Gilead Sciences has announced plans to provide lenacapavir, a ground-breaking HIV prevention medication, at a reasonable price point into 120 low- and middle-income nations. Administered as a twice-yearly injection, lenacapavir has demonstrated encouraging outcomes in clinical trials, notably lowering the incidence of HIV infection in both men and women.
HIV Prevention Medication To Be Made Accessible And Affordable In Nigeria And 119 Other Vountries
In clinical trials conducted in South Africa and Uganda, lenacapavir demonstrated remarkable efficacy in preventing HIV infections among female populations. Subsequently, an expanded trial involving male participants across multiple countries, including Argentina, Brazil, Mexico, Peru, South Africa, Thailand, and the United States, yielded highly promising results, indicating a near-complete protective effect against HIV acquisition.
In an official declaration, Gilead has established non-exclusive, royalty-free voluntary licensing agreements with six pharmaceutical manufacturers. This agreement permits the production and distribution of generic lenacapavir in designated countries. The manufacturers involved are Dr. Reddy’s Laboratories Limited, Emcure, Eva Pharma, Ferozsons Laboratories Limited, Hetero, and Mylan, a subsidiary of Viatris.
Gilead respectfully highlighted that the agreements were signed before any global regulatory approvals to enable the prompt introduction of generic versions of lenacapavir for HIV prevention. Furthermore, Gilead will generously provide its own supply of the drug to bridge the gap until the licensed manufacturers are operational, prioritizing registration in 18 countries with high HIV prevalence, including Botswana, Eswatini, Ethiopia, Kenya, Lesotho, Malawi, Mozambique, Namibia, Nigeria, the Philippines, Rwanda, South Africa, Tanzania, Thailand, Uganda, Vietnam, Zambia, and Zimbabwe.
Gilead’s agreements support the company’s strategy to facilitate extensive and enduring access to lenacapavir for pre-exposure prophylaxis (PrEP) worldwide, should it gain approval. These actions align with Gilead’s overarching vision of eradicating the HIV epidemic for all individuals, regardless of their location.
Gilead’s dual-pronged strategy seeks to guarantee affordable access to lenacapavir in resource-constrained nations by implementing a robust voluntary licensing program and supplying Gilead-provided products on a not-for-profit basis until generic manufacturers can fully satisfy demand. The agreements also encompass lenacapavir for HIV treatment in heavily treatment-experienced adults with multi-drug resistant HIV.
The CEO of Gilead, Daniel O’Day, emphasized the critical need to make lenacapavir accessible on a broad scale. He highlighted the company’s commitment to achieving this goal swiftly and efficiently. O’Day mentioned that Gilead teams have been actively collaborating with reputable generic manufacturers to ensure a smooth transition to voluntary license partners once lenacapavir receives approval for PrEP.