J Int AIDS Soc
· 2026 Mar · PMID 41867101
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INTRODUCTION: The 13th IAS Conference on HIV Science, held in Kigali, Rwanda (13-17 July 2025), highlighted key advances in clinical research. Presentations focused on sustaining HIV treatment and prevention amid financi...INTRODUCTION: The 13th IAS Conference on HIV Science, held in Kigali, Rwanda (13-17 July 2025), highlighted key advances in clinical research. Presentations focused on sustaining HIV treatment and prevention amid financial constraints, innovations in long-acting oral antiretrovirals, and the management of comorbidities and co-infections, particularly tuberculosis (TB) and mpox. DISCUSSION: Significant progress was reported on long-acting oral antiretrovirals, including a weekly treatment regimen and a promising monthly option for pre-exposure prophylaxis. These strategies could expand the current antiretroviral therapy (ART) portfolio to better meet individual needs. Additionally, the use of currently available long-acting regimens in non-suppressed individuals warrants further exploration, supported by growing evidence of their potential in this clinical context. Intermittent ART, previously studied as a means to reduce toxicity, is now gaining attention as a potential cost-saving strategy. However, more research is needed to define its role across diverse settings. While data from high-income countries is encouraging, results have been less favourable in resource-limited settings and among key populations such as adolescents. Two-drug and injectable regimens, increasingly used and supported by international guidelines in high-income settings, are now being explored in resource-limited contexts and incorporated into clinical guidelines-narrowing the gap between recommendations for high- and low-income regions. As the ART portfolio evolves towards regimens without tenofovir, hepatitis B reactivation emerged as a key topic at the conference. Management of TB, a long-standing clinical challenge, was also addressed in Kigali with trial data supporting early empiric TB treatment and the safety of same-day ART initiation in selected clinical scenarios. The UNITY trial on tecovirimat for mpox treatment showed no significant clinical benefit, underscoring the need to revise current management guidelines. Research on comorbidities examined ART-associated weight gain, showing that switching ART once obesity is established has a limited impact on weight outcomes. Studies in paediatric populations highlighted predictors of treatment failure and the benefits of dolutegravir-based regimens. CONCLUSIONS: In the face of growing economic pressures, innovation in HIV treatment and prevention remains essential. The conference emphasized the importance of sustainable public health strategies and individualized care approaches to ensure continued progress in the global HIV response.
Ratevosian J, Bekker LG, Eakle R
… +39 more, Baral S, Cepeda J, Dugas L, Dybul M, Alleyne G, Eholie SP, Esom K, Grimsrud A, Havlir D, Kamarulzaman A, Kasaie P, Kazatchkine M, Kilonzo N, Klag M, Klein M, Lewin S, Luo C, Makofane K, Martin N, Mayer K, Millett G, Ntusi N, Pace L, Piot P, Poniatowski B, Daskalakis D, Pozniak A, Quinn T, Reynolds C, Rockstroh J, Sippel S, Spire B, Starrs A, Strathdee S, Schechter M, Thomson N, Vickerman P, Weir B, Beyrer C
J Int AIDS Soc
· 2026 Mar · PMID 41804038
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J Int AIDS Soc
· 2026 Mar · PMID 41786660
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INTRODUCTION: Remarkable progress has been made in response to the global HIV epidemic, yet critical gaps and inequities remain, combined with challenges stemming from the current threats to global funding, complacency a...INTRODUCTION: Remarkable progress has been made in response to the global HIV epidemic, yet critical gaps and inequities remain, combined with challenges stemming from the current threats to global funding, complacency and competing global health priorities. These constraints threaten to unravel the hard-won gains and to stall progress towards control of the HIV epidemic. In response to this rapidly changing landscape, the integration of HIV services into primary care has emerged as a potential solution to this crisis that would bring possible efficiencies and sustainability of the response. DISCUSSION: Recognition that persons with HIV often experience a range of other health challenges over their lifetime has compelled the need for integration of non-HIV services into HIV programmes to allow for delivery of comprehensive person-centred care. However, most attention at present is centred on the integration of HIV treatment into primary care, raising concerns about whether this might risk the quality of care for persons with HIV. The limited availability of primary care services that offer comprehensive and effective continuity care in many low- and middle-income countries presents a major challenge to providing such care. Nonetheless, such integration offers a historic opportunity to enhance healthcare for all people with chronic health conditions, including for persons with HIV. CONCLUSIONS: The integration of non-HIV services into HIV programming is recognized as necessary to meet the needs of persons with HIV, enhancing their quality of life and health outcomes. At the same time, the imperative for integration of HIV treatment into primary care programmes raises an important question. Can primary care programmes be transformed to allow for the provision of the necessary continuity care with the required supportive services that persons with HIV need? Accomplishing this goal may present a pathway to sustaining the HIV response in the current resource-constrained context while enabling the long-desired transformation of primary care services to effectively deliver on their potential for advancing the health of all people.
