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INTRODUCTION Unhealthy alcohol use is common among persons with HIV (PWH) [1]. Sub‐Saharan Africa (SSA) is home to 68% of the 34 million PWH worldwide [2] and has the highest [...], : Introduction: Unhealthy alcohol use significantly contributes to viral non‐suppression among persons with HIV (PWH). It is unknown whether brief behavioural interventions to reduce alcohol use can improve viral suppression among PWH with unhealthy alcohol use in sub‐Saharan Africa (SSA). Methods: As part of the SEARCH study (NCT04810650), we conducted an individually randomized trial in Kenya and Uganda of a brief, skills‐based alcohol intervention among PWH with self‐reported unhealthy alcohol use (Alcohol Use Disorders Identification Test–Consumption [AUDIT‐C], prior 3 months, ≥3/female; ≥4/male) and at risk of viral non‐suppression, defined as either recent HIV viral non‐suppression (≥400 copies/ml), missed visits, out of care or new diagnosis. The intervention included baseline and 3‐month in‐person counselling sessions with interim booster phone calls every 3 weeks. The primary outcome was HIV viral suppression ( Results: Between April and September 2021, 401 persons (198 intervention, 203 control) were enrolled from HIV clinics in Uganda (58%) and Kenya (27%) and alcohol‐serving venues in Kenya (15%). At baseline, 60% were virally suppressed. Viral suppression did not differ between arms at 24 weeks: suppression was 83% in intervention and 82% in control arms (RR: 1.01, 95% CI: 0.93–1.1). Among PWH with baseline viral non‐suppression, 24‐week suppression was 73% in intervention and 64% in control arms (RR 1.15, 95% CI: 0.93–1.43). Unhealthy alcohol use declined from 98% at baseline to 73% in intervention and 84% in control arms at 24 weeks (RR: 0.86, 95% CI: 0.79–0.94). Effects on unhealthy alcohol use were stronger among women (RR 0.70, 95% CI: 0.56–0.88) than men (RR 0.93, 95% CI: 0.85–1.01) and among participants with a baseline PEth⩽200 ng/ml (RR 0.68, 95% CI: 0.53–0.87) versus >200 ng/ml (RR 0.97, 95% CI: 0.92–1.02). Conclusions: In a randomized trial of 401 PWH with unhealthy alcohol use and risk for viral non‐suppression, a brief alcohol intervention reduced unhealthy alcohol use but did not affect viral suppression at 24 weeks. Brief alcohol interventions have the potential to improve the health of PWH in SSA by reducing alcohol use, a significant driver of HIV‐associated co‐morbidities.

INTRODUCTION For people living with human immunodeficiency virus (PLHIV) on antiretroviral therapy (ART), viral load (VL) testing is the gold standard approach to timely monitor treatment effectiveness, identify virological failure [...], : Introduction: Antiretroviral therapy (ART) monitoring using viral load (VL) testing is challenging in high‐burden, limited‐resources settings. Chemokine IP‐10 (interferon gamma‐induced protein 10) strongly correlates with human immunodeficiency virus (HIV) VL. Its determination could serve to predict virological failure (VF) and to triage patients requiring VL testing. We assessed the field performance of a semi‐quantitative IP‐10 lateral flow assay (LFA) for VF screening in South Africa, and the cost‐effectiveness of its implementation in Mozambique. Methods: A cross‐sectional study was conducted between June and December 2021 in three primary health clinics in the Western Cape. Finger prick capillary blood was collected from adults on ART for ≥1 year for direct application onto the IP‐10 LFA (index test) and compared with a plasma VL result ≤1 month prior (reference test). We estimated the area under the receiver operating characteristic curves (AUC), sensitivity and specificity, to evaluate IP‐10 LFA prediction of VF (VL>1000 copies/ml). A decision tree model was used to investigate the cost‐effectiveness of integrating IP‐10 LFA combined with VL testing into the current Mozambican ART monitoring strategy. Averted disability‐adjusted life years (DALYs) and HIV acquisitions, and incremental cost‐effectiveness ratios were estimated. Results: Among 209 participants (median age 38 years and 84% female), 18% had VF. Median IP‐10 LFA values were higher among individuals with VF compared to those without (24.0 vs. 14.6; p Conclusions: The IP‐10 LFA is an effective VF triage test for routine ART monitoring. Combining a highly sensitive, low‐cost IP‐10 LFA‐based screening with targeted VL confirmatory testing could result in significant healthcare quality improvements and cost savings in settings with limited access to VL testing.

INTRODUCTION Adolescents and young people living with HIV (AYPLHIV) continue to have the worst health outcomes of all age groups living with HIV [1]. Rates of viral suppression remain lower [...], : Introduction: Achieving sustained HIV viral suppression is a key strategy to optimize the health and wellbeing of those living with HIV. Sub‐optimal adherence to antiretroviral therapy (ART) in adolescents and young people living with HIV (AYPLHIV) in Southern Africa, due to a range of social and contextual factors, including poor mental health, has presented a substantial challenge to meeting targets aimed towards improving treatment outcomes and reducing transmission. With the increasing availability of viral load (VL) testing in Southern Africa, there is an opportunity to better understand the relationship between VL literacy, wellbeing and adherence among adolescents. Methods: We conducted qualitative interviews with 45 AYPLHIV aged 10–24 years in three districts (urban, peri‐urban and rural) in Zimbabwe between March and August 2021. The sample was purposively selected to represent a range of experiences related to HIV status disclosure, gender, marital status and treatment experience. Separate workshops were conducted with 18 healthcare workers (HCWs) and 20 caregivers to better understand existing support mechanisms to AYPLHIV accessing ART. We used thematic analysis to examine adolescent VL literacy, treatment support networks, experiences of clinic interactions, VL testing procedures and barriers to adherence. Results: VL literacy was consistently under‐developed among participants. Comprehension of phrases commonly heard during clinic visits, such as TND (target not detected) and “high” and “low” VL, were better understood by older participants. VL testing was predominantly understood as a clinical procedure that enables HCWs to monitor treatment adherence. Absent throughout the interviews were descriptions of how viral suppression improves health and quality of life, likely fosters wellbeing and enhances self‐esteem, enables participation in education and social activities, and eliminates the risk of onward transmission. Conclusions: It is imperative that we reconsider how routine VL monitoring is communicated to and understood by AYPLHIV. Reframing ART, including VL test results, in terms of the psychosocial benefits that viral suppression can generate is likely to be crucial to motivating AYPLHIV to maintain optimal treatment engagement and develop self‐management approaches as they move into adulthood. Access to accurate information tailored to individual concerns and circumstances can support AYPLHIV to achieve wellbeing.

