Gilead, Merck begin phase 2 study of weekly two-drug HIV regimen
Click Here to Manage Email Alerts
Gilead Sciences and Merck said they have begun a phase 2 clinical study investigating a once-weekly oral regimen of islatravir and lenacapavir for people with HIV.
The companies announced in March that they had formed a partnership to codevelop lenacapavir (Gilead) and islatravir (Merck) — both investigational drugs — together as a long-acting regimen.
Both drugs have long half-lives and demonstrated activity at low dosages in independent clinical trials, supporting their development as an investigational combination regimen, the companies said in a news release.
Lenacapavir, a capsid inhibitor, was effective in a small phase 2/3 trial when given as a subcutaneous injection treatment every 6 months. Islatravir, a nucleoside reverse transcriptase translocation inhibitor, showed promise in a phase 2a trial as oral PrEP taken once per month.
“This innovative research collaboration builds on the efforts of both companies to help make the end of the epidemic a reality through continued scientific advances in HIV,” Gilead Vice President of HIV Clinical Development Jared Baeten, MD, PhD, said in the press release announcing the new phase 2 trial. “Initiating the trial represents an important step forward toward our goal of offering long-acting options that can help address the differentiated needs and preferences of the diverse range of people living with HIV.”
The phase 2, open-label, active-controlled, multicenter study will evaluate the safety and efficacy of the once-weekly combination at 25 sites in the United States.
According to the press release, the trial will consist of 75 participants aged 18 years or older who will be randomly assigned in a 2:1 ratio to receive oral weekly islatravir (20 mg) administered with oral lenacapavir (300 mg) on day 8 following a loading dose of islatravir (40 mg) and lenacapavir (600 mg) on days 1 and 2, or daily bictegravir (50 mg)/emtricitabine (200 mg)/tenofovir alafenamide (25 mg) (B/F/TAF) tablets.
Participants will receive study drugs for 48 weeks. Following week 48, participants in the first treatment group will continue to receive weekly islatravir in combination with oral lenacapavir and be evaluated every 12 weeks. Those in the second treatment group will switch from the daily oral B/F/TAF tablets to an oral weekly regimen of islatravir in combination with oral lenacapavir, starting with loading doses over 2 days, and continue the study with visits every 12 weeks.
“The initiation of this study is key to further understanding the potential of islatravir and lenacapavir in combination for the treatment of HIV-1 and demonstrates Merck and Gilead’s shared commitment to address the unmet needs of people living with HIV and to contribute to global efforts to end the pandemic,” Joan Butterton, MD, vice president of global clinical development of infectious diseases at Merck, said in the statement.
Perspective
Back to TopMelanie A. Thompson, MD
It’s exciting to see this next step in the courtship of islatravir and lenacapavir. The once-weekly oral study in people with viral suppression will explore the safety and efficacy of a two-drug regimen, capitalizing on the long half-lives of both compounds. If the outcomes are favorable, this study will strengthen the case for administration of both drugs in combination in their parenteral formulations, perhaps as infrequently as twice yearly.
Lenacapavir is already in studies using subcutaneous dosing every 6 months, while islatravir is being tested as an implantable formulation that could last as long as a year. Long-acting therapies that are safe and effective and that can be easily and infrequently administered could be very important in overcoming issues with adherence to medicines and clinic visits but also could alleviate stigma.
Of course, we will be keeping a close eye on the price tag because patients and our health care systems are struggling with the egregious cost of prescription drugs. This is truly the most exciting betrothal of the year, and we wish them success.
Collapse
Read more about
Click Here to Manage Email Alerts