- Multiregional Study Across Taiwan, South Korea, and Singapore Supports Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) Single-Tablet Regimen for the Treatment of People with HIV Initiating Therapy and Individuals with Prior Antiretroviral Therapy -

- Subanalysis of a Phase 3 Randomized Controlled Trial Demonstrates B/F/TAF Single-Tablet Regimen Well Tolerated and Effective Treatment in Adults of Asian Descent Living with HIV, as well as Those with HIV/HBV Co-Infected who are ART-Naïve-

HONG KONG, June 27, 2024 /PRNewswire/ -- Gilead Sciences, Inc. today 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.

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."

Details of the abstract presented at APACC 2024 are as follows:

About the BICSTaR Asia Study

The BICSTaR study is a large, multiregional, prospective and retrospective, observational study across five observational cohorts (Asia, Canada, Europe, Israel, and Japan). The Asia study looks at 24-month safety and effectiveness data for 240 prospectively or retrospectively enrolled people with HIV receiving B/F/TAF in routine clinical care in Taiwan, the South Korea, and Singapore. The study seeks to assess the effectiveness and safety of B/F/TAF as part of routine clinical care in a real-world cohort of TN and TE people with HIV in Asia.

About the ALLIANCE Asia Study

The ALLIANCE Asia study is a post-hoc analysis of a double-blind placebo-controlled trial with adults of reported Asian ethnicity with HIV-1/HBV co-infection randomized 1:1 to initiate with B/F/TAF or DTG + F/TDF.

About Gilead Sciences in HIV

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID19, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

For more than 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 12 HIV medications, including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV treatment medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people.

Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships, collaborations and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere. Gilead was recognized as the number one philanthropic funder of HIV-related programs in a report released by Funders Concerned About AIDS.

Learn more about Gilead's unique collaborations worldwide and the work to help end the global HIV epidemic.

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For more information on Gilead Sciences, please visit the company's website at www.gilead.com, follow Gilead on X (@GileadSciences) and LinkedIn or contact Gilead Public Affairs Asia 5 team at mediaasia@gilead.com.

MEDIA CONTACTS:

Agnes Lau

agnes.lau5@gilead.com

Helen Lee

hlee@apcoworldwide.com