ViiV Healthcare (London, UK) has announced 96-week data from a subgroup analysis of the PASO DOBLE (GeSIDA 11720) study, showing that switching to the two-drug regimen Dovato (dolutegravir/lamivudine; DTG/3TC) was associated with a lower proportion of steatotic liver disease (SLD) compared with the three-drug regimen Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide; BIC/FTC/TAF) in virologically suppressed adults living with HIV-1. The findings were presented at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI 2026) in Denver, Colorado.
PASO DOBLE is the largest head-to-head, phase IV randomized clinical trial to evaluate DTG/3TC versus BIC/FTC/TAF in adults with suppressed HIV-1. This planned 96-week sub-analysis focused on SLD, an increasingly recognized comorbidity in people living with HIV that is associated with metabolic health and weight gain.
The liver-focused sub-study included 111 participants who switched therapy: 58 to DTG/3TC and 53 to BIC/FTC/TAF. At Week 96, SLD was reported in 49 percent (26/53) of those receiving BIC/FTC/TAF compared with 29 percent (17/58) of those receiving DTG/3TC (p=0.033). The difference was more pronounced among participants with clinically meaningful weight gain (≥5 percent of baseline body weight). In this subgroup, SLD occurred in 76 percent (13/17) of individuals on BIC/FTC/TAF versus 17 percent (2/12) on DTG/3TC (p=0.002). No significant differences were observed among participants who gained less than 5 percent of their baseline body weight. After adjustment for baseline characteristics, treatment regimen remained independently associated with SLD.
Earlier 96-week results from PASO DOBLE demonstrated non-inferior virologic suppression between the two regimens, with less weight gain observed in those switching to DTG/3TC. The mean adjusted difference in weight between treatment arms was 1.52 kg. Given the known links between weight gain, metabolic changes, and liver steatosis, the latest findings provide further insight into long-term metabolic considerations when selecting HIV maintenance therapy.
Dovato is approved in the EU and US for the treatment of HIV-1 infection in adults and certain adolescents with no known or suspected resistance to integrase inhibitors or lamivudine.
viivhealthcare.com
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