Gilead announces new long-term data from BICSTaR study of Biktarvy

Gilead announced new long-term real-world data from the BICSTaR study highlighting the safety and efficacy profile of Biktarvy as a treatment regimen for a broad range of people with HIV, including those with a prior treatment history or comorbidities. These findings were presented at the 19th European AIDS Conference, or EACS 2023, taking place October 18-21 in Warsaw, Poland. New real-world data from the ongoing, multinational, observational, real-world BICSTaR study were collected from individuals with HIV who were enrolled in Canada, France, and Germany. Overall, Biktarvy was found to be highly effective for trial participants after three years of follow-up, with 97% of treatment-naive and 97% of treatment-experienced participants virologically suppressed. Additionally, there were no reports of treatment-emergent resistance. Overall, 10%, 2% and less than1% of participants had any drug-related adverse event, or DRAEs, across years one, two, and three respectively, with the most commonly reported DRAEs being weight change and depression. Numerically small median changes in estimated glomerular filtration rate (eGFR) and stable total cholesterol to high-density lipoprotein ratios were observed in both treatment-naive and treatment-experienced participants over the three-year period. Among study participants, the median change in weight from baseline to three years was +4.3kg for treatment-naive participants and +1.7kg for treatment-experienced participants. These findings are consistent with previously presented data. Initiation of therapy generally leads to weight change in people with HIV who have no prior treatment history, which is partially attributable to a return-to-health effect. Few participants discontinued Biktarvy due to DRAEs, with most discontinuations occurring in the first year. Mental health outcomes reported by treatment-experienced participants with pre-existing symptoms of depression, anxiety or insomnia in BICSTaR were also presented at EACS 2023. Rates of mental health conditions are higher among people with HIV compared to the general population. Mental health impairments can further increase the risk of negative health outcomes at every stage of the HIV care continuum. In this cohort of people with HIV who were receiving comedications for pre-existing mental health impairments and switched their treatment to Biktarvy, viral loads were assessed at baseline and 24 months. The rates of virologic suppression remained high over the 24-month period. In a missing excluded analysis, 94% of participants were virologically suppressed at two years. Self-reported symptoms associated with depression, anxiety, or insomnia remained stable over the course of treatment with Biktarvy, with small, numerical increases in Mental Health Component Summary score and treatment satisfaction. Drug-related adverse events of depression, anxiety, or insomnia were reported in 6%, which led to discontinuation of the study drug in four participants. No serious adverse events of depression, anxiety, or insomnia were reported. The results underline the importance of patient-reported outcomes as a person-centered approach to HIV research and can help us to better understand the impact on health-related quality of life and specifically, mental health status of people with HIV. This could help inform treatment strategies for these groups. Additional research studies evaluating Biktarvy include a pooled analysis of nine Phase 3 randomized studies in treatment-naive and virologically suppressed people with HIV who were restarting treatment with Biktarvy after experiencing virologic rebound. Out of the total participants, 2.5% experienced virologic rebound, resulting in 110 virologic rebound events. Virologic rebound events were defined as having a viral load of 1,000 copies per mL or higher after achieving virologic suppression. When excluding events where the outcome could not be evaluated due to the rebound occurring at the last assessment, the resuppression rate was 93%. The study found that the majority of participants who experienced virologic rebound achieved viral resuppression within 30 days after regaining virologic control. No instances of treatment-emergent resistance were observed in participants with persistent viremia. These findings support the ongoing evaluation of Biktarvy as a potential treatment option for individuals with viremia who had previously achieved virologically suppressed and restarting treatment. The use of Biktarvy in patients with a history of treatment failure is investigational and the safety and efficacy of this use has not been determined.