- In largest head-to-head randomized clinical trial evaluating the two medicines, Dovato (DTG/3TC) met the primary endpoint, demonstrating sustained non-inferior efficacy versus Biktarvy (BIC/FTC/TAF) in virologically suppressed adults who switched from their prior regimen
- In latest data, Dovato led to significantly less weight gain and fewer drug-related adverse events compared to BIC/FTC/TAF through two years of follow-up
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced 96-week findings from PASO DOBLE (GeSIDA 11720 study) showing that Dovato (dolutegravir/lamivudine [DTG/3TC]) is as effective as Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide fumarate [BIC/FTC/TAF]) in maintaining virological suppression in adults with HIV-1. Individuals taking Dovato also experienced statistically significant less weight gain and fewer drug-related adverse events over the two-year study period. Results will be presented at the European AIDS Clinical Society (EACS) annual congress, held in Paris, France (15-18 October).
PASO DOBLE is the largest head-to-head, phase IV randomized clinical trial investigating the two-drug regimen Dovato compared to the three-drug regimen BIC/FTC/TAF for the treatment of HIV-1 in people who are virologically suppressed and could benefit from treatment optimization. Results at 96 weeks showed patients who switched to Dovato achieved non-inferior efficacy in maintaining viral suppression compared with switching to BIC/FTC/TAF.1,2
Jean van Wyk, MBChB, MFPM, Chief Medical Officer at ViiV Healthcare, said: “For people living with HIV, achieving and maintaining viral suppression remains the cornerstone of effective treatment. However, HIV treatment options have now advanced to where we can also look to other health metrics to help define success. The 96-week results from PASO DOBLE provide long-term findings that show Dovato continues to deliver robust viral control as effectively as a three-drug regimen, and people taking Dovato also experienced less weight gain compared to those taking Biktarvy. ViiV Healthcare remains committed to developing innovative, patient-centric treatment options that are not only effective with a good safety profile, but also address the needs of the community, beyond viral suppression.”
In the PASO DOBLE clinical trial, 553 people living with HIV who were virally suppressed switched treatment to either Dovato (n=277) or BIC/FTC/TAF (n=276).1 The study population included individuals who were on therapy that could be optimized, such as multiple tablet regimens, or those containing pharmacokinetic boosting agents or drugs with cumulative toxicity, such as efavirenz (EFV) or tenofovir disoproxil fumarate (TDF). The study met its primary endpoint, with Dovato demonstrating sustained non-inferior efficacy versus BIC/FTC/TAF based on the proportion of participants with HIV-1 RNA ≥50 copies/mL at 96 weeks using the FDA snapshot and a 4% non-inferiority margin in the exposed intention-to-treat population.1
Esteban Martínez, MD, PhD, Chief Executive Investigator of the PASO DOBLE study and Senior Consultant in Infectious Diseases at Hospital Clínic of Barcelona, Spain said: “This 96-week data from PASO DOBLE underscores a favorable profile for Dovato, particularly regarding weight gain, which is an important consideration for virologically suppressed adults that may be on treatment for decades. Longer-term data for a two-drug regimen is crucial for HCPs and people living with HIV as they work together to make informed treatment decisions, considering long-term health management, beyond just viral suppression.”
At 96 weeks, Dovato was non-inferior to BIC/FTC/TAF (risk difference between Dovato [0.4%] minus BIC/FTC/TAF [1.1%] of –0.7%, 95% CI –2.1 to 0.7) in the maintenance of viral suppression. Three participants in the BIC/FTC/TAF arm and zero in the Dovato arm had protocol-defined virological failure through week 96 (HIV-1 RNA≥50 c/mL, followed by a second consecutive HIV-1 RNA assessment≥200 c/mL); no resistance was observed in any cases of virological failure.1 These findings showed an increase of two new virologic failures in the BIC/FTC/TAF arm since the initially reported 48-week findings.1,2
The trial was powered to assess weight gain as a key secondary endpoint. Data showed a statistically significant mean adjusted increase in weight gain with BIC/FTC/TAF (2.35kg, 95% CI 1.61–3.09) compared to Dovato (0.84kg, 95% CI 0.09–1.60) [difference: 1.52kg, 95% CI 0.74–2.29] through week 96.1 The findings also showed the mean adjusted weight gain difference between arms increased from 1.13kg at 48 weeks (95% CI 0.37-1.89) to 1.52kg at 96 weeks (95% CI 0.74-2.29).1,2 A significantly higher proportion of participants experienced a greater than 5% weight increase on BIC/FTC/TAF (34.8%) compared to Dovato (20.1%) (adjusted OR 2.05, 95% CI 1.37–3.07).1
The study also found that drug-related adverse events were less frequent with Dovato (7.6%) as compared to BIC/FTC/TAF (13.4%) (p=0.025). Six participants discontinued treatment due to adverse events, mainly neuropsychiatric (Dovato [n=2] vs BIC/FTC/TAF [n=4]), with no significant differences between arms (p=0.409).1