INTRODUCTION HIV controllers naturally suppress their HIV viral load (VL) to low levels without antiretroviral treatment (ART) [1]. Elite controllers maintain VLs Previous population‐level studies have reported the prevalence of [...], : Introduction: HIV controllers have low viral loads (VL) without antiretroviral treatment (ART). We evaluated viraemic control in a community‐randomized trial conducted in Zambia and South Africa that evaluated the impact of a combination prevention intervention on HIV incidence (HPTN 071 [PopART]; 2013–2018). Methods: VL and antiretroviral (ARV) drug testing were performed using plasma samples collected 2 years after enrolment for 4072 participants who were HIV positive at the start of the study intervention. ARV drug use was assessed using a qualitative laboratory assay that detects 22 ARV drugs in five drug classes. Participants were classified as non‐controllers if they had a VL ≥2000 copies/ml with no ARV drugs detected at this visit. Additional VL and ARV drug testing was performed at a second annual study visit to confirm controller status. Participants were classified as controllers if they had VLs Results: The final cohort included 126 viraemic controllers and 766 non‐controllers who had no ARV drugs detected. The prevalence of controllers among the 4072 persons assessed was 3.1% (95% confidence interval [CI]: 2.6%, 3.6%). This should be considered a minimum estimate, since high rates of ARV drug use in the parent study limited the ability to identify controllers. Among the 892 participants in the final cohort, controller status was associated with biological sex (female > male, p = 0.027). There was no significant association between controller status and age, study country or herpes simplex virus type 2 (HSV‐2) status at study enrolment. Conclusions: To our knowledge, this report presents the first large‐scale, population‐level study evaluating the prevalence of viraemic control and associated factors in Africa. A key advantage of this study was that a biomedical assessment was used to assess ARV drug use (vs. self‐reported data). This study identified a large cohort of HIV controllers and non‐controllers not taking ARV drugs, providing a unique repository of longitudinal samples for additional research. This cohort may be useful for further studies investigating the mechanisms of virologic control.

Introduction NK cells recognize ligands presented on the surface of HIV-1-infected cells, including infection-induced self-proteins (1, 2) and possibly the viral envelope protein (3), as well as Fc regions of [...], The role of NK cells against HIV-1 infections remains to be elucidated in vivo. While humanized mouse models potentially could be used to directly evaluate human NK cell responses during HIV-1 infection, improved functional development of human NK cells in these hosts is needed. Here, we report the humanized MISTRG-6-15 mouse model, in which NK cells were quick to expand and exhibit degranulation, cytotoxicity, and proinflammatory cytokine production in nonlymphoid organs upon HIV-1 infection but had reduced functionality in lymphoid organs. Although HIV-1 infection induced functional impairment of NK cells, antiretroviral therapy reinvigorated NK cells in response to HIV-1 rebound after analytic treatment interruption. Moreover, a broadly neutralizing antibody, PGT121, enhanced NK cell function in vivo, consistent with antibody-dependent cellular cytotoxicity. Monoclonal antibody depletion of NK cells resulted in higher viral loads in multiple nonlymphoid organs. Overall, our results in humanized MISTRG-6-15 mice demonstrated that NK cells provided direct anti- HIV-1 responses in vivo but were limited in their responses in lymphoid organs.

Role of NK cells in HIV infection NK cells are innate immune effectors capable of intrinsically recognizing and clearing virally infected cells through multiple mechanisms. Epidemiological and genetic studies have [...], NK cells are an Important subset of Innate Immune effectors with antiviral activity. However, NK cell development and immune responses in different tissues during acute and chronic HIV infection in vivo have been difficult to study due to the impaired development and function of NK cells in conventional humanized mouse models. In this issue of the JCI, Sangur et al. report on a transgenic MISTRG-6-15 mouse model with human IL-6 and IL-15 knocked into the previously constructed MISTRG mice. The predecessor model was deficient in Rag2 and [gamma] chain ([gamma]c) with knock-in expression of human M-CSF, IL-3, GM-CSF, and TPO, and transgenic expression of human SIRP[alpha]. The researchers studied tissue-specific NK cell immune responses during HIV infection and clearly show that the endogenous human NK cells in the humanized mouse model suppressed HIV-1 replication in vivo. These findings provide insight into harnessing the innate immune response for clinical antiviral therapies.

PE15.01 Transient viral exposures drive humoral responses in HIV-1 post-treatment controllers L.M. Molinos-Albert (1) ; V. Lorin (2) ; V. Monceaux (3) ; A. Essat (4) ; J. Dufloo (5) [...]

P111 EmERGE: feasibility and uptake of a co-designed digital health supported pathway of care for people living with medically stable HIV J Whetham (1); C Jones (2); S Bremner (2); [...]

P074 NAFLD with significant fibrosis in people living with HIV informs the natural history of cardiovascular disease J Milic (1); A Cervo (2); F Carli (3); G Ciusa (3); M [...]

INTRODUCTION Sub?Saharan Africa (SSA) as a region is experiencing significant demographic shifts [1]. Compared to other regions of the world, SSA has a smaller proportion of older aged persons as [...], : Introduction: With improved HIV treatment availability in sub?Saharan Africa, the population of older people with HIV (PWH) is growing. In this qualitative study, we intended to understand (1) the lived experiences of ageing people in rural Uganda, with and without HIV, (2) their fears and health priorities as they grow older. Methods: We conducted 36 semi?structured interviews with individuals with and without HIV in Mbarara, Uganda from October 2019 to February 2020. Interview guide topics included priorities in older age, physical functioning in daily activities, social functioning, HIV?related stigma and the impact of multimorbidity on health and independence. Interviews were conducted in Runyankole, transcribed, translated and inductively coded thematically by two researchers with tests for inter?coder reliability. Results: The respondents were purposively sampled to be evenly divided by sex and HIV serostatus. The median age of respondents was 57 (49?73). Two?thirds were married or cohabitating, 94% had biological children and 75% cited farming as their primary livelihood. Overall, PWH considered themselves as healthy or healthier than people without HIV (PWOH). PWH rarely considered their HIV status a barrier to a healthy life, but some reported a constant sense of anxiety as it relates to their long?term health. Irrespective of HIV status, nearly all respondents noted concerns about memory loss, physical pain, reductions in energy and the effect of these changes on their ability to complete physical tasks like small?scale farming, and activities of daily living important to the quality of life, such as participating in community groups. Increasing reliance on others for social, physical and financial support was also a common theme. The most prevalent health concern among participants involved the threat of non?communicable diseases and perceptions that physical functioning may diminish. Conclusions: In rural Uganda, we found that PWH consider themselves to be healthy and do not anticipate a different ageing experience from PWOH. Common priorities shared by both groups included the desire for physical and financial independence, health maintenance and social support for daily functioning and social needs. Entities supporting geriatric care in Uganda would benefit from attention to concerns about functional limitations and reported needs as people age with and without HIV.

