Dr Anchalee Avihingsanon: ALLIANCE Trial Findings Are Meaningful for HIV/HBV Coinfection

The ALLIANCE trial is the first randomized blinded trial to investigate tenofovir alafenamide vs tenofovir disoproxil fumarate in treatment-naive individuals who have comorbid HIV/hepatitis B virus (HBV) infection.

The ALLIANCE trial from Gilead was 1 of 6 studies highlighted in a pre-AIDS 2022 press conference on July 27, 2022. The phase 3 study is currently investigating the safety and effectiveness of the triplet regimen of bictegravir/emtricitabine (FTC)/tenofovir alafenamide (TAF) vs dolutegravir plus emtricitabine/tenofovir disoproxil fumarate (TDF) among persons living with comorbid HIV/hepatitis B virus infection not yet on a regular treatment regimen for these conditions.

Anchalee Avihingsanon, MD, PhD, HIV-NAT, Thai Red Cross AIDS Research Centre, Bangkok, Thailand, and principal investigator on the study, presented the 48-week ALLIANCE findings Friday.

Transcript

Can you introduce yourself and tell us about your work?

My name is Anchalee Avihingsanon. I am in infectious disease, working in Thailand. I’m working with men with HIV, hepatitis B, tuberculosis, and also all common comorbidities in HIV-infected patients—a group [with] HIV and coinfection, and HIV and comorbidity, and also hepatitis B and C and tuberculosis, with and without HIV. That’s my main research. I’m a senior physician at the HIV-NAT, Thai Red Cross AIDS Research Centre. HIV-NAT is a organization working with the Netherlands, Australia, and Thailand; it’s a collaboration in HIV resources. I’m also working with the AIDS Clinical Trial Group, the ACTG group, in the US as a clinical research site [inaudible] for what we call the CRS site, for ACGC study.

Can you provide an overview of the ALLIANCE study and its principal findings?

The ALLIANCE study is a randomized control trial comparing TAF vs TDF in HIV infection coinfected with hepatitis B in adults initiating first-line ART [antiretroviral treatment]. This study is a placebo control. The patients were randomized to get either bictegravir/FTC/TAF vs dolutegravir plus FTC and TDF. And there was 1 placebo for each group. Also, [the trial was done] in a blinded fashion. The total study is 96 weeks, but for this presentation, we report through week 48 of the study—an interim analysis.

The study has 2 primary end points: the HIV and hepatitis B end points. We look at this because we know that TAF and TDF are widely used for HIV and hepatitis B, but we don’t know for sure how they work in HIV and hepatitis B coinfected patients. Usually hep B is difficult to treat compared to HIV actually, with the disease burden and disease severity, so this is quite important for us in terms of [being] investigators or clinicians—so the study is meaningful on that.