Gilead's HIV Treatment Breakthrough: Single-Tablet Combo of Bictegravir and Lenacapavir Succeeds in Phase 3 Trial
Gilead Sciences has announced a significant milestone in HIV treatment with the successful phase 3 trial of its investigational single-tablet regimen combining bictegravir and lenacapavir (BIC/LEN). This development represents a potential game-changer for individuals currently managing complex multi-tablet HIV regimens.
Artistry-1 Trial Results
The open-label Artistry-1 trial evaluated the efficacy of switching to the once-daily BIC/LEN tablet in adults with HIV who were virologically suppressed on complex multi-tablet regimens. Participants were randomized 2:1 to either switch to the investigational treatment or continue their existing regimens.
Key findings from the trial include:
- The primary endpoint, measuring the percentage of participants with HIV-1 RNA levels ≤50 copies/mL at Week 48, was met.
- Efficacy of switching to BIC/LEN was found to be statistically non-inferior compared to maintaining baseline multi-tablet regimens.
- At baseline, patients were taking between 2 and 11 pills per day for their HIV treatment.
Dr. Chloe Orkin, professor of infection and inequities at Queen Mary University of London, emphasized the significance of these results, stating, "Developing new effective, convenient regimens for those left behind by advances in medical research is necessary to close the unmet HIV treatment gap."
Innovative Combination of Established Treatments
The BIC/LEN tablet combines two key components from Gilead's existing HIV portfolio:
- Bictegravir (75 mg): An integrase strand transfer inhibitor, also found in Gilead's blockbuster daily treatment, Biktarvy.
- Lenacapavir (50 mg): A capsid inhibitor used in the company's long-acting HIV treatment Sunlenca and twice-yearly PrEP drug Yeztugo.
This novel combination aims to provide a simplified treatment option for individuals who have been unable to benefit from single-tablet regimens due to factors such as drug resistance, tolerability issues, or drug-drug interactions.
Next Steps and Regulatory Plans
Following the success of Artistry-1, Gilead is preparing to submit these findings to regulatory authorities. The company also plans to present the results at future medical conferences, further solidifying the scientific basis for this innovative treatment approach.
Additionally, Gilead is awaiting top-line results from the Artistry-2 trial, expected by the end of the year. This study is evaluating the investigational tablet in patients already virologically suppressed on Biktarvy, potentially expanding the application of the BIC/LEN combination.
As the pharmaceutical industry continues to advance HIV treatment options, Gilead's BIC/LEN regimen represents a promising step towards simplifying complex treatment regimens and improving the quality of life for individuals living with HIV.
References
- Gilead hails phase 3 victory for single-tablet combo of bictegravir and lenacapavir, preps filings
For people who are currently on multi-tablet HIV regimens, many of whom are also on medicines for other conditions, the findings are "significant," an expert said.
Explore Further
What are the specific safety outcomes observed during the Artistry-1 trial for the BIC/LEN combination tablet?
How does the efficacy of the BIC/LEN regimen compare to existing single-tablet HIV treatments currently on the market?
What is the estimated target market size for individuals managing complex multi-tablet HIV regimens who could potentially switch to BIC/LEN?
Are there any known competitors developing similar single-tablet regimens that combine an integrase inhibitor and a capsid inhibitor for HIV treatment?
What is the expected regulatory approval timeline for the BIC/LEN combination tablet based on the Artistry-1 trial results?