Gilead's Single-Tablet HIV Regimen Shows Promise in Phase 3 Trial

Gilead Sciences has announced positive results from a phase 3 trial of its investigational single-tablet HIV regimen, combining bictegravir and lenacapavir (BIC/LEN). The study, known as Artistry-1, demonstrated that the once-daily tablet was non-inferior to complex multi-tablet regimens in maintaining viral suppression in adults with HIV.

Trial Results and Significance

The open-label Artistry-1 trial evaluated the efficacy of switching to BIC/LEN in adults with HIV who were virologically suppressed on complex multi-tablet regimens. Participants were randomized 2:1 to either switch to the investigational once-daily tablet 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.
• BIC/LEN demonstrated statistical non-inferiority compared to baseline multi-tablet regimens.
• At baseline, patients were taking between 2 and 11 pills per day for their HIV treatment.

Professor Chloe Orkin from Queen Mary University of London emphasized the significance of these findings, stating, "Developing new effective, convenient regimens for those left behind by advances in medical research is necessary to close the unmet HIV treatment gap."

Potential Impact on HIV Treatment

The BIC/LEN combination represents a promising development for individuals who have been unable to benefit from existing single-tablet regimens due to factors such as drug resistance, tolerability issues, or drug-drug interactions. By potentially offering a new option for those on complex multi-tablet regimens, this investigational treatment could simplify HIV management for a subset of patients.

Gilead's HIV portfolio already includes the blockbuster daily treatment Biktarvy and the long-acting pre-exposure prophylaxis (PrEP) medication Yeztugo. The success of BIC/LEN in this trial builds upon the company's strong position in the HIV market.

Next Steps and Regulatory Outlook

Following these positive results, Gilead plans to submit the data to regulatory authorities and present the findings at future medical conferences. The company is also awaiting top-line results from another phase 3 trial, Artistry-2, which is evaluating BIC/LEN in patients previously suppressed on Biktarvy. Results from Artistry-2 are expected by the end of the year.

As Gilead prepares for potential regulatory filings, the pharmaceutical industry will be watching closely to see how this new single-tablet regimen might reshape HIV treatment options for patients with complex needs.