"An Extraordinary Breakthrough for Global Health": US Approves Generic Version of Preventive HIV Treatment

The treatment will be available in 120 states at a price of 40 dollars per person per year, with two injections. The organization Unitaid hailed "an extraordinary breakthrough for global health."

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The US Food and Drug Administration (FDA) has approved a low-cost generic version of a preventive HIV treatment with an efficacy nearing 100%, the organization Unitaid welcomed on Monday, November 2. It is intended for low- and middle-income countries, representing "an extraordinary breakthrough for global health." This approval was announced by Dr. Reddy's Laboratories, the Indian manufacturer of the generic version of lenacapavir, and by Unitaid, an international organization whose work aims to facilitate access to medicines.

The treatment will be available at a price of 40 dollars (around 36 euros) per person per year, across 120 low- and middle-income countries, under an agreement announced in September 2025. The first medicines are expected "before the end of the year, with wider availability in 2027," Unitaid elaborates on its website.

This treatment consists of two annual injections and reduces the risk of HIV transmission by 99.9%, a small revolution in the field of drugs known as "pre-exposure prophylaxis," or "PrEP." Previously, these treatments, taken by people who are not infected but considered at risk, required taking a daily pill.

New Hope for Many Countries

"This is an extraordinary breakthrough for global health," Carmen Pérez-Casas, Unitaid's Senior HIV Strategy Manager, told AFP. "For too long, populations in low- and middle-income countries have had to wait ten years, or even longer, to access revolutionary medicines already available elsewhere. With lenacapavir, we have reduced this timeframe to just over a year." Contacted by AFP, the FDA did not immediately respond.

Lenacapavir, initially manufactured by the American laboratory Gilead, was approved in June 2025, but its very high price remained prohibitive. This new treatment thus raises hopes of reducing the number of new HIV infections, particularly in developing countries. "An estimated 1.2 million people contracted HIV last year," warned Carmen Pérez-Casas of Unitaid, "yet we now have a drug providing near-100% protection with just two injections per year."

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