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.

• 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