Gilead announces results from multiple Biktarvy studies

Gilead announced results from multiple studies reinforcing Biktarvy as a treatment option for a broad range of people with HIV. The latest findings include insights into the treatment of virologically suppressed pregnant women and children two years of age or older and Week 96 data from the ALLIANCE trial in adults with HIV/hepatitis B, or HBV, coinfection who were initiating therapy. The data were presented at the 12th International AIDS Society, or IAS, Conference on HIV Science, or IAS 2023, taking place July 23-26 in Brisbane, Australia. In an open-label study evaluating the pharmacokinetics, safety, and efficacy of switching to once-daily Biktarvy in virologically suppressed pregnant women with HIV, Biktarvy was generally well tolerated and all participants maintained virologic suppression at delivery. Moreover, no cases of perinatal HIV transmission were observed. No adverse events, or AEs, leading to premature discontinuation and no drug-related AEs were observed in the pregnant women or neonates. These results suggest Biktarvy may be an appropriate treatment option during pregnancy with no dose change required. Additional Biktarvy data presented at IAS 2023 included an analysis of two ongoing, open-label studies evaluating the weight, height, body mass index (BMI) and lipid metabolism parameters of virologically suppressed children with HIV who switched to Biktarvy or elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide. At Week 48, the proportion of participants who were underweight decreased from 20.4% to 14.3%, while the proportion of normal weight participants increased from 67.3% to 73.5%, respectively. Meanwhile, the proportion of overweight or obese participants remained stable at 12.2%. Overall, lipid metabolism parameters generally improved during 48 weeks of treatment. Presently, children with HIV must be on antiretroviral therapy for their entire lives. This underscores the importance of studying the impacts of treatment on weight, height, body mass index and lipid parameters in this young age group. ALLIANCE is an ongoing Phase 3 study evaluating Biktarvy versus dolutegravir 50 mg, or DTG, + emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg, F/TDF, DTG+F/TDF, in adults with HIV-1/HBV co-infection initiating treatment. The Week 96 results demonstrated the efficacy of both antiretroviral regimens. Participants who initiated treatment with Biktarvy or DTG+F/TDF had similarly high and sustained rates of viral suppression. These data, combined with the lower impact of TAF versus TDF on bone and renal parameters, show clinical benefits of Biktarvy for adults with both HIV-1 and HBV initiating antiviral therapy. The Week 96 results show numerically higher levels of hepatitis B viral suppression with Biktarvy. Importantly, participants who initiated treatment with Biktarvy had numerically higher alanine aminotransferase, or ALT, normalization and hepatitis B surface antigen loss and seroconversion. Expectedly, participants who initiated treatment with Biktarvy or DTG+F/TDF also had high rates of HIV suppression at Week 96 with mean CD4 cell count increases of 261 and 229 cells/microl from baseline, respectively. Beyond Week 96, select participants will be able to receive Biktarvy in an open-label extension phase for up to 48 weeks. Further results from the trial showed that safety findings were similar between the Biktarvy and DTG+F/TDF groups. Adverse events (AEs) included upper respiratory tract infection, COVID-19, pyrexia, ALT increase and nasopharyngitis.