Results From Phase II Study of Islatravir and Lenacapavir Combination Show Viral Suppression in Patients With HIV
Investigational, once-weekly combination shows promise as long-acting oral treatment option for those virologically suppressed with HIV.
Gilead Sciences and Merck have announced results from a Phase II clinical trial evaluating the investigational combination of islatravir, an investigational nucleoside reverse transcriptase translocation inhibitor, and lenacapavir, a first-in-class capsid inhibitor, according to a company press release.1
The late-breaking data at 24 weeks showed a high rate (94.2%) of viral suppression in patients using the novel investigational combination, which was a secondary endpoint of the study. Results of the primary endpoint at 24 weeks showed that one participant treated with islatravir and lenacapavir had a viral load of >50 copies/mL. The participant later suppressed on islatravir and lenacapavir at week 30.
“Human immunodeficiency virus (HIV) treatment is not one size fits all–developing once-weekly treatment options could help meet the needs of each individual, aiming toward maximizing long-term outcomes for people with HIV,” said Jared Baeten, MD, PhD, vice president, HIV clinical development, Gilead Sciences in the press release. “These promising data presented at the 31st Conference on Retroviruses and Opportunistic Infections (CROI) help bring us one step closer to our goal of providing a wide range of options that may help transform the HIV treatment landscape.”
According to the Centers for Disease Control and Prevention, an estimated 1.2 million people in the United States had HIV at the end of 2021. In the same year, 36,136 people received an HIV diagnosis in the United States. However, the annual number of new diagnoses decreased by 7 percent from 2017 to 2021.2
The Phase II clinical trial is an open-label, active-controlled study. According to the press release, the study will continue through week 48.
“Our strategies for managing and treating HIV must evolve with the needs of the HIV community and we are excited to have these promising first data from the Phase II study for islatravir and lenacapavir presented at CROI,” said Elizabeth Rhee, MD, vice president, global clinical development, Merck Research Laboratories in the press release. “Gilead and Merck remain committed to this collaboration and to the development of a potential once-weekly oral therapy for people living with HIV who may need additional options to help maintain viral suppression.”
References
- Gilead and Merck Announce Phase 2 Data Showing an Investigational Oral Once-Weekly Combination Regimen of Islatravir and Lenacapavir Maintained Viral Suppression at Week 24. News release. March 6, 2024. Accessed March 8, 2024. https://www.gilead.com/news-and-press/press-room/press-releases/2024/3/gilead-and-merck-announce-phase-2-data-showing-an-investigational-oral-once-weekly-combination-regimen-of-islatravir-and-lenacapavir-maintained-viral
- HIV Basics. Centers for Disease Control and Prevention. Reviewed May 22, 2023. Accessed March 8, 2024. https://www.cdc.gov/hiv/basics/statistics.html
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
Reaching Diverse Patient Populations With Personalized Treatment Methods
January 20th 2025Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more.
