On Thursday, the FDA approved lenacapavir, to be sold as Yeztugo, for the prevention of HIV in the U.S. The below essay, adapted from “Breakthrough: The Quest for Life-Changing Medicine” by William Pao, looks at lenacapavir’s decades-long journey to approval.
By the mid-1990s, the AIDS epidemic had become a pandemic, with more than 3 million new HIV infections and more than 1 million AIDS-related deaths each year. A million children, most of them in sub-Saharan Africa, had been orphaned by AIDS. The numbers just kept going up and up.
In December 1995, the first protease inhibitor was approved by the FDA. Saquinavir was developed by Roche and proved to be a game-changer in the fight against HIV. A cocktail of one protease inhibitor and two nucleoside reverse transcriptase inhibitors (NRTIs) was shown in trials to reduce viral loads to very low levels for up to a year. When these findings were announced at a conference in Vancouver, attendees gave a standing ovation, hugged each other, and cried. This so-called highly active antiretroviral therapy, or HAART, would be a lifesaver for thousands.
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