Data presented at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI 2026) in Denver, Colorado, indicate that HIV-1 patients who switched from Biktarvy to Dovato experienced a lower proportion of steatotic liver disease (SLD) at 96 weeks, according to ViiV Healthcare.
The findings stem from a sub-group analysis of the PASO DOBLE study, the largest head-to-head, phase IV randomized clinical trial comparing the two-drug regimen Dovato (dolutegravir/lamivudine) with the three-drug regimen Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) in virologically suppressed adults living with HIV-1. The analysis revealed that 29% (17 of 58 participants) switching to Dovato developed SLD, compared to 49% (26 of 53 participants) switching to Biktarvy.
Steatotic liver disease, characterized by the buildup of fat in the liver, is an increasingly recognized comorbidity among people living with HIV. ViiV Healthcare, a global specialist HIV company majority owned by GSK with Pfizer and Shionogi as shareholders, highlighted the data as building upon earlier metabolic findings supporting the use of Dovato.
“ViiV Healthcare has led innovation in HIV by developing effective regimens containing fewer medicines,” said Jean van Wyk, Chief Medical Officer at ViiV Healthcare. “This 96-week PASO DOBLE sub-analysis adds to the robust clinical and real-world data for Dovato, showing differences between the 2‑drug regimen DTG/3TC and BIC/FTC/TAF as a 3‑drug regimen in metabolic health.”
The PASO DOBLE study (GeSIDA 11720) involved adults who were already virologically suppressed on their initial HIV treatment. Participants were randomized to either switch to Dovato or continue on Biktarvy. The 96-week data focused specifically on the incidence of SLD within this cohort.
