The U.S. pharmaceutical company Gilead Sciences announced on Sept. 12 the findings of its most recent Phase 3 clinical trial for its twice-yearly injectable HIV prevention drug Lenacapavir show the drug is highly effective in preventing HIV infections, even more so than the current HIV prevention or PrEP drugs in the form of a pill taken once a day.
There were just two cases of someone testing HIV positive among 2,180 participants in the drug study for the twice-yearly Lenacapavir, amounting to a 99.9 percent rate of effectiveness, the Gilead announcement says.
The announcement says the trial reached out to individuals considered at risk for HIV, including “cisgender men, transgender men, transgender women, and gender non-binary individuals in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the United States who have sex with partners assigned male at birth.” “With such remarkable outcomes across two Phase 3 studies, Lenacapavir has demonstrated the potential to transform the prevention of HIV and help to end the epidemic,” Daniel O’Day, chair and CEO of Gilead Sciences said in the announcement. “Now that we have a comprehensive dataset across multiple study populations, Gilead will work urgently with regulatory, government, public health, and community partners to ensure that, if approved, we can deliver twice-yearly Lenacapavir for PrEP worldwide for all those who want or need it,” he said.
Carl Schmid, executive director of the D.C.-based HIV+ Hepatitis Policy Institute, called Lenacapavir a “miracle drug” based on the latest studies, saying the optimistic findings pave the way for the potential approval of the drug by the U.S.