Nevirapine Recommended for Approval

On June 7 the FDA's Antiviral Drugs Advisory Committee recommended accelerated approval of nevirapine, an experimental antiretroviral currently available through an expanded-access program. The vote in favor of the drug was 8-0. Official approval is almost certain; nevirapine will then be the first approved member of a new class of anti-HIV drugs (non-nucleoside reverse transcriptase inhibitors).

Nevirapine was recommended for use in combination with other antiretrovirals, because when the drug is used alone, viral resistance develops quickly. In triple combination with AZT plus ddI, it showed significantly greater improvement in CD4 count increase, and in viral load reduction, than AZT plus ddI plus placebo, lasting at least for the 48 weeks the trial was run.

In a separate one-year trial with previously untreated patients, those on the triple combination of nevirapine plus AZT plus ddI had an average CD4 increase of 138 at the end of the trial (computing the average increase from weeks 40-52), and the CD4 count was still increasing after one year. Without the nevirapine, those on AZT plus ddI had an increase of 81 in the same time period (weeks 40-52), and their counts were decreasing. The difference between the 138 increase and the 81 increase was statistically significant. Also, about two thirds of those receiving nevirapine plus AZT plus ddI had their viral load reduced to undetectable levels.

An in-depth article on nevirapine, by Jules Levin of the National AIDS Treatment Advocacy Project, looks in more detail at the nevirapine clinical trial results -- and at safety, drug interactions, viral resistance, status of approvals internationally, and contact information for the expanded access program. This article is available on the World Wide Web at http://www.natap.org/; if you do not have Internet access, you can reach Mr. Levin by fax at 718-624-8399, or by phone at 718-624-8541.