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. 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 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.
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.