Sörstedt E, Nduva G, Månsson F
… +7 more, Mellgren Å, Repits J, Fernvik E, Stubbs A, Schroeder M, Brännström J, Carlander C
J Int AIDS Soc
· 2026 Mar · PMID 41755425
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INTRODUCTION: HIV guidelines recommend switching from a three-drug regimen (3DR) to dolutegravir + lamivudine (DTG+3TC) for eligible individuals. This retrospective national cohort study used Swedish InfCareHIV registry...INTRODUCTION: HIV guidelines recommend switching from a three-drug regimen (3DR) to dolutegravir + lamivudine (DTG+3TC) for eligible individuals. This retrospective national cohort study used Swedish InfCareHIV registry data to evaluate long-term outcomes of adults with HIV RNA <50 copies/ml who switched to DTG+3TC or a guideline-recommended 3DR between July 2019 and May 2023 in routine clinical care. METHODS: Demographic and clinical data were obtained from InfCareHIV at baseline, 6, 12, 24, 36 and 42 months post-switch. The primary endpoint was virologic failure (VF) rates at each time point; secondary endpoints included VF rates in prespecified subgroups, time to VF, and incidence of viral blips and treatment-emergent resistance. Generalized estimating equations modelling was used to assess the effects of clinical predictors on VF. RESULTS: A total of 1125 individuals (46%) switched to DTG+3TC, and 1336 (54%) switched to 3DR. Adjusted VF rates post-switch were 0.1-2.9% in the DTG+3TC group and 0.3-2.2% in the 3DR group in the intent-to-treat analysis (0-0.4% and 0.3-2.3% in the on-treatment [OT] analysis, respectively). In the OT set, the odds of VF were significantly lower for DTG+3TC versus 3DR at 24, 36 and 42 months (p<0.001). Treatment-emergent resistance rates were low in both groups. CONCLUSIONS: In this long-term, real-world, national cohort, switching to DTG+3TC was associated with low rates of VF and antiretroviral therapy resistance, indicating that eligible individuals can be switched to DTG+3TC without increased risk of VF.
Vojnov L, Bekker LG, Cohen MS
… +6 more, Jahn A, Havlir D, Boeras D, Ford N, Kumarasamy N, Broyles LN
J Int AIDS Soc
· 2026 Feb · PMID 41733000
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INTRODUCTION: Despite increasingly widespread acceptance of the (undetectable = untransmittable) U = U concept, uncertainty remains about the implications of suppressed viral loads (detected but ≤1000 copies/ml, also oft...INTRODUCTION: Despite increasingly widespread acceptance of the (undetectable = untransmittable) U = U concept, uncertainty remains about the implications of suppressed viral loads (detected but ≤1000 copies/ml, also often referred to as low-level viraemia) for both sexual HIV transmission and individual patient outcomes. DISCUSSION: There has been no documented evidence of a transmission event when the index partner had a viral load <200 copies/ml, suggesting zero risk of sexual transmission. Additionally, the risk of sexual transmission when the index partner is taking medication as prescribed and has a viral load that is detectable but suppressed (≤1000 copies/ml) is negligible. The clinical implications, including drug resistance development, of persistent low-level viraemia in people with HIV (PWH) taking dolutegravir-containing antiretroviral therapy remains limited and relatively unknown; ongoing research and surveillance will be critical to monitor expanded scale-up of optimized treatment. To support widespread access to treatment monitoring for all PWH, viral load testing should be expanded using any combination of available viral load technologies and sample types, as they can all support the primary objectives of understanding the viral load of PWH, for both prevention and treatment. CONCLUSIONS: PWH who have an undetectable or suppressed viral load should be celebrated and encouraged to maintain their treatment adherence and engagement in care, while ensuring that no remaining barriers exist for them to do so.
