ViiV Healthcare reports positive data demonstrating 2-drug regimen Dovato is as effective as 3-drug regimen Biktarvy for HIV-1's maintenance therapy

GSK plc's ViiV Healthcare released 48-week results from the PASO DOBLE Phase IV trial, comparing Dovato (dolutegravir/lamivudine [DTG/3TC]) to Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide [BIC/FTC/TAF]) for treating HIV-1. The study demonstrated that DTG/3TC was non-inferior to BIC/FTC/TAF in maintaining viral suppression among virologically suppressed adults.

The trial involved 553 participants, with DTG/3TC showing similar efficacy to BIC/FTC/TAF (risk difference: 1.4%, 95% CI -0.5 to 3.4). DTG/3TC had fewer cases of virological failure compared to BIC/FTC/TAF. Weight gain was notably higher with BIC/FTC/TAF, with an adjusted mean increase of 1.81 kg versus 0.89 kg for DTG/3TC. The proportion of participants gaining more than 5% weight was also higher with BIC/FTC/TAF (29.9%) compared to DTG/3TC (20%).

PASO DOBLE is a Phase IV, open-label trial conducted across 30 sites in Spain, evaluating the efficacy of these regimens in maintaining viral suppression. Dovato is approved in various countries as a complete regimen for HIV-1 treatment.