Gilead Sciences' BICSTaR study illuminates path for HIV management in Asian populations

Recent advancements in HIV treatment and prevention, including the roll-out of pre-exposure prophylaxis (PrEP) and the bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) treatment regimen, have highlighted the critical need for ethnic-centered approaches in healthcare.

Therefore, understanding the nuances of treatment across different populations is crucial.

At the International Symposium on Antimicrobial Agents and Resistance & Korean Society of for Antimicrobial Therapy (ISAAR & KSAT) 2024 conference, held in Seoul, from Monday to Wednesday, Tin Hung Wong, Director of Medical Affairs for HIV & Covid-19 at Gilead Sciences, presented critical insights into the treatment and management of HIV in Asian populations, highlighting both challenges and advancements.

Wong emphasized the ongoing necessity for effective HIV treatment and prevention strategies that are attuned to the specific needs of different demographics.

Wong spotlighted the BICSTaR (BICtegravir Single Tablet Regimen) study as a pivotal project, assessing the effectiveness and safety of B/F/TAF in real-world settings for both antiretroviral treatment-naïve (TN) and treatment-experienced (TE) individuals living with HIV in various regions.

"BICSTaR is not just one study, it is a global endeavor spanning from North America to Europe and Asia, crucial for understanding the real-world effectiveness of HIV treatments," Wong said. "In an era where HIV treatment has become highly effective, understanding treatment satisfaction and quality of life improvements is as important as efficacy."

The BICSTaR study focuses on these patient-centric measures, and the company is delighted to see that even with high baseline satisfaction, B/F/TAF improved patient satisfaction, he added.

Particularly data from BICSTaR Asia, which includes Korea, Taiwan, and Singapore, Wong stressed that the study showed diverse patient needs that demand specialized attention.

With data from over 500 global participants, the study examined the effectiveness of the B/F/TAF regimen, demonstrating remarkable virological suppression rates of 98 percent in treatment-naïve and 97 percent in treatment-experienced individuals in Asia.

"This data is significant as historically many clinical trials have predominantly involved Western subjects," Wong said. "The focus on Asia aims to ensure that these populations are adequately represented in research, providing data that may lead to better-tailored treatments for these specific groups."

This is significant as it showcases B/F/TAF's robust efficacy outside the clinical trial setting, where real-world factors come into play, he added.

Discussing the unique characteristics of the Asian cohort, Wong revealed, "The participants in our Asia study have a lower median weight and BMI compared to their Western counterparts. This is why having specific Asian data is imperative to tailor HIV treatment effectively."

The BICSTaR study's findings have profound implications for the management of HIV in Asian populations.

Wong underscored the importance of the study by stating, "Our findings address key data gaps and will inform how we approach treatment resistance, regimen forgiveness, and heavily treatment-experienced patients with HIV."

The BICSTaR study's revelations extend beyond clinical effectiveness, as Wong explained, "We've been pleasantly surprised to see treatment satisfaction and mental health markedly improve after a year of B/F/TAF treatment—this is about enhancing the quality of life for those living with HIV as some patients feel that a daily pill is like a punishment."

This sentiment echoes Gilead Sciences' patient-centered approach, recognizing that the psychological aspects of daily medication and quality of life are integral to successful treatment.

Discussing weight changes associated with treatment, Wong stressed that for those who are treatment-experienced, the study identified that TDF had a suppressive effect on weight, and once removed, it led to a rebound."

This finding underscores the importance of considering prior medication history when evaluating treatment outcomes, he added.

With all these data, Wong stressed that the real challenge lies in implementation and how to translate these findings into practice.

Looking to the future, Wong emphasized Gilead Sciences' commitment to innovation by stating that the company's goal is to expand its understanding and to implement science to bridge the gap between clinical trial efficacy and real-world effectiveness.

"Our R&D strategy is focused on developing and delivering a full complement of options, particularly long-acting oral and injectable formulations that meet different dosing needs for different people," he said. "This strategy is part of a broader effort to reduce the stigma associated with HIV treatment and enhance adherence among diverse patient populations."