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Title
Week-96 results of ALLIANCE, a phase 3, randomized, double-blind study comparing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus dolutegravir + emtricitabine/tenofovir disoproxil fumarate (DTG+F/TDF) in treatment-naïve people with both HIV-1 and hepatitis B
Presenter
Anchalee Avihingsanon
Authors
A. Avihingsanon1, H. Lu2, C.L. Leong3, C.-C. Hung4, E. Koenig5, S. Kiertiburanakul6, M.-P. Lee7, K. Supparatpinyo8, F. Zhang9, S. Rahman10, M.L. D’Antoni10, H. Wang10, J.T. Hindman10, H. Martin10, J.M. Baeten10, T. Li11
Institutions
1HIV-NAT, Thai Red Cross AIDS Research Centre and Centre of Excellence in Tuberculosis, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand, 2Shanghai Public Health Clinical Center, Shanghai, China, 3Kuala Lumpur General Hospital, Department of Medicine, Kuala Lumpur, Malaysia, 4National Taiwan University Hospital Yunlin, Yunlin, Taiwan, Republic of China, 5Instituto Dominicano de Estudio Virologicos – IDEV, Santo Domingo, Dominican Republic, 6Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand, 7Queen Elizabeth Hospital, Kowloon, Hong Kong, SAR of China, 8Chiang Mai University, Chiang Mai, Thailand, 9Beijing Ditan Hospital, Capital Medical University, Beijing, China, 10Gilead Sciences, Inc., Foster City, United States, 11Peking Union Medical College Hospital, Beijing, China

BACKGROUND: ALLIANCE (NCT03547908) is the largest, and first randomized, study to date comparing the efficacy and safety of B/F/TAF versus DTG+F/TDF in people with both HIV-1 and HBV. In the primary analysis, B/F/TAF was noninferior to DTG+F/TDF at achieving HIV-1 RNA suppression and superior at achieving HBV DNA suppression at Week (W) 48. We report W96 outcomes for HIV-1 and HBV.
METHODS: Adults with HIV-1/HBV from 46 sites internationally (n=243) were randomized 1:1 to daily oral B/F/TAF or DTG+F/TDF (plus corresponding placebos). Secondary endpoints at W96 were HIV-1 suppression (HIV-1 RNA <50 copies/mL), HBV suppression (HBV DNA <29 IU/mL), change in CD4+ cell count/percentage, alanine aminotransferase (ALT) normalization, HBsAg loss. Additional endpoints at W96 were HBeAg loss, HBeAg seroconversion, HBsAg seroconversion.
RESULTS: Most participants were male (95.5%) and Asian (88.1%), with median age 32 years. At baseline, 29.6% had HIV-1 RNA >100,000 copies/mL, 40.3% CD4+ <200 cells/µL and 51.9% HBV DNA =8 log10 IU/mL; 77.8% were HBeAg+. At W96, similar proportions of participants had HIV-1 RNA and HBV DNA suppression with B/F/TAF versus DTG+F/TDF ([87.4% vs. 87.7%] and [74.8% vs. 70.5%], respectively; Table). Mean CD4+ cell count/percentage increased similarly from baseline in both treatment groups. Proportions of participants with ALT normalization and HBsAg loss/seroconversion were numerically higher, and with HBeAg loss/seroconversion were significantly higher, for B/F/TAF versus DTG+F/TDF at W96 (Table). Adverse events were similar between treatment groups. For B/F/TAF and DTG+F/TDF, respectively, median (IQR) changes from baseline for eGFRCG (mL/min) were -9.9 (-21.6, -0.6) and -12.0 (-17.4, -5.3), and for weight (kg) were 4.3 (0.9, 8.0) and 2.3 (-0.5, 5.7), at W96.


CONCLUSIONS: Treatment with B/F/TAF or DTG+F/TDF resulted in high and sustained rates of HIV-1 and HBV viral suppression over 96 weeks in adults with HIV-1/HBV. Markers of anti-HBV activity (ALT normalization, HBe/sAg loss/seroconversion) trended towards benefit of B/F/TAF over DTG+F/TDF.

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