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Novel Weekly Oral HIV Drug Safe in Early Trial of Healthy Volunteers

— In a phase Ia trial, long-acting integrase inhibitor was associated with very few adverse events

MedpageToday

Data from a of an oral, long-acting integrase inhibitor (GS-1720) in development for HIV demonstrated promising safety in healthy adults without HIV. The findings were presented at the recent IDWeek annual meeting in Los Angeles.

In this MedPage Today video, Joseph Eron, MD, of the University of North Carolina at Chapel Hill, discusses the findings.

Following is a transcript of his remarks:

We saw pharmacokinetic data on a new long-acting integrase inhibitor. So this is a drug that's still in development. So this is GS-1720. It's been studied as single doses in healthy volunteers without HIV infection, and also as a single dose in -- actually two doses 1 day apart -- in people with HIV. And that's been presented before. It is very active as two doses given at one time over an 11-day period. But this is the first study that is showing us about multiple doses.

This study is in healthy volunteers who are without living without HIV. And what they showed very clearly is that three different doses of [GS-]1720 had excellent levels given once weekly for 6 weeks and very, very few side effects, very, very few adverse effects, almost all grade 1. So that's good news. High levels well above the protein-adjusted IC95 [95% inhibitory concentration].

And then at the end of the talk, the presenter actually disclosed that this long-acting integrase inhibitor is being partnered with a pro-drug of lenacapavir [Sunlenca] and given once a week in phase II studies in people living with HIV, including people who are treatment naive. And you might add, well, why aren't they using once-weekly lenacapavir, because that's something that's being studied along with islatravir, and I think it has to do with pill size. I don't know for sure because I wasn't able to ask that question, but it's an exciting opportunity for another potential once-weekly oral treatment for HIV.

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    Greg Laub is the Senior Director of Video and currently leads the video and podcast production teams.