J Int AIDS Soc
· 2026 Feb · PMID 41732992
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INTRODUCTION: HIV remains a major global public health challenge, with nearly 1.3 million new HIV acquisitions annually. Despite the effectiveness of pre-exposure (PrEP) and post-exposure prophylaxis (PEP), barriers to a...INTRODUCTION: HIV remains a major global public health challenge, with nearly 1.3 million new HIV acquisitions annually. Despite the effectiveness of pre-exposure (PrEP) and post-exposure prophylaxis (PEP), barriers to access, initiation and adherence persist. Pharmacists, as accessible healthcare providers with medication expertise, are increasingly involved in HIV prevention. However, the scope and impact of pharmacist-led prophylaxis services have not been comprehensively synthesized. This study aimed to map and characterize the existing evidence on pharmacists' services, interventions and outcomes in HIV prophylaxis. METHODS: A scoping review was conducted with searches in Medline (PubMed), Embase, Scopus and LILACS, supplemented by grey literature (Google Scholar) until May 2025. Eligible studies included original research describing pharmacist-led clinical activities or interventions related to HIV prophylaxis. Two independent reviewers conducted study selection and data extraction. Pharmacists' roles were categorized based on the International Pharmaceutical Federation (FIP) and the Descriptive Elements of Pharmacist Intervention Characterization Tool (DEPICT) Version 2. The impacts of pharmacists on outcomes of care were categorized considering economic, clinical, humanistic and process-related outcomes. RESULTS: Out of 2736 records retrieved from searches, 26 studies published between 2014 and 2025 were included, which were conducted predominantly in the United States (n = 21). Pharmacists commonly performed direct patient care (e.g. patient counselling, PrEP/PEP prescribing, adherence monitoring, laboratory tests ordering), facilitated medication access and collaborated with other healthcare professionals via different communication methods (face-to-face, telephone, written, videoconference), especially in primary care and community pharmacies. Pharmacists' autonomy to prescribe and order laboratory tests was observed in several studies under both independent and collaborative practice models. Twenty studies reported positive process outcomes, such as increased PrEP initiation, adherence and retention, while fewer assessed clinical (n = 8), economic (n = 2) or humanistic (n = 1) outcomes. DISCUSSION: Expanding pharmacist-led services, particularly in underserved regions, represents a promising strategy to improve access, initiation and adherence to HIV prevention. Future research on economic and patient-centred outcomes is needed to inform integration of pharmacists into HIV prevention strategies. CONCLUSIONS: Pharmacists play a growing and multifaceted role in HIV prophylaxis across diverse healthcare settings. Evidence supports the expansion of pharmacist-led models through enabling legislation, reimbursement policies and interprofessional collaboration.
Beyrer C, Ratevosian J, Carpino T
… +5 more, Rosenberg NE, Gelderblom HC, Sullivan PS, Deeks SG, Gray G
J Int AIDS Soc
· 2026 Feb · PMID 41719110
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INTRODUCTION: The global HIV response, once a model of progress and innovation, faces a profound moment. Despite four decades of pivotal scientific and programmatic advances-most notably in antiretroviral therapy (ART) a...INTRODUCTION: The global HIV response, once a model of progress and innovation, faces a profound moment. Despite four decades of pivotal scientific and programmatic advances-most notably in antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP)-the world remains off track to meet the 2025 and 2030 targets for ending AIDS as a public health threat. New acquisitions and AIDS-related deaths remain unacceptably high, particularly among key populations and in low- and middle-income countries. The abrupt U.S. funding reversals in 2025 have severely disrupted support for HIV efforts. Cuts to U.S. and international institutions have compromised HIV prevention, treatment and surveillance systems worldwide, and may already have begun reversing two decades of progress. DISCUSSION: To avert this crisis, the HIV and public health community, together with governments and global funders, must urgently invest in scaling long-acting treatment and prevention tools, rebuild disaggregated data systems and strengthen implementation science rooted in community-led approaches. Digital health technologies offer promise to enhance service delivery, surveillance, monitoring and evaluation, especially in resource-constrained settings, but demand ethical governance and infrastructure investment. The global research ecosystem must become more evenly distributed and inclusive, with a shift towards country-led partnerships, national data sovereignty and regional co-operation. CONCLUSIONS: Looking to 2030 and beyond, the strategy to end HIV should include expanded access to long-acting ART and PrEP, sustained investments in HIV vaccine and cure research, and robust monitoring and evaluation systems. Achieving epidemic control-and ultimately ending the HIV pandemic-will require not only biomedical tools but also political will, community leadership and equitable financing. The lessons of the past underscore that sustained progress is possible, but only if we meet this moment with urgency, imagination and solidarity.