INTRODUCTION Resilience, defined as positive adaptation in the context of risk or adversity [1, 2], is instrumental to the quality of life and attainment of goals in young adulthood, particularly [...], : Introduction: Medical challenges, including perinatally acquired HIV (PHIV), can be considered adversity with the potential to compromise individuals? ability to meet societal expectations across the lifespan. Studies suggest that resilience, defined as positive adaptation in the context of adversity, helps individuals overcome challenges and improve their quality of life. Few longitudinal studies have examined resilience in young adults with perinatally acquired HIV (YAPHIV) or perinatal HIV exposure, uninfected (YAPHEU). We examined three young adult milestones, which can affect the life?long quality of life, as markers of resilience: high school graduation, postsecondary education and current employment. Methods: Analyses included YAPHIV and YAPHEU, ages 19?27 years, followed in longitudinal cohort studies: Pediatric HIV/AIDS Cohort Study Adolescent Master Protocol (AMP) (7?17 years) and AMP Up (?18 years). Factors known to influence the attainment of milestones (outcomes) were examined: executive function, cognitive efficiency (working memory and processing speed), behavioural/social?emotional functioning, parent/caregiver mental/physical health and cumulative risk. HIV disease markers for YAPHIV were examined. The most recent AMP assessment was used for each factor; outcomes were measured at AMP Up 1?year follow?up. Separate robust Poisson regression models were used to assess associations of each factor with each outcome; PHIV status was explored as an effect modifier of each association. Results: Participants (N = 315; YAPHIV = 228): 58% female, 67% Black and 27% Hispanic. Compared to YAPHEU, YAPHIV were older and from families with higher median income and fewer symptoms of parent/caregiver mental health/substance use disorders. Proportions of YAPHIV and YAPHEU, respectively, who achieved each milestone were comparable: 82% versus 78% for high school graduation (p = 0.49), 45% versus 51% for postsecondary education (p = 0.35) and 48% versus 54% for current employment (p = 0.32). Higher cognitive efficiency was positively associated with postsecondary education and current employment. Higher executive function, age?appropriate behavioural/social?emotional functioning and lower cumulative risk were associated with academic milestones. Among YAPHIV, positive associations were: higher current CD4 with postsecondary education and lower nadir CD4 with current employment. PHIV status did not modify any association. Conclusions: YAPHIV and YAPHEU demonstrated resilience, attaining at least one young adult milestone. Cognitive, behavioural and social resources to support resilience in childhood and adolescence may provide the foundation for continued achievement throughout adulthood.

Introduction HIV-1 cure is a global health priority. Although an HIV-1 cure is possible, there are multiple challenges that hinder the design of a durable cure (1). Long-lived cellular reservoirs [...], Long-lived HIV-1 reservoirs that persist despite antiretroviral therapy (ART) are a major impediment to a cure for HIV- 1. We examined whether human liver macrophages (LMs), the largest tissue macrophage population, comprise an HIV-1 reservoir. We purified LMs from liver explants and included treatment with a T cell immunotoxin to reduce T cells to 1% or less. LMs were purified from 9 HIV-1-infected persons, 8 of whom were on ART (range 8-140 months). Purified LMs were stimulated ex vivo and supernatants from 6 of 8 LMs from persons on ART transmitted infection. However, HIV-1 propagation from LMs was not sustained except in LMs from 1 person taking ART for less than 1 year. Bulk liver sequences matched LM-derived HIV- 1 in 5 individuals. Additional in vitro experiments undertaken to quantify the decay of HIV-1-infected LMs from 3 healthy controls showed evidence of infection and viral release for prolonged durations (>170 days). Released HIV-1 propagated robustly in target cells, demonstrating that viral outgrowth was observable using our methods. The [t.sub.1/2] of HIV-1-infected LMs ranged from 3.8-55 days. These findings suggest that while HIV-1 persists in LMs during ART, it does so in forms that are inert, suggesting that they are defective or restricted with regard to propagation.

INTRODUCTION Until COVID?19, tuberculosis (TB) was the leading infectious disease killer globally, including among people with HIV [1], who are disproportionally affected by TB [2,3]. In 2019, at least 1.2 [...], : Introduction: Until COVID?19, tuberculosis (TB) was the leading infectious disease killer globally, disproportionally affecting people with HIV. The COVID?19 pandemic is threatening the gains made in the fight against both diseases. Discussion: Although crucial guidance has been released on how to maintain TB and HIV services during the pandemic, it is acknowledged that what was considered normal service pre?pandemic needs to improve to ensure that we rebuild person?centred, inclusive and quality healthcare services. The threat that the pandemic may reverse gains in the response to TB and HIV may be turned into an opportunity by pivoting to using proven differentiated service delivery approaches and innovative technologies that can be used to maintain care during the pandemic and accelerate improved service delivery in the long term. Models of care should be convenient, supportive and sufficiently differentiated to avoid burdensome clinic visits for medication pick?ups or directly observed treatments. Additionally, the pandemic has highlighted the chronic and short?sighted lack of investment in health systems and the need to prioritize research and development to close the gaps in TB diagnosis, treatment and prevention, especially for children and people with HIV. Most importantly, TB?affected communities and civil society must be supported to lead the planning, implementation and monitoring of TB and HIV services, especially in the time of COVID?19 where services have been disrupted, and to report on legal, policy and gender?related barriers to access experienced by affected people. This will help to ensure that TB services are held accountable by affected communities for delivering equitable access to quality, affordable and non?discriminatory services during and beyond the pandemic. Conclusions: Successfully reaching the related targets of ending TB and AIDS as public health threats by 2030 requires rebuilding of stronger, more inclusive health systems by advancing equitable access to quality TB services, including for people with HIV, both during and after the COVID?19 pandemic. Moreover, services must be rights?based, community?led and community?based, to ensure that no one is left behind.

