Biktarvy Demonstrates High Efficacy for Broad Range of Patients Initiating Treatment for HIV

Participants who initiated treatment with Biktarvy demonstrated superior hepatitis B virus (HBV) DNA suppression and HBV e-antigen seroconversion.

New results have reinforced the efficacy of Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg) for a broad range of patients with HIV, including individuals who are coinfected with hepatitis B virus (HBV).

Coinfection with HIV and HBV is a major global public health threat that increases the morbidity and mortality beyond that of either infection on its own. HBV impacts approximately 8% of individuals with HIV globally, and coinfection rates can reach 25% in areas where both viruses are endemic. In some parts of Asia, for example, HBV is endemic with a projected 70% of the population showing serologic evidence of current or prior infection.

The ALLIANCE trial is an ongoing phase 3 trial evaluating Biktarvy versus dolutegravir 50 mg plus emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (DTG+F/TDF). The trial enrolled participants over 4 years from Asia, Europe, and North and Latin America.

Results from the trial demonstrated the efficacy of both regimens among adults with HIV and HBV who were initiating treatment, although the results at week 48 showed that Biktarvy demonstrated superior HBV DNA suppression.

“ALLIANCE is a landmark clinical trial, investigating the specific treatment responses of adults with HIV/HBV coinfection,” said Anchalee Avihingsanon, MD, PhD, senior researcher of HIV-NAT at the Thai Red Cross AIDS Research Center, in a press release. “Emerging HIV epidemics in areas of high HBV rates such as Asia are expanding the number of people with HIV/HBV coinfection. This inclusive and representative study enrolled and treated participants from 11 different geographies with 88% of participants of Asian descent, driving the availability of data from within those communities most impacted.”

Interim data from the ALLIANCE trial have found potential suppression of HBV, as well as HIV suppression, comparable to an alternative HIV regimen, according to the study. Furthermore, 5-year data from 2 phase 3 trials further demonstrated Biktarvy’s sustained efficacy, safety profile, and high barrier to resistance among adults initiating HIV therapy.

Notably, participants who initiated treatment with Biktarvy versus DTG+F/TDF demonstrated superior HBV DNA suppression and HBV e-antigen seroconversion. The week 48 results also showed that participants who initiated treatment with either Biktarvy or DTG+F/TDF had similarly high rates of HIV suppression with mean CD4 cell count increases of 200 and 175 cells/μl, respectively.

Further results showed that participants who initiated treatment with Biktarvy had numerically higher HBV surface antigen loss, HBeAg loss, and alanine aminotransferase normalization. Safety findings were similar between the Biktarvy and DTF+F/TDF groups, and included upper respiratory tract infection (17% vs 11%), COVID-19 (13% vs 11%), pyrexia (9% vs 12%), ALT increase (7% vs 11%), and nasopharyngitis (11% vs 4%). ALT flares occurred in 11 participants.

“As we strive to optimize HIV treatment and advance scientific innovation, we’re committed to tailoring our research to address the individual needs of all people with HIV, including those with comorbidities,” said Jared Baeten, MD, PhD, vice president of HIV Clinical Development at Gilead Sciences, in the press release. “The HIV treatment research data presented at the 24th International AIDS Conference are an important step in deepening our understanding of how to support the long-term and overall health of a broad range of people with HIV worldwide.”

REFERENCE

Biktarvy Demonstrates High Efficacy for a Broad Range of People Initiating Treatment for HIV, Including Those With HBV Coinfection. News release. Gilead; July 28, 2022. Accessed August 1, 2022. https://www.gilead.com/news-and-press/press-room/press-releases/2022/7/biktarvy-demonstrates-high-efficacy-for-a-broad-range-of-people-initiating-treatment-for-hiv-including-those-with-hbv-coinfection