First HIV Vaccine that Also Serves as Twice Yearly ARV Coming To Kenya Soon

October 4, 2024

Kenya stands on the brink of a revolutionary advancement in HIV prevention and treatment, as Gilead Sciences’ groundbreaking drug lenacapavir moves closer to widespread availability.

This innovative medication, which can be administered as an injection just twice a year, promises to serve both as a preventive vaccine and an antiretroviral (ARV) treatment, offering new hope in the fight against HIV/AIDS.

In a landmark decision on Wednesday, Gilead Sciences granted royalty-free licenses to six generic drug manufacturers, paving the way for affordable versions of lenacapavir to be produced and distributed across 120 low and lower-middle income countries, including Kenya.

This move comes after months of pressure from HIV advocates and civil rights groups who criticized the company for prioritizing profits over patient access.

The significance of this development for Kenya cannot be overstated. With 1.6 million people living with HIV/AIDS and 1.1 million children orphaned by the epidemic, the country has long grappled with the devastating impact of the virus.

Lenacapavir offers a beacon of hope, particularly for vulnerable populations such as women, adolescent girls, and the LGBTQ+ community.

Clinical trials have shown remarkable results for lenacapavir. Among more than 2,000 participants, only two HIV cases were recorded. Most notably, the drug provided complete protection against HIV for women and adolescent girls during trials, a crucial finding for Kenya’s fight against the epidemic.

The licensing agreements include India’s Dr. Reddy’s Laboratories, Emcure Pharmaceuticals, and Hetero Labs, as well as US-based Viatris’ unit Mylan, Egypt’s Eva Pharma, and Pakistan-based Ferozsons Laboratories.

These manufacturers will be able to produce generic versions of lenacapavir for as little as $40 annually, a fraction of the $42,250 annual list price in the United States. At cost, the drug would retail at under Ksh500 a month.

Gilead has prioritized Kenya, along with 17 other countries including South Africa and Nigeria, for early access to lenacapavir. The company plans to provide branded versions of the drug in these nations until generic production can fully meet demand.

This strategy aims to ensure that countries representing about 70% of global HIV cases have immediate access to this potentially game-changing medication.

Beyond its preventive capabilities, lenacapavir also offers hope as a treatment for individuals with multi-drug resistant HIV. For those who have failed other treatments, this new option could provide a crucial lifeline. The licensing agreement covers both the preventive and treatment uses of the drug, addressing multiple facets of the HIV epidemic.

While the People’s Medicines Alliance, an advocacy group made up of over 100 organizations, has criticized the exclusion of several countries, particularly in Latin America, from the agreement, the impact on Kenya and other high-burden countries remains significant.

As Gilead prepares to file for global regulatory approval for lenacapavir as an HIV prevention regimen by the end of this year, Kenya stands to benefit from early access to this innovative drug.

The potential for a low-cost, highly effective prevention and treatment option could mark a turning point in the country’s long-standing battle against HIV/AIDS.



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