Try our mobile app

Clinical and Patient-Reported Outcomes in People Living With HIV on Biktarvy® in Observational BICSTaR Study Demonstrate Consistent Efficacy Profile in Real-World Setting

Published: 2021-10-29 11:30:00 ET
<<<  go to GILD company page

– Clinical Data Across a Diverse Range of People Living With HIV on Biktarvy Treatment in the International BICSTaR Study Showed High Effectiveness and High Levels of Adherence –

– Long-Term Switch Data Presented at EACS 2021 Further Establish the Robust and Durable Efficacy Profile of Biktarvy –

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced interim results from the ongoing, multinational, observational single-arm, non-comparative real-world cohort BICSTaR study, which is designed to evaluate the antiviral effectiveness and safety profile of Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in 1,135 people living with HIV. The BICSTaR study also 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. These data were presented at the 18th European AIDS Conference (EACS 2021).

Gilead presented an analysis of patient-reported outcomes after 12 months of treatment with Biktarvy from the BICSTaR study. During the study, conducted at sites in Europe, Canada and Israel, people living with HIV who initiated treatment with Biktarvy between June 2018 and September 2020 completed questionnaires at baseline and 12 months. The questionnaires assessed patient-reported outcomes covering a range of measures. The results underline the importance of collecting patient-reported outcomes in order to understand the impact on mental health status, health-related quality of life and treatment satisfaction of people living with HIV.

“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, Medical Affairs, HIV 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.”

In a second analysis of the BICSTaR study, 97% (n=149/154) of treatment-naïve adults and 96% (n=771/800) of treatment-experienced adults achieved and maintained virologic suppression (HIV-1 RNA