A large clinical trial conducted in South Africa and Uganda has demonstrated that a bi-annual injection of a new drug provides young women with complete protection against HIV infection.
Lenacapavir, marketed as Sunlenca by Gilead, is a new capsid inhibitor with potent antiviral properties. The trial involved subcutaneous injections administered twice a year to over 5,300 cisgender women and adolescents aged 16 to 25, across 25 research sites in South Africa and three in Uganda. During the randomized phase of the trial, none of the 2,134 women who received Lenacapavir contracted HIV, resulting in 100% efficacy.
“With the bi-annual injection, we know participants will be very enthusiastic simply because it’s an injection rather than a pill,” explained Handeka Nkosi, a clinical trial coordinator at the Desmond Tutu Health Foundation. “We found that adherence is not always optimal with pills due to various reasons such as lack of time or difficulty in getting to a clinic to collect the pills. This injectable, administered twice a year, offers participants greater choice and makes adherence to treatment easier.”
The trial also aimed to determine if two other medications, Truvada (F/TDF) and Descovy (F/TAF), taken daily as tablets, could prevent HIV. In the group that received the pills, about 2% contracted HIV from infected sexual partners.
The United Nations agency for HIV/AIDS has urged Gilead to share the patent for Sunlenca with a UN-supported program, enabling generic manufacturers to produce affordable versions for low-income countries.
Gilead and Sunlenca are approved in the United States, Canada, Europe, and other regions solely as treatments for HIV. The American manufacturer stated that it is awaiting results from tests on men before seeking approval for the drug’s use in HIV prevention.