Lenacapavir is in a relatively new class of antiretroviral medicines which interferes with the protein shell that protects HIV’s genetic material and the enzymes it needs for viral replication.
The six months of protection provided per shot with lenacapavir is a substantial improvement on the two months of protection provided by another HIV-prevention injection called long-acting cabotegravir . In addition to comparing HIV infections in the lenacapavir and TAF arms to the TDF arm, the researchers also compared it to the background rate of HIV incidence in the communities where the study was conducted.
Gilead told Spotlight that according to the DSMB the study had met its key efficacy endpoints of showing that twice-yearly lenacapavir injections were superior to prevention pills and superior to the background HIV incidence rate in the community., there were 0 new HIV infections among the 2 134 women in the lenacapavir group – compared to 16 among the 1 068 women in the TDF group, and 39 among the 2 136 women in the TAF group.
He underscored the importance of monitoring and addressing potential long-term side effects, saying:"As with all new drugs, we need to be cautious. This was a big study, and carefully conducted, but drug safety is always an ongoing project."To see no infections at all in over 2 000 young women in Uganda and South Africa is just unprecedented and incredible.
APHA serves as the secretariat of the African Women’s Prevention Community Accountability Board, which was involved in the study. A Gilead representative told Spotlight the company is"prioritising speed to enable the most efficient path" for the regulatory approval of the lenacapavir injection"in countries that account for most of the global disease burden".
"We are pursuing a direct voluntary licensing strategy for access to lenacapavir in high-incidence, resource-limited countries," Gilead told Spotlight.
Health Health Latest News, Health Health Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
South Africa: Twice-Yearly HIV Prevention Shot Succeeds in Pivotal Trial, but Questions Loom Over Future AccessAn HIV prevention injection that provides six months of protection per shot has been shown to be highly effective in a pivotal trial largely conducted in South Africa. There are however some concerns as to when the injection will become available and how widely.
Source: allafrica - 🏆 1. / 99 Read more »