Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.
The Wall Street Journal - June 25, 1996
Laurie McGinley, Staff Reporter of The Wall Street Journal
Viramune, manufactured by Boehringer Ingelheim Pharmaceuticals Inc., a subsidiary of the German pharmaceutical and chemical giant Boehringer Ingelheim GmbH, is the first [non-nucleoside] 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 a 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.
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