ALLIANCE Study: B/F/TAF Achieves Sustained HIV and HBV Suppression
Anchalee Avihingsanon, MD, PhD presents results showing 95.4% HIV RNA suppression and 86.6% HBV DNA suppression after 48 weeks of B/F/TAF in HIV-HBV co-infected patients.
At CROI 2025, Anchalee Avihingsanon, MD, PhD, principal investigator of the ALLIANCE study and researcher at the HIV-NAT at the Thai Red Cross AIDS Research Centre in Bangkok, Thailand, discussed findings from the ALLIANCE trial. This Phase 3 study evaluated the efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) compared to dolutegravir + emtricitabine/tenofovir disoproxil fumarate (DTG+F/TDF) in adults with HIV-1 and hepatitis B virus (HBV) co-infection.
The study demonstrated that B/F/TAF was noninferior to DTG+F/TDF for HIV-1 RNA suppression and superior for HBV DNA suppression at Week 48. Following 96 weeks of the randomized phase, participants who switched from DTG+F/TDF to B/F/TAF continued treatment for an additional 48 weeks in the open-label extension (OLE), showing continued success in managing both HIV-1 and HBV.
Avihingsanon explained the study design and results, "In this study, we enrolled 243 HIV and hepatitis B (HBV) co-infected participants who received one of two drug regimens: either bictegravir (BIC) plus emtricitabine (FTC) and tenofovir alafenamide (TAF), or dolutegravir (DTG) plus tenofovir disoproxil fumarate (TDF) and FTC. The backbone for hepatitis B treatment was either TDF or TAF, and our main goal was to compare these two drugs in terms of their effectiveness for both HIV and HBV treatment.”
“We had two primary endpoints: 1) HIV viral suppression, and 2) HBV viral suppression and HBV-related outcomes. The first phase of the study was a randomized phase, which lasted 96 weeks, where participants were assigned to one of the two regimens. After 96 weeks, patients who had been receiving the DTG+TDF regimen were given the option to switch to the BIC+FTC+TAF regimen. Of the 122 patients eligible for the switch, 89 chose to continue into the open-label extension phase for an additional 48 weeks.”
Avihingsanon outlined the positive impact of switching to B/F/TAF on HBV suppression and liver health, "At the end of the 96-week randomized phase, we observed that both regimens were equally effective at suppressing HIV viral load. However, the outcomes for hepatitis B were different. Starting from the 48-week mark, the TAF-containing regimen showed better results for HBV suppression and also higher rates of HBeAg (hepatitis B e-antigen) and HBsAg (hepatitis B surface antigen) loss, which are important markers of HBV replication and infection resolution.”
“Before switching to the TAF-based regimen, nearly 85% of patients had abnormal alanine aminotransferase (ALT) levels, indicating liver inflammation. After switching to the TAF-based regimen, almost 50% of patients achieved ALT normalization, which is important because abnormal ALT levels suggest ongoing liver inflammation, which can lead to liver fibrosis, cirrhosis, and liver cancer over time.”
Avihingsanon emphasized the importance of TAF in managing HIV and HBV co-infection, “For patients co-infected with HIV and hepatitis B, it's essential to consider both HIV and hepatitis B outcomes. The TAF-based regimen is very effective for both HIV and hepatitis B. Therefore, any regimen containing TAF should be preferred as the first-line treatment for HIV and HBV co-infected patients.”
She also compared TAF and TDF-based regimens, “Additionally, when comparing TAF-based regimens to TDF-based regimens, TAF has the advantage of being safer for renal and bone health. This is important for HIV co-infected patients because they often have a higher risk of renal toxicity and related kidney problems.”
Avihingsanon discussed the long-term goals of hepatitis B treatment, “In terms of hepatitis B serology, the ultimate goals of treatment are ALT normalization, HBeAg loss, and HBsAg loss. Achieving these goals suggests a functional cure for hepatitis B, especially when there is HBsAg seroconversion. This is the ideal outcome we want to see. If we can normalize liver function, it helps reduce the risk of liver inflammation, liver fibrosis, cirrhosis, and ultimately liver cancer in the long term.”
Avihingsanon concluded by highlighting the importance of addressing both infections and their comorbidities, “For HIV and hepatitis B co-infection, it's not just about managing HIV; we must also consider the hepatitis B co-infection and the long-term comorbidities. Hepatitis B increases the risk not only of liver cancer but also of ALT-associated hepatotoxicity. Therefore, we must focus on how to rapidly reduce hepatitis B DNA, decrease HBeAg and HBsAg, and normalize ALT levels. These are crucial steps to managing the co-infection effectively and preventing future liver complications.”