Erguera XA, Smith MB, Pareek P
… +15 more, Dawdani A, Dance KV, Walker RS, Grochowski J, Oskarsson J, Hickey MD, Johnson MO, Sauceda J, Gutierrez JI, Montgomery ET, Colasanti JA, Collins LF, McNulty MC, Koester KA, Christopoulos KA
J Int AIDS Soc
· 2026 Feb · PMID 41681062
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INTRODUCTION: Long-acting injectable (LAI) cabotegravir/rilpivirine (CAB/RPV) represents a breakthrough in HIV treatment. However, understanding how to optimize real-world service delivery and user experiences among peop...INTRODUCTION: Long-acting injectable (LAI) cabotegravir/rilpivirine (CAB/RPV) represents a breakthrough in HIV treatment. However, understanding how to optimize real-world service delivery and user experiences among people with HIV (PWH) remains limited. METHODS: Between August 2022 and December 2024, we conducted semi-structured interviews with PWH at four academic Ryan White-funded HIV clinics in Atlanta, Chicago and San Francisco. Eligibility criteria were current LAI-CAB/RPV use with ≥3 injections or having discontinued. Interviews were analysed using thematic analysis grounded in descriptive phenomenology. RESULTS: Among 69 participants, 48 of whom were receiving LAI-CAB/RPV and 21 who had discontinued, we identified three themes that highlighted opportunities to enhance patient-centred service delivery of LAI-CAB/RPV: (1) enhancing knowledge and self-efficacy in using oral antiretroviral therapy (ART) in cases of missed or late injections; (2) improving patient comfort and confidence, particularly regarding injection anxiety, pain management and blood draws; (3) attending to the potential evolution of patient-provider relationships, as in most cases injection visits outnumber primary care visits. In addition, PWH may experience depressive feelings upon discontinuation, even if they view it as the right decision. CONCLUSIONS: Optimizing the LAI-CAB/RPV patient journey requires developing a specialized support framework that is distinct from oral ART protocols. This new treatment modality requires a tailored approach that addresses unique challenges, including facilitating candid discussions about adherence contingencies, managing the physical and psychological aspects of injection experiences, ensuring meaningful and consistent provider relationships amid changing care patterns and providing enhanced support during treatment transitions.
Kimmel AD, Pan Z, Murenzi G
… +7 more, Brazier E, Elul B, Muhoza B, Yotebieng M, Anastos K, Nash D, Central Africa International epidemiology Databases to Evaluate AIDS (CA‐IeDEA)
J Int AIDS Soc
· 2026 Feb · PMID 41674109
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INTRODUCTION: HIV prevention and treatment supported by the United States President's Emergency Plan for AIDS Relief (PEPFAR) have saved millions of lives. Rwanda is among the most successful countries worldwide in achie...INTRODUCTION: HIV prevention and treatment supported by the United States President's Emergency Plan for AIDS Relief (PEPFAR) have saved millions of lives. Rwanda is among the most successful countries worldwide in achieving global targets with PEPFAR support. Abrupt PEPFAR funding uncertainty raises concerns about continued HIV epidemic control. We projected the impact of the Government of Rwanda's (GoR's) capacity to offset PEPFAR funding elimination on adult HIV epidemic and care continuum outcomes over 10 years. METHODS: Using an HIV policy model calibrated to Rwanda, we assessed capacity to sustain HIV services at: 50% (with no capacity by GoR to cover the PEPFAR funding gap), 75%, 90% and 100% (with full capacity by GoR to cover the gap). Scenarios involved reducing the number on antiretroviral therapy (ART), immediately discontinuing ART and proportionally decreasing HIV diagnosis, ART initiation, and care re-engagement. We projected epidemic outcomes (HIV prevalence, HIV incidence, number with HIV, new HIV infections, deaths) and care continuum outcomes (percentage diagnosed, percentage on ART among those diagnosed, percentage virally suppressed among those on ART). We calculated differences in projected outcomes for partial or no capacity versus full capacity. Secondary analyses assessed the timing of the GoR's response. RESULTS: Compared to full capacity at 10 years, the model projected a 13.9%-38.7% increase in HIV prevalence and 69.0%-246.7% increase in HIV incidence across coverage capacity scenarios. This translated to 29,000-64,000 additional adults with HIV and 20,000-92,000 cumulative new adult HIV infections. Cumulative projected deaths increased by 10,000-51,200. The model projected continual reductions in percentage diagnosed at 10 years; percentage virally suppressed among those on ART was similar across scenarios. Higher, and more delayed, coverage capacity had projected outcomes similar to lower, and less delayed, coverage capacity. Outcomes for gradual increases in coverage capacity were generally similar to or better than full, but delayed, coverage capacity. CONCLUSIONS: Even in countries like Rwanda that have achieved epidemic control, abrupt and persistent elimination of PEPFAR funding could drastically reverse critical gains. Evidence quantifying the consequences of different capacities to sustain HIV services underscores the high stakes of rapid and sufficient action.
