ViiV Healthcare, the HIV-focused subsidiary majority-owned by GSK with Pfizer and Shionogi as shareholders, has reported positive topline results from the Phase IV PASO DOBLE study. This clinical trial compared ViiV’s two-drug regimen Dovato (dolutegravir/lamivudine) to Gilead’s three-drug regimen Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide fumarate) in the treatment of HIV-1 over a period of 48 weeks. The study demonstrated that Dovato’s efficacy in maintaining viral suppression was non-inferior to Biktarvy, offering a potential alternative for patients who are virologically suppressed and could benefit from treatment optimization. Additionally, Dovato was associated with less weight gain, a common concern with long-term antiretroviral therapy.
The PASO DOBLE study included 553 participants with HIV-1 who were already virologically suppressed and on regimens that could be optimized. The trial’s primary endpoint was the proportion of participants with viral RNA ≥50 copies/mL at 48 weeks, showing non-inferiority for Dovato compared to Biktarvy. A key secondary endpoint revealed a significant difference in weight gain, with 20% of Dovato recipients experiencing a weight gain greater than 5%, compared to 29.9% with Biktarvy.
These findings are particularly noteworthy as they position Dovato as a treatment option that not only provides effective viral suppression but also addresses the significant issue of treatment-related weight gain. The results of the PASO DOBLE study will be presented at the 25th International AIDS Conference (AIDS 2024) in Munich, Germany, offering the global HIV community further insights into treatment options that balance efficacy with long-term health outcomes.
ViiV Healthcare’s commitment to innovation in HIV treatment is evident in its pipeline, which includes Dovato, a once-monthly single-tablet regimen that has already been approved in the US, Europe, Japan, and other countries worldwide. The company’s focus on developing therapies that meet the diverse needs of people living with HIV is a cornerstone of its mission to transform HIV treatment and care.- Flcube.com
