GSK's Dovato Competes with Biktarvy in HIV Treatment

As the competitive landscape for HIV treatments intensifies, ViiV Healthcare, a division of GSK, has presented compelling new evidence supporting its two-drug regimen, Dovato (dolutegravir/lamivudine), in comparison to Gilead Sciences' three-drug regimen, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide). The recent results from the Phase IV PASO DOBLE study reveal Dovato's potential not only in maintaining effective viral suppression but also in addressing treatment-related weight gain, a significant concern for patients.

The PASO DOBLE study involved 553 virologically suppressed adults living with HIV, who were randomly assigned to switch to either Dovato or Biktarvy. The participants were previously on regimens that included at least one pill a day, boosters, or drugs with cumulative toxicity like efavirenz or tenofovir disoproxil fumarate (TDF), making them eligible for the study. The primary endpoint was to demonstrate that Dovato was non-inferior to Biktarvy in maintaining viral suppression over 48 weeks of therapy.

The trial results, presented at the International AIDS Conference, indicated that Dovato successfully met the primary endpoint. Specifically, 2.2% of participants in the Dovato group had viral RNA levels ≥50 copies/mL at the 48-week mark, compared to 0.7% in the Biktarvy group. The difference of 1.4% between the groups was well within the predefined 4% non-inferiority margin. Notably, one participant in the Biktarvy group experienced protocol-defined confirmed virological failure, while none in the Dovato group did, over the 48-week period.

A key secondary endpoint of the study focused on treatment-related weight gain, an area of growing concern among people living with HIV. The results showed a significant difference between the two regimens. Participants who switched to Biktarvy experienced an average adjusted weight increase of 1.81 kg, whereas those who switched to Dovato had an average weight gain of 0.89 kg. Furthermore, 29.9% of the Biktarvy group experienced weight gain exceeding 5%, compared to 20% in the Dovato group, a statistically significant difference.

Dr. Esteban Martínez, chief executive investigator of the PASO DOBLE study, emphasized the importance of examining the broader impacts of HIV therapies beyond just viral suppression. Harmony Garges, chief medical officer at ViiV, echoed this sentiment, highlighting that treatment-related weight gain is a critical issue for many patients.

The safety profiles of Dovato and Biktarvy were found to be comparable, with few dropouts due to adverse events in both groups; specifically, one patient in the Dovato arm discontinued, compared to two in the Biktarvy arm.

In terms of market performance, Dovato generated £1.8 billion ($2.3 billion) in 2023, a 32% increase from the previous year. On the other hand, Biktarvy, Gilead's top-selling product, achieved sales of $11.8 billion in the same period, marking a 14% rise from 2022.

These findings underscore the ongoing efforts by HIV drug developers to enhance their therapies not just for viral suppression but also to address other critical aspects of patient health, such as treatment-related weight gain. By offering an effective and potentially more weight-neutral alternative, ViiV Healthcare aims to strengthen Dovato's position in the competitive HIV treatment market.