Peay HL, Otwombe K, Barnabas S
… +15 more, Barrios-Tascon A, Lain MG, Nhampossa T, Rutebarika D, Jupimai T, Archary M, Maiga AI, Violari A, Spyer MJ, Reddy K, Palma P, Pahwa S, Lichterfeld M, Cotton M, Kuhn L
J Int AIDS Soc
· 2026 Feb · PMID 41664887
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INTRODUCTION: The development of approaches and interventions to achieve HIV remission continues to accelerate. Children living with HIV who started antiretroviral therapy (ART) at a young age and sustain viral suppressi...INTRODUCTION: The development of approaches and interventions to achieve HIV remission continues to accelerate. Children living with HIV who started antiretroviral therapy (ART) at a young age and sustain viral suppression are an ideal clinical trial population. Trials may require analytic treatment interruptions (ATIs). Paediatric trials depend on the willingness of guardians to consent to child participation, yet there are few data about guardian willingness or attitudes. Here, we investigated the opinions of guardians of children likely to be eligible for ATI trials. METHODS: Children and youth who started ART ≤ 3 months of age, and who remained well-controlled on ART older than 7 years, were recruited in South Africa, Mozambique, Uganda, Mali and Thailand. A survey was conducted among guardians of these paediatric participants. The survey utilized a vignette describing a trial with ATI and assessed attitudes and intentions (measured on 7-point scales) of the guardians regarding their children's participation in a hypothetical trial. RESULTS: Guardians of 99 children were recruited. Guardians' median age was 45 years (range 24-73) and most (89.9%) were female. The median age of the child or youth with HIV was 13.2 years (range 7-18.5 years). Most respondents endorsed a positive intention to enrol their child in a future HIV remission trial (mean 6.5 [SD:1.3] on a 7-point scale), with significant variation across the sites (p = 0.0024). Most respondents strongly endorsed a range of trial benefits, including better future HIV treatments (93.8%) and access to better care (88.0%). Some endorsed concern about the trial burden to themselves (33.3%) and the child (35.4%). Almost half strongly believed that the trial would result in the child no longer needing ART (48%) and the child being cured of HIV (46.5%). CONCLUSIONS: Across multiple countries, guardians of children and youth who were treated early were positive about participation in trials with ATI. Only a third expressed some concern about trial burden, while almost half had unrealistic expectations about potential benefits. Recruitment into trials involving ATI will need to include effective communication strategies to ensure that participants and caregivers are adequately informed about burden, potential risks and the likelihood of personal benefit.
Guillén JR, Stevenson M, Talero MÁB
… +2 more, Torres MA, Wirtz AL
J Int AIDS Soc
· 2026 Feb · PMID 41664877
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INTRODUCTION: Foreign aid provided by the United States government (USG), including support for HIV services, has been suspended or dismantled since January 2025. Early research and modelling projections have suggested s...INTRODUCTION: Foreign aid provided by the United States government (USG), including support for HIV services, has been suspended or dismantled since January 2025. Early research and modelling projections have suggested significant impacts globally and in sub-Saharan Africa. We aimed to evaluate the consequences of USG funding suspensions on community-led HIV services in Latin America and the Caribbean (LAC). METHODS: We surveyed community-led organizations providing HIV services in LAC in February-March 2025. Organization leaders were recruited through a network of HIV service organizations. Survey items measured USG funding (past 12 months) and funding sources; experiences of funding suspensions; and programmes, beneficiaries and workforce affected by funding suspensions. RESULTS: Of 40 respondent organizations, 24 (60%) had received USG funding in the past 12 months. Of the 24, 21 (87%) organizations representing 10 countries reported that they had experienced a funding suspension. These included direct and indirect funding from PEPFAR (62%), USAID (48%) and, less frequently, other USG agencies. Programmes most frequently affected by the funding freeze included sexual prevention programmes, HIV testing services, psychosocial support and humanitarian services. An estimated 156,164 beneficiaries had been receiving HIV services across respondent organizations that were affected by funding suspensions. Populations commonly served included (but were not limited to) people living with HIV, transgender people, people engaged in sex work, men who have sex with men, migrant populations and women. CONCLUSIONS: LAC HIV programmes have had comparatively less reliance on USG funding than other regions; however, they are still likely to be significantly affected by funding suspensions and the dismantling of USAID. Achievement of global HIV goals in LAC will require support from government and foreign donors, as well as collaboration with pharmaceutical companies to ensure access to biomedical HIV prevention and treatment.
