOR 6.26, 95% CI 3.45-11.38, p

Background: Once-daily (qd) darunavir/ritonavir (DRV/r) 800/100mg was evaluated in two randomised and controlled Phase III trials, showing high response rates in treatment-naive (ARTEMIS; TMC114-C211) and treatment-experienced patients with no DRV resistance-associated mutations (ODIN; TMC114-C229). Treatment interruptions, medical co-morbidities, drug-drug interactions, and challenges to adherence can decrease exposures and result in suboptimal DRV coverage. Consequences of suboptimal dosing could be detrimental to patients, namely the selection of drug-resistant HIV strains. No relevant relationship between DRV area under the plasma concentration-time curve over 24 hours (AUC 24h ) or plasma trough concentrations (C 0h ) and efficacy or safety were observed in ARTEMIS or ODIN [1,2]. The PK/PD analysis for efficacy has been extended using a generalized additive model (GAM). Methods: A univariate GAM analysis was undertaken for each trial, exploring the relationship between DRV C 0h and virological response at Week 48. A quadratic spline (2 degrees of freedom) was selected, based on the Akaike information criterion value. Additionally, a linear logistic regression model was applied to model virologic response as a function of DRV C 0h . Results: In ARTEMIS, there was no relationship between DRV C 0h and the observed virological response or virological response predicated in the GAM analysis, with no indication that lower values within the observed DRV C 0h range are associated with lower predicted virological response (Figure A). The mean predicted virological response was 92.8% in the total population (N=304). A 50% reduction in DRV C 0h would result in a similar predicted mean virological response (93.9%). In ODIN, for values of DRV C 0h up to 3000ng/mL, there was no clear relationship between DRV C 0h and observed virological response. The GAM analysis showed a counter-intuitive inverse relationship between DRV C 0h and predicted virological response (Figure B). The mean predicted virological response was 80.6% in the total population (N=252). For each trial, similar results to GAM were obtained when a linear logistic regression model was applied. Conclusion: In patients who received 800/100mg qd DRV/r in the ARTEMIS and ODIN trials, a reduction in DRV C 0h of up to 50% is not associated with a reduced virologic response at Week 48, as predicted by both the GAM and logistic regression model. DRV/r doses below 800/100mg qd should not be administered. (Published: 11 November 2012) Citation: Abstracts of the Eleventh International Congress on Drug Therapy in HIV Infection Kakuda T et al. Journal of the International AIDS Society 2012, 15 (Suppl 4):18338 http://www.jiasociety.org/index.php/jias/article/view/18338 | http://dx.doi.org/10.7448/IAS.15.6.18338

Background: Darunavir, a second-generation protease inihibitor, is used with a low boosting dose of ritonavir to improve its clinical efficacy. The boosting dose of ritonavir acts as an inhibitor of CYP3A4, thereby increasing darunavir bioavailability. Recently, ritonavir tablet has been on sale in place of soft capsule. However, pharmacokinetic study of darunavir by changing ritonavir form is still not clear. In this study, we aimed to compare with plasma darunavir concentrations by switching ritinavir soft capsule to tablet in Japanese HIV-1 infected patients. Methods: We analyzed 34 Japanese HIV-1 infected patients (32 males: 2 females) recruited at the National Hospital Organization Nagoya Medical Center. All patients had been administered with 800/100 mg darunavir/ritonavir once daily in combination with other antiretrovirals. Plasma darunavir concentrations were determined by an HPLC method. A pared t-test was used to compare with their concentrations by switching from ritonavir soft capsule to tablet. Results: The mean of age, body weight, and duration of antiretroviral therapy for 34 patients were 41.9 (range: 24-62) years, 66.3 (range: 51.4-90.0) kg, and 436 (range: 182-739) days, respectively. The mean±SD darunavir concentration was 3.44±1.78 µg/ml when ritonavir soft capsule was co-administered. After switching to ritonavir tablet, the mean±SD darunavir concentration was 3.30±2.02 µg/ml. Statistical difference was not found in plasma trough darunavir concentration between ritonavir soft capsule and tablet (P=0.826). On the other hand, the mean of viral load was 78 copies/ml when ritonavir soft capsule was administered. After switching to ritonavir tablet, the mean viral load was 33 copies/ml. Conclusion: Recruited all patients have been sustained an ndetectable viral load (less than 40 copies/ml) after switching to ritonavir tablet. In this study, switching to ritonavir tablet had no significant difference on plasma darunavir concentrations in Japanese HIV-1 infected patients. (Published: 11 November 2012) Citation: Abstracts of the Eleventh International Congress on Drug Therapy in HIV Infection Shibata M et al. Journal of the International AIDS Society 2012, 15 (Suppl 4):18360 http://www.jiasociety.org/index.php/jias/article/view/18360 | http://dx.doi.org/10.7448/IAS.15.6.18360

