GSK's ViiV reveals positive results for two-drug HIV regimen Dovato

GSK’s ViiV Healthcare has recently revealed promising results from a comparative study of its two-drug HIV treatment, Dovato (dolutegravir/lamivudine), in virologically suppressed patients. The Phase 4 PASO DOBLE trial is assessing Dovato's efficacy against Gilead Sciences’ three-drug regimen, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), as a maintenance therapy for HIV-1. This study targets patients who could benefit from optimized treatment, particularly those taking multiple tablets daily or experiencing cumulative drug toxicity.

The trial achieved its primary goal, with Dovato demonstrating comparable effectiveness in maintaining viral suppression after 48 weeks of treatment compared to Biktarvy. Specifically, 2.2% of patients on Dovato had viral RNA levels of 50 copies/ml or higher, compared to 0.7% for those on Biktarvy.

Furthermore, the study highlighted that patients who switched to Dovato experienced notably less weight gain than those on Biktarvy. After 48 weeks, the adjusted mean change in body weight was 0.89kg for the Dovato group, compared to 1.81kg for the Biktarvy group. Harmony Garges, chief medical officer of ViiV Healthcare, emphasized the significance of these findings, noting that treatment-related weight gain is a crucial concern for many individuals living with HIV.

In England, the number of people living with diagnosed HIV and accessing care rose from 91,368 in 2021 to 94,397 in 2022. Esteban Martínez, chief executive investigator of PASO DOBLE from Hospital Clínic of Barcelona, stressed the importance of studying the broader impacts of HIV therapies beyond just viral suppression. He noted that the PASO DOBLE results demonstrate that Dovato not only matches the efficacy of a three-drug regimen but also results in less weight gain over 48 weeks.

Dovato is already approved for treating HIV-1 in adults with no prior antiretroviral (ARV) treatment history or for those who are virologically suppressed on a stable ARV regimen with no history of treatment failure and no known resistance to any components of Dovato.