GSK’s ViiV Healthcare has shared positive results from a head-to-head study of its two-drug human immunodeficiency virus (HIV) regimen, Dovato (dolutegravir/lamivudine), in patients who are virologically suppressed.
The phase 4 PASO DOBLE trial has been evaluating Dovato against Gilead Sciences’ three-drug regimen Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) as a maintenance therapy for HIV-1 in patients who could benefit from treatment optimisation, such as those on multiple tablets a day or taking drugs with cumulative toxicity.
The study met its primary endpoint, with Dovato demonstrating non-inferior efficacy in maintaining viral suppression after 48 weeks of treatment compared to Biktarvy.
At the time of analysis, 2.2% of Dovato-treated patients had viral RNA of 50 copies/ml or above, versus 0.7% for those receiving Biktarvy.
Results also showed that patients who switched to Dovato experienced significantly less weight gain than those who were given Biktarvy, with an adjusted mean change in body weight of 0.89kg and 1.81kg for the two cohorts, respectively, after 48 weeks.
“This is a meaningful outcome, as treatment-related weight gain is an important topic for many people living with HIV,” said Harmony Garges, chief medical officer of ViiV, which is majority owned by GSK, with Pfizer and Shionogi as shareholders.
The number of people living with a diagnosed HIV infection and accessing care in England rose from 91,368 in 2021 to 94,397 in 2022.
Chief executive investigator of PASO DOBLE, Esteban Martínez, Hospital Clínic of Barcelona, said: “The HIV treatment regimens that are commonly prescribed today are all highly effective, which makes it critical that we study the impact of these therapies beyond just viral suppression.
“The results from PASO DOBLE show Dovato, a two-drug regimen, not [only] demonstrated the same efficacy as a three-drug regimen but also showed less weight gain compared to [Biktarvy] through 48 weeks.”
Dovato already holds approvals to treat HIV-1 in adults with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed on a stable ARV regimen with no history of treatment failure and no known resistance to any component of Dovato.