Objective: BUZZ is a workshop designed to enhance communication between patients and health care providers (HCPs) and results to date will be described. Background: A study of HIV patients interviewed about their treatment, identified several barriers to communication with their health care teams. Another study called BEAHIV, demonstrated low levels of agreement between patients and HCPs surrounding bothersome symptoms of ARV treatment. With a grant from Janssen, a workshop was designed by a faculty of HIV clinicians from across Canada, in conjunction with a behavioural specialist. The workshop covered several topics: identifying barriers to communication for HIV patients, learning about one's own preferred communication style, how to determine a patient's communication style, and ways to uncover issues associated with the patient's treatment, such as ARV-associated side effects. To date, 15 workshops have been conducted across the country. Results: At the end of the workshop, 85% of participants said they would start or continue to identify barriers to communication. At the start of each workshop, several before/after questions were asked. Only 45% of HCPs felt comfortable in adapting their communication towards patients with different behavioural styles prior to participating in the workshop. This increased to 84% after the workshop. Prior to the workshop, 68% of HCPs said they currently engage patients in proactive discussions surrounding ARV-associated side effects, increasing to 82% post-workshop. Prior to the workshop, 60% proactively engaged patients on the impact of ARV side effects on quality of life, which increased to 80% post-workshop. Several weeks after each workshop, a follow up with participants was conducted and it was found that many implemented changes in their practices as a result of what they learned. Conclusion: A workshop designed to enhance communication may have a beneficial effect on reducing communication barriers and enhancing HIV patient care. (Published: 11 November 2012) Citation: Abstracts of the Eleventh International Congress on Drug Therapy in HIV Infection Lico S. Journal of the International AIDS Society 2012, 15 (Suppl 4):18370 http://www.jiasociety.org/index.php/jias/article/view/18370 | http://dx.doi.org/10.7448/IAS.15.6.18370

Between 1986 and 2011, 100 children have been diagnosed with HIV-1 in Cuba. 38 have acquired HIV-1 by vertical transmission, 6 by blood transfusion and 56 by sexual contacts (teenager). Currently, AZT/D4T+3TC+NVP/KALETRA are available for the treatment of pediatric patients. The aim of the study was to monitor the subtype distribution and emergence of drug resistance in pediatric HIV-1 infections. Plasma from 46 HIV-1-infected children were collected from November 2005 to November 2011, subsequently extracted, amplified and sequenced. Phylogenetic analysis was performed using Mega 4 (Neighbour joining, Kimura 2). The CPR toolv6.0 (WHO list 2009) was used to interpret transmitted drug resistance (TDR). In addition, acquired drug resistance was interpreted according to HIVdbv6.1.1. Experiments were successful for 28 samples from 20 patients (5 patients with multiple samples). At the moment of analysis, 17 children were receiving ART. The median age at diagnosis was 1.9 years, whereas the median age at sampling was 4.5 years. Ten children were male (50%), 16 (80%) were infected by vertical transmission, 1 by blood transfusion (5%) and 3 by sexual route (15%). The subtypes were CRF18_cpx (25%), CRF19_cpx (25%), B (20%), CRF20_BG (10%), G (10%), CRF24_BG (5%)and C (5%). 82.3% of the children who were receiving ART at sampling (14/17) displayed at least one drug resistance mutation. The most common NRTI and NNRT mutations were: M184V (55.5%), T215FY (16.6%) and K70R (16.6%); and K103NS (61.1%) and G190A (22.0%). In contrast, only one PI mutation, L90M (5.5%), was observed. 5.8% of these children displayed single NRTI class resistance, 17.4% single NNRTI class resistance, 59% double NRTI+NNRTI class resistance and 5.8% triple NRTI+NNRTI+PI class resistance. According to HIVdb, NRTI, NNRTI and PI resistance was present in respectively 42.8%, 58.7% and 8.08% of the treated children. High-level NVP and EFV resistance was observed in 76.5% and 58.8%, respectively. 35.2% displayed already low-level resistance to ETR/RPV. For NRTI, high-level resistance to 3TC/FTC was detected in 50%. High-level resistance to NFV was detected in only one sample. No NNRTI TDR was observed, while one patient displayed PI TDR (L90M) and another NRTI TDR (D67N, T215S and K219Q) (2/11) (18.1%). At this moment, insufficient data is available whether resistance is associated with TDR, poor adherence to treatment or poor efficacy of ART regimens in use. The present study reinforces the usefulness of resistance tests for the correct management of ART. (Published: 11 November 2012) Citation: Abstracts of the Eleventh International Congress on Drug Therapy in HIV Infection Perez L et al. Journal of the International AIDS Society 2012, 15(Suppl 4):18186 http://www.jiasociety.org/index.php/jias/article/view/18186 | http://dx.doi.org/10.7448/IAS.15.6.18186

The viral load quantification constitutes a cornerstone of antiretroviral therapy management. After the switch from the Cobas Ampliprep Amplicor HIV-1 Monitor Test, v. 1,5 (CAP/CA) (Roche Diagnostics, Mannheim, Germany) to CTM2 in August 2009 at the HIV department of the General Hospital in Vienna, multiple internal reports accumulated concerning an increase of detectable HIV-1 viral loads in patients with previous long-term virological suppression. In order to evaluate these observations and their clinical consequences, a retrospective analysis of the number of elevated VL measurements in formerly virological suppressed patients during the first year of CTM2 use was performed. Furthermore, we monitored for consecutive numbers of repeated VL measurements, genotypic testing and for changes of antiretroviral therapy (ART). We recruited 373 of 2078 patients meeting the chosen inclusion criteria (Initiation of ART prior to August 6, 2008; ≥1 VL measurement in the pre-CTM2 period from August 6, 2008 to August 5, 2009, all VL measurements below the limit of quantification as defined by applied nucleic acid quantification assay (CAP/CA with 400 copies/mL. Of these newly detectable patients, 132 had a VL repeat and 72 became undetectable, the remaining 60 patients remained detectable. Remarkably, it was striking to find that in the group of patients who when switching to CTM2 reached at once viral loads exceeding 400 copies/mL, 48.3% became undetectable after viral load repeat using again CTM2, suggesting a high test variability at low detection limit but also beyond. Three genotypic resistance testings were performed and 16 patients underwent subsequent ART changes. In summary, the transition to CTM2 was followed by a dramatic increase of detectable viral loads in patients with stable ART and prior virological suppression, which at least in part could not be reproduced in repeat measurements. (Published: 11 November 2012) Citation: Abstracts of the Eleventh International Congress on Drug Therapy in HIV Infection Taylor N et al. Journal of the International AIDS Society 2012, 15 (Suppl 4):18207 http://www.jiasociety.org/index.php/jias/article/view/18207 | http://dx.doi.org/10.7448/IAS.15.6.18207

