Biktarvy Demonstrates Consistent Efficacy in Real-World Setting for Patients With HIV

Interim results from Gilead’s ongoing, multinational, observational single-arm, non-comparative real-world cohort BICSTaR study evaluating Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in patients with HIV demonstrated that 97% of treatment-naïve adults and 96% of treatment-experienced adults achieved and maintained virologic suppression after 1 year of treatment. The study also collected patient-reported outcomes in routine clinical practice to understand the impact of treatment on health-related quality of life.

“Despite advances in antiretroviral therapy, people living with HIV experience burdensome multidimensional symptoms and concerns requiring person-centered care,” said Fernando Bognar, MD, vice president of Medical Affairs, HIV at Gilead Sciences, in a press release. “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 [European AIDS Conference 2021] 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.”

The study population included adults 50 years of age or older, cisgender women, and late presenters. Biktarvy was generally well-tolerated, with 13% of patients experiencing any adverse events (AEs) and less than 1% experiencing a serious AE. The most common AEs were weight increase (3%), nausea (1%), depression (1%), headache (1%), fatigue (1%), diarrhea (1%), and sleep disorder (1%).

Throughout the BICSTaR study, participants who initiated treatment with Biktarvy between June 2018 and September 2020 completed questionnaires at baseline and 12 months. These questionnaires were designed to assess patient-reported outcomes covering a range of measures.

According to the investigators, the study results highlight the importance of collecting patient-reported outcomes to understand the impact on mental health status, health-related quality of life, and treatment satisfaction of people living with HIV.

REFERENCE

Clinical and patient-reported outcomes in people living with HIV on Biktarvy® in observational BICSTaR study demonstrate consistent efficacy profile in real-world setting [news release]. Gilead; October 29, 2021. Accessed October 29, 2021. https://www.gilead.com/news-and-press/press-room/press-releases/2021/10/clinical-and-patient-reported-outcomes-in-people-living-with-hiv-on-biktarvy-in-observational-bicstar-study-demonstrate-consistent-efficacy-profile-i