Jamieson L, Rosen S, Meyer-Rath G
… +10 more, Mokhele I, Musakwa N, Imai-Eaton JW, Reed DM, Apollo T, Uetela DM, Shodell D, Ehrenkranz P, Fox MP, Closing The Gap Working Group
J Int AIDS Soc
· 2026 Feb · PMID 41664349
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INTRODUCTION: Many countries with high HIV burden have made substantial progress towards UNAIDS 95-95-95 targets and ending AIDS, but gaps in some sub-populations hinder overall achievement, even as programmes face poten...INTRODUCTION: Many countries with high HIV burden have made substantial progress towards UNAIDS 95-95-95 targets and ending AIDS, but gaps in some sub-populations hinder overall achievement, even as programmes face potentially diminished resources. While certain broad groups defined by age, sex or large geographic regions are commonly labelled as "high-risk" for being out of care, most individuals within these groups are in care and virally suppressed. Characteristics beyond age and sex (e.g. behavioural, socio-economic, smaller geographic areas) may differentiate those requiring targeted intervention strategies. Our Closing The Gap project aims to characterize unreached and disengaged sub-populations for targeted HIV interventions across Mozambique, South Africa and Zimbabwe, countries selected for their varied target achievement and diverse populations. We discuss overarching themes from the first Closing The Gap workshop, convening government stakeholders, implementers, researchers and community representatives in February 2025. DISCUSSION: Key themes emerged from the workshop: (1) the importance of considering absolute sub-population size, alongside percentages, when assessing service gaps; (2) limitations of existing data and analytic paradigms beyond age-and-sex categories, highlighting the need for richer, contextual data linked to care cascade outcomes (e.g. clinical markers, mobility, socio-economic circumstances) and analyses incorporating additional factors for identifying more granular sub-populations; (3) need to identify individuals who do not require differentiated care to better prioritize resources to those not served by existing models; and (4) in the context of decreasing funding, the need to balance the cost and complexity of differentiated interventions with the feasibility and cost-effectiveness of standardized approaches, including self-selection strategies. CONCLUSIONS: It is critically important to generate more efficient strategies to close HIV care cascade gaps and sustain positive progress amidst potentially reduced future resources towards HIV. This may need a paradigm shift in service differentiation that specifically identifies sub-populations most-at-risk of suboptimal outcomes, beyond age/sex categories, while efficiently balancing sub-population size and proportionate risk. Data-driven prioritization of cost-effective interventions targeting the unreached and underserved is essential for sustaining progress in the evolving HIV response.
Nalintya E, L Schwartz E, Nerima P
… +16 more, Fieberg A, M Najjuka S, Ajilong RE, Adzemovic T, Namakula O, Mucunguzi A, Kandole Tadeo K, Oilor M, Sekar P, Lehman A, Larson B, Dai B, Meya DB, Boulware DR, Rajasingham R, ENCORE team
J Int AIDS Soc
· 2026 Jan · PMID 41566892
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INTRODUCTION: Despite significant progress in HIV care globally, a persistent 30-40% of people present with advanced HIV disease with ≤200 CD4 cells/µl. The Visitect CD4 Advanced Disease platform is a point-of-care CD4 t...INTRODUCTION: Despite significant progress in HIV care globally, a persistent 30-40% of people present with advanced HIV disease with ≤200 CD4 cells/µl. The Visitect CD4 Advanced Disease platform is a point-of-care CD4 test being implemented in resource-limited settings. We sought to assess clinical outcomes of survival and retention-in-care among people with advanced HIV disease based on CD4 testing modality. METHODS: We performed a cluster randomized clinical trial to evaluate the Visitect CD4 compared with onsite standard laboratory-based CD4 testing. The trial was conducted at 16 outpatient HIV clinics in Uganda. Those identified with CD4≤200 cells/µl received a standardized package of care for advanced HIV disease. The primary outcome was 24-week survival with retention-in-care. A costing analysis was performed. Randomization by CD4 methodology was stopped on 18 June, 2024, as the Visitect CD4 Advanced Disease platform was being implemented widely in Uganda, and randomization to non-Visitect CD4 platforms was unethical if no alternative CD4 strategies were available in a timely manner. We conducted a micro-costing analysis to estimate the resources used for each trial participant over the 6-month study period. RESULTS: Between 5 May 2022 and 18 February 2025, 1724 participants were enrolled; 927 participants received Visitect CD4 testing (eight clusters), and 797 received standard CD4 testing (eight clusters). The composite endpoint of death or lost to follow-up occurred in 7.0% (63/901) who received Visitect CD4 testing and 7.2% (57/788) who received standard CD4 testing (hazard ratio, 0.98; 95% CI, 0.69, 1.40). The estimated risk difference between arms was 0.01% (95% CI, -2.5, 2.5). Median time to antiretroviral therapy initiation was 0 days with Visitect testing versus 7 days with standard CD4 testing (adjusted hazard ratio, 1.23; 95% CI, 1.05, 1.45). Mean cost of 6-month care was US$115 for Visitect CD4 testing versus US$131 for standard-of-care CD4 testing. CONCLUSIONS: Implementation of Visitect CD4 testing demonstrated more rapid initiation of HIV therapy with equivalent 24-week survival and retention-in-care compared with other point-of-care CD4 strategies at equivalent cost. Despite its poor specificity, the Visitect CD4 platform remains a cost-neutral option compared to standard CD4 modalities. ARTICLE SUMMARY LINE: In this cluster randomized trial, we identified that participants with advanced HIV disease who were randomized to receive the Visitect CD4 Advanced Disease platform had equivalent 24-week survival with retention-in-care compared with standard CD4 testing strategies.
