FDA today granted accelerated approval for nevirapine, the first in a new class of drugs -- non-nucleoside reverse transcriptase inhibitors. Non-nucleoside reverse transcriptase inhibitors (NNRTIs) interfere with HIV replication in a similar manner to the older nucleoside analogues AZT, ddC, ddI, and D4T.
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Reviewed in 119 days, nevirapine was approved for use in combination with nucleoside analogues to treat adults with HIV infection who have experienced clinical and/or immunological deterioration. Studies showed that AZT and ddI, combined with nevirapine, together were more effective than AZT and ddI alone in improving laboratory markers such as CD4 cell counts, an indication of immune system strength, and the amount of HIV RNA that could be detected in the bloodstream throughout the 48-week study period.
These studies also showed that the virus rapidly becomes resistant when nevirapine is used alone. Therefore, nevirapine is only recommended for use in combination with at least one antiretroviral agent.
Nevirapine's most common and important side effect is rash, and the drug labeling advises health care providers to discontinue nevirapine in patients who develop a severe rash or a rash accompanied by fever, blistering, oral lesions, conjunctivitis, swelling, muscle or joint aches, or general malaise.
To decrease the incidence of rash, nevirapine is to be administered with a starting dose of 200 mg once daily for two weeks, doubling the dose after that introductory period.
While safety and effectiveness of nevirapine have not been established for pediatric patients, the drug manufacturer is currently conducting Phase II studies in pediatric HIV patients.
Boehringer Ingelheim Pharmaceuticals Inc. Of Ridgefield, Conn., manufactures nevirapine under the trade name Viramune, and Roxane Laboratories Inc. O Columbus, Ohio, will distribute and market Viramune.