User:Amandannhit/sandbox

Introduction:

Stavudine (d4T) is an antiretroviral medication used to prevent and treat HIV/AIDS.[1]  It is of the nucleoside analog reverse-transcriptase inhibitor (NRTI) class and is used in combination antiretroviral therapy (ART) in resource-constrained countries due to its low cost.The pharmaceutical company, Bristol-Myers Squiibb, manufactures and sells Stavudine as the brand name Zerit.

The World Health Organization (WHO) recommends Stavudine to be phased out to due to its high toxicity levels. If the drug must be used, it is recommended to use low dosages to reduce the occurrence of side effects; however, a 2015 Cochrane review found no clear advantage between high and low dosage regimens.[2]

Stavudine is on the World Health Organization's List of Essential Medicines, the most important medication needed in a basic health system.[3]

History:

Stavudine was first created by Jerome Horwitz in the 1960s and was originally named D4T. When the AIDS epidemic occurred in the 1980s, William Prusoff and Dr. Tai-Shun Lin discovered the anti-HIV properties of Stavudine. The pharmaceutical company Bristol-Myers Squibb manufactures the drug under the trade name Zerit.

It is also the first drug to be granted parallel track status in 1992 by the US Food and Drug Administration (FDA), which allowed for the agency to make Stavudine available to patients before being approved. Stavudine was submitted under the FDA’s accelerated approval process. Through this process, Stavudine’s effectiveness was measured by its effect on the surrogate marker, CD4, instead of clinical endpoints. The FDA concluded that an increase in CD4 cell counts was an indicator of how effective the drug would be against AIDS and HIV infection. Stavudine was the fourth drug to be approved for the treatment of AIDS and HIV infection by the FDA on June 27, 1994. Even after approval, studies were continued to evaluate the clinical benefit of the drug. If there is no indication of clinical benefits, the accelerated approval may be withdrawn.