HIV-Prevention Drug — In a major breakthrough for global health, Unitaid and the Bill & Melinda Gates Foundation have announced separate agreements with Indian pharmaceutical manufacturers to produce low-cost, generic versions of the long-acting HIV-prevention drug lenacapavir. This innovative, twice-yearly injectable medication has shown remarkable effectiveness—reducing the risk of HIV transmission by more than 99.9%.
Under the new agreements, these generic versions are expected to be available by 2027 at an annual cost of just $40 (approximately R692.15) across more than 100 low- and middle-income countries (LMICs). The initiative is seen as a critical step toward ending the HIV epidemic, particularly in regions hardest hit by the virus.
Lenacapavir, marketed in the United States under the brand name Yeztugo by California-based pharmaceutical giant Gilead Sciences, currently costs around $28,000 annually. Due to its high cost, access to this life-saving HIV-prevention drug has been extremely limited in lower-income regions.
However, the new licensing deals aim to reverse this trend. Carmen Perez Casas, Unitaid’s strategic lead for HIV, emphasized the significance of making generic lenacapavir widely available.
“Far cheaper generic versions are really critical for the scale-up of HIV prevention. Now, with this product, we can end HIV,” she told AFP.
Unitaid has partnered with Indian pharmaceutical company Dr. Reddy’s Laboratories, the Clinton Health Access Initiative (CHAI), and the Wits Reproductive Health Institute (Wits RHI). This collaboration will ensure that the drug is produced at scale and delivered affordably to LMICs beginning in 2027.
Global Impact and Progress in HIV Prevention
Initially, the generic versions of lenacapavir will be manufactured in India. However, Unitaid and its partners are already exploring possibilities for regional production in Africa and other continents to boost accessibility and reduce reliance on centralized manufacturing.
In a parallel effort, the Gates Foundation has established a separate partnership with Hetero, another major Indian pharmaceutical company. This move is expected to further accelerate the availability of affordable versions of the HIV-prevention drug.
Trevor Mundel, head of global health at the Gates Foundation, highlighted the importance of equitable access to scientific innovations.
“Scientific advances like lenacapavir can help us end the HIV epidemic—if they are made accessible to the people who can benefit from them the most,” he said in a statement.
Despite significant progress in the fight against HIV over the past decade, challenges remain. According to UNAIDS data, global efforts since 2010 have led to a 40% reduction in new HIV infections. However, in 2024 alone, an estimated 1.3 million people contracted the virus—highlighting the ongoing need for innovative, accessible prevention tools.
Lenacapavir represents a new frontier in pre-exposure prophylaxis (PrEP). Unlike daily oral PrEP pills, this injection is administered only twice a year, making it more convenient and increasing adherence among at-risk populations.
In October 2024, Gilead had already taken steps to expand access by signing licensing agreements with six generic drug manufacturers to supply lenacapavir to lower-income countries. These latest partnerships build upon that foundation and bring the world closer to realizing equitable access to this vital HIV-prevention drug.
While full-scale rollout of the generics is expected in 2027, efforts are already underway to make lenacapavir accessible sooner in select countries. Gilead and the Global Fund have formed a temporary agreement to provide the drug at reduced prices for lower-income countries until the generic versions are available.
The United States government recently reaffirmed its support for this initiative, ensuring continued funding for affordable access, despite political shifts in foreign aid policy.
This early access strategy includes plans to deliver initial supplies of Yeztugo to at least one African country by the end of 2025.
The development and planned global rollout of affordable, generic lenacapavir marks a turning point in HIV prevention. By drastically lowering the cost and simplifying the dosing schedule, this HIV-prevention drug has the potential to reshape the future of global health.
As Unitaid and the Gates Foundation push forward with their respective strategies, the global health community is watching closely. The hope is that by 2030, with widespread access to long-acting PrEP options like lenacapavir, the goal of ending the HIV epidemic could finally become a reality.
Source- EWN
