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Lenacapavir HIV prevention rollout and efficacy
Overview
Lenacapavir, a long-acting injectable medication for HIV pre-exposure prophylaxis (PrEP), has demonstrated high efficacy in clinical trials. The drug, which requires only two doses per year, is administered via subcutaneous injection to improve adherence compared to traditional daily oral regimens. Clinical trials PURPOSE 1 and PURPOSE 2 yielded results so significant that an independent monitoring committee recommended stopping the randomized phases early. Following its rollout in June 2026, the drug has seen significant demand in South Africa. As of September 7, 2026, the Department of Health reported that 55,123 individuals have been initiated on the treatment across approximately 360 public health facilities in 24 districts. In Latin America, Mexico’s sanitary regulatory agency, Cofepris, has authorized lenacapavir for HIV prevention following a scientific review of its quality, safety, and efficacy. This authorization aligns with the Pan American Health Organization (PAHO) agreement with Gilead Sciences to provide a coordinated procurement pathway through PAHO’s Regional Revolving Funds, covering 14 countries including Argentina, Brazil, Chile, Colombia, and Mexico. This decision follows 2025 recommendations from the World Health Organization regarding the use of biannual injectable lenacapavir as an additional PrEP option. In Africa, expansion efforts continue despite logistical hurdles. While Mozambique reports high uptake, Nigeria is experiencing supply shortages in several pilot states, including Benue, Kwara, Gombe, and Cross River. The National Agency for the Control of AIDS (NACA) attributed these stock-outs to funding and logistics challenges, though officials in Lagos report sufficient doses alongside low uptake among eligible residents. Meanwhile, in Ghana, the Ghana AIDS Commission continues to promote PrEP in tablet form due to limited injectable availability. Deployment is currently underway in South Africa, Kenya, Zambia, Nigeria, and Eswatini.
Entities
lenacapavir · Gilead Sciences · World Health Organization · Pan American Health Organization · Cofepris
Claims
What the coverage asserts, and how many sources carry each claim.
Coverage disagrees
Sources make claims that cannot both be true. CLSTR reports the disagreement; it does not decide who is right.
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"Dr Reddy's Laboratories signed a royalty-free, non-exclusive voluntary licensing agreement with Gilead Sciences for once-yearly lenacapavir." www.news18.com
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"The once-yearly version of lenacapavir is currently in Phase 3 clinical trials and has not yet received regulatory approval." www.news18.com
One claim asserts a licensing agreement exists for a once-yearly version of lenacapavir, while the other states the once-yearly version has not yet received regulatory approval.
- [DISPUTED] Dr Reddy's Laboratories signed a royalty-free, non-exclusive voluntary licensing agreement with Gilead Sciences for once-yearly lenacapavir. www.news18.com
- [DISPUTED] The once-yearly version of lenacapavir is currently in Phase 3 clinical trials and has not yet received regulatory approval. www.news18.com
- [● 18 SOURCES] The medication is administered as a subcutaneous injection twice per year. www.diariolibre.com · lopezdoriga.com · www.diarioevolucion.com.mx · www.archynewsy.com · laprensa.mx · +13 more
- [● 15 SOURCES] Cofepris granted sanitary registration to lenacapavir after reviewing its quality, safety, and efficacy. www.ultimahora.com · www.diariolibre.com · lopezdoriga.com · www.diarioevolucion.com.mx · www.archynewsy.com · +10 more
- [● 15 SOURCES] Lenacapavir provides an alternative to PrEP regimens that require daily oral intake or more frequent applications. www.ultimahora.com · www.diariolibre.com · lopezdoriga.com · plazadearmas.com.mx · www.diarioevolucion.com.mx · +10 more
- [● 15 SOURCES] The World Health Organization recommended injectable lenacapavir twice a year as an additional PrEP option in July 2025. www.ultimahora.com · www.diariolibre.com · lopezdoriga.com · www.diarioevolucion.com.mx · plazadearmas.com.mx · +10 more
- [● 8 SOURCES] PAHO and Gilead Sciences reached an agreement to provide access to lenacapavir in Latin America and the Caribbean. croniosv.com · www.larepublica.ec · www.saludiario.com · blink102.com.br · fatopaulista.com.br · +3 more
- [● 8 SOURCES] Fourteen countries in Latin America and the Caribbean, including El Salvador, Argentina, Brazil, and Mexico, can acquire lenacapavir through PAHO's Regional Revolving Funds. croniosv.com · www.larepublica.ec · www.saludiario.com · blink102.com.br · fatopaulista.com.br · +3 more
- [● 7 SOURCES] The PURPOSE 1 clinical trial recorded zero new HIV infections among 2,134 participants receiving lenacapavir. www.ultimahora.com · www.diariolibre.com · lopezdoriga.com · plazadearmas.com.mx · massinformacion.com.mx · +2 more
- [● 7 SOURCES] The PURPOSE 2 clinical trial recorded two HIV infections among participants receiving the drug. www.ultimahora.com · www.diariolibre.com · lopezdoriga.com · plazadearmas.com.mx · massinformacion.com.mx · +2 more
- [● 4 SOURCES] Approximately 140,000 new HIV infections are recorded annually in Latin America and the Caribbean. blink102.com.br · fatopaulista.com.br · sitedaserra.com.br · www.cbc.bb
- [● 3 SOURCES] Gilead Sciences is working with the Brazilian Ministry of Health to explore local production of lenacapavir. sitedaserra.com.br · www.larepublica.ec · observatoriog.com.br
Timeline
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[HEALTH] 2 sourcesLenacapavir injectable offers new breakthrough in HIV prevention
Lenacapavir, a twice-yearly injectable HIV prevention drug, shows high efficacy in trials. While deployment begins in parts of Africa, concerns persist regarding global access and cost.
