New manufacturing process to make HIV prevention more accessible, affordable

RICHMOND, Va. (WRIC) — A new manufacturing process is on track to make developing HIV-prevention medication more affordable and potentially decrease new HIV infections in hard-hit countries.

Virginia Commonwealth University (VCU) announced on Monday, Dec. 1, that its Medicines for All Institute has developed a low-cost process to manufacture the active pharmaceutical ingredient (API) for lenacapavir.

Lenacapavir is used to prevent and treat infection from HIV, which can lead to AIDS.

The medication, also known as Yeztugo by Gilead Sciences Inc., was approved by the Food and Drug Administration (FDA) in June as "the first and only twice-yearly injectable preventative option to prevent HIV acquired through sexual contact."

American patients currently pay nearly $30,000 a year for the treatment, per VCU.

Medicines for All Institute said its approach to creating lenacapavir's API has reduced raw material cost between 20% and 30% compared to Gilead's process.

"This open-access process is available to any manufacturer, thus promoting expanded production and sustainability while increasing global access to an essential drug at a more affordable price," the university said in a Monday press release.

The new process is expected to have a strong impact in low and middle-income countries with high prevalence of HIV infection.

According to HIV.gov, certain regions across the world are disproportionately affected by HIV. In 2023, eastern and southern Africa had 20.8 million people with HIV infection, while Asia and the Pacific had 6.7 million.