Clinical pharmacokinetic data on antiretroviral drugs are scarce in African HIV-1 infected patients. Most available pharmacokinetic data are derived from ethnically distinct Caucasian research volunteers. This presentation will focus on the clinical pharmacokinetics training and research outputs of an HIV Research Trust scholarship recipient in Uganda. The work highlights the need for post-marketing pharmacokinetic studies in the target populations in order to optimise therapy for patients in resource-limited settings. (Published: 11 November 2012) Citation: Abstracts of the Eleventh International Congress on Drug Therapy in HIV Infection Lamorde M. Journal of the International AIDS Society 2012, 15 (Suppl 4):18079 http://www.jiasociety.org/index.php/jias/article/view/18079 | http://dx.doi.org/10.7448/IAS.15.6.18079

The unprecedented, successful collaborative international effort to provide universal access to HIV care, including effective antiretroviral therapy (ART), has reached a critical time point. The global economic downturn, changing donor priorities and competing priorities in the health sector threaten the capacity of various agencies to maintain support for the continued scale-up of access toward the UN General Assembly-agreed target of 15 million people with HIV/AIDS receiving ART by 2015. This aspiration has recently received added impetus as we have come to understand that treatment acts as prevention by reducing the infectiousness of treated individuals. It is now necessary to review the elements of the success to date, in order to be able to do more with less. These elements include efforts to optimise delivery of HIV care, including ART, in low- and middle-income countries (LMIC); the emergence of new agents and drug classes which have simplified HIV treatment and made broader successful management more achievable; and changes to commencement protocols. Recent studies have indicated that earlier commencement of HIV therapy is beneficial, leading to changes in the recommended ART initiation threshold in LMIC to

Purpose of the study : Virological outcomes and resistance patterns in children initiating PI-based antiretroviral therapy (ART) immediately following HIV-1 diagnosis are not well described. Challenges include maintaining adherence in asymptomatic patients with very high pre-ART viral loads. The CHER trial compared deferred but continuous ART (arm 1) with early limited ART (arms 2 and 3). Methods : LPV/r+ZDV+3TC was commenced either immediately (in 250 of 252 children randomised in arms 2 and 3) or at clinical/immunological progression (103 of 125 children in arm 1). Interruption of ART occurred after 40 (arm 2) or 96 weeks (arm 3) and re-initiation with LPV/r+ZDV+3TC was based on immunologic/clinical criteria. Viral load was measured on all children with a stored specimen at their last visit, having been on initial or restarted ART following interruption (arms 2 and 3) for at least 24 weeks. Children in arms 1, 2 and 3 not initiating ART due to death (16, 0, 0), LTFU (2, 2, 0) or other reason (4, 0, 0) are excluded. Resistance testing was performed on samples with a VL ≥1000 c/ml together with the matched baseline sample, if available. Reverse transcriptase (NRTI and NNRTI) and protease (PI) inhibitor mutations were analysed using a validated in-house population-based sequencing assay and the IAS 2011 mutation list. Results : 377 infants were enrolled; median age 7.4 (IQR 6.7-8.9) weeks, median baseline viral load was log 10 5.7. By end of study (June 2011), 353/377 children had started LPV/r+ZDV+3TC. Median (IQR) age at ART initiation in arms 1, 2 and 3 was 26.1 (19.9 to 40), 7.4 (6.6-8.7) and 7.5 (6.6-9.0) weeks. Median (IQR) duration on ART was 240 (216-252), 243 (200-260) and 240 (194-257) weeks in arms 1, 2 and 3 respectively. HIV-1 RNA was 1000 c/ml (2/5, 8/14, 12/13 in arms 1, 2 and 3) have had resistance tests to date, 9 (41%) had mutations. There were seven with M184V mutations (1, 4, 2 in arms 1, 2 and 3); two with major PI mutations (V82A/L76V) (1 in each of arms 1 and 2); two with major NNRTI mutations (K103N/M230L) (1 in each of arms 2 and 3). 2 of 10 children tested to date had NNRTI mutations prior to starting PI-based triple therapy. Conclusions : Virological response on ART was excellent in this large cohort of infants initiating LPV/r+ZDV+3TC at a very young age, with no differences between randomised strategies, suggesting that planned interruption after early limited ART does not adversely affect virological outcomes. Overall ~40% of those on ART with VL >1000 c/ml had a resistance mutation; PI mutations were infrequent, despite around 5 years on therapy. Ongoing work will investigate impact of length of time with detectable viral load on risk of developing resistance. (Published: 11 November 2012) Citation: Abstracts of the Eleventh International Congress on Drug Therapy in HIV Infection Violari A et al. Journal of the International AIDS Society 2012, 15 (Suppl 4):18085 http://www.jiasociety.org/index.php/jias/article/view/18085 | http://dx.doi.org/10.7448/IAS.15.6.18085

