ViiV Healthcare’s two-drug regimen for HIV treatment is as effective as Gilead’s Biktarvy in treatment-naïve patients, as per findings from a Phase IIIb trial.
In the VOGUE study (NCT05979311), Dovato (dolutegravir/lamivudine (DTG/3TC)) demonstrated non-inferior efficacy to the three-drug regimen Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF)) in treatment-naïve adults living with HIV, including people with high viral loads or a low CD4+ cell count.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
At week 48, virologic suppression was achieved in 89% of patients receiving Dovato compared with 92% receiving Biktarvy. Median time to viral suppression was rapid and similar in both groups at around 4.1 weeks.
The findings also reinforced DTG/3TC’s high barrier to resistance, with zero cases of treatment-emergent resistance identified across treatment arms. The overall safety profiles for both treatment groups were comparable, with no new safety signals observed.
The data will be presented at the 26th International AIDS Conference (AIDS 2026) in Rio de Janeiro, Brazil, taking place from 27 to 31 July.
Jean van Wyk, MBChB, MFPM, chief medical officer at ViiV Healthcare, said: “HIV treatment is lifelong, so the number of medicines people take over decades of care can matter. As the first randomised, head-to-head study comparing DTG/3TC with BIC/FTC/TAF in treatment-naïve adults living with HIV, VOGUE adds to 10 years of real-world evidence showing that people starting treatment can successfully manage their HIV with fewer daily drugs. The data demonstrates that from day one, we can potentially reduce the number of antiretroviral drugs a person receives with DTG/3TC, without compromising on efficacy or the barrier to resistance.”
The ongoing multi-country, open-label, VOGUE study randomised 509 treatment-naïve adults living with HIV.
ViiV is a global HIV specialist which is majority owned by GSK, with Shionogi as a shareholder.
The company said these findings build on 10 years of evidence supporting Dovato as the first and only oral two-drug regimen for treatment-naïve people living with HIV.
Dovato was first approved by the US Food and Drug Administration (FDA) in April 2019 in adult patients with HIV. The label was expanded in 2024 to include adolescents above 12 years of age weighing at least 25kg in the US, with no known or suspected resistance to the integrase inhibitor class or lamivudine.
The drug was also approved in the EU in 2019 for use in adults and children aged 12 and over who weigh at least 40kg.
Dovato sales reached £2.7bn ($3.4bn) in fiscal year 2025, driven by strong global demand. While achieving blockbuster status, these sales were significantly eclipsed by Biktarvy, which brought in $14.3bn in 2025.
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.
