B/F/TAF was not inferior to DTG+F/TDF in inhibiting HIV RNA replication while demonstrating superior efficacy for inhibiting HBV DNA replication.
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, con- ducted by Jason Hindman, PharmD, and colleagues
included 243 participants who were randomly as- signed 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.
Source: Hindman J, et al. Week 48 results of a phase 3 randomized controlled trial of bictegravir/
emtricitabine/tenofovir alafenamide (B/F/TAF) vs dolutegravir + emtricitabine/tenofovir disoproxil
fumarate (DTG+F/TDF) in ART-naive, HIV/ HBV-coinfected adults (ALLIANCE). Presented at: DDW 2023;
May 6-9, 2013; Chicago.