Moolla H, Kassanjee R, Euvrard J
… +12 more, Maartens G, Prozesky HW, Fox MP, Orrell C, Fatti G, Tanser F, Wandeler G, Davies MA, Waal R, Nyakato P, Johnson LF, International epidemiology Databases to Evaluate AIDS Southern Africa (IeDEA‐SA) Collaboration
J Int AIDS Soc
· 2026 Jan · PMID 41555785
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INTRODUCTION: Viral suppression estimates are essential for monitoring the performance of HIV programmes. South Africa introduced dolutegravir (DTG)-based antiretroviral therapy (ART) in 2019. We sought to generate updat...INTRODUCTION: Viral suppression estimates are essential for monitoring the performance of HIV programmes. South Africa introduced dolutegravir (DTG)-based antiretroviral therapy (ART) in 2019. We sought to generate updated estimates of viral suppression in South African adults on ART and investigate predictors of viral non-suppression. METHODS: This retrospective cohort study used data from seven South African cohorts participating in the International epidemiology Databases to Evaluate AIDS collaboration. Three main analyses were performed using a viral suppression threshold of 1000 HIV RNA copies/ml. In the first analysis, we fitted a logistic regression model using the full data from the study period (2005-2023). Then, in two causal analyses, we used logistic regression with inverse probability weighting to assess the effects of starting ART on DTG-based regimens (as opposed to starting on non-DTG-based ART) and switching to DTG while virally suppressed (compared to remaining on non-DTG-based ART). In sensitivity analyses, we reduced the suppression threshold to 400 copies/ml and excluded those with missing baseline CD4+ cell count measurements. RESULTS: There were 380,720 participants contributing 2,090,912 person-years of observation. Most participants were female (64.7%), and the median age at ART initiation was 35.0 years (interquartile range 28.9-42.3). Viral suppression increased over time, reaching 95.9% in 2023. Twenty-one percent of participants either started ART on DTG-based regimens (7.1%) or switched to DTG-based regimens from a virally suppressed state (14.0%). DTG-based ART was protective against viral non-suppression in both causal models, with adjusted odds ratios of 0.54 (95% confidence interval [CI] 0.48-0.61) and 0.36 (95% CI 0.32-0.39) for those initiating ART on DTG and those switching to DTG, respectively. A history of ART interruption was strongly associated with viral non-suppression, with adjusted odds ratios ranging from 2.49 to 4.55. The odds of non-suppression decreased with increasing age, increasing duration on ART and increasing baseline CD4+ cell count. Results were consistent across sensitivity analyses. CONCLUSIONS: DTG-based regimens improve viral suppression among both ART-naïve individuals and those transitioning while suppressed. ART interruptions pose a risk to the sustained success of ART programmes and may further impede efforts to recover from the impacts of recent funding cuts.
