Forty-five years ago today, the Food and Drug Administration approved the first ever drug for the treatment of Human Immunodeficiency Virus (HIV). This new drug, called Azidothymidine (AZT) or Zidovudine, is a reverse transcriptase inhibitor.
Whoa, big science words - I know we all love those. Basically the way that HIV develops and eventually transforms into Acquired Immune Deficiency Syndrome (AIDS) is through the replication of the HIV retrovirus cells, or the cells that are causing the problem.
AZT targets the enzyme that drives this replication and therefore prevents the virus from developing further. It is also credited with the preventative measure of decreasing the chance of a mother transferring the virus to her fetus. This FDA approval was revolutionary to the virus, which up until then was customarily considered a death sentence.
The first case of AIDS was reported in 1981, but its connection with a human retrovirus was not recognized until 1984. Once the cause of the fatal disease was determined, scientists in all realms of the medical field began researching possible treatments.
In 1984, Burroughs-Wellcome (now GlaxoSmithKline), a consumer healthcare company, began studying the reverse transcriptase enzyme responsible for replication in retroviruses, but did not necessarily place its focus on HIV alone.
Almost simultaneously, the National Cancer Institute (NCI) shifted slightly off its typical course and created a program aimed at developing some type of HIV therapy. The two organizations decided to collaborate in order to find a solution: A decision that would end up sprouting a great deal of controversy over where credit was due.
Prior to this dispute, these joined forces experienced great success. Burroughs-Wellcome sent the NCI a sample of one of its reactive compounds, and it proved to be rather effective in a test tube of HIV.
The next step took place the following year in 1985 when the two organizations, along with additional scientists from Duke University, began a clinical trial. The randomized placebo trial demonstrated that AZT was both safe in patients and displayed a significant increase in CD4 proteins on T helper cells: White blood cells that are vital to the body's immune defenses. With just 25 months between the first signs of reactivity and FDA approval, AZT's rapid success gave it one of the shortest development periods for any drug.
Since the drug's initial FDA approval in 1987, AZT has experienced a great deal of expansion and modification. In February of 1990, the FDA approved an intravenous form of AZT. Also, in that same year, they approved variations in dosages, usage in early stages, and usage in children.
On December 31, 1990, in response to the escalating number of cases of AZT-related anemia, the FDA also approved a drug called Epogen to treat the specific side effect. Since the drug itself became public domain in 2005, the FDA has approved four generic versions of AZT.
Today AZT is taken in combination with other reverse transcriptase inhibitors in order to prevent the virus from mutating and developing resistance to the drug.
The collaboration, rapid and vigorous research and on-going persistence have transformed a most certain deadly diagnosis into an illness that is not yet curable, but endurable. This revolutionary adjustment from certain death to realistic survival, took one of its first groundbreaking steps on this very day back in 1987.
- Freestone is a sophomore from Brownsburg, Ind., majoring in history and biology.
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