Genotypic tests are the most common methods to identify patients eligible for CCR5 inhibitors administration in Europe. Among the available tools geno2pheno coreceptor (G2P) is the most used online system in routine diagnostics. This study was conceived to assess if the combination of G2P prediction with V3 peptide net charge (NC) value could improve the accuracy of tropism prediction. Sequences (129) were analyzed by G2P according to European Guidelines. NC values were calculated by the online software Peptide Property Calculator. Phenotypic assay was performed cloning the complete env gene into pcDNA 3.1 TOPO vector; infectivity of pseudotyped virions was tested on U87_CD4+CCR5+ and U87_CD4+CXCR4+ cells lines to assess viral tropism. Sequences were stratified into 3 groups according to the agreement between NC values and G2P results. Group 1: sequences assigned to the same group by both tools, group 2: sequences assigned to one group by G2P but indeterminate by NC and group 3: sequences for which G2P and NC gave discordant results. 61% of sequences predicted as X4 by G2P showed NC values higher than 5; similarly, 76% of sequences predicted as R5 by G2P had NC values below 4 (Group 1). Sequences with NC values between 4 and 5 (Group 2) were associated to different G2P predictions: 59% samples were predicted as R5-tropic and 41% sequences as X4-tropic. These data support the hypothesis that 4 to 5 NC values could be associated to the presence of dual/mixed-tropic variants (DM). Sequences identified as X4 by NC value had at least one positive residue in positions known to be involved in tropism prediction (58%) and positive residues in position 32 (39%). To further verify NC-based prediction, phenotypic assay was performed on a subset of sequences from each group. The assay confirmed the tropism prediction for group 1 sequences and demonstrated that the variants with net charge between 4 and 5 have DM tropism. Moreover, in vitro phenotyping of discordant viruses confirmed NC result, showing that this parameter is strongly associated with phenotypic assay. These results show that the combination of G2P and NC could increase the accuracy of tropism prediction and the ability to discriminate DM viruses. A more reliable identification of X4 variants would be useful for better selecting candidates for maraviroc administration, but also as a predictive marker in coreceptor switching, strongly associated to the phase of infection. (Published: 11 November 2012) Citation: Abstracts of the Eleventh International Congress on Drug Therapy in HIV Infection Montagna M et al. Journal of the International AIDS Society 2012, 15 (Suppl 4):18215 http://www.jiasociety.org/index.php/jias/article/view/18215 | http://dx.doi.org/10.7448/IAS.15.6.18215

Initiation of HIV-positive patients on antiretroviral therapy (ART) in Nigeria was restricted to secondary and tertiary level hospitals due to weak health systems in primary health centres (PHCs). Shell Petroleum Development Company (SDPC) Nigeria and FHI 360 using a systems strengthening approach, piloted ART enrolment in a PHC in south-eastern Nigeria. This study sought to evaluate patients’ adherence and mortality on ART, and associated risk factors. We reviewed clinic records of adult patients initiating ART between January 2007 and December 2009. Adherence was calculated as the number of days of medication dispensed as a percentage of total number of days evaluated. Outcome measures were probability of being alive and retained in care at 12 and 24 months on ART. Competing risks regression models were used to assess potential predictors associated with mortality. Total of 196 patients (64.8% males) were initiated on ART. Patients’ median age was 35 years (IQR 30–44); median CD4 at initiation was 132 cells/mm3 (IQR 82–212), Patients in WHO stage III and IV constituted 73 (37.6%) and 83 (42.8%) respectively. Majority (108 [55.1%]) of patients had adherence rates >95%. Adherence levels ranged: 70–85%, 50–65% and 95% adherence level). In conclusion, majority of attrition was due to mortality. Poor adherence was associated with 27 times higher risk of death compared with patients with >95% adherence. Mortality is likely to reduce by establishing a more robust adherence counselling process.

Life expectancies (LEs) of patients in UK Collaborative HIV Cohort (UK CHIC) stratified by CD4 count at start of antiretroviral therapy (ART) have been estimated [1] but not gains in years of life in response to ART. We estimated LE associated with attained CD4 count and viral suppression at different durations of ART. Patients in UK CHIC aged > 20 years who started ART in 2000 to 2008 (excluding person who injects drugs) were followed to end of 2010. All-cause mortality was ascertained from clinic notes and by linkage to national records. We used the nearest CD4 count before ART and the last in each of years 1 to 5 of ART and determined whether patients were virally suppressed (HIV-1 RNA < 400 copies/mL) in the past year for those remaining under follow-up. Poisson models were used to estimate mortality rates by sex, age, latest CD4 count ( 5 years. The difference in LE between suppressed versus unsuppressed patients was around 11 years. The figure shows that both CD4 count and viral suppression contribute to changes in LE. Male patients that increased their CD4 in the 1st year of ART from < 200 to 200–349 or ≥ 350 gained 6 and 11 years of LE to 42 and 48 years, respectively, with similar rises for women. Overall, LE was 4 years greater for those on ART for > 5 years compared with those starting ART. Individuals that attain viral suppression and a CD4 count > 350 within 1 year of ART start have a normal LE with 35-year olds estimated to live to over 80 years on average. LE in patients with CD4 count < 200 beyond 5 years on ART drops by 15 years. Estimated LE may be biased by under-ascertainment of deaths, missing CD4 measurements and extrapolation beyond available data.

