Approval of a cheap version of HIV-prevention shot lenacapavir raises hopes in low-income countries

The U.S. Food and Drug Ad­min­is­tra­tion has ap­proved a gener­ic ver­sion of the world’s on­ly twice-a-year shot to pre­vent HIV — a big step to­ward mak­ing the drug avail­able in­ex­pen­sive­ly and more quick­ly in 120 low- and mid­dle-in­come coun­tries.

The an­nounce­ment was made on Mon­day morn­ing by the man­u­fac­tur­er and or­ga­ni­za­tions that helped to speed up de­vel­op­ment of the med­ica­tion, called lenaca­pavir.

The drug is ex­pect­ed to cost $40 a year per per­son in the coun­tries where it will be avail­able, the same price as dai­ly pre­ven­tive pills avail­able now. But the shots are much more con­ve­nient than the pills be­cause they’re need­ed much less fre­quent­ly and they near­ly elim­i­nat­ed new in­fec­tions in two ground­break­ing stud­ies of peo­ple at high risk.

Peo­ple don’t al­ways take their dai­ly dose of med­ica­tion, “and if you do not take it, you can­not get pro­tect­ed against HIV,” said Car­men Pérez Casas, HIV lead for the grant-mak­ing or­ga­ni­za­tion Uni­taid, a glob­al health agency. “With lenaca­pavir, we are much more hope­ful.”

Ul­ti­mate­ly, ad­vo­cates said, the med­ica­tion should help dri­ve down cas­es of HIV and AIDS — and deaths. Ac­cord­ing to the World Health Or­ga­ni­za­tion, 41 mil­lion peo­ple world­wide were liv­ing with HIV and 570,000 died from HIV-re­lat­ed caus­es last year.

With an af­ford­able, high-qual­i­ty gener­ic med­ica­tion now avail­able, “we could help to scale this to the 20 mil­lion peo­ple around the world who need PrEP,” pre­scrip­tion med­i­cine tak­en by peo­ple at risk of HIV be­fore be­ing ex­posed to the virus, said Car­olyn Amole, who leads the HIV pro­gram for the Clin­ton Health Ac­cess Ini­tia­tive, a glob­al health or­ga­ni­za­tion.

“And if we scale to those lev­els,” she added, “we can ac­tu­al­ly be­gin to bring an end to the HIV epi­dem­ic.”

Gener­ic lenaca­pavir can’t be sold in the U.S. be­cause a brand-name ver­sion, Yez­tu­go, made by Gilead Sci­ences and ap­proved last year, is still pro­tect­ed by a patent. The U.S. list price for that ver­sion, mean­ing the cost be­fore in­sur­ance, is $28,218 a year. Gilead of­fi­cials say that’s sim­i­lar to some oth­er types of PrEP, which stands for pre-ex­po­sure pro­phy­lax­is.

The new gener­ic was ap­proved by the FDA un­der a long­stand­ing prac­tice de­signed to en­sure the qual­i­ty of HIV-re­lat­ed drugs pro­vid­ed to oth­er coun­tries by the U.S. gov­ern­ment. Ap­proval of a drug by the U.S. FDA can speed reg­u­la­to­ry ap­proval in many oth­er coun­tries. The ap­proval is con­sid­ered “ten­ta­tive,” the FDA’s stan­dard des­ig­na­tion for gener­ics while the orig­i­na­tor re­mains un­der patent.

Un­til now, Gilead has been the sole sup­pli­er of lenaca­pavir, and de­mand has out­stripped sup­ply in low- and mid­dle-in­come coun­tries. Last year, Gilead es­tab­lished roy­al­ty-free li­cens­ing agree­ments with six gener­ic man­u­fac­tur­ers to en­able pro­duc­tion. Those vol­un­tary li­cens­es cov­er a spe­cif­ic set of coun­tries in sub-Sa­ha­ran Africa, Asia and Latin Amer­i­ca.

“We share the sense of ur­gency around ex­pand­ing ac­cess to lenaca­pavir for HIV pre­ven­tion,” a Gilead spokesper­son said in a state­ment. “We be­lieve we have en­abled the fastest and most sus­tain­able path to ex­pand­ing ac­cess for com­mu­ni­ties most af­fect­ed by HIV.”

FILE - A pharmacist holds a vial of lenacapavir, the new HIV prevention injectable drug, at the Desmond Tutu Health Foundation's Masiphumelele Research Site, in Cape Town, South Africa, Tuesday, July 23, 2024, which was one of the sites for Gilead's lenacapavir drug trial. (AP Photo/Nardus Engelbrecht)

The gener­ic was de­vel­oped by In­dia-based Dr. Red­dy’s Lab­o­ra­to­ries un­der an agree­ment bro­kered by Uni­taid, the Clin­ton Health Ac­cess Ini­tia­tive and Wits RHI, a health re­search in­sti­tute in Africa. The part­ners sought to ac­cel­er­ate de­vel­op­ment and make the drug avail­able at an af­ford­able price.

Com­mon side ef­fects with lenaca­pavir in­clude in­jec­tion site re­ac­tions, headache and nau­sea. Peo­ple al­so must be test­ed for HIV pri­or to start­ing the drug and with each in­jec­tion; drug-re­sis­tant HIV has been iden­ti­fied when used by peo­ple with an un­di­ag­nosed HIV in­fec­tion.

“For any kind of PrEP … you need to have HIV test­ing in ad­vance,” said Saiqa Mul­lick, di­rec­tor of im­ple­men­ta­tion sci­ence with Wits RHI. “For many of the low- and mid­dle-in­come coun­tries, that is a rapid test.”

Gener­ic lenaca­pavir should start to be­come avail­able in some places with­in weeks, those help­ing with the ef­fort said, al­though it could take a bit longer in coun­tries that re­quire the drug to go through their own ap­proval process­es be­fore peo­ple can start tak­ing it. Gener­ic ver­sions made by the oth­er man­u­fac­tur­ers have yet to be ap­proved by FDA.

“The work is not done. Now, we need the fund­ing to ac­tu­al­ly buy it for every­one who needs it and then we need to do the hard work of get­ting it to the mil­lions of peo­ple who need it and want it,” Amole said. “But this is a great mile­stone.”

Casas said she’s op­ti­mistic that sci­en­tif­ic ad­vances — along with po­lit­i­cal will and fund­ing — can help the world curb HIV.

“Now,” she said, “we have the tools.” (AP)

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Sto­ry by LAU­RA UN­GAR | As­so­ci­at­ed Press

Ger­ald Im­ray in Cape Town, South Africa, con­tributed to this sto­ry.