ViiV Healthcare Announces 96-Week PASO DOBLE Results Showing Dovato as Effective as Biktarvy in Maintaining Viral Suppression

ViiV Healthcare recently announced new 96-week results from the phase IV PASO DOBLE (GeSIDA 11720) study. The findings show that the 2-treatment regimen dolutegravir/lamivudine; DTG/3TC (Dovato) maintains virological suppression as effectively as the 3-treatment regimen bictegravir/emtricitabine/tenofovir alafenamide fumarate; BIC/FTC/TAF (Biktarvy) in adults with HIV. Participants taking Dovato also experienced significantly less weight gain and fewer drug-related adverse events over the two-year period. Results will be presented at the recent European AIDS Clinical Society (EACS) Congress in Paris.

“For people living with HIV, achieving and maintaining viral suppression is essential. These long-term results show that Dovato delivers durable viral control comparable to a three-drug regimen, while offering benefits such as less weight gain and fewer drug-related side effects," Jean van Wyk, MBChB, MFPM, chief medical officer at ViiV Healthcare, said in a statement.

Study Overview

PASO DOBLE is the largest head-to-head, randomized, phase IV trial comparing the two-drug Dovato regimen to the three-drug BIC/FTC/TAF regimen in people living with HIV who are virologically suppressed and candidates for treatment optimization. At 96 weeks, Dovato demonstrated non-inferior efficacy in maintaining viral suppression (HIV RNA ≥50 copies/mL) compared with BIC/FTC/TAF, meeting the study’s primary endpoint.

The trial enrolled 553 participants (Dovato n=277; BIC/FTC/TAF n=276), many of whom switched from multi-tablet regimens or those containing agents associated with long-term toxicity, such as efavirenz (EFV) or tenofovir disoproxil fumarate (TDF).

Key Findings

• Dovato was non-inferior to BIC/FTC/TAF in maintaining viral suppression (risk difference –0.7%, 95% CI –2.1 to 0.7). No participants in the Dovato group experienced virological failure versus three in the BIC/FTC/TAF arm, with no resistance detected in any cases.
• Dovato was associated with a significantly lower mean weight gain (0.84 kg) compared with BIC/FTC/TAF (2.35 kg) through week 96 — a difference of 1.52 kg (95% CI 0.74–2.29). A greater proportion of participants on BIC/FTC/TAF experienced >5% body weight increase (34.8% vs 20.1%).
• Drug-related adverse events occurred less frequently with Dovato (7.6%) than with BIC/FTC/TAF (13.4%) (p=0.025). Six participants discontinued treatment due to adverse events (Dovato n=2; BIC/FTC/TAF n=4).

About PASO DOBLE

The PASO DOBLE randomized clinical trial is a phase IV, open-label, randomized multicenter clinical trial evaluating the efficacy of DTG/3TC versus BIC/FTC/TAF for the maintenance of virologic suppression in people living with HIV-1, conducted in 30 sites across Spain. Virologically suppressed people living with HIV-1 on regimens containing ≥1 pill/day, boosters, or drugs with cumulative toxicity such as efavirenz or TDF were eligible and were randomized (1:1) to switch to either DTG/3TC or BIC/FTC/TAF. The primary endpoint was virologic suppressions in people living with HIV-1 with RNA ≥50 copies/mL at 48 weeks (FDA snapshot, 4% non-inferiority margin) in the intention-to-treat exposed population. Secondary outcomes measured included, among others, absolute weight gain, BMI change, and the proportion of participants with weight change greater than 5%.

Reference
ViiV Healthcare announces 96-week data reaffirming Dovato is as effective as Biktarvy in maintaining virological suppression of HIV-1 with significantly less weight gain. ViiV press statement. October 17, 2025. Accessed October 19, 2025.
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