Gilead Announces High Efficacy and Adherence in Biktarvy HIV Treatment Trial

Gilead announced positive interim results from their ongoing, multinational, study of the HIV treatment drug Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF).

BICSTaR, the observational single-arm, non-comparative real-world cohort study, was designed to evaluate the antiviral efficacy and safety profile of Biktarvy in 1,135 people living with HIV. The BICSTaR study was conducted in Europe, Canada, and Israel, and collected patient-reported outcomes in routine clinical practice to better understand the impact of treatment on health-related quality of life in people living with HIV.

During the study, participants who began a Biktarvy regimen between June 2018 and September 2020 completed questionnaires that assessed their mental health status, health-related quality of life, and treatment satisfaction. The patient-outcomes after 12 months of treatment with Biktarvy were presented by Gilead at the 18 European AIDS Conference (EACS 2021).

According to Fernando Bognar, MD, Vice President of Medical Affairs at Gilead Sciences, “The patient-reported outcomes observed in the BICSTaR study provide a first-hand assessment of the impact of HIV treatment and care on the quality of life that people living with HIV experience. As physicians and people living with HIV look to understand what long-term treatment means to them individually, these data presented at EACS also reinforce that Biktarvy can meet the specific treatment needs of diverse groups of people, including men and women aging with HIV and those with existing comorbid conditions.”

After 1 year of treatment, Biktarvy achieved and maintained virological suppression in 97% (149/154) of adults with no history of HIV treatment, and 96% (771/800) of treatment-experienced adults. The participants included persons 50 years of age and older, cisgender women, and late presenters (CD4 <200 cells/μl and/or ≥1 AIDS-defining event at baseline). Treatment-naïve and treatment-experienced participants had high adherence to Biktarvy (91%, n=1032/1135). Biktarvy was generally well-tolerated and there were no reactions to the components of Biktarvy. 148 (13%) participants had an adverse event and 2 (<1%) had a serious adverse event, the most common of which were weight gain (3%), nausea (1%), depression (1%), headache (1%), fatigue (1%), diarrhea (1%), and sleep disorder (1%). Gilead interpreted their results as a testament to the real-world effectiveness of Biktarvy across populations.

Biktarvy combines 3 medicines to form the smallest integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) available. It is a powerful daily STR that can be taken with or without food. Earlier this month, the FDA approved a low-dose Biktarvy for children living with HIV.

Biktarvy is a complete treatment regimen for adults and pediatric patients over 14 kg with HIV-1 infection with no history of antiretroviral therapy (ART) or to replace a current ART regimen in those who are virologically suppressed. The most common adverse reactions to Biktarvy (incidence ≥5%) were diarrhea (6%), nausea (6%), and headache (5%).