INTRODUCTION The success of combination antiretroviral therapy (ART) in relation to survival and quality of life in patients with HIV has led HIV researchers to pursue new avenues toward finding [...], : Introduction: Elite controllers (EC) are a rare group of HIV?1?positive individuals who suppress viral loads (VL) to undetectable levels with elevated CD4 T?cell counts in the absence of ART. While rates of short? and mid?term progression have been described in these patients, few studies have focused on their long?term outcome This study aims to describe the virological and immunological behaviour in a cohort of elite controllers followed up for a median of 17 years in the University Hospital, and to identify factors that may be related to disease progression. Methods: We conducted a descriptive, prospective and single?centre study of all HIV?positive adults recorded in the University Hospital database who met the definition criteria for EC. EC were defined as patients having two consecutive undetectable VL without ART for at least one year. Patients were followed from baseline up to December 2019, to the development of a progression event (loss of VL control, CD4+ T cell decline, AIDS or death) or to the censoring date (lost to follow?up or initiation of ART). Predictive models of progression were calculated. Results: Fifty?nine EC were identified with a median follow?up of 17 years contributing 1033 PYFU. The median (95% CI) time duration from HIV?1 diagnosis to disease progression was four (1.7 to 6.3) years. Forty?nine (83%) presented progression to the composite end?point, 44 (74.6%) lost viral control, 39 (66.1%) lost immunological control, two developed AIDS and two died. Only 10 patients (16.9%) did not show progression of any kind. Independent predictors of virological progression were sexual risk of HIV?1 acquisition and VL blips during the first year of follow?up (baseline). The only independent predictor detected for progression to a composite end?point was VL blips during the first year of follow?up (baseline). Conclusions: The rate of long?term progression in EC was very high. Only a minority of patients did not show clinical progression after a median of 17 years of follow?up. These results should be taken in account when considering EC as a model of HIV?1 remission.

INTRODUCTION A tenacious driver of the higher rates of morbidity and mortality amongst adolescents living with HIV (ALHIV) is suboptimal adherence to HIV treatment [1?4] Although the global target is [...], : Introduction: Low rates of viral suppression among adolescents living with HIV (ALHIV) indicate that more effective support is urgently required at scale. The provision of peer support has generated considerable enthusiasm because it has the potential to ameliorate the complex social and relational challenges which underpin suboptimal adherence. Little is known about the impact on young peer supporters themselves, which is the focus of this paper. Methods: We present qualitative findings from the Zvandiri trial investigating the impact of a peer support intervention on the viral load for beneficiaries (ALHIV, aged 13 to 19 years) in Zimbabwe. The Zvandiri peer supporters aged 18 to 24 years, known as community adolescent treatment supporters (CATS), are themselves living with HIV. Individual in?depth interviews were conducted in late 2018 with 17 CATS exploring their experiences of delivering peer support and their own support needs. Interviews were analysed iteratively using thematic analysis. Results: The CATS reported that being peer supporters improved their own adherence behaviour and contributed to an improved sense of self?worth. The social connections between the CATS were a source of comfort and enabled them to develop skills to manage the challenging aspects of their work. Two substantial challenges were identified. First, their work may reveal their HIV status. Second, managing the emotional labour of this caring work; given how commonly the complexity of the beneficiaries? needs mirrored the circumstances of their own difficult lives. Both challenges were ameliorated by the support the CATS provided to each other and ongoing supervision from the adult mentor. There was variation in whether they felt their roles were appropriately valued through the remuneration they received and within the health system. There was a consensus that their experience meant that they would graduate from being a CATS with transferable skills that could enhance their employability. Conclusions: Their experiences illustrate the advantages and opportunities of being a CATS. To minimize potential harms, it is vital to ensure that they feel valued in their role, which can be demonstrated by the provision of appropriate remuneration, recognition and respect, and that there is continued investment in ongoing support through ongoing training and mentoring.

INTRODUCTION The first case of coronavirus disease 2019 (COVID?19), caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS?CoV?2) was reported in Wuhan, China in December 2019 [1]. Within months, the [...], : Introduction: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS?CoV?2) has infected >6 million people worldwide since December 2019. Global reports of HIV/SARS?CoV?2 coinfection are limited. To better understand the impact of the coronavirus disease 2019 (COVID?19) pandemic on persons with HIV and improve their care, we present an outpatient and inpatient clinical experience of HIV/SARS?CoV?2 coinfection from Rhode Island, US. Methods: We describe outpatient and inpatient preparedness for the COVID?19 pandemic, and present a case series of all known patients with HIV/SARS?CoV?2 coinfection at The Miriam Hospital and Rhode Island Hospital, and The Miriam Hospital Infectious Diseases and Immunology Center, in Providence, Rhode Island, US. Results and discussion: The Infectious Diseases and Immunology Center rapidly prepared for outpatient and inpatient care of persons with HIV and SARS?CoV?2. Between 30 March and 20 May 2020, 27 patients with HIV were diagnosed with SARS?CoV?2. Twenty were male, six female and one transgender female; average age was 49 years; 13/27 were Hispanic and 6/27 were African American. All had HIV viral load Conclusions: We highlight challenges of outpatient and inpatient HIV care in the setting of the COVID?19 pandemic and present the largest detailed case series to date from the United States on HIV/SARS?CoV?2 coinfection, adding to limited global reports. The aggregated clinical findings suggest that the clinical presentation and outcomes of COVID?19 appear consistent with those without HIV. Whether SARS?CoV?2 infection is more frequent among persons with HIV remains to be determined. More data are needed as we develop our understanding of how HIV and antiretroviral therapy are affected by or have an impact on this pandemic.

As cases of COVID?19, the disease caused by the novel coronavirus (SARS?CoV?2), continue to spread globally, public health experts have warned about the devastating impact this pandemic may have on [...]

Introduction Lifelong antiretroviral therapy (ART) is crucial to optimize health outcomes for people living with HIV. Retention in care is a critical component to reaching the second and third UNAIDS [...], : Introduction: Lifelong antiretroviral therapy (ART) improves health outcomes for HIV?positive individuals, but is jeopardized by irregular clinic attendance and hence poor adherence. Loss to follow?up (LTFU) is typically defined retrospectively but this may lead to biased inferences. We assessed incidence of and factors associated with LTFU, prospectively and accounting for recurrent LTFU episodes, in the Kilombero and Ulanga Antiretroviral Cohort (KIULARCO) of HIV?positive persons in rural Tanzania. Methods: We included adults (?15 years) enrolled in 2005 to 2016, regardless of ART status, with follow?up through April 2017. LTFU was defined as >60 days late for a scheduled appointment. Participants could experience multiple LTFU episodes. We performed analyses based on the first (prospective) and last (retrospective) events observed during follow?up, and accounting for recurrent LTFU episodes. Time to LTFU was estimated using cumulative incidence functions. We assessed factors associated with LTFU using cause?specific proportional hazards, marginal means/rates, and Prentice, Williams and Peterson models. Results: Among 8087 participants (65% female, 60% aged ?35 years, 42% WHO stage 3/4, and 47% CD4 count Conclusions: LTFU episodes were common and prompt tracing efforts are urgently needed. We identified socio?demographic and clinical characteristics associated with LTFU that can be used to target tracing efforts and to help inform the design of appropriate interventions. Incidence of and risk factors for LTFU differed based on the LTFU definition applied, highlighting the importance of appropriately accounting for recurrent LTFU episodes. We recommend using a prospective definition of LTFU combined with recurrent event analyses in cohorts where repeated interruptions in care are common.

