Gilead’s BICSTaR study RWE: sustained impact of Biktarvy^® for treatment of people living with HIV plus comorbidities

Gilead presented RWD from their BICSTaR study at HIV Glasgow 2022 showing Biktarvy^® is an efficacious and well-tolerated regimen regardless of prior treatment or comorbidity status for people living with HIV. This BICSTaR RWE complements and endorses results also presented from two Biktarvy Phase III clinical trials.

Gilead presented the real-world results of their BICSTaR study at the 30th International Congress on Drug Therapy in HIV Infection held at the end of October 2022 in Glasgow. The BICSTaR RWD shows Biktarvy to be an effective and well-tolerated treatment for people living with HIV and a range of comorbidities, irrespective of any prior treatment. This BICSTaR RWE complements and endorses results also presented at the conference from two Biktarvy Phase III trials on patients switching from a regimen containing dolutegravir.

Biktarvy is a complete HIV treatment that combines three medicines into a single tablet. It combines the novel, unboosted integrase strand transfer inhibitor bictegravir 50 mg, with the Descovy^® (emtricitabine 200 mg/tenofovir alafenamide 25 mg) backbone.

The Bictegravir Single Tablet Regimen (BICSTaR) study is a multinational, real-world cohort study evaluating the effectiveness, safety, tolerability, and patient-reported outcomes of Biktarvy use in clinical practice across nine countries (an observational single-arm, non-comparative analysis). 107 treatment-naïve and 521 treatment-experienced people with HIV, with a high baseline prevalence of comorbidities, were enrolled in the study. The analysis over 24 months included follow-up during the COVID-19 pandemic and considered age, race, sex, adherence, and late diagnosis in the population group.

High viral suppression (HIV-1 RNA <50 copies/ml) was observed at 24 months in almost all trial participants who initiated treatment with Biktarvy: 97% of treatment-naïve and 95% of treatment-experienced participants. There were no reports of treatment-emergent resistance. Treatment discontinuations were low (14% overall), and few people (7%) discontinued Biktarvy as a result of drug-related adverse events (DRAEs). The most reported DRAEs were weight change (3%) and depression (1%). These data demonstrate the safety and durability of Biktarvy for people with HIV with a high level of comorbidities.

The RWE from the BICSTaR study complements the latest 5-year data from two Phase III clinical trials (Study 1489 and Study 1490: randomized, double-blind, active-controlled studies) that Gilead also presented at HIV Glasgow 2022. Data from these trials show Biktarvy to have sustained high efficacy and safety for people switching to the treatment from a regimen containing dolutegravir. On 14 October 2022, the FDA approved a label change for Biktarvy, updating the prescribing information to include efficacy and safety data from Study 1489 and Study 1490. The combination of these clinical trial results with the new BICSTaR RWE solidifies the robust and durable efficacy and safety profile of Biktarvy.

Benoit Trottier, Director of Research at Clinique de Médecine Urbaine du Quartier Latin, Montreal, Canada asserted: “Factors such as aging and comorbidities are vital components of long-term health discussions. The BICSTaR study reinforces the real-world effectiveness of Biktarvy across populations with a range of comorbidities and the findings are consistent with evidence from randomized clinical trials of Biktarvy treatment.”

“Gilead’s ongoing, person-centered research is focused on the evolving needs and preferences of people living with HIV”, said Jared Baeten, Vice President HIV Clinical Development, Gilead Sciences. “These latest data presented at HIV Glasgow 2022 demonstrate the clinical use of innovative medicines like Biktarvy to help a broad range of people with HIV, regardless of their burden of comorbidities.”