Gilead’s New Single-Pill HIV Treatment Shows Strong Trial Results

Gilead Sciences Inc. (NASDAQ: GILD) announced significant results from its Phase 3 ARTISTRY-1 trial, showcasing the potential of a new single-pill HIV treatment. The trial assessed the effectiveness of an investigational combination of bictegravir 75 mg and lenacapavir 50 mg (BIC/LEN) in HIV patients who are already virologically suppressed. This study marks a crucial step in simplifying treatment regimens for individuals living with HIV.

The ARTISTRY-1 trial was an open-label study that aimed to compare the responses of participants switching from traditional multi-tablet regimens to the once-daily BIC/LEN regimen. According to Gilead’s findings, the new single-tablet treatment met the primary criterion for non-inferiority compared to existing antiretroviral therapies. This was measured by the percentage of participants with HIV-1 RNA levels equal to or exceeding 50 copies/mL at Week 48, as defined by the FDA snapshot algorithm.

In the trial, BIC/LEN demonstrated a favorable safety profile, with no significant new safety concerns emerging. Participants generally tolerated the regimen well, providing further confidence in its potential for widespread use.

Trial Design and Key Findings

ARTISTRY-1 was a multicenter Phase 2/3 clinical trial, enrolling participants who were virologically suppressed and on complex treatment regimens. Participants were randomized in a 2:1 ratio to receive either the fixed-dose combination of BIC/LEN or to continue their existing therapy.

In addition to the primary endpoint, key secondary endpoints included the proportion of individuals achieving virologic suppression, changes in CD4 cell counts, and the occurrence of treatment-emergent adverse events (TEAEs) at the 48-week mark.

The promising results from ARTISTRY-1 lay the groundwork for further investigation through the Phase 3 ARTISTRY-2 trial. This upcoming study will assess the safety and efficacy of switching from BIKTARVY (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg) to the new BIC/LEN combination for individuals who are virologically suppressed. The topline data readout for this trial’s primary endpoint is expected before the end of 2025.

Gilead’s stock reacted positively to the trial results, rising by 2.97% to reach $127.07 on the day of the announcement. The company continues to position itself at the forefront of HIV treatment innovations, emphasizing its commitment to improving patient outcomes and simplifying treatment protocols.

As the global fight against HIV/AIDS continues, advancements such as the BIC/LEN regimen represent critical steps toward enhancing the quality of life for those affected by the virus.