Bictegravir/Emtricitabine/Tenofovir Alafenamide in Adults with HIV/HBV Coinfection: An Open-Label, Single-Arm, Safety and Efficacy Switch Study
Background: HIV and hepatitis B virus (HBV) coinfection has been associated with a higher risk of morbidity and mortality. HBV-active antiretroviral regimens have significantly improved the outcomes for coinfected people. Although bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) is safe...
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| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2025-03-01
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| Series: | Viruses |
| Subjects: | |
| Online Access: | https://www.mdpi.com/1999-4915/17/4/510 |
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| Summary: | Background: HIV and hepatitis B virus (HBV) coinfection has been associated with a higher risk of morbidity and mortality. HBV-active antiretroviral regimens have significantly improved the outcomes for coinfected people. Although bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) is safe and efficacious for the treatment of HIV, there are few randomized studies on the treatment of HIV/HBV coinfection. Methods: This open-label switch study enrolled adults with HIV/HBV coinfection from two clinical centers. The participants were switched from their current antiretroviral regimen (regardless of viral suppression) to BIC/FTC/TAF, taken once daily for 48 weeks. The primary endpoints were the proportion of participants with HIV RNA < 50 copies/mL and HBV DNA < 29 IU/mL at Week 24. Results: Twenty-eight participants were enrolled, with a median age of 51 years; the majority were Black (89%) and male (86%). At baseline, 71% (20/28) and 79% (22/28) were HIV- and HBV-suppressed, respectively, and 64% (18/28) exhibited suppression for both. At week 24, 89% (25/28) and 86% (24/28) were HIV- and HBV-suppressed, respectively, and 82% (23/28) exhibited suppression for both. The most common treatment-related adverse event was nausea (2/28). None of the participants discontinued the treatment due to an adverse event. No serious adverse events or hepatitis flares were observed. Conclusion: BIC/FTC/TAF is a safe and suitable option for the treatment of HIV/HBV-coinfected patients. |
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| ISSN: | 1999-4915 |