Gilead Sciences announced results reinforcing Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) as a highly efficacious treatment option for a broad range of people with HIV, including individuals with HIV/hepatitis B (HBV) coinfection. Interim data from the ALLIANCE trial evaluating Biktarvy in adults with HIV/HBV coinfection who were initiating therapy show potential suppression of HBV and HIV suppression comparable to an alternative HIV regimen. Additionally, 5-year data from two Phase 3 trials further demonstrated Biktarvy’s sustained efficacy, safety profile and high barrier to resistance in adults with HIV initiating therapy. The data were presented at the 24th International AIDS Conference (AIDS 2022).
Data from the ALLIANCE trial, which is an ongoing Phase 3 trial evaluating Biktarvy versus dolutegravir 50 mg (DTG) + emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg, F/TDF, DTG+F/TDF, demonstrated the efficacy of both antiretroviral regimens, in adults with HIV/HBV co-infection initiating treatment. The Week 48 results show Biktarvy demonstrated superior HBV DNA suppression. Importantly, participants who initiated treatment with Biktarvy versus DTG+F/TDF demonstrated superior HBV DNA suppression (<29 IU/mL) (63% vs. 43%, p=0.0023) and hepatitis B e-antigen (HBeAg) seroconversion (23% vs. 11%, p=0.031). The Week 48 results also showed that participants who initiated treatment with Biktarvy or DTG+F/TDF both had similarly high rates of HIV suppression (HIV-1 RNA <50 copies/ml). Participants who initiated treatment with Biktarvy or DTG+F/TDF both had high rates of HIV suppression at Week 48 (95% vs. 91%; 95% CI - 2.5% to 10.8%, p=0.21) with mean CD4 cell count increases of 200 and 175 cells/μl from baseline, respectively. The ALLIANCE trial will continue in a blinded fashion through Week 96 to determine longer-term safety and efficacy.
HIV/HBV coinfection is a major global public health threat that increases the morbidity and mortality beyond either infection alone. HBV impacts approximately 8% of people with HIV globally, and HIV/HBV coinfection rates can reach 25% in areas where both viruses are endemic, such as Asia. In some parts of Asia, HBV is endemic with a projected 70% of the population showing serologic evidence of current or prior infection. Because each virus affects the other's natural history and response to therapy, HIV/HBV co-infection requires dedicated research.