Heitner JA, Stansfield SE, Mitchell KM
… +9 more, Doyle CM, Milwid RM, Moore M, Donnell DJ, Xia Y, Maheu-Giroux M, Barnabas RV, Boily MC, Dimitrov DT
J Int AIDS Soc
· 2026 Jan · PMID 41549755
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INTRODUCTION: Long-acting injectable cabotegravir (CAB-LA) is superior to daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) for HIV pre-exposure prophylaxis (PrEP) and could expand PrEP usage. Given price...INTRODUCTION: Long-acting injectable cabotegravir (CAB-LA) is superior to daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) for HIV pre-exposure prophylaxis (PrEP) and could expand PrEP usage. Given price differentials between CAB-LA and TDF/FTC, evaluating the cost-effectiveness of potential PrEP coverage scenarios is warranted. METHODS: We simulated PrEP coverage expansion among men who have sex with men (MSM) via introducing CAB-LA using two age- and risk-stratified HIV transmission models separately calibrated to local data from a high-incidence (Atlanta, USA) and a low-incidence (Montréal, Canada) North American setting. PrEP coverage of HIV-negative MSM was simulated to increase from 6% to 15%, 30%, 40% or 50% (Montréal) or from 29% to 40% or 50% (Atlanta), within 5 or 10 years, with 0%, 15%, 30%, 50% or 100% of current TDF/FTC users switching to CAB-LA. Costing took a healthcare payer perspective and included PrEP pharmaceuticals, PrEP programmatic costs and HIV-related care. Atlanta scenarios considered oral PrEP acquired at average recent market prices (primary analysis), and both settings modelled universal acquisition at the lowest available generic price (LAGP). Simulations were compared to baseline projections without CAB-LA-based expansions over 20 years, with costs and disability-adjusted life years (DALYs) discounted 3% annually. Incremental cost-effectiveness ratios (ICERs) of expansions were assessed against a $100,000 per DALY averted threshold. RESULTS: In Atlanta, scenario median ICERs at recent prices ranged from $141,600 (90% CI $60,100-$256,000) to $203,800 ($99,300-$359,200) per DALY averted. All uncertainty intervals covered $100,000. Under universal LAGP TDF-FTC, median ICERs ranged from $255,800 ($112,900-$452,30) to $370,700 ($172,200-$669,100). The strongest expansion scenarios were expected to remain cost-effective until approximately $2800/dose, or approximately $1350 with universal LAGP TDF/FTC. In Montréal, scenarios had median ICERs from $920,000 to $2,540,000, excluding dominated runs. CONCLUSIONS: In a high-incidence Atlanta MSM population, CAB-LA-based PrEP expansions are not projected to be cost-effective, though a minority of simulations achieved cost-effectiveness. However, lower prices could achieve cost-effectiveness. In a low-incidence Montréal MSM population, broad expansions are not expected to be cost-effective at modelled prices. Prioritizing CAB-LA to Montréal MSM facing access, adherence or persistence barriers to oral PrEP warrants a cost-effectiveness assessment.
Chapman E, Sued O, Barreto JOM
… +5 more, Cortes CP, Ramírez BC, Vidal JE, Camiro-Zúñiga A, Perez F
J Int AIDS Soc
· 2026 Jan · PMID 41543971
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INTRODUCTION: Advanced HIV disease (AHD) remains a leading cause of mortality in Latin America and the Caribbean (LAC), driven by late diagnosis, treatment gaps and structural barriers, particularly among key populations...INTRODUCTION: Advanced HIV disease (AHD) remains a leading cause of mortality in Latin America and the Caribbean (LAC), driven by late diagnosis, treatment gaps and structural barriers, particularly among key populations and children. Persistent disparities in healthcare access, stigma, and limited health system capacity highlight the need for targeted research to improve AHD outcomes in the region. METHODS: The modified Delphi process to prioritize AHD research questions in LAC was conducted between August and November 2024. Systematic reviews, expert consultations and two Delphi rounds involving 74 and 69 participants from 17 LAC countries assessed questions based on public health relevance, feasibility and equity. A subsequent in-person workshop with 24 experts refined and validated the results, organizing the prioritized questions into short-, medium- and long-term priorities. RESULTS: Seventy-seven high-priority research questions were identified, 60 focused on adults and 17 on children. These questions centred on opportunistic infections (OIs), HIV-related cancers and health system interventions. Tuberculosis was the most frequently addressed OI (44% of OI-related questions), followed by cryptococcosis, histoplasmosis and HIV-related malignancies. Short-term priorities included interventions to reduce late diagnosis, improve retention in care and strengthen health systems, particularly for vulnerable populations such as children, pregnant women and incarcerated individuals. CONCLUSIONS: This study presents a comprehensive research agenda for AHD in LAC, emphasizing interventions to address OIs, strengthen the health system and support at-risk populations. The prioritized questions provide a roadmap for researchers, policymakers and funders to allocate resources effectively, ultimately improving AHD outcomes and reducing HIV-related mortality. Strengthening regional collaboration and political commitment will be critical to translating research into actionable policies and interventions.