Data Support Biktarvy Tablets for Virologic Suppression Among Patients With HIV

Bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets ([B/F/TAF] Biktarvy; Gilead) demonstrated sustained efficacy and safety for patients with HIV, according to data from the phase 3 Bictegravir Single Tablet Regimen (BICSTaR) study, presented at the 19th European AIDS Conference (EACS 2023), taking place from October 18-21 in Warsaw, Poland. In an outcomes analysis at 24 months, 94% of participants had virologic suppression (HIV-1 RNA <50 copies/mL).

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“HIV affects a wide range of people so understanding a treatment’s efficacy and safety profile through real-world studies can help further inform HIV clinical care,” said study author Michael Sabranski, MD, a physician at the ICH Study Center in Hamburg, Germany, in a press release.

At 3 years of follow-up, no patients experienced treatment-emergent resistance. Further, 97% (58/60) of treatment-naïve participants were virologically suppressed (HIV-1 RNA <50 copies/mL; missing=excluded analysis). The same percentage of people who were treatment-experienced had virologic suppression at 3 years.

BICSTaR is an ongoing, multinational, observational, single-arm, non-comparative real-world trial enrolling patients with HIV in Canada, France, and Germany. The study is assessing the efficacy, safety, tolerability, and patient-reported outcomes of B/F/TAF for patients with HIV who are treatment‐naïve or treatment‐experienced.

"Real-world evidence and observational studies can help bridge the gap between clinical trials and clinical practice, providing valuable insights into the characteristics of individuals with HIV in specific regions or communities, particularly those historically underrepresented in HIV clinical research," said Fernando Bognar, MD, vice president of Global Medical Affairs for HIV at Gilead Sciences, in the press release.

During the study, investigators also evaluated B/F/TAF for patients with pre-existing mental health conditions (depression, anxiety, and insomnia). A higher number of patients with HIV experience mental health conditions than people without HIV and knowing the drug’s effects on quality of life can help shape future treatment strategies.

Symptoms of depression, anxiety, or insomnia self-reported by patients were stable while on B/F/TAF treatment. The study authors even noted small increases in treatment satisfaction, according to scores from the Mental Health Component Summary. Further, only 4 patients discontinued B/F/TAF because of drug-related mental health conditions.

At the 1-year follow-up, 10% of participants experienced drug-related adverse events (DEAEs). The most common DEAEs were depression and weight change, with the average change from baseline to 3 years at 4.3 kg or greater among treatment-naïve participants and 1.7 kg or greater among treatment-experienced participants. At 2 and 3 years, 2% and less than 1% of participants had DEAEs, respectively.

Investigators also conducted a pooled analysis of patients with HIV across 9 phase 3 randomized trials in which patients were treatment-naïve, virologically suppressed, and experiencing virologic rebound. The analysis revealed that B/F/TAF produced an average resuppression rate of 93%, given certain exclusion criteria. All these data support the ongoing investigation of B/F/TAF for HIV, according to the investigators.

Bognar concluded, “the results presented at EACS complement the results observed in multiple Phase 3 clinical trials, which demonstrate the sustained efficacy, safety profile, and high barrier to resistance of B/F/TAF.”

Reference

Real-World Evidence Reinforces Biktarvy® as a Long-Term Treatment Option With a High Barrier to Resistance for People With HIV and a Range of Comorbidities. Gilead Sciences, Inc. News Release. October 19, 2023. Accessed on October 19, 2023. https://www.gilead.com/news-and-press/press-room/press-releases/2023/10/real-world-evidence-reinforces-biktarvy-as-a-long-term-treatment-option-with-a-high-barrier-to-resistance-for-people-with-hiv-and-a-range-of-comorbid