(RTTNews) - Gilead Sciences Inc. (GILD) said that it presented real-world results from the BICSTaR study, highlighting Biktarvy as a generally well tolerated and efficacious regimen regardless of prior treatment and comorbidity status in people with HIV.
The latest five-year data from two Phase 3 studies provide evidence of the long-term safety and efficacy profile of Biktarvy in those who switch from a dolutegravir-containing regimen.
New real-world data was presented from the 24-month BICSTaR follow-up analysis, evaluating the effectiveness and safety of Biktarvy in clinical practice across nine countries. Trial participants who initiated treatment with Biktarvy experienced high viral suppression.
Overall, 97% (104/107) of treatment-naïve and 95% (497/521) of treatment-experienced participants achieved viral suppression (missing=excluded analysis) at 24 months. There were no reports of treatment-emergent resistance.
Treatment discontinuations (14% overall) were low, and few people (7%) discontinued Biktarvy as a result of drug-related AEs (DRAEs). The most commonly reported drug-related adverse events were weight change (3%) and depression (1%).
The data reinforced the safety and durability of Biktarvy for people with HIV with a high level of comorbidities.
Biktarvy is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 14 kg who have no antiretroviral treat-ment history or to replace the current antiretroviral regimen in those who are virologically-suppressed on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy.
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