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ViiV HEALTHCARE ANNOUNCES POSITIVE DATA DEMONSTRATING 2-DRUG REGIMEN DOVATO IS AS EFFECTIVE AS 3-DRUG REGIMEN BIKTARVY FOR MAINTENANCE THERAPY OF HIV-1
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• Largest head-to-head randomised clinical trial between DTG/3TC and BIC/FTC/TAF, conducted by SEIMC-GeSIDA Foundation (FSG) showed DTG/3TC demonstrated non-inferior efficacy compared to BIC/FTC/TAF as a switch regimen for virologically-suppressed adults living with HIV over 48 weeks of therapy
• DTG/3TC-treated individuals had significantly less weight gain compared to those randomised to BIC/FTC/TAF
London, 23 July 2024 - ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, announces 48-week findings from PASO DOBLE (GeSIDA 11720 study), the largest head-to-head, phase IV randomised 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 who could benefit from treatment optimisation.
Findings showed that switching to DTG/3TC in virologically suppressed adults living with HIV demonstrated non-inferior efficacy in maintaining viral suppression compared with switching to BIC/FTC/TAF.1 These data will be presented at the 25th International AIDS Conference (AIDS 2024), held in Munich, Germany (22-26 July).
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 optimised, 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 (risk difference between DTG/3TC [2.2%] minus 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).
The study found in a key secondary endpoint 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. Equally, 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, whereas 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.1
About PASO DOBLE
The PASO DOBLE (NCT04884139) randomised clinical trial is a phase IV, open-label, randomised multicentre 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 on regimens containing ≥1 pill/day, boosters, or drugs with cumulative toxicity such as efavirenz or TDF were eligible and were randomised (1:1) to switch to either DTG/3TC or BIC/FTC/TAF. The primary endpoint was the proportion of people living with HIV 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%.
References:
1. P. Ryan, et al. Non-inferior efficacy and less weight gain when switching to DTG/3TC than when switching to BIC/FTC/TAF in virologically suppressed people with HIV (PWH): the PASODOBLE (GeSIDA 11720) randomised clinical trial. Presented at the 25th International AIDS Conference. July 2024
https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2024/july/viiv-healthcare-announces-positive-data-demonstrating/
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