“This appears to be a new breakthrough for HIV prevention. If these injections can be widely distributed at low cost, it would dramatically reduce the risk of new HIV infections worldwide,” said Sarah Palmer, co-director of the Center for Virus Research at the Westmead Institute for Medical Research in Sydney, who was not involved in the peer-reviewed study. “It is especially encouraging this research focused on young women in Africa who are so highly at-risk for HIV infection.”
Worldwide there are about 1.3 million new HIV infections every year, with women and girls accounting for 44 percent of them. In sub-Saharan Africa, that proportion is 62 percent.
The shots were produced by drugmaker Gilead Sciences, which funded the trial, and some of the researchers were Gilead employees. Lenacapavir, sold under the brand name Sunlenca, is approved as a treatment for HIV infections in the United States. The goal of the trial was to prove its safety and efficacy for the prevention of infection in adolescent girls and young women. A separate trial for men is underway.
When it became clear that the shots were more effective than daily pills — 1.5 percent to 1.8 percent of participants who received one of two daily pills as part of the trial contracted HIV from their partners — the trial was halted and all participants were offered the option of receiving the injections, the researchers said. The researchers also found the incidence of HIV was lower with the use of the shots than the usual rate of HIV in the community.
HIV can be prevented through the use of protective measures such as condoms and daily pills that are in wide use in high-income countries around the world. But health experts say it can be difficult to maintain a daily pill routine in places like Africa, where limited access to health care and a dearth of educational programs put girls at particular risk for HIV.
Doctors Without Borders and other groups are calling for global action to break Gilead’s monopoly on lenacapavir to allow mass production of the drug and reduce its cost. Gilead charges $42,250 per patient per year for lenacapavir in the United States.
“Lenacapavir could be life-changing for people at risk of getting HIV and could reverse the epidemic if it is made affordable in the countries with the highest rate of new infections,” said Helen Bygrave, a chronic disease adviser at Doctors Without Borders.
Gilead previously said it was committed to lowering the cost of its drugs in low-income countries.
