GSK’s Dovato Outperforms in Head-to-Head Study

GSK's (LON: GSK) ViiV Healthcare has reported promising outcomes from a head-to-head study of its two-drug HIV regimen, Dovato, when compared to the three-drug regimen, Biktarvy by Gilead Sciences. This favourable data focuses on patients who have already achieved viral suppression.

According to the findings from the phase 4 PASO DOBLE clinical trial, Dovato exhibited non-inferior effectiveness in preserving viral suppression over a period of 48 weeks when put side-by-side with Biktarvy, successfully meeting the study's primary endpoint. This suggests that Dovato can maintain its antiretroviral effects comparable to that of the three-drug regimen.

At the point of the analysis, it was found that 2.2% of patients being treated with Dovato had a viral RNA count of 50 copies/ml or more. This is in contrast to the lower rate of 0.7% observed in patients undergoing treatment with Biktarvy. Despite this difference, Dovato still proved its efficacy in maintaining viral suppression.

Additionally, Dovato demonstrated an advantage regarding one significant side effect of antiretroviral therapy — weight gain. Over a 48-week duration, patients who were switched to Dovato experienced a lesser average weight increase of 0.89kg, compared to the 1.81kg gain observed in those who remained on Biktarvy. The weight management benefits present a notable consideration for people living with HIV, as highlighted by Harmony Garges, chief medical officer of ViiV Healthcare.

This recent study aligns with a broader trend within England, where the number of individuals diagnosed with HIV and receiving care has risen from 91,368 in 2021 to 94,397 in 2022. Such statistics underscore the ongoing need for effective and manageable treatment options for people living with the virus.

The comprehensive analysis of HIV therapies' impacts extends beyond just viral suppression, and as Esteban Martínez, chief executive investigator of PASO DOBLE from Hospital Clínic of Barcelona, commented, this recent study is setting a positive standard in that broader evaluation.

Dovato, already approved for the treatment of HIV-1 in adults with no prior antiretroviral (ARV) treatment history, is also sanctioned as a substitution for the current ARV regimen in patients who have maintained viral suppression with no history of treatment failure or resistance. These upbeat trial results support Dovato's position as a key player in the evolving landscape of HIV treatment.

The PASO DOBLE study has provided important insights into the effectiveness and potential advantages of two-drug regimens like Dovato in the treatment of virologically suppressed HIV patients. With an added focus on side effects such as weight gain, this data reinforces the value of such treatment options in the ongoing fight against HIV/AIDS.