Author(s): Peter Rusert [1]; Roger D Kouyos [1, 2]; Claus Kadelka [1, 2]; Hanna Ebner [1]; Merle Schanz [1]; Michael Huber [1]; Dominique L Braun [1, 2]; Nathanael Hozé [3]; [...], Broadly neutralizing antibodies (bnAbs) are a focal component of HIV-1 vaccine design, yet basic aspects of their induction remain poorly understood. Here we report on viral, host and disease factors that steer bnAb evolution using the results of a systematic survey in 4,484 HIV-1-infected individuals that identified 239 bnAb inducers. We show that three parameters that reflect the exposure to antigen--viral load, length of untreated infection and viral diversity--independently drive bnAb evolution. Notably, black participants showed significantly (P = 0.0086-0.038) higher rates of bnAb induction than white participants. Neutralization fingerprint analysis, which was used to delineate plasma specificity, identified strong virus subtype dependencies, with higher frequencies of CD4-binding-site bnAbs in infection with subtype B viruses (P = 0.02) and higher frequencies of V2-glycan-specific bnAbs in infection with non-subtype B viruses (P = 1 x 10[sup.-5]). Thus, key host, disease and viral determinants, including subtype-specific envelope features that determine bnAb specificity, remain to be unraveled and harnessed for bnAb-based vaccine design.

Author(s): Katherine M Bruner [1]; Alexandra J Murray [1]; Ross A Pollack [1]; Mary G Soliman [1]; Sarah B Laskey [1]; Adam A Capoferri [1, 2]; Jun Lai [1]; Matthew [...]

The main mechanisms that hinder HIV-1 eradication despite effective ART are the existence of long-lived latently-HIV-1-infected resting memory CD4 T cells and/or the existence of residual virus replication that replenishes [...], The mechanisms responsible for the persistence of HIV-1 after many years of suppressive antiretroviral therapy (ART) have been only partially elucidated. Most of the studies investigating HIV-1 persistence have been performed with blood, although it is well known that germinal centers (GCs) within lymph nodes (LNs) serve as primary sites for HIV-1 replication. We sought to identify the memory CD4 T cell populations in blood and LNs that are responsible for the production of replication-competent and infectious HIV-1, as well as for active and persistent virus transcription in ART-treated (for 1.5-14.0 years), aviremic (

Background: Elevated maternal viral load (VL) increases HIV transmission risk for breastfeeding infants. We describe results from a non-blinded randomized controlled trial in Johannesburg comparing three-monthly point-of-care (POC) VL testing [...]

Background: The persistence of the viral reservoir is the main barrier to curing HIV. Initiation of ART during primary HIV infection can limit the size and diversity of the viral [...]

Background: Vesatolimod (VES), an oral TLR7 agonist, induces interferon-stimulated genes and circulating cytokines in a dose-dependent manner in healthy volunteers and PWH on ART. In a Phase 1b trial of [...]

Introduction There is a growing cohort of adolescents and young adults living with HIV (AYLH), largely due to the increasing number of children with perinatally acquired HIV surviving into adolescence [...], : Introduction: As adolescents and young people living with HIV (AYLH) age, they face a ?transition cascade,? a series of steps associated with transitions in their care as they become responsible for their own healthcare. In high?income countries, this usually includes transfer from predominantly paediatric/adolescent to adult clinics. In sub?Saharan Africa, paediatric HIV care is mostly provided in decentralized, non?specialist primary care clinics, where ?transition? may not necessarily include transfer of care but entails becoming more autonomous for one's HIV care. Using different age thresholds as proxies for when ?transition? to autonomy might occur, we evaluated pre? and post?transition outcomes among AYLH. Methods: We included AYLH aged Results: A total of 5516 AYLH from 16 sites were included at ?transition? age 16 (transition?16y), 3864 at 18 (transition?18y), 1463 at 20 (transition?20y) and 440 at 22 years (transition?22y). At transition?18y, in the 12 months pre? and post?transition, 83% versus 74% of AYLH had no gap in care (difference 9.3 (95% confidence interval (CI) 7.8 to 10.9)); while 65% versus 62% were virally suppressed (difference 2.7 (?1.0 to 6.5%)). The strongest predictor of being retained post?transition was having no gap in the preceding year, across all transition age thresholds (transition?16y: adjusted risk ratio (aRR) 1.72; 95% CI (1.60 to 1.86); transition?18y: aRR 1.76 (1.61 to 1.92); transition?20y: aRR 1.75 (1.53 to 2.01); transition?22y: aRR 1.47; (1.21 to 1.78)). Conclusions: AYLH with gaps in care need targeted support to prevent non?retention as they take on greater responsibility for their healthcare. Interventions to increase virologic suppression rates are necessary for all AYLH ageing to adulthood.

Introduction Combination antiretroviral therapy (cART) has revolutionized the care of HIV-infected individuals (1). Although cART effectively suppresses virus replication and prevents morbidity and mortality from HIV-related complications, cART regimens do [...], A substantial research effort has been directed to identifying strategies to eradicate or control HIV infection without a requirement for combination antiretroviral therapy (cART). A number of obstacles prevent HIV eradication, including lowlevel viral persistence during cART, long-term persistence of HIV-infected cells, and latent infection of resting [CD4.sup.+] T cells. Mechanisms of persistence remain uncertain, but integration of the provirus into the host genome represents a central event in replication and pathogenesis of all retroviruses, including HIV. Analysis of HIV proviruses in [CD4.sup.+] lymphocytes from individuals after prolonged cART revealed that a substantial proportion of the infected cells that persist have undergone clonal expansion and frequently have proviruses integrated in genes associated with regulation of cell growth. These data suggest that integration may influence persistence and clonal expansion of HIV-infected cells after cART is introduced, and these processes may represent key mechanisms for HIV persistence. Determining the diversity of host genes with integrants in HIV-infected cells that persist for prolonged periods may yield useful information regarding pathways by which infected cells persist for prolonged periods. Moreover, many integrants are defective, and new studies are required to characterize the role of clonal expansion in the persistence of replication-competent HIV.

