A newly presented analysis from the ALLIANCE Phase III study at the 2024 HIV Glasgow Conference highlights the long-term efficacy and safety of Biktarvy (TAF-based regimen) for treating adults with HIV and Hepatitis B (HBV) co-infection. After three years of treatment, Biktarvy demonstrated sustained high rates of virologic suppression for both HIV-1 and HBV, offering a promising treatment option for this challenging dual infection.
At Week 144, the regimen achieved HIV-1 RNA suppression in 99% of patients and HBV DNA suppression in 80.2%, confirming its robust performance over time. These findings are particularly significant given the complexities of managing HIV/HBV co-infection, where effective treatment must address both viral infections simultaneously.
Superior Hepatitis B Outcomes with TAF-Based Regimen
The ALLIANCE trial compared the effectiveness of TAF-based Biktarvy with TDF plus emtricitabine (FTC) in combination with dolutegravir (DTG), a regimen known as F/TDF+DTG. While both regimens are highly effective, the study revealed notable differences in their impact on Hepatitis B.
According to Anchalee Avihingsanon, MD, PhD, principal investigator of the study at the Thai Red Cross Research Center in Bangkok, Thailand, the TAF-based regimen was associated with a more rapid decline in Hepatitis B DNA at 48 weeks, with a higher proportion of patients achieving viral suppression compared to the TDF-based regimen. Furthermore, the TAF regimen demonstrated superior Hepatitis B outcomes.
"HBeAg seroconversion and loss were higher in the TAF regimen, which is a good sign of Hepatitis B treatment success," Avihingsanon noted. Additionally, nearly 70% of patients in the TAF group achieved ALT normalization, a critical marker for liver health. The higher rates of S antigen loss and HBeAg seroconversion further underscored the benefits of the TAF-based regimen in this patient population.
Long-Term Safety and Tolerability
Long-term safety findings from the study were consistent with Biktarvy’s established safety profile. In the open-label extension phase, treatment-emergent adverse events (TEAEs) were reported in 32% of participants, with most being mild to moderate. Only 1% of participants discontinued due to TEAEs. These safety outcomes support Biktarvy’s viability as a long-term treatment option for co-infected patients.
Clinical Implications and Future Directions
"The study demonstrated the clinical benefits of Biktarvy for adults with both HIV-1 and HBV initiating antiviral therapy," Avihingsanon said. "The regimen was well-tolerated, and its long-term efficacy is evident in the suppression of both HIV and HBV viral loads."
Avihingsanon emphasized that the current treatment guidelines recommend early initiation of ART (antiretroviral therapy) for optimal outcomes, noting that early treatment has shown significant benefits for both HIV and Hepatitis B. While there have been some concerns regarding weight gain and metabolic changes with TAF, Avihingsanon suggested that the long-term benefits for kidney and bone health could outweigh these concerns.
The ALLIANCE trial continues to provide valuable data on the long-term use of Biktarvy in HIV/HBV co-infected patients. As the trial progresses, the findings may lead to updated treatment guidelines that better address the needs of patients with HIV and Hepatitis B.
