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
- 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
- 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.
This article was provided by the International Association of Physicians in AIDS Care
©1996, Medical Publications Corporation