FDA approves twice-a-year HIV prevention drug that could help end the virus worldwide

The FDA has given the green light to Yeztugo, also known as lenacapavir or LEN, which is an injection administered twice a year that prevents HIV from replicating within cells. This reduces the likelihood of virus transmission by 96%. Advocates for HIV believe this new medication could lower transmission rates nationwide because it is easier to use than the existing daily medicines, according to ‘LGBTQ Nation’.

Mitchell Warren, executive director of the AIDS Vaccine Advocacy Coalition (AVAC), a nonprofit organisation focused on HIV advocacy, commented to NBC News, “This represents the most significant opportunity in 44 years of HIV prevention.” The FDA approved the injectable following Gilead Sciences’ successful early Phase 3 trials last September. Warren added, “LEN's approval is an essential boost for HIV prevention, especially considering the solid scientific basis and disruption to HIV programs globally. However, US FDA approval is merely the start of ensuring that injectable LEN can diminish the 1.3 million new HIV infections annually.”

Colleen Kelley, MD, a lead researcher in Phase 3 trials, noted, “Twice-yearly injectable lenacapavir for PrEP could be a cornerstone intervention, especially since adherence to daily oral medication can be challenging, potentially decreasing new infections and aiding in ending HIV in the U.S.”

AVAC emphasised that urgent actions are required for the drug to lower global HIV rates. Currently, lenacapavir costs $3,450 (£2,576) per month as a treatment, according to NBC News. AVAC has urged Gilead to offer the drug at $100 (approximately £75) or less and to permit the development of generic versions.

The organisation has also asked governments to quickly adopt the drug into their health programs and encouraged funding bodies to contribute through initiatives like the Global Fund’s Children’s Investment Fund Foundation, aiming to provide enough of the drug for two million people globally by 2027.

This drug introduction occurs as the current administration has significantly reduced funding for HIV research, cut medical programs benefiting high-risk Black, Latino, and LGBTQ+ populations, and made deep cuts to the USAID, responsible for overseas HIV-prevention programs.

“No single donor, government, or manufacturer can achieve this goal alone,” Warren stated, highlighting the need for action from all involved parties, including Gilead, the U.S.A. President’s Emergency Plan for AIDS Relief, and the Gates Foundation, ensuring that people everywhere, irrespective of geography, income, or identity, can access this groundbreaking prevention method.

Wawira Nyagah, AVAC’s director for product introduction and access, stated, “This is the moment to capitalize on scientific advancements, especially as LEN for PrEP is advancing through regulatory procedures faster than any previous prevention option. It's crucial to ensure that the reduction in global HIV infections, enabled by communities worldwide, remains a priority for all stakeholders.”

According to UNAIDS, in 2023, new HIV infections worldwide were approximately 1.3 million, significantly down from the peak of 3.3 million in 1995. This decrease is largely attributed to the availability of pre-exposure prophylactics (PrEP), a daily medication capable of reducing transmission risk by up to 99%.