The United States Food and Drug Administration approves Saquinavir, the first protease inhibitor to treat HIV/AIDS. Within 2 years of its approval, annual deaths from AIDS in the United States fall from over 50,000 to approximately 18,000.

The United States Food and Drug Administration is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.

Saquinavir, sold under the brand name Invirase among others, is an antiretroviral medication used together with other medications to treat or prevent HIV/AIDS. Typically it is used with ritonavir or lopinavir/ritonavir to increase its effect. It is taken by mouth.

Protease inhibitors (PIs) are medications that act by interfering with enzymes that cleave proteins. Some of the most well known are antiviral drugs widely used to treat HIV/AIDS, hepatitis C and COVID-19. These protease inhibitors prevent viral replication by selectively binding to viral proteases and blocking proteolytic cleavage of protein precursors that are necessary for the production of infectious viral particles.

The human immunodeficiency virus (HIV) is a retrovirus that attacks the immune system. Without treatment, it can lead to a spectrum of conditions including acquired immunodeficiency syndrome (AIDS). It is a preventable disease. It can be managed with treatment and become a manageable chronic health condition. While there is no cure or vaccine for HIV, antiretroviral treatment can slow the course of the disease, and if used before significant disease progression, can extend the life expectancy of someone living with HIV to a nearly standard level. An HIV-positive person on treatment can expect to live a normal life, and die with the virus, not of it. Effective treatment for HIV-positive people involves a life-long regimen of medicine to suppress the virus, making the viral load undetectable.