ALLIANCE trial shows positive HIV/HBV coinfection treatment data
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SEATTLE — The ALLIANCE trial showed positive data on bictegravir/emtricitabine/tenofovir alafenamide treatment for HIV and hepatitis B coinfection while also providing data on treatment outcome predictors.
“HIV and HBV coinfection requires dedicated research because each virus affects the other's natural history and response to therapy,” Anchalee Avihingsanon, MD, PhD, researcher at the Thai Red Cross AIDS Research Center, told Healio. “Coinfection also increases the morbidity and mortality beyond either infection alone, including liver disease progression.”
At the Conference on Retroviruses and Opportunistic Infections, Avihingsanon presented a subanalysis of week 48 data from the ALLIANCE study.
The phase 3 study assessed the efficacy and safety of bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets (B/F/TAF) compared with dolutegravir 50 mg plus emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg, (DTG + F/TDF) for the treatment of HIV/HBV coinfection in adults initiating ART. Patients with HIV/HBV coinfection were randomly assigned 1:1 to initiate blinded treatment with either B/F/TAF or DTG+F/TDF.
The primary endpoints of the study 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, although a subgroup analysis was also conducted to determine rates of hepatitis B e antigen (HBeAg) seroconversion, the proportion of patients with normal alanine aminotransferase (ALT) and predictors of hepatitis B treatment response.
In total, 243 participants were randomly assigned — 121 to receive B/F/TAF and 122 DTG+F/TDF. Avihingsanon said that the study demonstrated that rates of HBV suppression, HBeAg seroconversion and the proportion of participants with normal ALT were “significantly higher” in the B/F/TAF group.
Specifically, the study showed that HBV suppression was 63% for patients given B/F/TAF and 43% for the given DTG+F/TDF, HBeAg seroconversion was seen in 23% of patients compared to 11%, and normal ALT was achieved in 72% of patients versus 58%.
Avihingsanon added that baseline predictors for HBV DNA less than 29 IU/mL included being treated with B/F/TAF, as well as having HBeAg-negative status, HBV DNA less than log10 IU/mL, and having ALT levels greater than the upper limit of normal and CD4 counts greater than 200.
“HIV/HBV coinfection represents a major global public health threat. It is estimated that 8% of people with HIV globally are living with HBV coinfection, and coinfection rates can reach 20% in areas where both viruses are endemic, such as Asia,” Avihingsanon said. “The use of B/F/TAF in individuals with HIV/HBV coinfection is investigational, and the safety and efficacy of this use have not been established.”
Looking forward, Avihingsanon said that ALLIANCE will continue with patients receiving blinded treatment through week 96 to determine longer term safety and efficacy.
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Avihingsanon A, et al. Abstract 116. Presented at: Conference on Retroviruses and Opportunistic Infections; Feb. 19-22, 2023; Seattle.
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