ALLIANCE trial delivers important treatment data for people with HIV, HBV coinfection
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Treatment with bictegravir/emtricitabine/tenofovir alafenamide resulted in high HIV and hepatitis B virus suppression among adults with HIV and HBV coinfection, according to results from the ALLIANCE trial.
“HIV and HBV coinfection is a major public health issue that threatens patient outcomes more than either infection alone,” Anchalee Avihingsanon, MD, PhD, researcher at the Thai Red Cross AIDS Research Center, said during a press conference at the International AIDS Conference. “Alliance ... is a landmark trial, investigating HIV and HBV coinfections in people with no prior treatment history.”
According to results from the ongoing phase 3 trial, a tenofovir-containing antiretroviral regimen is recommended in most people with HIV and HBV coinfection, but there have not been randomized studies of tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide fumarate (TAF) in treatment-naive HIV- and HBV-coinfected people.
To provide additional data on this, the researchers randomly assigned adults with HIV and HBV coinfection in a 1:1 ratio to initiate treatment with bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) or dolutegravir with emtricitabine/tenofovir disoproxil fumarate (DTG+F/TDF). The primary endpoints were the proportion of participants with HIV RNA less than 50 copies/mL and plasma HBV DNA less than 29 IU/mL at week 48 of the study.
In total, 243 participants were randomly assigned, with 121 receiving B/F/TAF and 122 DTG+F/TDF. The study showed that B/F/TAF was noninferior to DTG+F/TDF at achieving HIV RNA less than 50 copies/mL (95% vs. 91%; 95%) with mean CD4 gains of +200 and +175 cells/mL, respectively, at week 48. Additionally, B/F/TAF was superior to DTG+F/TDF at achieving HBV DNA below 29 IU/mL (63% vs. 43%).
According to the study, participants treated with B/F/TAF vs. those treated with DTG+F/TDF had higher HBsAg loss (13% vs. 6%; P = .059), HBeAg loss (26% vs. 14%; P = .055), HBeAg seroconversion (23% vs. 11%; P = .031) and alanine aminotransferase (ALT) normalization (73% vs. 55%; P = .066). The study also showed that the adverse events were similar between the two treatment groups, with the most frequent adverse events being upper respiratory tract infection (17%, 11%), COVID-19 (13%, 11%), pyrexia (9%, 12%), ALT increase (7%, 11%) and nasopharyngitis (11%, 4%).
“This study is really exciting, and these findings have important implications beyond just HIV and HBV coinfection and also for the many, many people living with HBV alone,” Sharon Lewin, MBBS, PhD, president-elect of the International AIDS Society and director of The Peter Doherty Institute for Infection and Immunity in Melbourne, Australia, said at the meeting.
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Avihingsanon A, et al. Abstract 12565. Presented at: International AIDS Conference; July 27-Aug. 2, 2022; Montreal (hybrid meeting).
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