#United States #Foster City #Gilead Sciences #HIV Treatment #BIC/LEN

Gilead Achieves Major Milestone with ARTISTRY-2 Trial

Gilead Sciences, headquartered in Foster City, California, announced on December 15 significant positive top-line data from its Phase III ARTISTRY-2 trial, a pivotal clinical study aimed at enhancing treatment options for adults living with HIV who have achieved virologic suppression. This double-blind trial evaluated the efficacy of a regimen consisting of Bictegravir (BIC) and Lenacapavir (LEN) in a single tablet format, demonstrating that it is statistically non-inferior to the current standard treatment, Biktarvy (B/F/TAF).

The ARTISTRY-2 trial met its primary endpoint, showing that the once-daily BIC/LEN regimen was effective in maintaining viral suppression among participants. The effectiveness was measured by the proportion of individuals who experienced virologic non-suppression at 48 weeks, where viral loads remained above 50 copies/mL, according to the FDA’s Snapshot algorithm. The treatment was generally well-tolerated, with no significant new safety concerns reported during the trial.

The BIC/LEN combination brings together two innovative mechanisms of action: Bictegravir, a recommended integrase inhibitor known for its strong resistance barrier, and Lenacapavir, a first-in-class capsid inhibitor that does not exhibit cross-resistance with existing drug classes. According to Gilead, this emerging treatment option could significantly transform the treatment landscape for HIV-positive individuals, offering greater opportunities for achieving sustained viral suppression in conjunction with the latest advancements in HIV treatment development.

Dr. Eric Meissner, an associate professor and director of HIV and Hepatitis Patient Care and Research at the Medical University of South Carolina, commented: “Recent breakthroughs in medical research have led to the approval of new treatment options that make it easier for people living with HIV to maintain viral suppression. This not only improves health outcomes for those affected but also helps curtail the spread of the virus. The findings from the ARTISTRY-2 trial confirm that the developing combination therapy of Bictegravir and Lenacapavir has comparable efficacy to the integrase inhibitors recommended in international guidelines, thereby expanding the current treatment options available for HIV-positive patients.”

The ARTISTRY-2 trial (NCT06333808) was an expansive, multi-center, double-blind, randomized Phase III clinical trial comparing the safety and efficacy of the once-daily Bictegravir and Lenacapavir combination against Biktarvy in HIV-positive participants who achieved virologic suppression. Subjects receiving Biktarvy were randomized in a 2:1 ratio to either switch to the BIC/LEN regimen or remain on Biktarvy. The primary endpoint of the study focused on the proportion of participants who did not achieve virologic suppression at the 48-week mark.

Secondary endpoints included the proportion of subjects who achieved virologic suppression, changes in CD4 cell counts from baseline, and the percentage of participants who experienced treatment-emergent adverse events during the study. Gilead's Jared Baeten, MD, PhD, Senior Vice President of Clinical Development and Head of Infectious Disease, emphasized that these data may provide a significant additional treatment option for adults living with HIV who have already achieved virologic suppression. He noted the importance of focusing on individualized treatment approaches that address the evolving needs and preferences of those affected by HIV.

As the promising results from ARTISTRY-2 are integrated with outcomes from the ARTISTRY-1 trial (NCT05502341), Gilead plans to submit these findings to regulatory authorities to support potential approval applications. The top-line data released from ARTISTRY-1 highlighted that the BIC/LEN combination demonstrated good tolerability and non-inferiority compared to existing multi-tablet regimens utilized in antiretroviral therapy.

Currently, both Bictegravir and Lenacapavir are still in the research phase, and their safety and efficacy have yet to be established by the U.S. Food and Drug Administration (FDA), accordingly, no cure exists for HIV or AIDS at this time.

Overview of Bictegravir and Lenacapavir

Bictegravir

Bictegravir is an integrase strand transfer inhibitor (INSTI) with a high barrier to resistance, as recommended in international treatment guidelines. These drugs target the integrase enzyme by which HIV integrates its genetic material into the host cell’s DNA, showcasing a strong effectiveness when combined with other antiretroviral agents in managing HIV.

Lenacapavir

Lenacapavir has garnered approval in several countries for its use as pre-exposure prophylaxis (PrEP) among individuals at risk of contracting HIV through sexual contact. Moreover, it has approval for treating multidrug-resistant HIV-positive adults, formed on a unique mechanism of action that operates on multiple stages of the HIV lifecycle, showing no cross-resistance with currently approved drug classes.

The ongoing research of Lenacapavir underlines Gilead's commitment to providing innovative long-acting options for HIV treatment and prevention. This includes both oral and injectable formulations, targeting individual needs and preferences to enhance adherence to therapy in various populations.

Gilead has been a leader in HIV treatment innovation for over three decades, introducing groundbreaking therapies that have turned HIV into a manageable, chronic condition for millions. Through ongoing scientific exploration, partnerships, and charitable contributions, Gilead aims to address the needs of the global community affected by HIV and aims to contribute to the cessation of the epidemic. With significant investments announced for 2025, Gilead continues to strengthen its operational foundation while developing new therapeutic solutions for patients worldwide.

Gilead’s dedication to resolving the challenges faced by individuals living with HIV is seen through its collaborative initiatives and a strong commitment to addressing social barriers to care, reflecting their mission to create a healthier world for everyone.