HIV persistence Since the early days of highly active antiretroviral therapy (HAART), it has been clear that, despite strong and long-lasting suppression of the virus in peripheral blood, HIV can [...], HIV persistence in patients undergoing antiretroviral therapy is a major impediment to the cure of HIV/AIDS. The molecular and cellular mechanisms underlying HIV persistence in vivo have not been fully elucidated. This lack of basic knowledge has hindered progress in this area. The in vivo analysis of HIV persistence and the implementation of curative strategies would benefit from animal models that accurately recapitulate key aspects of the human condition. This Review summarizes the contribution that humanized mouse models of HIV infection have made to the field of HIV cure research. Even though these models have been shown to be highly informative in many specific areas, their great potential to serve as excellent platforms for discovery in HIV pathogenesis and treatment has yet to be fully developed.

Targeting the latent HIV-1 reservoir: challenge for a cure Despite the efficacy of antiretroviral therapy (ART) in suppressing HIV-1 replication, there is still no cure for HIV-1 infection due to [...], While antiretroviral therapy (ART) can reduce HIV-1 to undetectable levels, the virus generally reappears if treatment is stopped. Resurgence of the virus is due to the reactivation of T cells harboring latent integrated provirus, and recent studies indicate that proliferation of these latently infected cells helps maintain the HIV-1 reservoir. In this issue of the JCI, Lee et al. evaluated [CD4.sup.+] T cell subsets to determine whether certain populations are more likely to harbor full-length, replication-competent provirus. The authors identified an enrichment of clonally expanded Th1 cells containing intact HIV-1 proviruses, suggesting that this polarized subset contributes to the persistence of the reservoir. Strategies to target these provirus-harboring cells need to be considered for future therapies aimed toward HIV-1 cure.

PU02.01 Subtle variations in HIV-1 subtype C env sequence features obtained from a slow progressing Indian donor and their association with sensitivity to neutralizing antibodies with distinct epitope specificities S. [...]

PE14.01 Broadly neutralizing plasma antibodies effective against diverse autologous circulating viruses in infants with multivariant HIV-1 infection N. Mishra (1) ; S. Sharma (1) ; A. Dobhal (1) ; S. [...]

OA13.04 I. Auchus; K. Jaradeh; A. Tang; B. Boslett and J. Marzan University of California, 360 Wellness Center, San Francisco, United States https://doi.org/10.1002/jia2.25659 Please Note: Illustration(s) are not available due [...], Background: In the United States, up to 35% of HIV primary care patients struggle to routinely attend follow-up appointments. The COVID-19 pandemic forced many institutions to transition to a tele-health-focused model of care to maintain patient and provider safety. However, it was unknown how telehealth would impact patient attendance and perceptions about their care, particularly in populations at high risk of appointment non-adherence. To understand the impact of telehealth on retention in care for a vulnerable HIV-infected population, we assessed patient perspectives of telehealth and its effect on appointment attendance. Methods: We studied patients at the UCSF 360 Wellness Center, an HIV Primary Care Clinic at the University of California, San Francisco, during the 2019 to 2020 fiscal year. To assess the effect of the city-wide shelter-in-place orders and subsequent transition to telehealth, we compared appointment attendance before and after the order. Patient perceptions were collected via anonymous survey through a secure online portal. The survey included multiple-choice questions and free-text responses. Patients who did not have portal access were reached by telephone. Responses were analyzed and coded for themes. Results: Before March 16, telehealth comprised 5.2% of all clinic visits; after, telehealth comprised 86.9% of visits. No-show rates across all in-person visits before March 16th averaged 16.5% during the prior 6 months. Telehealth visits after March 16th had a no-show rate of 13.7%. Of the 134 survey responses, 19.6% of patients reported preference for in-person visits, 9.8% reported preference for tele-health visits, and 70.7% had no preference. Perceived strengths of telehealth included: 1) improved convenience; 2) safety in avoiding other patients; and 3) increased privacy. Several disadvantages included: 1) technical barriers; 2) lack of familiarity with video visit platform; and 3) lack of human connection as compared to in-person visits. Conclusions: The majority of our respondents (80.5%) said they are equally or more likely to attend telehealth visits as compared to in-person visits, and our data demonstrated improvement in appointment attendance. We plan to continue telehealth visits as a permanent and prevalent visit option to support HIV care for our patients. To further improve the telehealth experience, patients would benefit from more robust technical support.

P094 Phylodynamics of sexually acquired HCV-3a in HIV coinfected patients in Hong Kong T Kwan (1); B Wong (2); D Chan (1); N Wong (1) and S Lee (1) (1) [...]

P072 A 10-year case series of HHV8-related diseases in an ethnically diverse HIV cohort: is human herpesvirus 8 level a clue to the underlying pathology? A Oliveira (1); N Patel [...]

O241 HIV care in the COVID-19 era: a community perspective A Von Lingen (1); J Hows (2); I Hodgson (3); R Stuikyte (4); B West (5); B Cigan (1) and [...]

O111 Fat distribution and density in people living with HIV with [greater than or equal to]5% weight gain G Guaraldi (1); S Draisci (2); J Milic (3); F Carli (4); [...]

Introduction Maternal body composition and its changes during pregnancy have an impact on women's health and their birth outcomes. The interaction of HIV/AIDS disease progression and nutrition is well established [...], We describe change in weight, midupper arm circumference (MUAC), arm muscle area (AMA) and arm fat area (AFA) in 1130 pregnant HIV-infected women with CD4 counts > 200 as part of the BAN Study (www. thebanstudy.org), a randomized, controlled clinical trial to evaluate antiretroviral and nutrition interventions to reduce mother-to-child transmission of HIV during breast feeding. In a longitudinal analysis, we found a linear increase in weight with a mean rate of weight gain of 0.27 kgs/week, from baseline (12 to 30 weeks gestation) until the last follow-up visit (32-38 weeks). Analysis of weight gain showed that 17.1% of the intervals between visits resulted in a weight loss. In unadjusted models, MUAC and AMA increased and AFA declined during late pregnancy. Based on multivariable regression analysis, exposure to the famine season resulted in larger losses in AMA [-0.08, 95% CI -0.14, -0.02; p = 0.01] while AFA losses occurred irrespective of season [-0.55, 95%: -0.95, -0.14, p = 0.01]. CD4 was associated with AFA [0.21, 95% CI 0.01, 0.41, p = .04]. Age was positively associated with MUAC and AMA. Wealth was positively associated with MUAC, AFA, and weight. While patterns of anthropometric measures among HIV-infected, pregnant women were found to be similar to those reported for uninfected women in sub-Saharan Africa, effects of the famine season among undernourished, Malawian women are of concern. Strategies to optimize nutrition during pregnancy for these women appear warranted. Keywords HIV * Pregnancy * Malawi * Seasonality * Body composition * MUAC

Background: TB preventive therapy (TPT) among people living with HIV (PLHIV) reduces the risk of developing TB disease. In Fort Portal region, data on TPT outcomes among PLHIV are scarce. [...]