Background: Women living with HIV are at higher risk of developing HPV-related diseases. Albeit they are systematically referred for cervical cancer screening, difficulties in obtaining timely appointments are the main barrier for an adequate gynecological care. In our unit, according to a previous survey, 67% of women reported this problem. Therefore, in January 2011 the integration of HIV and gynecological care was sought through the provision of gynecological care within the Infectious Diseases Unit in our hospital. Methods: A weekly specific clinic for women living with HIV cared by HIV and gynecological specialists was implemented. Appointments are given at the HIV clinic, with no need of referral. Pap smear and colposcopy are offered in the same place. Data are collected through standardized forms. Baseline data from the first hundred patients referred are presented. Results: Ninety-six women were assisted. Median age was 40 years (IQR 36-46.5). Median time from HIV diagnosis was 10.6 years (IQR 4.9-16.4). 82% patients were on HAART. Median CD4 cell count was 473 cells/cc (IQR: 287-614) and 49% had viral load

Previous published evidences showed that taking HAART once-daily (OD) is associated to better adherence when compared to BID or TID regimens. However, no further studies investigated whether, among OD regimens, adherence levels can be differently influenced. Aim of the study was to evaluate levels of self-reported adherence in HIV+ people according to type of HAART dosing (STR, OD with more than one pill or BID). To limit reporting biases, the study was performed in five different non-clinic settings covering North and Central Italy. A total of 230 patients on stable HAART were asked to complete a semi-structured, anonymous questionnaire reporting their attitude toward HAART, their adherence and the acceptability of their regimen. Self-perception of adherence was also investigated with a single item for comparison with real adherence behavior. Most of the subjects were males (66%) with a mean age of 46 years, with higher education level (72%) and a long history of HIV infection (mean 13.6 years). 17% of patients were on a first-line regimen. 21% reported to miss at least one dose during the past week (STR: 6%; OD >1 pill 23% and BID 21%; p 1 pill (6 and 4% vs 11%). People taking therapies other than HAART reported similar adherence levels of people taking only HAART, even when stratified for dosing groups. Even people judging their adherence as 'optimal' or 'very good', 10 and 17% respectively, reported having missed a dose during the last week. At stepwise regression model, optimal adherence was correlated to being male (OR 2.38; 95% CI 1.19-4.74), younger (OR 3.04; 95% CI 1.01-9.13) and with a shorter HIV infection (OR 3.58; 95% CI 1.04-12.38). People taking simpler once-daily STR tend to report better adherence than people taking OD >1 pill or BID. Perception of optimal adherence is largely variable among HIV-infected people taking HAART, although only a minority of subjects showing less than perfect adherence do judge their behavior as 'optimal'. (Published: 11 November 2012) Citation: Abstracts of the Eleventh International Congress on Drug Therapy in HIV Infection Murri R et al. Journal of the International AIDS Society 2012, 15 (Suppl 4):18101 http://www.jiasociety.org/index.php/jias/article/view/18101 | http://dx.doi.org/10.7448/IAS.15.6.18101

Background : Neurocognitive impairment (NCI) and HIV-associated neurocognitive disorders (HAND) remain prevalent despite HAART. We examined sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and correct classification rate (CCR) of screening tools for the detection of NCI and HAND in HAART treated patients. Methods : We examined 101 unselected HAART-treated patients. Patients were administered the self-reported three questions (EACS Guidelines), the International HIV-Dementia Scale (IHDS), the Mini-Mental Status Examination (MMSE), and a comprehensive 6-domain (17-test) neuropsychological (NP) battery (120 minutes) that included, among others, the Digit Symbol (DS), the Trail Making Modalities (TM), and the Grooved Pegboard (GP) tests. NCI was defined according to the AAN criteria. HAND was diagnosed after exclusion of confounding conditions. Results : Our cohort was relatively healthy (mean CD4 count: 575 cells/mm 3 , undetectable plasma HIV RNA 85%). Prevalence of NCI and HAND were 39.6% (40 of 101) and 30.7% (31 of 101), respectively. Mean scores of IHDS (9.9 vs 10.8; p

Purpose of the study: National guidelines recommend the routine offer of an HIV test to all acute medical admissions when the local diagnosed HIV prevalence exceeds 0.2%. We investigated the feasibility and acceptability, to staff and patients, of routinely offering HIV tests in an acute admissions unit (AAU). Supplement: Abstracts of the Tenth International Congress on Drug Therapy in HIV Infection http://www.biomedcentral.com/content/pdf/1758-2652-13-S4-info.pdf Conference: Tenth International Congress on Drug Therapy in HIV Infection 7-11 November 2010 Glasgow, UK (Published: 8 November 2010) doi:10.1186/1758-2652-13-S4-P219 Cite this article as: Cridford et al.: HIV testing in non-traditional settings: feasibility and acceptability in an acute admissions unit. Journal of the International AIDS Society 2010 13(Suppl 4):P219. Full text: PubMed Central: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3113004/

Objective: To evaluate the rate of and risk factors associated with hepatotoxicity in tuberculosis (TB) and human immunodeficiency virus type 1 (HIV-1) co-infected patients while receiving nonnucleoside reverse transcriptase inhibitors (NNRTI)-based antiretroviral therapy (ART) and rifampicin (RMP)-containing anti-TB regimens. Supplement: Abstracts of the Tenth International Congress on Drug Therapy in HIV Infection http://www.biomedcentral.com/content/pdf/1758-2652-13-S4-info.pdf Conference: Tenth International Congress on Drug Therapy in HIV Infection 7-11 November 2010 Glasgow, UK (Published: 8 November 2010) doi:10.1186/1758-2652-13-S4-P90 Cite this article as: Mankhatitham et al.: Hepatotoxicity in patients coinfected with HIV and tuberculosis while receiving NNRTI-based antiretroviral regimen and rifampicin. Journal of the International AIDS Society 2010 13(Suppl 4):P90. Full text: PubMed Central: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3113098/

