B/F/TAF in people with both HIV-1 and hepatitis B: outcomes from the ALLIANCE open-label extension phase

AIDS Research and Therapy

卷:23

Research

Anchalee Avihingsanon^1,2  Chee Loon Leong³  Chien-Ching Hung^4,5,6  Sasisopin Kiertiburanakul⁷  Man-Po Lee⁸  Michelle L. D’Antoni⁹  Sharline Madera¹⁰  Hongyuan Wang¹¹  Jason T. Hindman¹⁰  Taisheng Li¹² 

[1] Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand

[2] Department of Medicine, Queen Elizabeth Hospital, Kowloon, Hong Kong, China

[3] Biostatistics, Gilead Sciences, Inc., Foster City, CA, USA

[4] HIV-NAT, Thai Red Cross AIDS and Infectious Diseases Research Centre, Bangkok, Thailand

[5] Department of Medicine, Kuala Lumpur General Hospital, Kuala Lumpur, Malaysia

[6] Center of Excellence in Tuberculosis, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand

[7] Department of Infectious Disease, Peking Union Medical College Hospital, Beijing, China

[8] Clinical Development, Gilead Sciences, Inc., Foster City, CA, USA

[9] Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan

[10] Department of Tropical Medicine and Parasitology, National Taiwan University College of Medicine, Taipei, Taiwan

[11] Department of Internal Medicine, National Taiwan University Hospital Yunlin Branch, Yunlin, Taiwan

[12] Clinical Virology, Gilead Sciences, Inc., Foster City, CA, USA

关键词: Chronic hepatitis B;    Tenofovir;    Functional cure;    HIV;    HBV;    B/F/TAF;    ALLIANCE;    Clinicaltrial;    Switch;   

DOI  :  10.1186/s12981-026-00891-4

 received in 2026-02-11, accepted in 2026-04-16,  发布年份 2026

来源: Springer

【 摘 要 】

BackgroundData on bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in people with both HIV-1 and HBV are limited, particularly for treatment-experienced people.MethodsALLIANCE was a randomized, double-blind, active-controlled, phase 3 study of B/F/TAF versus dolutegravir (DTG) + emtricitabine/tenofovir disoproxil fumarate (F/TDF) in treatment-naïve adults with HIV-1 RNA ≥ 500 copies/mL and HBV DNA ≥ 2000 IU/mL. Participants received continuous B/F/TAF through 144 weeks (≥ 96 weeks of blinded treatment plus 48-week optional open-label extension [OLE]) or switched to B/F/TAF after ≥ 96 weeks of DTG + F/TDF through 48 weeks of OLE. Here we report outcomes from the OLE.Results121 participants were included in the continuous B/F/TAF group; 89 in the switch group. Median B/F/TAF exposure was 186.4 and 48 weeks, respectively. HIV-1 and HBV suppression rates (missing = excluded) were maintained in both groups (B/F/TAF Week 144: 99.0% and 80.2%; switch OLE Week 48: 95.4% and 86.6%, respectively). Both groups had improved alanine aminotransferase normalization. HBV envelope antigen loss and seroconversion occurred in 44.8% and 29.3%, respectively, of participants receiving continuous B/F/TAF (Week 144) and 17.0% and 12.8% in the switch group (OLE Week 48). HBV surface antigen loss and seroconversion occurred in 22.5% and 15.5% (continuous B/F/TAF), and 4.3% and 0% (switch group) of participants, respectively. One participant (continuous B/F/TAF) discontinued due to study drug–unrelated treatment-emergent adverse event. No treatment-emergent resistance was reported.ConclusionB/F/TAF was effective in HIV-1 and HBV suppression and well tolerated in treatment-naïve individuals for ≤ 3 years and ≤ 1 year after switching from a TDF-based regimen.Trial registration ClinicalTrials.gov NCT03547908 (first registration 2018-05-24).

【 授权许可】

CC BY   
© The Author(s) 2026

【 图 表 】

Fig. 1