HIV treatment is advancing with significant findings from ViiV Healthcare, a global specialist HIV company majority-owned by GSK, with Pfizer and Shionogi as shareholders. ViiV Healthcare recently announced positive 48-week findings from PASO DOBLE (GeSIDA 11720 study), the largest head-to-head, phase IV randomized clinical trial (RCT) investigating the 2-drug regimen Dovato (dolutegravir/lamivudine [DTG/3TC]) compared to the 3-drug regimen Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide fumarate [BIC/FTC/TAF]) for the treatment of HIV-1 in people who are virologically suppressed and could benefit from treatment optimization.
The PASO DOBLE study, conducted by the SEIMC-GeSIDA Foundation (FSG), demonstrated that switching to DTG/3TC in virologically suppressed adults living with HIV showed non-inferior efficacy in maintaining viral suppression compared to switching to BIC/FTC/TAF over 48 weeks of therapy. The study also revealed that individuals treated with DTG/3TC had significantly less weight gain compared to those treated with BIC/FTC/TAF. These findings were presented at the 25th International AIDS Conference (AIDS 2024) held in Munich, Germany.
HIV Treatment Progress: ViiV Healthcare’s Dovato Shows Comparable Efficacy and Lower Weight Gain in PASO DOBLE Trial
Dr. Harmony P. Garges, Chief Medical Officer at ViiV Healthcare, stated, “The results from PASO DOBLE show that Dovato demonstrated non-inferior efficacy compared to Biktarvy, and that the average weight gain for trial participants taking DTG/3TC was significantly lower than those taking BIC/FTC/TAF over the course of the year. This is a meaningful outcome, as treatment-related weight gain is an important topic for many people living with HIV. At ViiV Healthcare, we’re dedicated to bringing innovative HIV treatments to people living with HIV that are not only safe and effective but also address their specific needs beyond viral suppression.”
In the PASO DOBLE clinical trial, 553 people living with HIV and virally suppressed switched treatment to either DTG/3TC (n=277) or BIC/FTC/TAF (n=276). 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 or tenofovir disoproxil fumarate (TDF). The study met its primary endpoint when DTG/3TC demonstrated non-inferior efficacy versus BIC/FTC/TAF based on the proportion of participants with viral RNA ≥50 copies/mL at 48 weeks using the FDA snapshot and a 4% non-inferiority margin in the exposed intention-to-treat population.
At 48 weeks, DTG/3TC was non-inferior to BIC/FTC/TAF, with a risk difference between DTG/3TC (2.2%) and BIC/FTC/TAF (0.7%) of 1.4% (95% CI -0.5 to 3.4). One participant in the BIC/FTC/TAF arm and zero in the DTG/3TC arm had protocol-defined confirmed virological failure through week 48 (HIV-1 RNA ≥50 c/mL followed by a second consecutive HIV-1 RNA assessment ≥200 c/mL).
HIV Study Highlights: Greater Weight Gain in Patients Switching to BIC/FTC/TAF Compared to DTG/3TC
A key secondary endpoint revealed that weight increased significantly more in participants who switched to BIC/FTC/TAF (adjusted mean change 1.81kg, 95% CI 1.28-2.34) than in those who switched to DTG/3TC (adjusted mean change 0.89kg, 95% CI 0.37-1.41) [difference 0.92kg, 95% CI 0.17-1.66] through week 48. Additionally, the proportion of participants with weight gain greater than 5% at week 48 was significantly higher at 29.9% for BIC/FTC/TAF compared to 20% for DTG/3TC (adjusted OR 1.81, 95% CI 1.19-2.76).
Weight change with DTG/3TC did not differ between men and women or based on the previous regimen of participants. In contrast, the proportion of trial participants experiencing greater than 5% weight gain with BIC/FTC/TAF was approximately 45% higher than those taking DTG/3TC when switching from a regimen with abacavir (30.6% BIC/FTC/TAF vs 21.1% DTG/3TC), and about 2-fold higher when switching from a regimen with TDF (40.7% BIC/FTC/TAF vs 19.5% DTG/3TC). Safety was comparable through week 48 and consistent with known safety profiles. There were few discontinuations due to adverse events in both study arms (DTG/3TC = 1, 0.4%; BIC/FTC/TAF = 2, 0.7%), with no differences between arms.
Dr. Esteban MartÃnez, Chief Executive Investigator of the PASO DOBLE study and Senior Consultant in Infectious Diseases at Hospital ClÃnic of Barcelona, Spain, emphasized the importance of these findings: “The HIV treatment regimens that are commonly prescribed today are all highly effective, which makes it critical that we study the impact of these therapies beyond just viral suppression. The results from PASO DOBLE show Dovato, a 2-drug regimen, not only demonstrated the same efficacy as a 3-drug regimen, but also showed less weight gain compared to BIC/FTC/TAF through 48 weeks.”
These results highlight the potential benefits of the 2-drug regimen DTG/3TC, offering a highly effective and well-tolerated option for people living with HIV who are virologically suppressed. The findings from the PASO DOBLE trial underscore the importance of considering factors beyond viral suppression, such as weight gain, when optimizing treatment regimens for people living with HIV.
Resource: Business Wire, July 23, 2024
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