Purpose of the study: To understand the relationship between HAART and preterm delivery (PTD). Methods: Analysis of prospectively collected data from all patients attending HIV antenatal services at a single UK centre 1995—2010. Fisher's exact test two tailed for categorical variables. T-test for continuous variables. Supplement: Abstracts of the Tenth International Congress on Drug Therapy in HIV Infection http://www.biomedcentral.com/content/pdf/1758-2652-13-S4-info.pdf Conference: Tenth International Congress on Drug Therapy in HIV Infection 7-11 November 2010 Glasgow, UK (Published: 8 November 2010) doi:10.1186/1758-2652-13-S4-P158 Cite this article as: Taylor et al.: High preterm delivery rates associated with initiation of HAART during pregnancy. Journal of the International AIDS Society 2010 13(Suppl 4):P158. Full text: PubMed Central: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3112936/

Atazanavir/r (ATV/r) is a recommended PI option for treating ART-naive patients in recent guidelines. TDF/FTC is the most commonly used recommended backbone in this setting. Our objectives were to compare times 1) to discontinuation of the third drug, 2) to virologic suppression (VL< 50 copies/ml), with discontinuation of the third drug considered as failure, 3) to an increase of at least 100 CD4 cells/mm 3 , with discontinuation of the third drug considered as failure, 4) to AIDS or death from any cause, with an intention to continue approach 5) to hospitalization, AIDS or death with an intention to continue approach in patients initiating with ATV/r or another recommended third drug plus TDF/FTC. Supplement: Abstracts of the Tenth International Congress on Drug Therapy in HIV Infection http://www.biomedcentral.com/content/pdf/1758-2652-13-S4-info.pdf Conference: Tenth International Congress on Drug Therapy in HIV Infection 7-11 November 2010 Glasgow, UK (Published: 8 November 2010) doi:10.1186/1758-2652-13-S4-P9 Cite this article as: Billaud et al.: Outcomes in antiretroviral-naive HIVinfected patients initiating therapy with TDF/FTC plus either atazanavir/ r or another third recommended drug. Journal of the International AIDS Society 2010 13(Suppl 4):P9. Full text: PubMed Central: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3113097/

To compare ART initiation with 2NRTI+NNRTI versus 2NRTI+PI through a retrospective analysis and incorporate these results in a cost-effectiveness analysis. Supplement: Abstracts of the Tenth International Congress on Drug Therapy in HIV Infection http://www.biomedcentral.com/content/pdf/1758-2652-13-S4-info.pdf Conference: Tenth International Congress on Drug Therapy in HIV Infection 7-11 November 2010 Glasgow, UK (Published: 8 November 2010) doi:10.1186/1758-2652-13-S4-P237 Cite this article as: Aragao et al.: Cost-effectiveness of 2NRTI+NNRTI versus 2NRTI+PI as the initial cART regimen. Journal of the International AIDS Society 2010 13(Suppl 4):P237. Full text: PubMed Central: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3113024/

There are three classes of HIV-1 based on diversity of the viral envelope: M (major), O (outlying) and N (new). The M group is subclassified into nine major subtypes including A—D, F—H, J and K, as well as several recombinant forms. There is a growing need to evaluate antiretroviral (ARV) treatment in these diverse subtypes. Supplement Abstracts of the Tenth International Congress on Drug Therapy in HIV Infection http://www.biomedcentral.com/content/pdf/1758-2652-13-S4-info.pdf Conference Tenth International Congress on Drug Therapy in HIV Infection 7-11 November 2010 Glasgow, UK doi:10.1186/1758-2652-13-S4-P30 Cite this article as: Maroldo et al.: Efficacy and safety of lopinavir/ ritonavir (LPV/r) in antiretroviral-experienced subjects infected with different subtypes of HIV-1. Journal of the International AIDS Society 2010 13(Suppl 4):P30. Full text: PubMed Central: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3113032/

The question of Highly Active Antiretroviral Treatment (HAART) simplification is important due to long term toxicity and cost of HAART. Pro-viral HIV DNA associated with Peripheral Blood Mononuclear Cells (PBMC) is a marker of the HIV reservoir which is predictive of the evolution of HIV infection. It remains the only virological quantitative marker detectable during suppressive HAART. A pro-viral DNA > 2.7log before treatment interruption is predictive of a decline of CD4 T lymphocytes after interruption. Supplement: Abstracts of the Tenth International Congress on Drug Therapy in HIV Infection http://www.biomedcentral.com/content/pdf/1758-2652-13-S4-info.pdf Conference: Tenth International Congress on Drug Therapy in HIV Infection 7-11 November 2010 Glasgow, UK (Published: 8 November 2010) doi:10.1186/1758-2652-13-S4-P143 Cite this article as: Zucman et al.: Pro-viral DNA and antiretroviral treatment simplification. Journal of the International AIDS Society 2010 13 (Suppl 4):P143. Full text: PubMed Central: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3112920/

Background: MVC is the first-in-class CCR5 antagonist approved for use in treatment of CCR5-tropic (R5) HIV-1 infection; however, there is limited experience with MVC in regimens containing newer PIs and other new agents. This open-label 96-week multi-center study evaluates MVC in a variety of regimens to obtain additional safety and efficacy data in TE patients with limited options due to intolerance or resistance in Brazil. Supplement: Abstracts of the Tenth International Congress on Drug Therapy in HIV Infection http://www.biomedcentral.com/content/pdf/1758-2652-13-S4-info.pdf Conference: Tenth International Congress on Drug Therapy in HIV Infection 7-11 November 2010 Glasgow, UK (Published: 8 November 2010) doi:10.1186/1758-2652-13-S4-P105 Cite this article as: Furtado et al.: Safety and efficacy of maraviroc (MVC) combined with multiple different therapeutic agents in highly treatmentexperienced (TE) patients in Brazil. Journal of the International AIDS Society 2010 13(Suppl 4):P105. Full text: PubMed Central: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3112879/

