Nevirapine Recommended for Approval in Combination With Nucleosides

Read Mark Mascolini's full report in the July, 1996 Journal of the International Association of Physicians in AIDS Care

The FDA's Antiviral Drugs Advisory Committee recommended that nevirapine--the first nonnucleoside reverse transcriptase inhibitor considered for licensing--should be approved for use with one or, if possible, two nucleoside analogs that a person has not taken before. The panel chose not to specify a disease stage to which use of the drug should be restricted. These are the key findings so far:

• When combined with zidovudine (ZDV) and didanosine (ddI) in antiretroviral-experienced individuals, nevirapine produced a sustained improvement in CD4+ count when compared with ZDV plus ddI.

• Antiretroviral-experienced persons with a T-lymphocyte count between 50 and 200 cells/mm³ derived the greatest CD4+ benefit from adding nevirapine.

• Those pretreated only with ZDV did better on this triple regimen than those who were also ddI experienced.
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• Nevirapine-induced reductions in viral load were transient in heavily pretreated populations.

• In antiretroviral-naive individuals with T-cell counts between 200 and 600 cells/mm³, nevirapine plus ZDV/ddI resulted in a 140-cell absolute change from baseline at 52 weeks, compared with a 26-cell increase with ZDV/ddI and a 2-cell decrease with ZDV/nevirapine.

And there were a few surprises:

• HIV remained susceptible to nevirapine in a few antiretroviral-naive individuals for six months when they took the drug with ZDV and ddI and remained compliant with their drug regimen.

• Among eight children treated with nevirapine, ZDV, and ddI for 168 days, the viral loads of two dropped below the limit of detection (200 HIV RNA copies/mL). These two children are now ELISA negative and are losing positivity on Western blot.

• In another pediatric trial, the cerebrospinal fluid-to-plasma ratio for nevirapine ranged from 37 to 48 percent in the six children evaluated.

©1996, Medical Publications Corporation