An injection containing the antiretroviral drug lenacapavir is highly effective at preventing HIV infection for six months per shot. This is according to top-line study findings announced last week by the pharmaceutical company Gilead. Detailed study findings have not yet been presented at a major scientific conference or published in a reputable scientific journal.
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.
"To see no infections at all in over 2 000 young women in Uganda and South Africa is just unprecedented and incredible," said Bekker."This really gives hope that this prevention modality, if widely available, could protect young women in this region." According to Venter Integrating lenacapavir into existing healthcare frameworks presents both challenges and opportunities. He points out that"PrEP uptake has been very low, in the public and private sector." Prevention pills have been available at public sector clinics for several years. Spotlight previously reported on possible reasons for low uptake here.
Gilead has also indicated that it will license generic manufacturers to produce the injection. Having several companies manufacturing a drug typically leads to greater and more reliable supply. It also tends to result in significant price reductions once a sufficient number of generic manufacturers are in the market.
Gilead told Spotlight they have a two-pronged access strategy"ensuring dedicated Gilead supply in the countries where the need is greatest until voluntary licensing partners are able to supply high-quality, low-cost versions of lenacapavir, and developing a robust direct voluntary licensing program to expedite access to those versions of lenacapavir in high-incidence, resource-limited countries".