Gilead Releases New Data On HIV Prevention
Gilead Sciences, Inc. has developed the first, and only, twice-yearly HIV prevention injection. New data was released on October 8th at the HIV Research for Prevention Conference in Lima, Peru on their medicine, lenacapavir. According to their trial, phase 3 PURPOSE 2, twice-yearly lenacapavir reduced the risk of HIV infection by 96% compared to background HIV incidence (bHIV), and the reigning choice of HIV prevention, once-daily Truvada. Lenacapavir would be used as preventative care for pre-exposure prophylaxis (PrEP).
Colleen Kelley, MD, MPH, and Professor of Medicine at Emory University says, “These data reinforce that twice-yearly lenacapavir could be a highly effective and potentially game-changing HIV prevention choice that we have long hoped for in our efforts to end the HIV epidemic.” Among the trial participants, 99.9% were successful in not contracting HIV, with two incident cases out of 2,179 total participants. This is a major breakthrough for the reduction of HIV across the world. Of the project Kelley states, “PURPOSE 2 was intentionally designed to reflect the lives and locations of many people who are disproportionately affected by HIV around the world by focusing on gender, racial, ethnic and geographic diversity.”
The trial was conducted over 88 sites in Argentina, Brazil, Mexico, Peru, South Africa, Thailand, and the United States. This was the second phase 3 trial to prove the superior efficacy of lenacapavir to be used for PrEP. In fact, the trial was ended early due to meeting its key efficacy points earlier than expected. Because the trial was done on cisgender men, transgender men and women, and gender non-conforming individuals who have sex with people assigned male at birth, across several geographical regions, the data is even more reliable. The ability for lenacapavir to become the number one prevention for HIV is likely. This trial and the PURPOSE 1 trial done on cisgender women, which had a 100% success rate, will support global regulatory filings to begin by the end of 2024. Gilead is also working with several pharmaceutical companies across the globe. Through non-exclusive and royalty-free voluntary licensing, they are able to provide low-cost high-efficiency medicine to 120 low and lower-middle income countries.
