Medicines for All Institute develops low-cost process to make HIV-prevention medication

By Leila Ugincius

The Medicines for All Institute at Virginia Commonwealth University has developed a low-cost process to manufacture the active pharmaceutical ingredient for lenacapavir — a medication used to prevent and treat infection from HIV, which can lead to AIDS.

The development could help make the drug more affordable, with especially strong impact in low- and middle-income countries that carry the highest burden of HIV infection.

“Lenacapavir has the potential to change the whole paradigm behind how we deal with HIV infections,” said B. Frank Gupton, Ph.D., CEO of Medicines for All, which works to lower the production costs of high-priority pharmaceuticals. “The pre-exposure prophylaxis - or PrEP - program will allow the drug to be widely distributed amongst individuals highest at risk of acquiring HIV to mitigate the spread of the disease across countries that are hardest hit.”

In June, the Food and Drug Administration approved Gilead Sciences Inc.’s Yeztugo® (lenacapavir) as the first and only twice-yearly injectable preventive option to prevent HIV acquired through sexual contact. Though groundbreaking, the treatment carries an annual cost of nearly $30,000 per patient in the United States.

In the past year, Gilead and global partners have taken several major actions to promote affordable, worldwide access to lenacapavir for HIV prevention.

Medicines for All’s new process will build on these efforts by further reducing costs to help ensure that anyone, anywhere can benefit from the transformative HIV prevention option.

The institute’s synthetic approach to creating the drug’s API achieves a 20-30% reduction in raw material cost compared with 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.

Medicines for All has been driving down the production costs of essential drugs that fight HIV, malaria, tuberculosis and neglected tropical diseases since it was established in 2017 with funding from the Gates Foundation. In early 2020, the institute marshalled its resources to tackle the urgent new threat of coronavirus.

The institute’s manufacturing optimization process for lifesaving drugs reduces costs, increases efficiencies and spurs technical innovation to give competitive advantages in the production of essential medications. Medicines for All is also a recognized leader in the development of green chemistry methods to reduce waste and decrease pollution.