A twice-yearly shot was 100% effective in preventing HIV infections in young women and teen girls, according to the results of what some are calling a "breakthrough" phase 3 trial. The randomized, double-blind trial by drugmaker Gilead Sciences involved more than 5,000 young women and girls in South Africa and Uganda, who are considered at high risk for HIV. Some participants received a twice-yearly injection of lenacapavir, sold under the brand name Sunlenca, which is US-approved to treat HIV but not to protect against infection, per the AP. Others received HIV-prevention pills, to be taken daily.
Just under 2% of participants who received Gilead's Truvada or Descovy contracted HIV from their partners before the trial was ended early and pill users were given the option of receiving the injections instead, according to the results published Wednesday in the New England Journal of Medicine. Health experts note it can be hard to maintain a daily pill routine in places with limited access to health care. Only 30% of participants offered the pills actually took them, a figure that fell over time, the AP reports. Researchers identified no safety concerns with lenacapavir, per CNN. Winnie Byanyima, executive director of the UN's AIDS program, said the drug "could change the trajectory of the HIV epidemic," per the AP.
But "Gilead charges $42,250 per patient per year for lenacapavir" in the US, the Washington Post reports, noting that Doctors Without Borders and other groups are urging the company to allow mass production in order to reduce costs and save lives. "This is about as close as you can get to an HIV vaccine," Andrew Hill of the University of Liverpool, said at the ongoing International AIDS Conference in Munich, per the AP. He and colleagues estimated the cost of Sunlenca would fall to $40 per treatment once production expanded to treat 10 million people. A trial of lenacapavir involving men, transgender women, and gender nonbinary people is still underway, per CNN. (More HIV/AIDS stories.)