The FDA TLOVR algorithm has been commonly used to assess virologic response to antiretroviral (ARV) regimens. The FDA Snapshot algorithm has been proposed to replace the TLOVR algorithm, as it is simpler and is expected to yield similar results. Multiple studies determined that efficacy of LPV/r dosed once-daily (QD) + nucleoside reverse transcriptase inhibitors (NRTIs) was statistically similar to LPV/r dosed twice-daily (BID) + NRTIs using the FDA TLOVR algorithm. The purpose of the analyses presented here is to compare the TLOVR and Snapshot algorithms in the context of studies evaluating QD vs. BID LPV/r-based regimens. Supplement: Abstracts of the Tenth International Congress on Drug Therapy in HIV Infection http://www.biomedcentral.com/content/pdf/1758-2652-13-S4-info.pdf Conference: Tenth International Congress on Drug Therapy in HIV Infection 7-11 November 2010 Glasgow, UK (Published: 8 November 2010) doi:10.1186/1758-2652-13-S4-P58 Cite this article as: Qaqish et al.: A comparison of the FDA TLOVR and FDA Snapshot algorithms based on studies evaluating once-daily vs. twice daily lopinavir/ritonavir (LPV/r) regimens. Journal of the International AIDS Society 2010 13(Suppl 4):P58. Full text: PubMed Central: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3113062/

Purpose of the study: The Antiretroviral Pregnancy Registry (APR) is an international collaborative operation which utilizes a prospective exposure-registration design to study antiretroviral (ARV) drug exposures during pregnancy. This study assessed the potential for human teratogenic risk of atazanavir (ATV), a protease inhibitor used to treat HIV infection in combination with other ARV agents. ATV exposures are increasingly reported to the APR in this population, reinforcing the need to better understand the risk of birth defects. Supplement: Abstracts of the Tenth International Congress on Drug Therapy in HIV Infection http://www.biomedcentral.com/content/pdf/1758-2652-13-S4-info.pdf Conference: Tenth International Congress on Drug Therapy in HIV Infection 7-11 November 2010 Glasgow, UK (Published: 8 November 2010) doi:10.1186/1758-2652-13-S4-P113 Cite this article as: Esker et al.: Assessing the risk of birth defects associated with atazanavir exposure in pregnancy. Journal of the International AIDS Society 2010 13(Suppl 4):P113. Full text: PubMed Central: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3112888/

Purpose of the study: The clinical course of HIV/AIDS and pattern of opportunistic infections vary from patient to patient and from country to country. Hence, we aimed to study clinical presentation of HIV/AIDS patients according to their first admission sequence to our outpatient clinic. Supplement: Abstracts of the Tenth International Congress on Drug Therapy in HIV Infection http://www.biomedcentral.com/content/pdf/1758-2652-13-S4-info.pdf Conference: Tenth International Congress on Drug Therapy in HIV Infection 7-11 November 2010 Glasgow, UK (Published: 8 November 2010) doi:10.1186/1758-2652-13-S4-P220 Cite this article as: Aydin Altuntas et al.: Clinical profile of HIV/AIDS patients admitted to a tertiary outpatient clinic in Istanbul, Turkey. Journal of the International AIDS Society 2010 13(Suppl 4):P220. Full text: PubMed Central: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3113006/

ODIN was a Phase IIIb, randomised, open-label trial showing non-inferiority of DRV/r 800/100mg qd vs 600/100mg bid (+ ≥2 NRTIs) in treatment-experienced HIV-1-infected adults with no DRV resistance-associated mutations at screening. We evaluated the effect of demographic and baseline (BL) disease parameters on virological response (VR) of qd vs bid DRV/r at Week 48. Supplement: Abstracts of the Tenth International Congress on Drug Therapy in HIV Infection http://www.biomedcentral.com/content/pdf/1758-2652-13-S4-info.pdf Conference: Tenth International Congress on Drug Therapy in HIV Infection 7-11 November 2010 Glasgow, UK (Published: 8 November 2010) doi:10.1186/1758-2652-13-S4-P25 Cite this article as: Sension et al.: Influence of demographic and disease parameters on virological response to once- vs twice-daily darunavir/ ritonavir (DRV/r) at week 48 in ODIN. Journal of the International AIDS Society 2010 13(Suppl 4):P25. Full text: PubMed Central: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3113026/

Nephrotoxicity of tenofovir (TDF)-containing HAART may be associated to several factors related to treatment or to patient's characteristics. We tried to assess Glomerular Filtration Rate (GFR) changes and their relationship with multiple clinical parameters in an Italian cohort receiving a TDF-containing HAART. Supplement: Abstracts of the Tenth International Congress on Drug Therapy in HIV Infection http://www.biomedcentral.com/content/pdf/1758-2652-13-S4-info.pdf Conference: Tenth International Congress on Drug Therapy in HIV Infection 7-11 November 2010 Glasgow, UK (Published: 8 November 2010) doi:10.1186/1758-2652-13-S4-P84 Cite this article as: Uglietti et al.: Smoking, female gender and PI use are associated with decreasing renal function in TDF-containing HAART. Journal of the International AIDS Society 2010 13(Suppl 4):P84. Full text: PubMed Central: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3113091/

