Blog

– Multi-regional Study across Taiwan, South KoreaAnd Singapore Supports the efficacy of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) One-tablet regimen for the treatment of HIV initiation patients and persons with prior antiretroviral therapy –

– Subanalysis of a randomized controlled phase 3 trial confirms B/F/TAF One-tablet regimen: Well-tolerated and effective treatment in adults of Asian descent with HIV and in HIV/HBV co-infected individuals who have not previously received antiretroviral therapy–

HONG KONG, 27 June 2024 /PRNewswire/ — Gilead Sciences, Inc. today presented results from two comprehensive studies evaluating the efficacy and tolerability of the B/F/TAF single tablet regimen for the treatment of HIV-naive and treatment-experienced adults, as well as ART-naive, HIV/HBV co-infected adults of Asian descent. The data were selected for presentation at the hybrid Asia-Pacific AIDS and Co-Infections Conference (APACC) 2024, being held June 27-29 in Hong Kongis the first time that these findings are being presented at a regional conference.

BICtegravir Single Tablet Regimen Asia (BICSTaR Asia), one of two Asia-specific real-world trials, is a 24-month study designed to demonstrate the efficacy and tolerability of B/F/TAF in the real world, evaluating outcomes in both treatment-naive individuals and those previously treated with other HIV regimens. In addition, BICSTaR Asia will evaluate the efficacy, safety and patient-reported outcomes of B/F/TAF outside of controlled clinical trials across Asia. Taiwan, South Korea And Singapore. The results confirm that B/F/TAF is highly effective in suppressing HIV viral load in Asians. Less than 1% of patients discontinued treatment due to drug-related adverse events, and no serious drug-related adverse events were reported over the entire 24-month study period.

Notably, the BICSTaR Asia results also indicate an improvement in mental component summary (MCS) scores and high treatment satisfaction among people already treated with stable antiretroviral therapy (ART) regimens other than B/F/TAF who switched to B/F/TAF. This suggests that B/F/TAF offers additional benefits for people living with HIV beyond viral suppression. The results highlight the importance of patient-reported outcomes as a person-centered approach in HIV research and can help us better understand the impact on health-related quality of life and particularly mental health status in people living with HIV. This could help develop treatment strategies for this group.

The story goes on

DR. Chia Jui YangDirector of the Infection Control Center at the Far Eastern Memorial Hospital in Taiwanemphasized: “These studies underscore the urgent need to provide specific data for people of Asian descent living with HIV to better understand how treatments impact different ethnic groups. This will contribute to greater equity and effectiveness in health care for all patient groups, fill a significant gap in HIV treatment research, and ensure personalized, effective care for this population.”

Gilead will also present the results of a sub-analysis of an ongoing randomized controlled Phase 3 trial (ALLIANCE Asia) in an oral presentation. Week 96 results evaluating B/F/TAF compared to dolutegravir + emtricitabine/tenofovir disoproxil fumarate (DTG + F/TDF) in adults of Asian descent with HIV-1/HBV co-infection at baseline confirmed the high efficacy of B/F/TAF in suppressing HIV and HBV in 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 groundbreaking clinical trial investigating the specific treatment responses of adults of Asian descent with HIV/HBV co-infection,” said Anchalee Avihingsanon, MD, PhD, principal investigator, HIV–NAT, Thai Red Cross AIDS Research Center, Thailand. “Emerging HIV epidemics in areas with high HBV rates such as Asia The number of people with HIV/HBV co-infection is increasing. Participants from several countries around the world took part in this representative study and received treatment. Asia region, thereby promoting the availability of data from the most affected communities.”

“Gilead is committed to further improving HIV treatment in Asia. We recognize the critical importance of providing tailored data for Asian patients to ensure an accurate understanding of how treatments affect different ethnic groups,” said Caroline ChoiSenior Director, Asia 5 Medical Affairs, Gilead Sciences. “Therefore, the Asia-specific data on B/F/TAF aim to understand the benefits that single-tablet therapy can bring to HIV-infected Asians. They will fill a significant gap in HIV treatment research, ensure personalized, effective treatment for this population, and help promote equity in healthcare for all patient groups.”

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 with five observational cohorts (Asia, Canada, Europe, IsraelAnd Japan). The Asia The study will examine 24-month safety and efficacy data for 240 prospectively or retrospectively enrolled people living with HIV receiving B/F/TAF in routine clinical care in TaiwanThe South KoreaAnd SingaporeThe aim of the study is to evaluate the efficacy and safety of B/F/TAF as part of routine clinical care in a real-world cohort of TN and TE patients with HIV in Asia.

About the ALLIANCE Asia Study

The Alliance Asia The study is a post hoc analysis of a double-blind, placebo-controlled trial in adults of Asian descent with HIV-1/HBV co-infection who were randomized 1:1 to induction with B/F/TAF or DTG + F/TDF.

About Gilead Sciences in HIV

Gilead Sciences, Inc. is a biopharmaceutical company that has been pursuing and achieving medical breakthroughs for more than three decades with the goal of creating a healthier world for all. The company is committed to developing innovative medicines to prevent and treat life-threatening diseases such as HIV, viral hepatitis, COVID19 and cancer. Gilead operates in more than 35 countries worldwide and is headquartered 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 medicines, including the first one-pill regimen to treat HIV, the first antiretroviral pre-exposure prophylaxis (PrEP) to reduce new HIV infections and the first long-acting, injectable HIV treatment medicine given twice a year. Our advances in medical research have helped make HIV a treatable, preventable and chronic disease for millions of people.

Gilead is committed to continuous scientific innovation to find solutions to the evolving needs of people living with HIV around the world. Through partnerships, collaborations and philanthropic giving, the company also works to improve education, expand access and reduce barriers to treatment with the goal of ending the HIV epidemic for everyone, everywhere. Gilead was recognized as the largest philanthropic funder of HIV-related programs in a report published by Funders Concerned About AIDS.

Learn more about Gilead’s unique collaborations around the world and work to end the global HIV epidemic.

Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc. or its affiliates.

For more information about Gilead Sciences, please visit the company’s website at www.gilead.comfollow Gilead on X (@GileadSciences) and LinkedIn or contact the Gilead Public Affairs Asia 5 team at [email protected].

MEDIA CONTACTS:

Agnes Lau
[email protected]

Helen Lee
[email protected]

View original content to download multimedia: https://www.prnewswire.com/apac/news-releases/new-data-support-the-use-of-bictegravir-table-regimen-to-treat-people-with-hiv-and-individuals-with-hivhbv-coinfection-in-asia-302183939.html

Never miss a story from Gilead Sciences, Inc.