Scientific Leadership Spotlighted as Gilead Presents Research Data Across Its Broad and Innovative HIV Treatment Portfolio and Pipeline

– Four-Year Outcomes from the BICSTaR Study Further Demonstrate the Long-Term Efficacy and Safety Profile of Biktarvy®, Providing Insights for HIV Clinical Care –

– New Data on HIV Treatment Patterns Reinforce the High Barrier to Resistance of Biktarvy –

– Investigational Regimens with Once-Daily, Once-Weekly and Twice-Yearly Dosing Frequencies Across Administration Methods Aim to Expand Options, Help Address Unmet Needs in HIV Treatment and Contribute to Ending the Global Epidemic –

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced the presentation of new research data from its innovative HIV treatment portfolio and pipeline, including a broad range of data on investigational and marketed agents with varied dosing frequencies and administration methods. The key findings presented at the International Congress on Drug Therapy in HIV Infection (HIV Glasgow 2024) reflect a transformative portfolio and future-looking pipeline focused on person-centered drug development strategies to address unmet needs in HIV treatment and help end the global epidemic.

“We will not end the epidemic without bringing forward innovative options that help enable all people to achieve long-term success in HIV treatment. The complexities of HIV care require biomedical innovations that put people at the center of the drug development process, with research conducted to help maximize the impact of current treatment options and diligent work to develop more therapies for the future,” said Jared Baeten, MD, PhD, Senior Vice President, Virology Therapeutic Area Head. “Our contributions to HIV Glasgow highlight our ongoing commitment to a people-first approach to scientific discovery that seeks to expand choices and enhance outcomes for those with HIV.”

Long-Term, Observational Data from the BICSTaR Study

New outcomes from two datasets derived from the Bictegravir Single Tablet Regimen (BICSTaR) study are consistent with the results observed from multiple Phase 3 clinical trials, which demonstrated the sustained efficacy, safety profile, and high barrier to resistance of Biktarvy.

BICSTaR (NCT03580668) is a multinational, prospective, observational, single-arm, non-comparative two-year cohort study, which aims to evaluate the effectiveness, safety, tolerability, and patient-reported outcomes of treatment with Biktarvy in treatment‐naïve (TN) and treatment‐experienced (TE) people with HIV in routine clinical practice. The study enrolled 2,379 people with HIV across 12 countries. Among the people with HIV enrolled in the BICSTaR study, there is a high baseline prevalence of comorbidities.

The first presentation reported on four-year outcomes in BICSTaR participants from Canada, France, and Germany. Biktarvy continued to demonstrate high levels of effectiveness and tolerability in clinical practice, with some improvements in patient reported outcomes (PROs) observed in participants who were treatment-naïve (TN). At four years, overall symptoms improved in TN participants and remained stable in TE participants. Similarly, mental component summary scores showed improvements among TN participants and remained stable among TE participants. At 4 years, Biktarvy maintained high rates of virologic suppression (HIV-1 RNA