In June, South Africa’s health department started rolling out the six-monthly lenacapavir HIV prevention injection to around 10% of public sector clinics. While the rollout of this jab still has a long way to go, the next generation of HIV prevention products is already on the horizon.
Two of those new products stand out. One is a new formulation of lenacapavir that looks as if it can provide 12 months of protection at a time. While results so far are promising, the pivotal data on this once-yearly HIV prevention jab is only expected in a year or two.
The other product that has many people in the HIV world excited is a monthly HIV prevention pill that contains a highly potent antiretroviral medicine called alimatravir (it was previously called MK-8527). It starts working within around an hour after someone takes it and appears to provide a month of protection at a time. One benefit of the pill, compared to the lenacapavir injection, is that it would be easier to distribute at scale, given that there is no need for a nurse to administer an injection.
As we reported in some depth last year, alimatravir looked very promising in a phase 2 study, although for now the jury is still out on the drug’s safety and efficacy. It is currently being evaluated in two pivotal phase 3 clinical trials called EXPRESSIVE-10 and EXPRESSIVE-11. Both these studies started last year and are expected to be completed by around mid-to-late 2027. Medicines are typically only registered for use after positive results in such phase 3 studies.
The monthly pill offers an alternative for people who would like a long acting, less frequently dosed PrEP but not needle friendly … so it really is about giving more options especially on the pill side,” Professor Linda-Gail Bekker, primary investigator in South Africa on the EXPRESSIVE-10 study, told Spotlight. “You could imagine that just having to remember to take a small easy to swallow pill on the day you pay your bills monthly could be very easy for people. We understand that the packaging is also going to be very user friendly- looking more like a gum packet than a bottle of antiretroviral pills which may also reduce stigma.” (PrEP refers to pre-exposure prophylaxis like HIV prevention pills or injections.)
License to make generics
The prospects for future access to alimatravir got a major boost last week when the pharmaceutical company Merck (known as MSD outside of the United States and Canada) announced that it granted licenses to seven different companies to produce generic versions of the monthly pill. One of the seven companies is South Africa’s Aspen Pharmacare. The others are Uganda’s Quality Chemical Industries Limited, Kenya’s Universal Corporation Ltd, and Aurobindo, Cipla, Emcure and Viatris in India.
Early responses to the licenses have mostly been positive.
Having a generic company with a license in South Africa is excellent news, said Bekker.
“It is particularly exciting to see manufacturers in Kenya, South Africa and Uganda included in these licenses,” Mitchell Warren, Executive Director of AVAC (a global HIV advocacy group), told Spotlight by e-mail. “These are the first generic PrEP licenses in East and Southern Africa, meaning manufacturing can happen where trials are happening, where need is greatest and where we have the largest PrEP markets.”
“Through our agreement with MSD (Merck), we have the opportunity to support the future supply of an innovative HIV prevention option while strengthening local pharmaceutical manufacturing and healthcare resilience across the continent,” Stephen Saad, Aspen Group Chief Executive, said in a media statement. Under the agreement, the company says it will receive a technical package from Merck, together with licensing rights covering 129 countries, including all African countries.
