The once-daily therapeutic agent is effective for pediatric patients and pregnant women with HIV.
Bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets (Biktarvy; B/F/TAF) allowed pregnant women with HIV type 1 (HIV-1) to maintain virologic suppression at delivery, according to a Gilead press release announcing recent data presented at the 12th International AIDS Society (IAS) Conference on HIV Science (IAS 2023), occurring July 23-26 in Brisbane, Australia.
During the conference session, investigators also presented positive data from studies evaluating B/F/TAF for virologically suppressed children aged 2 years and older (81.6% Black; weight of 14 kg to less than 25 kg) and adults with HIV/hepatitis B (HBV) coinfection.
“These studies build on our understanding of B/F/TAF and its role in helping people affected by HIV by providing clinically relevant treatment data for pregnant women, children and those living with comorbidities like HBV,” said Jared Baeten, MD, PhD, vice president, HIV Clinical Development, Gilead Sciences, in a press release.
In an open-label study evaluating once-daily treatment for pregnant women, results show that B/F/TAF was well-tolerated and had no observable mother-to-child disease transmission.
"This study demonstrates the potential role of B/F/TAF as a treatment of HIV in pregnant women, a population that has historically been difficult to study and that continues to have significant needs,” said Anchalee Avihingsanon, MD, PhD, senior researcher, HIV–NAT, Thai Red Cross AIDS Research Center, Thailand, in a Gilead press release. “The clinical profile of Biktarvy is further supported by safety data and no mother-to-child transmission in this study and data showing that normal dosing may be appropriate. These are important findings for pregnant women and their health care providers when considering HIV treatment.”
There are 2 ongoing, open-label studies evaluating weight, height, body mass index (BMI), and lipid metabolism parameters in children who received B/F/TAF or elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF).
“It is important that we limit the potential for weight and metabolic changes as a result of antiretroviral treatment in young children with HIV,” said Eva Natukunda, MD, head of Department of Pediatrics, Joint Clinical Research Centre, Uganda, in the press release.
At 48 weeks, both TAF-based therapies decreased the percentage of underweight patients (20.4% to 14.3%) while increasing the percentage of normal weight patients (67.3% to 73.5%). In addition, investigators noticed an improvement in lipid metabolism parameters.
The FDA first approved low-dose B/F/TAF tablets for pediatric patients in this weight class with viral suppression and/or who are new to antiretroviral therapy in 2021.
Investigators also presented positive data from week 96 of the ALLIANCE (NCT03547908) trial. ALLIANCE is evaluating B/F/TAF against dolutegravir 50 mg (DTG) plus emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (Descovy; F/TDF) (DTG+F/TDF) for adults with HIV/HBV coinfection.
At week 96, the B/F/TAF and DTG+F/TDF regimens led to similar rates of viral suppression—defined as having less than 50 copies/mL of HIV-1 RNA—which were 87% and 88%, respectively. However, B/F/TAF led to better HBV DNA suppression (less than 29 IU/mL) than DTG+F/TDF (75% and 70%, respectively). The results also show that both regimens increased CD4 count and presented similar adverse events.
B/F/TAF is a complete single-tablet regimen for HIV. It is the smallest 3-drug, integrase strand transfer inhibitor (INSTI) currently available. It combines this INSTI with F/TAF to make a complete STR that poses limited drug interaction potential and provides a large barrier to resistance, according to Gilead.
New Biktarvy® Data Presented at IAS 2023 Further Demonstrate Safety and Efficacy Profile in a Broad Range of People and Communities Affected by the Global HIV Epidemic. Gilead. News Release. July 23, 2023. Accessed on July 24, 2023. https://www.gilead.com/news-and-press/press-room/press-releases/2023/7/new-biktarvy-data-presented-at-ias-2023-further-demonstrate-safety-and-efficacy-profile-in-a-broad-range-of-people-and-communities-affected-by-the-gl