The Effect of Nevirapine in Combination With Nelfinavir in Heavily Pretreated HIV-1-Infected Patients [Jensen-Fangel S et al. JAIDS 2001; 27: 124]: This is a report from Denmark in which patients who had virologic failure with PI-based HAART regimens were randomized to receive either nelfinavir or nelfinavir plus nevirapine, each in combination with two NRTIs. The regimen used was nelfinavir (1250 mg bid) plus nevirapine (200 mg/day x 14 days, then 200mg bid). Analysis at 36 weeks showed plasma HIV-RNA levels <200 c/ml in 52% of the 29 who received four-drug therapy compared with 22% who received the three-drug regimen. The authors conclude that the addition of nevirapine to nelfinavir after failing a PI-based HAART regimen has a substantial benefit for HIV suppression. Nevertheless, the authors acknowledged that diarrhea was a particularly common side effect, presumably from nelfinavir, and 17% of participants had to discontinue nevirapine due to rash.
Comment: The results of this trial are somewhat predictable since these were all patients who were NNRTI naive. One of the major issues concerns the possibility that NVP alone would have been equally effective. It should be acknowledged that this combination of NVP plus NFV is one of the few combinations in which there are virtually no drug interactions that require dose adjustment.
posted 7/3/2001

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