Background: Tuberculosis (TB) is the commonest opportunistic infection and cause of death in patients with human immunodeficiency virus (HIV) in developing countries. Successful TB treatment outcomes are lower among HIV-infected [...]

Background: Evaluating the hepatitis C virus (HCV) care cascade can provide a benchmark to track the effectiveness of interventions and identify service gaps at the population level. This study evaluated [...]

Background: Adipose tissue (AT) is a critical regulator of metabolic health and is emerging as important in HIV. Despite this, data on the complex cellular milieu and immune regulation are [...]

Antibodies play an essential role in the protection against viral infection, acting through different effector mechanisms to prevent viral entry into host cells and eliminate infected cells. A few viruses, [...], HIV infection leads to progressive destruction of infected CD4 T cells, hypergammaglobulinemia, and loss of memory B cells. Germinal centers, which are key to memory B cell formation and protective antibody responses, are major HIV reservoirs in which the virus replicates within T follicular helper (TFH) cells. In this issue of the JCI, the Koup and Streeck groups report that chronic SIV/HIV infection promotes TFH cell accumulation, which may drive B cell dysregulation. Their discoveries suggest that HIV harnesses TFH cells to evade the antibody response.

PU03.01 Generation of HIV-specific CD4 and CD8 T-cell clones for use in HIV viral inhibition assays N. Fernandez; J. Makinde; P. Hayes; L. Black; D. King and J. Gilmour IAVI [...]

OA22.03 D. Maric; T.J. Hope; M. McRaven; G. Cianci and L. Corbin Northwestern University, Cell and Developmental Biology, Chicago, United States https://doi.org/10.1002/jia2.25659 Please Note: Illustration(s) are not available due to [...], Background: The objective of this study is to characterize the early infection events using the wild-type virus at the mucosal sytes. We hypothesized that as infection progresses the infected cells will be more heterogeneous due to the recruitment of different immune cell types to the site of infection. Also we hypothesized to see differences in infected cell profiles between stratified squamous tissues of anus and simple columnar epithelia of the rectum. Methods: Twelve female rhesus macaques were challenged rectally with a mixture of a single round luciferase reporter virus and wild-type SIVmac239. Animals were sacrificed either 48-, 72- or 96 h later. Luciferase signal was used to quickly scan large areas of the tissue and hone in on small regions that likely contain infected cells. Infected cells were identified microscopically by staining for SIV viral proteins and were validated by spectral imaging and nested PCR. Results: Comprehensive phenotyping of nearly 2000 SIV infected cells revealed that the Th17 T cells infection rate does not vary much over the first 96 h. However, from 48 h to 96 h, there is a pronounced decrease in immature dendritic cells infection rate and an increase in infection of other T cell subtypes, suggesting immune cell recruitment to the site of infection. Since anorectal tissues are composed of two structurally different tissues- squamous epithelia in the anus and columnar epithelia in the rectum, we compared the infected cell phenotypes in these tissues. Much like in FRT the infected cells in the anus are mostly T cells (75%) while those in the rectum are mostly non-T cells (69%). We are currently in the process of studying if these two cell types are targeted preferentially or if targeting were solely a function of relative abundance. Conclusions: We demonstrated that early infection events at the mucosal sites are very dynamic. While certain cell types are infected at the constant rates others increase or decrease as the infection progresses. In our future work we hope to paint the full picture of the HIV/SIV sexual transmission in time and in space by developing three dimensional imaging techniques to visualize the infected cell foci and immune cell responses.

OA20.03 N. Haigwood (1); M. Shapiro (2); T. Cheever (1); S. Pandey (1); E. Mahyari (3); K. Onwuzu (3); J. Reed (4); H. Sidener (5); J. Smedley (1); L. Colgin [...], Background: Progress in preventing vertical HIV-1 transmission has stalled, with 160,000 infants infected annually. Newborns and infants exhibit higher viral loads and more rapid disease progression than adults and older children, with the lowest survival rates in those infected as newborns. While immunologic immaturity likely promotes pathogenesis and poor viral control, little is known about immune damage in infants. Neonatal immunity is distinct from that of adults in ways that are presumed to hinder newborns' ability to control viral infection. Methods: Here we examined virologic and immunologic outcomes in rhesus macaques exposed to [SHIV.sub.SF162P3] at one to two weeks or four months of age. To answer this question, we compared virologic outcomes, adaptive immune responses, frequencies and phenotypes of key leukocyte subsets, and transcriptome profiles during pathogenic SHIV infection in Newborn (one to two weeks old) and Infant (15 to 16 weeks old) rhesus macaques that were lacking the two major MHC-I alleles for post-acute viral control. Results: Although differences in plasma viremia and seeded reservoirs during acute infection were minimal, we observed age-dependent alterations in leukocyte subsets and gene expression. Compared with infants, newborns had stronger skewing of monocytes and CD8+ T cells toward differentiated subsets and little evidence of type I inter-feron responses by transcriptomic analysis. Infants had evidence of a robust antiviral program mediated by type I IFN responses. In contrast, newborns had a transcriptional signature dominated by the downregulation of genes involved in mitotic, cell cycle, and activation processes; the near-absence of a viral infection response; and upregulation of CXCL10, a biomarker of greater disease severity. Conclusions: Taken together, our findings suggest a role for defective innate defenses and elevated immune activation in age-dependent differences in pathogenesis. We conclude that SHIV, like HIV-1, wreaks greater havoc in newborns than in infants infected at older ages, reinforcing the validity of this model for understanding mechanisms of pathogenesis in vertically acquired HIV infection. Ultimately, therapeutic intervention as early as possible after birth is more likely to have a durable effect on disease progression by limiting damage to the immune system.

