ViiV Healthcare’s two-monthly HIV drug has demonstrated superiority over daily oral medication in a Phase III trial conducted in four African countries.
The LATA study (NCT05154747) pitted Cabenuva (cabotegravir and rilpivirine), which was administered by injection every two months, against daily oral dolutegravir/tenofovir disoproxil fumarate/lamivudine in 476 virologically suppressed adolescents aged 12 to 19 years living with HIV. Countries patients enrolled from included Kenya, South Africa, Uganda and Zimbabwe.
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After 96 weeks, in the Cabenuva arm, a viral rebound was confirmed to have occurred in 0.9% compared with 6.4% receiving daily oral therapy.
Of the 228 who received Cabenuva, 94% reported that long-acting injections were much easier to take than daily oral therapy.
ViiV said that these findings contribute to evidence in an adolescent population, where adherence and retention in care can be challenging.
Cabenuva is not yet widely or commercially accessible through public health sectors in African countries, though studies have found it to be safe and effective for the continent’s populations. Africa bears the heaviest global burden of HIV and AIDS, with sub-Saharan Africa accounting for over two-thirds of all people living with the virus, meaning launching therapies in these countries is vital as the World Health Organization (WHO) aims to end the HIV/AIDS epidemic as a public health threat by 2030.
It also builds on data from the OPERA study (EUPAS1000000165), an observational, real-world study of Cabenuva. In the OPERA trial, Cabenuva-dosed patients maintained virologic suppression comparable to Gilead’s daily oral Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) in nearly 6,800 virologically suppressed adults living with HIV.
Of the patients receiving the study drug, 89% had viral load <50 copies/mL at a median time point of 15 months compared to 83% in the control group at a time point of 22 months.
Confirmed virologic failure risk was low and comparable in both groups, occurring in 1% of those who received Cabenuva and 2% of those who received Biktarvy.
ViiV Healthcare is a global specialist HIV company majority-owned by GSK, with Shionogi as a shareholder.
This data was presented at the 26th International AIDS Conference (AIDS 2026) in Rio de Janeiro, Brazil, which is taking place from 27 to 31 July.
CMO at ViiV Healthcare, Jean van Wyk, said: “The data presented at AIDS 2026 underscore the depth and breadth of evidence ViiV Healthcare has generated for long-acting injectables across HIV treatment and prevention. With OPERA, real-world evidence from nearly 6,800 adults in routine care shows Cabenuva maintained high and comparable virologic suppression to daily oral therapy, helping us better understand how it performs outside clinical trials and supports people over time. Together with clinical and patient-reported data, this evidence provides a trusted foundation for the next generation of innovation, shaped by people affected by HIV and designed to deliver impact at scale.”
The study marks the second important readout for ViiV at AIDS 2026. Earlier in the week, the company presented positive data for its two-drug regimen, Dovato (dolutegravir/lamivudine), which demonstrated non-inferior efficacy to the three-drug regimen Biktarvy in treatment-naïve adults living with HIV, including people with high viral loads or a low CD4+ cell count.
According to GlobalData analysis, the HIV market across the seven major markets (7MM: US, France, Germany, Italy, Spain, the UK, and Japan) is forecast to grow from $26.5bn in 2023 to $32.1bn in 2033 at a compound annual growth rate (CAGR) of 1.9%. The US accounts for the majority of market sales, and is projected to grow from $23bn in 2023 to $27.4bn in 2033 at a CAGR of 1.8%.
GlobalData is the parent company of Clinical Trials Arena.
GlobalData’s report, Human Immunodeficiency Virus (HIV): Seven-Market Drug Forecast, reveals that market growth will primarily be driven by the increased uptake of long-acting injectable therapies, as well as the launch of novel single-tablet regimens (STRs).
Notable drugs include Gilead’s biannual injectable Yeztugo (lenacapavir) for pre-exposure prophylaxis (PrEP). The marketed drug demonstrated 100% efficacy in preventing new HIV infections in the PURPOSE1 Phase III trial and thus has shown its potential as an important new tool for PrEP.
