A clinical trial demonstrated 100% efficacy in preventing HIV in more than 5,000 women through the half-yearly supply and injection of lenacapavir, according to the results presented this Wednesday by the Zimbabwean scientist Linda-Gail Bekker in the framework of the 25th World AIDS Conference in Munich (southern Germany). Germany).
The test, entitled ‘Purpose 1’, offered a 100% protection for more than 5,000 women and adolescents in South Africa and Uganda, according to the report by the American pharmaceutical company Gilead.
“This means that there were no new infections and that, therefore, it would be, today, the most effective alternative to other types of PrEP,” Vanessa López, director of Health for Rights, a non-governmental organization focused on the implementation of health rights around the world, told EFE.
The drug lenacapavir, marketed under the name Sunlenca by the pharmaceutical firm Gilead, is administered to the patient by injection every six months and has the capacity to prevent infections and reduce the viral load to undetectable levels in people already living with the Human Immunodeficiency Virus (HIV), the pathogen that causes AIDS.
Lopez added that the fact that the medication is administered every six months improves “enormously“adherence versus other options.
“The data confirm that lenacapavir, for HIV prevention, is a revolutionary advance with enormous public health potential”said Sharon Lewin, President of the International AIDS Society (IAS).
“If approved and delivered quickly, affordably and equitably to those in need, this long-acting tool would help accelerate global progress in HIV prevention.”“, he added.
A high cost for treatment
Despite the efficacy and good results demonstrated by the study, lenacapavir is not yet used for prevention, as it is currently only authorized for treatment since 2022 and has a high price, of more than US$ 41,000 (about 37,310 euros) per year per patient.
However, the US pharmaceutical giant aims to set the price of mass production of a generic version of the drug at $40 (36.40 euros) a year, according to the report presented at the conference.
The medicine can “mark a step forward for HIV prevention” if it were available “quickly and at an affordable price”said UNAIDS, the joint United Nations programme on HIV/AIDS.
Since the Munich conference, organisations from around the world have gathered at Gilead’s headquarters to demand that it reduce the price of lenacapavir and ensure that it reaches the countries that need it most.
Worldwide trials
The pharmaceutical company Gilead is also developing ‘Purpose 2’, another clinical trial that will evaluate whether lenacapavir helps reduce the possibility of contracting HIV through sexual relations and that expects to obtain results from the study at the end of 2024, beginning of 2025.
It is being developed in the United States, South Africa, Peru, Brazil, Argentina, Mexico and Thailand and will include men, transgender women, transgender men and nonbinary people who have sex, according to Gilead.
The submission of the application for authorization of lenacapavir for pre-exposure prophylaxis (PrEP) will include the results of ‘Purpose 1’ and ‘Purpose 2’.
If the results are positive, the company hopes that lenacapavir for PrEP could be approved for use in multiple populations and communities that are most in need of additional HIV prevention options, Gilead said in a statement.
“A plan for access to the drug if it is approved for HIV prevention should include granting voluntary licenses, registering the product globally and, if necessary, issuing compulsory licenses,” Lopez concluded.
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Source: Gestion

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