OA20.01 L. Romero-Martin (1); M.L Rodriguez de la Concepcion (2); J. Carrillo (2); J. Blanco (2); B. Mothe (3); M. Ruiz-Riol (2); C. Brander (2) and A. Olvera (2) (1) [...], Background: T cell populations showing a particular cytokine polarization may have a key role in inducing and maintaining effective cellular and humoral immunity to HIV. In addition to the commonly assessed Th1 and CTL responses, other T cell profiles involved in the immune response to HIV infection are not well characterized and their contribution to virus control remains unknown. Methods: Cryopreserved PBMCs from HIV-1 controllers (n = 15, median plasma HIV-1 RNA, pVL: 210 copies/mL, median CD4+ T-cell count: 786 cells/[mm.sup.3]) and non-controllers (n = 15, median pVL: 52,435 copies/mL, median CD4+ T-cell count: 406 cells/[mm.sup.3]) were stimulated with 17 peptide pools covering the entire HIV proteome. Effector function profiles of virus-specific T-cells were evaluated by "boosted flow cytometry"; a novel methodology based on labeling cytokines that characterize specific T cell profiles with the same fluorochrome (Th1/Tc1: INFg, IL-2, TNFa; Th2/Tc2: IL-4, IL-5, IL-13; Th17/Tc17: IL-17A, IL-22; Treg: IL-10, TGFb and Tfh/Tfc: IL-4, IL-21). We also evaluated the humoral response to HIV (IgM, IgA and IgG) to identify T-cell profile associated with humoral response. Finally, cellular and humoral responses correlated with respective clinical parameters (pVL, CD4 count). Results: The total magnitudes of HIV-specific CD4+ Tfh and CD8+ responses with a Tc2 or Tfc profiles were significantly higher in HIV controllers. Total Tfh/Tfc (CD4+ and CD8+) responses correlated negatively with pVL. Different polarization profiles were observed for responses targeting different HIV proteins, and overall a broader range of alternative effector functions were seen in cells from HIV controllers (Rev/Vpr/Env-specific Tc2, Pol/Env-specific Tfc and Pol-specific Tfh responses). HIV controllers also showed higher IgG responses to HIV-gp120 while their virus-specific IgM antibodies titers were lower than in HIV non-controllers. IgM titers correlated positively with pVL and negatively with HIV Tfc-specific responses. The frequency of Tfc cells correlated with the gp120-IgG/IgM ratio, supporting a possibly pivota role of those in HIV control and antibody isotype switching. Conclusions: We have identified a subpopulation of CD8+ T-cells with Tfc-like cytokine profile targeting HIV Pol and Env that correlated with pVL and antibody class switching. Further characterization of those Tfc-like cells is needed to confirm their role in natural HIV control.

OA14.02 L. Franchitti; Z. Zhang; M. Statzu; H. Wang; M. Paiardini; G. Silvestri and D. Kulpa Emory University, Department of Pathology and Experimental Medicine, Atlanta, United States https://doi.org/10.1002/jia2.25659 Please Note: [...], Background: Therapeutic strategies to reactivate the latent reservoir to facilitate clearance of HIV-infected cells have had limited success in vivo. Recent studies have demonstrated that the presence of CD8+ T cells may inhibit virus replication during treated HIV/SIV infection; however, the mechanisms responsible for this antiviral effect remain poorly understood. Methods: We used our primary cell based in vitro model of HIV latency to study the CD8+ T cell mediated suppression of HIV expression. To examine the impact of CD8+ T cells on the activity of latency reversing agents (LRA), CD4+ T cells generated in our in vitro latency model were treated with IL-15, the IL-15 superagonist N-803, or TCR stimulated in the presence or absence of activated autologous CD8+ T lymphocytes (1:1 or 1:5 target: effector ratios). To identify the phenotype of CD8+ T lymphocytes with pro-latency activity, we sorted memory and naive subsets based upon CD45RA, CD27 and CCR7 surface expression, followed by co-culture with HIV-infected CD4+ T cells. All assays were monitored for intracellular Gag expression on CD4+ T cells, and the frequency of integrated HIV DNA was determined by qPCR. Results: Treatment with LRA in the presence of activated CD8+ T lymphocytes resulted in a significant suppression of HIV latency reversal. TCR activation induced a high frequency of Gag+ cells in the monoculture (~27%, n = 8), that was reduced 3-fold at 1:1 (p = 0.0002) and 17-fold at 1:5 ratio (p < 0.0001). Treatment with IL-15 or N-803 induced a lower frequency of Gag expression in the monocultures (~4% and 3% respectively), but also showed a significant decrease in latency reversing activity in the presence of CD8+ T cells at a 1:1 (p = 0.0041; 0.005) or 1:5 (p < 0.0001) target: effector ratio. CD45RA-CD27+ CCR7+ CD8+ T cells displayed the highest suppression activity in our assays. Conclusions: Our studies demonstrated a CD8+ lymphocyte mediated suppression of HIV expression in CD4+ T cells capable of maintaining latency in the presence of activation signaling. Understanding the mechanisms by which CD8+ lymphocytes suppress virus transcription and ultimately promote HIV latency in ART-treated HIV-infected individuals may provide critical insight to the design of HIV eradication approaches.

Oral Abstracts Mo?Monday Moaa0101 A murine viral outgrowth assay to detect HIV in patients with undetectable viral loads Introduction Sensitive assays are needed for detection of residual HIV in patients [...]

Table 1: Impact of a change in HIV?1 viral load quantification assay Roche VL (copies/mL) Total no of VLs requested No of VLs per patient No of additional VLs VC [...], Introduction: Due to discontinuation of the Siemens Versant HIV?1 RNA (bDNA) assay in the UK, our laboratory switched to the Roche Cobas Ampliprep/Taqman HIV?1 viral load (VL) assay (Roche) in April 2013. This assay has a lower cut?off of 20 RNA copies/mL (compared with Methods: A retrospective cohort analysis of treated patients with stable undetectable VL by bDNA ( Results: One hundred and ninety patients were included. Demographics: 79.5% male; 60.6% homosexual; mean age of 46 years. Duration on stable treatment was 46.35 (std. dev. 38.15) months. Current treatment regimens were 43.3% PI?based; 43.3% NNRTI?based and 13.7% other. Patients were stratified into VL 20?49 copies/mL (n=109); VL 50?199 copies/mL (n=71) and VL 200?399 copies/mL (n=10). In total, there were 471 VLs measured of which 274 were additional as a result of the assay switch. This resulted in six HIV?1 genotype requests and 16 VC discussions (Table 1). Longer duration on HAART was associated with reduced frequency of VL testing. The relative risk of ongoing detectability according to drug class are: PI 1.62 (95% CI 1.18?2.21); NNRTI 0.507 (95% CI 0.30?0.85) and other 1.09 (95% CI 0.48?2.43). Conclusions: Changes in assay can result in difficulties in interpretation of patient results. The assay switch in our service had significant impact on patient and staff time and cost with an increase in patient recalls; increased frequency of VL measurement, genotypes and discussions in VC. Choice of assay is paramount to running an efficient and cost?effective clinical service.