First Protease Inhibitor Becomes Available

In a development that would forever change the HIV/AIDS treatment landscape, the FDA approved an open label study of saquinavir in June 1995. The first drug of its kind to be made available outside ongoing clinical trials, saquinavir is a protease inhibitor. It targets a cell’s protease, which is a protein needed by HIV to replicate itself.

On December 6, 1995, just 6 months later—virtually a nanosecond on a typical drug approval timeline—saquinavir was approved for use in combination with other nucleoside analogue medications. The age of combination therapy—and a new era of hope for people with access to the new treatment—had arrived.

The news media referred to the new treatment variously as a “drug cocktail,” “triple combination therapy,” “combination therapy,” “antiretroviral therapy” and, often, simply as “protease inhibitors.” Among scientists, the use of drugs (usually two) in combination with a protease inhibitor was called highly active antiretroviral therapy, or HAART.

HAART became widely available to people living with HIV/AIDS in 1996. AIDS morbidity and mortality fell almost immediately in the industrialized world, and the way we think about AIDS also changed forever.