ViiV Healthcare has announced new 96‑week findings from a sub‑group analysis of the PASO DOBLE study, showing that adults living with HIV‑1 who switched to Dovato experienced a lower proportion of steatotic liver disease compared with those switching to Biktarvy.
The analysis, presented at the Conference on Retroviruses and Opportunistic Infections 2026, evaluated virologically suppressed adults taking either the 2‑drug regimen dolutegravir/lamivudine or the 3‑drug regimen bictegravir/emtricitabine/tenofovir alafenamide.
PASO DOBLE is the largest head‑to‑head phase 4 randomised trial comparing these regimens.
This planned sub‑study focused on steatotic liver disease, an increasingly recognised comorbidity linked to metabolic health and weight gain in people living with HIV.
Jean van Wyk, MBChB, MFPM, Chief Medical Officer at ViiV Healthcare, said: “ViiV Healthcare has led innovation in HIV by developing effective regimens containing fewer medicines. 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 outcomes.”
He added: “These findings allow healthcare providers and people living with HIV to make informed choices regarding long-term HIV treatment, including considerations around impact on metabolic health.”
The sub‑study included 111 adults who switched treatment while remaining virologically suppressed.
At Week 96, steatotic liver disease was observed in 49% of participants on Biktarvy compared with 29% on Dovato.
The difference was most marked in those with clinically meaningful weight gain of at least 5% of baseline body weight, where 76% of participants on Biktarvy had steatotic liver disease versus 17% on Dovato.
No significant difference was seen in participants who gained less than 5% of their baseline weight, and treatment regimen remained independently associated with steatotic liver disease after adjusting for baseline factors.
Earlier 96‑week PASO DOBLE results showed that switching to Dovato was associated with less weight gain than switching to Biktarvy, while maintaining non‑inferior virologic suppression.