Background: Despite improved access to life-saving antiretroviral drugs, HIV associated mortality remains high in most settings in sub-Saharan Africa. Several studies have shown remarkable temporal distribution of these mortality figures, with a disproportionately higher number of patients dying within the first few months of commencing HAART. Supplement: Abstracts of the Tenth International Congress on Drug Therapy in HIV Infection http://www.biomedcentral.com/content/pdf/1758-2652-13-S4-info.pdf Conference: Tenth International Congress on Drug Therapy in HIV Infection 7-11 November 2010 Glasgow, UK (Published: 8 November 2010) doi:10.1186/1758-2652-13-S4-P221 Cite this article as: Dashe: Aetiologies and factors associated with mortality among HIV-infected patients at Taraba State Specialist Hospital, Jalingo, Nigeria. Journal of the International AIDS Society 2010 13 (Suppl 4):P221. Full text: PubMed Central: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3113007/

Background: A4001078 is a study in therapy naive patients of Maraviroc (MVC) plus boosted atazanavir. The Trofile ES (ESTA) was used to determine tropism at Screening. Few re-analyses of genotypic tropism have examined all screened and non-reportable (NR) populations. We aimed to define correlations between methods at screening and evaluate the quantity of X4 using virus in discordant results using ultra-deep sequencing (UDS). Supplement: Abstracts of the Tenth International Congress on Drug Therapy in HIV Infection http://www.biomedcentral.com/content/pdf/1758-2652-13-S4-info.pdf Conference: Tenth International Congress on Drug Therapy in HIV Infection 7-11 November 2010 Glasgow, UK (Published: 8 November 2010) doi:10.1186/1758-2652-13-S4-P128 Cite this article as: Portsmouth et al.: Population and ultra-deep sequencing for tropism determination are correlated with Trofile ES: genotypic re-analysis of the A4001078 maraviroc study. Journal of the International AIDS Society 2010 13(Suppl 4):P128. Full text: PubMed Central: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3112903/

Purpose of the study: Medication adherence is crucial for successful Highly Active Antiretroviral Treatment (HAART). Adherence may be divided into execution (how dosing history corresponds to the prescribed drug dosing regimen) and persistence (the time from the first to last taken dose). Medical Electronic Monitoring System (MEMS) monitors record bottle opening events providing a graphical printout of adherence. This can be used to provide positive feedback and correct any perceptual inaccuracies as to adherence. MEMRI assesses the use of such feedback as an intervention to support adherence. The primary endpoint is based on execution. Supplement: Abstracts of the Tenth International Congress on Drug Therapy in HIV Infection http://www.biomedcentral.com/content/pdf/1758-2652-13-S4-info.pdf Conference: Tenth International Congress on Drug Therapy in HIV Infection 7-11 November 2010 Glasgow, UK (Published: 8 November 2010) doi:10.1186/1758-2652-13-S4-P120 Cite this article as: Davies et al.: Does feedback of medication execution using MEMS caps aid adherence to HAART?: the MEMRI study (MEMS as Realistic Intervention). Journal of the International AIDS Society 2010 13 (Suppl 4):P120. Full text: PubMed Central: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3112895/

Background: The UK National Guidelines for HIV Testing 2008 recommends that HIV testing should be offered to all general medical admissions where the reported prevalence of HIV is >2/1000 (1). We have previously reported that in Newcastle, 72% of new diagnoses in 2007 were late presenters (2) compared to 55% nationally. Supplement: Abstracts of the Tenth International Congress on Drug Therapy in HIV Infection http://www.biomedcentral.com/content/pdf/1758-2652-13-S4-info.pdf Conference: Tenth International Congress on Drug Therapy in HIV Infection 7-11 November 2010 Glasgow, UK (Published: 8 November 2010) doi:10.1186/1758-2652-13-S4-P168 Cite this article as: Ellis et al.: Offering HIV testing in an emergency admission unit in Newcastle upon Tyne, UK — a pilot audit study. Journal of the International AIDS Society 2010 13(Suppl 4):P168. Full text: PubMed Central: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3112947/

HIV-1-infected inmates have an increased prevalence of some particular comorbidities. However, the cardiovascular risk(CVR) of this population has rarely been evaluated. Supplement: Abstracts of the Tenth International Congress on Drug Therapy in HIV Infection http://www.biomedcentral.com/content/pdf/1758-2652-13-S4-info.pdf Conference: Tenth International Congress on Drug Therapy in HIV Infection 7-11 November 2010 Glasgow, UK (Published: 8 November 2010) doi:10.1186/1758-2652-13-S4-P67 Cite this article as: Golf et al.: Prevalence of cardiovascular risk factors in Spanish HIV-1-infected male inmates. Journal of the International AIDS Society 2010 13(Suppl 4):P67. Full text: PubMed Central: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3113072/

Introduction: Death rates and causes of death in patients infected with HIV seem to be related to the kind of ARV therapy they have been treated with and have altered the causes of death along the years. Supplement: Abstracts of the Tenth International Congress on Drug Therapy in HIV Infection http://www.biomedcentral.com/content/pdf/1758-2652-13-S4-info.pdf Conference: Tenth International Congress on Drug Therapy in HIV Infection 7-11 November 2010 Glasgow, UK (Published: 8 November 2010) doi:10.1186/1758-2652-13-S4-P222 Cite this article as: Mendez et al.: Causes of death in patients infected with HIV from 1985 to 2008. Journal of the International AIDS Society 2010 13(Suppl 4):P222. Full text: PubMed Central: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3113008/