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. 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.
The ALLIANCE trial, the first randomized clinical trial comparing TAF-based Biktarvy to TDF-based regimens in HIV/HBV co-infection, provides crucial insights into effective treatment strategies for this challenging dual infection. The study's findings are important for clinicians and patients considering long-term treatment options.
Anchalee Avihingsanon, MD, PhD, principal investigator of the study at the Thai Red Cross Research Center in Bangkok, Thailand, discussed the implications of these results and the key differences between the TAF-based and TDF-based regimens during an exclusive interview with Contagion.
Avihingsanon explained that the ALLIANCE study aimed to compare the effectiveness of TAF-based Biktarvy with TDF plus emtricitabine (FTC) in combination with dolutegravir (DTG), a regimen known as F/TDF+DTG. Both regimens are highly effective and have a high genetic barrier for resistance, but there are notable differences in their impact on Hepatitis B.
“We know that both TAF-based and TDF-based regimens are highly effective, with both having a high genetic barrier for resistance," Avihingsanon stated. "However, for HIV/HBV co-infection, this population is different from HIV mono-infection. These patients usually have high viral loads for Hepatitis B and may also have subclinical or suboptimal liver disease. It's crucial to treat both HIV and Hepatitis B together."
The study found that 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. By weeks 90-96, the proportions were similar between the two groups.
Importantly, the TAF regimen also showed 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 findings from the study were consistent with Biktarvy’s established safety profile. In the open-label extension phase, the study found that 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.
“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 also pointed out that the use of Biktarvy in HIV/HBV co-infection is still investigational, and while the regimen shows promise, further studies are needed to establish its safety and efficacy definitively.
Avihingsanon noted that even patients with high baseline viral loads responded well to treatment when asked about specific subgroups with higher viral loads or advanced liver disease. The study had limited patients with severe liver conditions such as cirrhosis. One patient with cirrhosis responded well to treatment but later developed hepatocellular carcinoma.
“Side effects were generally mild, and we didn’t see any significant adverse effects related to HIV or Hepatitis B treatment,” she explained. “However, because we had fewer patients with severe liver disease, we can’t say for sure whether the response would be the same in those with advanced liver conditions.”
What You Need To Know
At Week 144, Biktarvy achieved 99% suppression of HIV-1 RNA and 80.2% suppression of HBV DNA, demonstrating robust long-term efficacy in co-infected patients.
The TAF-based regimen showed faster and higher rates of HBeAg seroconversion, ALT normalization, and S antigen loss, indicating stronger Hepatitis B suppression compared to the TDF-based regimen.
Biktarvy was well-tolerated over three years, with mild to moderate adverse events reported in 32% of patients, and only 1% discontinuing treatment due to side effects, supporting its use as a long-term therapy for co-infected individuals.
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.
Despite 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 weight gain can generally be managed and compared to the benefits for kidney and bone safety, TAF would be the preferred regimen for long-term health in patients with renal or bone concerns," she said.
The ALLIANCE trial continues to provide valuable data on the long-term use of Biktarvy in HIV/HBV co-infected patients. With high rates of virologic suppression and favorable safety outcomes, Biktarvy shows great promise as a treatment option. As the trial progresses, the findings may lead to updated treatment guidelines that better address the needs of patients with HIV and Hepatitis B.
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