ViiV Healthcare set to unveil Phase IIIb data comparing Dovato with Biktarvy in treatment-naïve adults alongside INSTI-powered long-acting injectable advances at AIDS 2026

ViiV Healthcare has recently announced a series of new clinical and real-world data presentations highlighting its integrase strand transfer inhibitor-focused portfolio, including long-acting medicines and pipeline progress, to be shared at the 26th International AIDS Conference in Rio de Janeiro, Brazil, from 26 to 31 July.

Phase IIIb data from the VOGUE study will compare ViiV Healthcare’s established two-drug regimen dolutegravir and lamivudine against the three-drug regimen bictegravir, emtricitabine, and tenofovir alafenamide in treatment-naïve adults living with HIV. Additional VOGUE analyses will examine study population characteristics including adults presenting with high viral loads. A pooled analysis spanning multiple clinical trials will also assess on-study viraemic events and outcomes for the two-drug regimen compared to three-drug alternatives.

A body of evidence supporting long-acting injectable HIV treatment will be presented, drawing on late-breaking LATA results and OPERA real-world data to add further weight to the case for cabotegravir plus rilpivirine long-acting. Late-breaking week 96 results from the LATA study, led by University College London, will assess the efficacy, safety, and acceptability of cabotegravir plus rilpivirine long-acting against daily oral tenofovir disoproxil fumarate, lamivudine, and dolutegravir in virologically suppressed adolescents living with HIV across sub-Saharan Africa. Fresh OPERA data, including from a US-based cohort, will compare the virologic effectiveness of injectable cabotegravir plus rilpivirine long-acting against daily oral bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed adults. Week 96 findings from the IMPALA study, led by the London School of Hygiene and Tropical Medicine, will offer new insight into the use of cabotegravir plus rilpivirine long-acting in adults with prior adherence difficulties across sub-Saharan Africa, tracking treatment outcomes over time. Data from Ask Us Europe, a community co-produced survey led by an academic team in London, will explore whether people living with HIV across Europe are having meaningful and equitable conversations with their healthcare providers about long-acting treatment options.

Cabotegravir long-acting for pre-exposure prophylaxis will also feature prominently, with CLARITY results comparing cabotegravir long-acting with lenacapavir informing how long-acting injectable prevention options translate into real-world use. Six-month findings from the Phase I CLARITY study will report on participant experience and the acceptability of each injection following a single dose, alongside late-breaking participant-reported outcomes designed to guide decision-making when beginning long-acting injectable pre-exposure prophylaxis. CAPTIVATE results will describe real-world patterns of use, acceptability, and delivery of cabotegravir long-acting for pre-exposure prophylaxis in routine US clinical practice. Updated PrEPFACTS findings will characterise real-world uptake and adherence patterns for cabotegravir long-acting pre-exposure prophylaxis in the US, drawing on healthcare administrative claims data.

Rounding out the presentations, baseline data from the Phase IIb registrational EXTEND 4M trial will describe the population being studied in the first evaluation of a new cabotegravir long-acting formulation dosed three times a year for HIV prevention. Building on the well-established evidence for the six-times-yearly dosing schedule, the study will examine the pharmacokinetics, safety, and tolerability of this new formulation.

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Related Topics and Keywords

AIDS 2026, biktarvy, Dovato, Phase IIIb data, ViiV Healthcare