Gilead Sciences, Inc. has announced a significant move to broaden access to HIV prevention treatments by striking licensing agreements with six pharmaceutical manufacturers. These deals will enable the production and distribution of generic versions of Gilead’s investigational HIV prevention drug, lenacapavir, in 120 countries, primarily those with high HIV incidence and limited resources. This strategy aims to increase access to life-saving medication in low- and lower-middle-income countries, pending regulatory approvals.
Lenacapavir, a long-acting drug, has the potential to revolutionize HIV prevention through pre-exposure prophylaxis (PrEP). With the agreements in place ahead of global regulatory submissions, Gilead is positioning these countries to quickly adopt affordable, generic versions of lenacapavir once it gains approval. The initiative also includes provisions for using lenacapavir in HIV treatment for adults with multi-drug resistant HIV, offering hope for those who have exhausted other treatment options.
As of 2023, approximately 38.4 million people are living with HIV globally. While significant progress has been made, with annual new infections reduced to 1.5 million and 29.8 million people on antiretroviral therapy (ART), challenges remain. Sub-Saharan Africa bears the highest burden, and vulnerable populations, including young women and people who inject drugs, continue to face barriers to care.
AIDS-related deaths have declined to around 630,000 annually, but access to treatment is still limited, with 9 million people lacking ART. The UNAIDS 95-95-95 targets aim to end the epidemic by 2030, but achieving these goals remains difficult due to healthcare access gaps and stigma. Expanding access to prevention methods, like pre-exposure prophylaxis (PrEP), and innovative treatments like Gilead’s lenacapavir are essential in addressing these challenges.
Gilead’s CEO, Daniel O’Day, emphasized the importance of making lenacapavir widely accessible as quickly as possible. “Given the transformative potential of lenacapavir for prevention, our focus is on making it available as quickly and broadly as possible where the need is greatest,” O’Day said. Gilead has worked diligently to bring on board high-volume generic manufacturers to ensure a smooth transition to mass production after the drug receives approval for PrEP.
The pharmaceutical manufacturers involved in the licensing agreements are Dr. Reddy’s Laboratories, Emcure, Eva Pharma, Ferozsons Laboratories, Hetero, and Mylan, a subsidiary of Viatris. These companies were selected based on their proven track record in producing high-quality generics for HIV and other infectious diseases. Gilead collaborated with global health advocates to ensure these partners represent a range of countries and continents, reflecting the global nature of the HIV epidemic.
While building the manufacturing capacity for lenacapavir, Gilead is prioritizing regulatory approval in 18 countries that account for around 70% of the HIV burden in the 120 targeted nations. These countries include high-incidence nations like South Africa, Kenya, Nigeria, and Thailand. During this period, Gilead will supply lenacapavir at no profit until the generic manufacturers can fully meet demand.
Earlier this year, Gilead’s Phase 3 trials, PURPOSE 1 and PURPOSE 2, demonstrated that lenacapavir was superior to once-daily oral Truvada® in preventing HIV infections. Based on the strong results, Gilead is preparing to submit regulatory filings for lenacapavir by the end of 2024. The company is working with international regulatory bodies to expedite the approval process, ensuring lenacapavir reaches high-incidence regions as soon as possible.