The co-occurrence of HIV and HBV infection poses a significant global health challenge, with increased morbidity and mortality compared with each infection alone. With chronic hepatitis B affecting approximately 8% of people living with HIV globally, effective treatment strategies are crucial. International guidelines recommend TDF or TAF-based antiretroviral regimens, but no randomized studies have compared TDF with TAF-based antiretroviral therapy in treatment-naïve patients—until now.
The double-blind, phase 3 ALLIANCE study study included 243 participants who were randomly assigned to receive either bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF or emtricitabine/tenofovir disoproxil fumarate (DTG+F/TDF), with a follow-up period of 96 weeks. The study participants were recruited from a range of 46 global sites, with a predominant representation from the Asian region. The primary endpoints were HIV and HBV suppression at week 48 (defined as HIV-1 RNA >50 copies/mL and HBV DNA <29 IU/mL).
The primary results demonstrated the noninferiority of B/F/TAF compared with DTG+F/TDF in achieving HIV RNA suppression, with 95% and 91% of participants reaching the target, respectively (95% CI, -2.5 to 10.8). Additionally, B/F/TAF exhibited superiority in HBV DNA suppression, with 63% of participants achieving the desired levels, compared with 43.4% in the DTG+F/TDF group (95% CI, 5.9–27.3; P=0.023).
Adverse events were generally mild, with no participants in the B/F/TAF group developing treatment-emergent HIV resistance. Both regimens were well tolerated, with no significant differences in drug-related adverse events or discontinuations.
The ALLIANCE trial will continue in a blinded manner for an extended period of 96 weeks to assess long-term safety and efficacy outcomes.ai
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