Therapy with Efavirenz plus Indinavir in Patients with Extensive Prior Nucleoside Reverse-Transcriptase Inhibitor Experience: A Randomized, Double-Blind, Placebo-Controlled Trial [Haas DW, et al. JID 2001;183:392]: This is a multicenter study of patients with prior NRTI therapy and a baseline HIV RNA level >10,000 c/mL plus no prior PI or NNRTI therapy. One group received efavirenz (600 mg hs) plus indinavir (1,000 mg q8h), and the control group received indinavir (800 mg q8h). Both groups received concomitant NRTIs. Analysis at 24 weeks showed that the number who achieved viral load levels <400 c/mL was 68% in the group receiving EFV plus IDV compared to 52% in those treated with IDV alone (p = 0.004). These results were sustained at 48 weeks.
Comment: The results here seem to be substantially better than those achieved with a similar protocol in ACTG 364. One difference is that the PI used in ACTG 364 was nelfinavir plus efavirenz. The participants had substantial prior NRTI therapy with an average duration of 2.8 years. They were PI and NNRTI-naïve, and some would question the wisdom of exposing patients to all three classes. Nevertheless, practitioners will agree with the substantial challenge in those who have extensive exposure NRTIs.
posted 2/22/2001

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