PASO-DOBLE is the largest head-to-head phase 4 randomized clinical trial comparing the 2-drug regimen DTG/3TC with the 3-drug regimen BIC/FTC/TAF in this population. The 96-week substudy focused on SLD, an increasingly recognized comorbidity linked to metabolic health and weight gain in people living with HIV.
“This 96-week PASO-DOBLE subanalysis 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,” ViiV Healthcare Chief Medical Officer Jean van Wyk, MBChB, MFPM, said in a statement. “These findings allow health care providers and people living with HIV to make informed choices regarding long-term HIV treatment, including considerations around impact on metabolic health.”
Learn more about the PASO-DOBLE study with insights from van Wyk.
What You Need to Know
Switching to DTG/3TC was associated with significantly lower rates of steatotic liver disease than switching to BIC/FTC/TAF at 96 weeks.
The difference in SLD was most pronounced in participants who gained 5% or more of baseline body weight, highlighting the link between metabolic changes and liver health.
Alongside maintained virologic suppression and less weight gain, the findings add to evidence supporting DTG/3TC as a long-term treatment option with potential metabolic health advantages.
The substudy included 111 adults who switched treatment: 58 to DTG/3TC and 53 to BIC/FTC/TAF. At week 96, SLD was observed in 49% of participants receiving BIC/FTC/TAF compared with 29% of those on DTG/3TC (P = .033). Differences were most pronounced among individuals with clinically meaningful weight gain (≥ 5% of baseline body weight), where SLD occurred in 76% of participants on BIC/FTC/TAF vs 17% on DTG/3TC (P = .002). No significant differences were seen in participants with less than 5% weight gain, and the treatment regimen remained independently associated with SLD after adjustment for baseline factors.
These findings build on previously reported 96-week PASO-DOBLE results showing less weight gain with DTG/3TC compared with BIC/FTC/TAF while maintaining noninferior virologic suppression. Given the close relationship between weight gain, metabolic changes, and liver steatosis, the new data provide further insight into long-term metabolic and hepatic outcomes following treatment switches.
Reference
ViiV Healthcare announces data showing switching to Dovato was associated with a lower proportion of steatotic liver disease versus Biktarvy for HIV-1 treatment. Press release. ViiV Healthcare. February 23, 2026. Accessed February 24, 2026.
https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2026/february/steatotic-liver-disease-versus-biktarvy/
