AEGiS-WSJ: Boehringer Drug, Viramune, Cleared as HIV Treatment

Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.

Boehringer Drug, Viramune, Cleared as HIV Treatment

The Wall Street Journal - June 25, 1996
Laurie McGinley, Staff Reporter

WASHINGTON -- The U.S. Food and Drug Administration approved Viramune, the first in a new class of treatments for HIV, the virus that causes AIDS. Viramune, manufactured by Boehringer Ingelheim Pharmaceuticals Inc., a subsidiary of the German pharmaceutical and chemical giant Boehringer Ingelheim GmbH, is the first reverse transcriptase inhibitor cleared by the FDA. The new class of drugs, like older AIDS drugs such as AZT, attacks an enzyme known as a reverse transcriptase, interfering with the virus's ability to replicate. But the new class of medications disable the enzyme in a different way and are chemically different from the older drugs, known as nucleoside analogs.

The agency warned that Viramune, which is known generically as nevirapine, should be used with at least one other AIDS drug because the virus rapidly develops resistance when nevirapine is used alone.

At a time when researchers say the best assault on HIV comes from mixing a cocktail of treatments, nevirapine "adds a new option to combination therapy," said Maureen Myers, clinical program director for virology at Boehringer Ingelheim Pharmaceuticals, which is based in Ridgefield, Conn. The FDA said studies showed that nevirapine increased the effectiveness of AZT in bolstering CD4 cell counts, an indication of immune-system strength.

The FDA approved the drug on an accelerated basis, a regulatory mechanism that allows quick clearance for a product based on laboratory markers, such as CD4 counts, rather than on longer-term data, such as disease progression.

The drug's most common side effect is rash, and the FDA urges its discontinuance in patients who develop a severe rash or one accompanied by fever, blistering, oral lesions, conjunctivitis, swelling, or muscle or joint aches. The medication is expected to be available by August.
960625
WJ960605

AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Broadway Cares/Equity Fights AIDS, Elton John AIDS Foundation, the National Library of Medicine, Pacific Life Foundation and donations from users like you.

Always watch for outdated information. This article first appeared in 1996. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 1996. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .