Gilead Sciences, Inc. has announced important initiatives to increase access to lenacapavir, a potentially transformative HIV medication, in high-incidence and resource-limited countries. This lenacapavir access strategy emphasizes the company’s commitment to those in urgent need, particularly in low- and lower-middle-income nations.

Voluntary Licensing Agreements

Gilead has signed non-exclusive, royalty-free voluntary licensing agreements. These include six generic pharmaceutical manufacturers: Dr. Reddy’s Laboratories Limited, Emcure, Eva Pharma, Ferozsons Laboratories Limited, Hetero, and Mylan (a subsidiary of Viatris). These agreements enable the production and sale of generic lenacapavir in 120 primarily low- and lower-middle-income countries, subject to necessary regulatory approvals.

Scope of Agreements

The agreements cover two key indications for lenacapavir:

• Pre-exposure Prophylaxis (PrEP): Aimed at preventing HIV, although this use is still investigational and not yet globally approved.
• HIV Treatment: Specifically for heavily treatment-experienced (HTE) adults dealing with multi-drug resistant HIV-1 infection.

Access Strategy

Gilead is implementing a two-part strategy to ensure broad access to lenacapavir:

• Voluntary Licensing Program: This allows generic manufacturers to produce and distribute lenacapavir in the licensed regions.
• No-Profit Supply: For the immediate future, Gilead will supply lenacapavir at no profit until the generic manufacturers can adequately meet the demand.

Prioritization of Countries

The company is prioritizing registration in 18 countries that collectively account for about 70% of the HIV burden in the licensed areas. These countries include Botswana, Eswatini, Ethiopia, Kenya, Lesotho, Malawi, Mozambique, Namibia, Nigeria, Philippines, Rwanda, South Africa, Tanzania, Thailand, Uganda, Vietnam, Zambia, and Zimbabwe.

Manufacturing and Quality

The selected generic manufacturers have a strong history of producing high-quality, sterile injectable medicines. They have also previously collaborated with Gilead on HIV and infectious disease treatments. This ensures that generic versions of lenacapavir will meet strict quality standards.

Regulatory Filings

Gilead plans to initiate regulatory filings for lenacapavir for PrEP by the end of 2024. This will promote the swift introduction of generic versions once they receive approval.

Global Impact

This initiative forms an integral part of Gilead’s broader strategy to combat the HIV epidemic globally. The company has consistently partnered with generic manufacturers, governments, and NGOs, enabling millions in low- and middle-income countries to access high-quality and affordable therapies for HIV, viral hepatitis, and COVID-19.

In summary, Gilead’s proactive approach aims to expedite the availability of lenacapavir in regions with the greatest need. By leveraging voluntary licensing and a no-profit supply model, the company seeks to ensure sustainable and wide access to this essential medication.