One of the largest-head-to-head trials shows that a two-drug regimen of Dovato is as effective as a three-drug regimen of Biktarvy in virologically suppressed adults living with human immunodeficiency virus (HIV).
UK-based pharmaceutical company ViiV healthcare will reveal full data from the Phase IV PASO DOBLE trial (NCT04884139) evaluating the two-drug regimen Dovato (dolutegravir/lamivudine [DTG/3TC]) compared to the three-drug regimen Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide fumarate [BIC/FTC/TAF]) for the treatment of HIV in people who are virologically suppressed and who could benefit from treatment optimisation.
According to ViiV, the trial met its primary endpoint with Dovato demonstrating non-inferior efficacy to Biktarvy at 48 weeks. Another significant benefit of the trial is that Dovato patients had significantly less weight gain compared to Biktarvy patients.
ViiV Healthcare chief medical officer Harmony Garges said: “This is a meaningful outcome, as treatment-related weight gain is an important topic for many people living with HIV. At ViiV Healthcare, we're dedicated to bringing innovative HIV treatments to people living with HIV that are not only safe and effective, but also address their specific needs beyond viral suppression.”
The trial enrolled 553 patients living with HIV who were randomised to one of the treatment regimens.
One patient in the Biktarvy arm suffered protocol-defined confirmed virological failure at week 48 compared to zero in the Dovato arm.
ViiV Healthcare will be announcing the data at the 25th International AIDS Conference (AIDS 2024), held in Munich, Germany, between 22 and 26 July.
Dovato is an anti-retroviral agent that was developed by ViiV Healthcare, a joint venture between GSK, Pfizer, and Shionogi. The drug received approval by the US Food and Drug Administration (FDA) in March 2019.
Biktarvy is an anti-retroviral agent developed by Gilead Sciences. It received approval from the FDA in February 2018.
The AIDS 2024 conference will also see presentations by Gilead about its pre-exposure prophylaxis (PReP) lenacapavir which has previously shown 100% efficacy in women in a Phase III study.
On the first day of the conference, the executive director of UNAIDS Winnie Byanyima called on Gilead to make the PReP therapy more easily available for developing countries where the virus is more prevalent.
