Gilead, Merck partner to develop long-acting two-drug HIV regimen
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Gilead Sciences and Merck announced a partnership to codevelop lenacapavir and islatravir as a long-acting two-drug regimen for patients with HIV.
The collaboration will focus on the development of long-acting oral and injectable formulations of the two investigational drugs, with clinical trials set to begin in the second half of 2021, the companies said.
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Lenacapavir, which was developed by Gilead Sciences, and Merck’s islatravir are among several long-acting agents that have produced encouraging results in clinical trials as HIV PrEP, treatment, or both.
Lenacapavir, a novel investigational capsid inhibitor, was effective in a small phase 2/3 trial when given as a subcutaneous injection treatment every 6 months.
“Our work in HIV over the past decades has been shaped by listening to people living with HIV and the physicians who treat them,” Gilead CEO Daniel O’Day said in a press release. “Now we are taking the same approach with long-acting therapies, combining the most advanced science from both companies to accelerate progress.”
Once-monthly oral islatravir showed promise as PrEP in a phase 2a trial and is scheduled to enter phase 3 development by itself. It is a novel investigational nucleoside reverse transcriptase translocation inhibitor.
“This collaboration with Gilead brings together two companies dedicated to the fight against HIV to develop potential new long-acting treatment options and is an important step forward in our strategy to harness the full potential of islatravir for the treatment of HIV,” Merck CEO Kenneth C. Frazier, said in the release.
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With our quest to end HIV by 2030, the expansion of user-friendly options for HIV is really the need of the hour. The success of any treatment regimen depends on adherence, and even more so in viral disorders like HIV. We know that compliance with ART is key, and these long-acting agents, with their less frequent dosing, show promise in this regard. What we are also seeing coming into play here is the camaraderie between rival companies, who are joining forces to fight this disease — similar to what we have seen in COVID-19 vaccine production. If approved, this combination would be an effective addition to the changing landscape of HIV treatment and yet another tool in our armamentarium against this disease — at a critical time.
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Raghavendra Tirupathi, MD, FACP
This announcement from Merck and Gilead is a welcome step toward pharmaceutical cooperation and coordination to help develop effective, safe treatments for people living with HIV. Islatravir and lenacapavir are novel, potentially first-in-class medications that are in late-stage clinical trials, and I look forward to studies investigating combination formulations of these antivirals. Long-acting antiretrovirals are the future of HIV treatment, and having multiple therapeutics in our arsenal for oral and injectable formulations will go a long way to provide new meaningful treatment options to our patients.
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