Effectiveness of B/F/TAF treatment in HIV/HBV co-infection

A novel investigation offers new insights into the management of individuals who are concomitantly infected with HIV and HBV. The Alliance study (NCT03547908) compared bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus dolutegravir + emtricitabine/tenofovir disoproxil fumarate (DTG+F/TDF) in participants initiating treatment for both viruses. The findings indicate that B/F/TAF is not inferior to DTG+F/TDF in inhibiting HIV RNA replication while demonstrating superior efficacy in 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 [1]. 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. However, until now, no randomised studies have compared TDF versus TAF-based antiretroviral therapy in treatment-naïve patients.

This phase 3, double-blind study included 243 participants, randomised to receive either B/F/TAF or DTG+F/TDF, with a follow-up period of 96 weeks. The study participants were recruited from a diverse range of 46 global sites, predominantly 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, respectively.

The primary results demonstrated the non-inferiority 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 -2.5–10.8; P=0.21). 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.

1. Hindman J, et al. Week 48 results of a phase III 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). Lecture 330, DDW 2023, 6–9 May, Chicago, IL, USA.

 

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Posted on 13 June, 202313 June, 2023