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New Data Back Bictegravir for HIV/HBV in Asia

HONG KONG, June 27, 2024 — Gilead Sciences, Inc. unveiled findings from two comprehensive studies examining the effectiveness and tolerability of the B/F/TAF single-tablet regimen for the treatment of adults with HIV who are treatment-naïve and treatment-experienced, as well as ART-naïve, HIV/HBV co-infected adults of Asian descent. The data selected for presentation at the hybrid Asia-Pacific AIDS and Co-Infections Conference (APACC) 2024, taking place 27 June to 29 June in Hong Kong, marks the first time that these findings have been featured at a regional conference.

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BICtegravir Single Tablet Regimen Asia (BICSTaR Asia), which is one of two Asian-specific real-world investigations, is a 24-month study that aims to showcase the effectiveness and tolerability of B/F/TAF in the real-world setting, evaluating outcomes for both treatment-naïve individuals and those previously treated with other HIV regimens. Additionally, BICSTaR Asia seeks to examine the efficacy, safety, and patient-reported outcomes of B/F/TAF outside controlled clinical trial settings across Taiwan, South Korea and Singapore. Results confirm B/F/TAF is highly effective at suppressing HIV viral load among Asians, with less than 1% discontinuation due to drug-related adverse events and no serious drug-related adverse events reported over the entire 24-month study period.

Notably, the outcomes from BICSTaR Asia also indicate an enhancement in the mental component summary (MCS) score and high treatment satisfaction among individuals who are treatment-experienced on stable antiretroviral therapy (ART) regimens other than B/F/TAF who switched to B/F/TAF, suggesting additional benefits of B/F/TAF beyond viral suppression for people with HIV. 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 this group.

Dr. Chia-Jui Yang, Director of the Infection Control Center at Far Eastern Memorial Hospital in Taiwan, emphasized, “These studies highlight the critical need for providing specific data for people with HIV of Asian descent, enabling a better understanding of how treatments affect different ethnic groups. This facilitates healthcare equity and efficacy for all patient populations, bridging a significant gap in HIV treatment research and ensuring personalized, effective care for this demographic.”

Gilead will also present outcomes from a sub-analysis of an ongoing Phase 3 randomized controlled trial (ALLIANCE Asia) in an oral presentation. The Week 96 results, which evaluate B/F/TAF as compared to dolutegravir + emtricitabine/tenofovir disoproxil fumarate (DTG + F/TDF) in adults of Asian descent with HIV-1/HBV-coinfection initiating treatment, confirmed the high efficacy of B/F/TAF in suppressing both HIV and HBV among Asians. Compared with DTG + F/TDF, B/F/TAF was associated with significantly higher rates of HBsAg loss, HBeAg loss, and HBeAg seroconversion.

ALLIANCE Asia is a landmark clinical trial, investigating the specific treatment responses of adults of Asian descent with HIV/HBV co-infection,” said Anchalee Avihingsanon, MD, PhD, Senior Researcher, HIV–NAT, Thai Red Cross AIDS Research Center, Thailand. “Emerging HIV epidemics in areas of high HBV rates such as Asia are expanding the number of people with HIV/HBV coinfection. This representative study enrolled and treated participants from multiple different countries in the Asia region, driving the availability of data from within those communities most impacted.”

“Gilead is committed in further advancing HIV care in Asia. We recognize the critical importance of providing tailored data for Asian patients, ensuring accurate understanding on how treatments affect different ethnic groups,” said Caroline Choi, Senior Director, Asia 5 Medical Affairs, Gilead Sciences. “Hence, Asian specific data regarding B/F/TAF aims to understand the benefits that single tablet regimen can bring to Asian people with HIV. It will fill a significant gap in HIV treatment research, ensuring personalized, effective care for this population and help facilitate healthcare equity for all patient populations.”

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