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[HEALTH] 3 sourcesCofepris approves Lenacapavir for HIV prevention in Mexico
Mexico's Cofepris has approved Lenacapavir, a long-acting HIV prevention medication (PrEP) administered via subcutaneous injection just twice a year.
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[HEALTH] 3 sourcesNigeria faces Lenacapavir shortages as HIV prevention demand rises
Rising demand for the twice-yearly HIV prevention injection Lenacapavir has caused supply shortages in several Nigerian pilot states, including Benue and Kwara.
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[HEALTH] 20 sourcesMexico authorizes lenacapavir for semiannual HIV prevention
Mexico has authorized lenacapavir, a twice-yearly subcutaneous injection for HIV prevention (PrEP). PAHO also announced new access routes for the medication across 14 Latin American and Caribbean nations.
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[HEALTH] 3 sourcesHIV testing expands in Paraguay as Oruro reports rising cases
Paraguay has tripled its annual HIV testing and gained access to the injectable preventative drug lenacapavir, while Oruro, Bolivia, reports a rise in HIV cases during the first half of 2026.
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[HEALTH] 10 sourcesPAHO and Gilead expand lenacapavir access in Latin America
PAHO and Gilead Sciences have partnered to provide access to the long-acting HIV prevention drug lenacapavir to 14 Latin American and Caribbean countries via regional revolving funds.
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[HEALTH] 3 sourcesSouth Africa reports 55,000 initiations of new HIV prevention injection
Over 55,000 people in South Africa have started using Lenacapavir, a new twice-yearly injectable HIV prevention medication, following its public sector rollout earlier this year.
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[HEALTH] 6 sourcesHIV prevention efforts expand in Mozambique and Ghana via PrEP
Mozambique and Ghana are expanding HIV prevention efforts through the use of Pre-Exposure Prophylaxis (PrEP), utilizing both injectable lenacapavir and oral tablets to reduce infection risks.
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[HEALTH] 2 sourcesLenacapavir HIV prevention injection expands access in Gauteng and India
Gauteng is expanding access to Lenacapavir, a long-acting HIV prevention injection, amid high demand, while India explores the drug as a tool to combat rising HIV infection rates.
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[HEALTH] 5 sourcesLenacapavir shows high efficacy in HIV prevention clinical trials
The HIV prevention drug lenacapavir has shown unprecedented efficacy in clinical trials, offering a twice-yearly injection that improves adherence compared to daily oral PrEP regimens.
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[HEALTH] 2 sourcesKenya rolls out long‑acting injectable HIV prevention Lenacapavir
Kenya launches lenacapavir injectable HIV prevention, reducing doses to twice a year, while research shows broadly neutralising antibodies can extend viral control in a subset of patients.
Sources
adomonline.com · aimnews.org · aljama.co.za · altonivel.com.mx · am.com.mx · archynewsy.com · bizcommunity.com · blink102.com.br · cbc.bb · croniosv.com · dailyreport.ng · diarioestrategia.cl · diarioevolucion.com.mx · diarioimagen.net · diariolibre.com · ebnewsdaily.co.za · eenergetica.com.ar · elheraldopy.com · exclusivaspuebla.com.mx · fatopaulista.com.br · journaldeguinee.com · kpbs.org · ksfr.org · lapatria.bo · laprensa.mx · larepublica.ec · lopezdoriga.com · lucesdelsiglo.com.mx · massinformacion.com.mx · myjoyonline.com · mznews.co.mz · news18.com · noticias.mmo.co.mz · nouvelles-du-monde.com · nprinternedition.org · nuevolaredo.tv · observatoriog.bol.uol.com.br · ocio.farodevigo.es · parrotnewspaper.com · plataformanoticias.mx · plazadearmas.com.mx · psi.org · punchng.com · saludiario.com · sapo.pt · sciencedaily.com · sdpnoticias.com · sitedaserra.com.br
This summary has been updated 7 times: see revision history