AZT in oral, injectable, and suppository form. Image: MastCell, WikimediaOn March 20, 1987, the FDA approved AZT, the first government sanctioned HIV drug. AZT reduces the replication of the HIV virus in patients and has led to clinical and immunologic improvements.

Moreover, HIV positive pregnant women can take it to prevent the virus being transmitted to their baby during labor. It can also be used prophylactically to prevent someone who may have come in contact with the virus from contracting HIV. In HIV positive people, it does not cure the virus. However, it greatly slows the speed at which the virus replicates. 

In May 1984, after HIV had been unambiguously proven as the cause of AIDS, Samuel Broder, Hiroaki Mitsuya and Robert Yarchoan of the National Cancer Institute (NCI) began seeking therapies for HIV/AIDS, following in the footsteps of Gertrude Belle Elion. They developed an assay to screen drugs for their ability to protect CD4+ T cells from HIV. This assay tested both the anti-HIV effect of the compounds and their toxicity against infected T cells.

Wanting to move drugs into the clinic as soon as possible, they worked with scientists the company now called GlaxoSmithKline. The company had expertise in nucleoside analogs and viral diseases. Their research efforts were focused in part on the viral enzyme reverse transcriptase. Reverse transcriptase is an enzyme that retroviruses, including HIV, utilize to replicate themselves.

One compound that they were working with, AZT, had already demonstrated remarkable efficacy against certain mouse viruses. Not working with HIV, the scientists form GlaxoSmithKline sent 11 compounds to the NCI team for testing against HIV in their new assay. The CDC and NIH both praised the early HIV study process for its rigorous standards.

The FDA committee that examined the drug voted 10 to one to recommend the approval of AZT. Twenty-five months between the first demonstration that AZT worked and its approval. That's in the shortest drug development time in history.

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