Indian Generics Makers Set to Revolutionize HIV Prevention with Affordable Yeztugo

In a groundbreaking development for global HIV prevention, Indian generic pharmaceutical companies are poised to produce and distribute significantly cheaper versions of Gilead Sciences' twice-yearly HIV pre-exposure prophylaxis (PrEP) drug, Yeztugo (lenacapavir). This initiative, supported by international health organizations and philanthropic foundations, aims to dramatically improve access to long-acting PrEP in low- and middle-income countries.

Partnerships Forge Path for Affordable Access

Dr. Reddy's Laboratories has entered into an agreement with Unitaid, the Clinton Health Access Initiative (CHAI), and Wits RHI to provide Yeztugo at a groundbreaking price of $40 per year in 120 low- and middle-income countries starting in 2027. This pricing strategy aligns the long-acting injectable with the cost of daily oral PrEP medications, potentially revolutionizing HIV prevention in resource-limited settings.

Simultaneously, Hetero Labs has secured support from the Bill & Melinda Gates Foundation to enhance access to generic Yeztugo. The Gates Foundation is committing over $80 million in "catalytic investments" to accelerate market readiness, scale delivery, and expedite generic entry.

These developments stem from Gilead's voluntary licensing agreements, signed in October 2024, which allow six generic manufacturers to produce and sell Yeztugo in 120 high-incidence, resource-limited countries without paying royalties.

Challenges and Critiques

Despite the progress, some activists argue that the 120-country limitation in Gilead's licensing agreements excludes critical regions, potentially hindering global access. Health Global Access and Prevention (GAP) Executive Director Asia Russell stated, "Any restrictions on access to an affordable generic price for this essential prevention tool is unacceptable."

Public Citizen highlighted that more than one in four new HIV infections worldwide occur in 26 countries left out of Gilead's licensing agreements, including Argentina, Brazil, Mexico, and Peru.

Responding to these concerns, Gilead has indicated it is pursuing "multiple strategies" to support access in excluded middle-income countries with high HIV burdens. These strategies include tiered pricing and public-private partnerships, as well as collaborations with the United States President's Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund to provide Yeztugo access for up to 2 million people over three years in certain countries.

Implications for Global HIV Prevention

The introduction of affordable, long-acting PrEP has the potential to transform HIV prevention efforts worldwide. By providing a twice-yearly alternative to daily oral medications, Yeztugo could significantly improve adherence and reduce the burden on healthcare systems in resource-limited settings.

As generic manufacturers prepare to enter the market, the competition is expected to maintain low prices and offer procurement flexibility. This new model of innovation and access could set a precedent for future drug development and distribution in global health.