Indian Generics Makers to Produce Affordable Versions of Gilead's HIV PrEP Drug Yeztugo

In a significant development for global HIV prevention efforts, Indian generic pharmaceutical companies have secured agreements to manufacture and distribute more affordable versions of Gilead Sciences' twice-yearly HIV pre-exposure prophylaxis (PrEP) drug, Yeztugo (lenacapavir). These partnerships aim to increase access to the long-acting injectable medication in low- and middle-income countries, potentially revolutionizing HIV prevention strategies worldwide.

Partnerships for Affordable Access

Dr. Reddy's Laboratories, one of India's leading generic drug manufacturers, 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. This pricing strategy, set to begin in 2027, puts the long-acting injectable on par with daily oral PrEP medications, making it a cost-effective alternative for HIV prevention.

In a parallel effort, Hetero Labs, another prominent Indian generics producer, has secured support from the Bill & Melinda Gates Foundation to bolster access to generic Yeztugo. The Gates Foundation has committed over $80 million in "catalytic investments" to accelerate market readiness, scale up delivery, and expedite the timeline for generic entry.

Gilead's Global Access Strategy

These agreements stem from Gilead Sciences' proactive approach to expanding access to Yeztugo. In October 2024, before the drug's June approval, Gilead signed voluntary licensing agreements with six generic manufacturers, including Dr. Reddy's and Hetero Labs. These royalty-free agreements permit the production and sale of generic Yeztugo in 120 high-incidence, resource-limited countries.

Gilead is also pursuing additional strategies to support access in middle-income countries with high HIV burdens that are not covered by the voluntary licensing program. These efforts include tiered pricing and public-private partnerships. Furthermore, Gilead has partnered 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 select countries.

Challenges and Criticisms

Despite these efforts, some activists argue that the 120-country limitation in Gilead's licensing agreements excludes several key regions, potentially hindering broader 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."

According to Public Citizen, 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. This gap in coverage highlights the ongoing challenges in achieving truly global access to innovative HIV prevention tools.