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High‐Dose Nevirapine in Previously Untreated Human Immunodeficiency Virus Type 1‐Infected Persons Does Not Result in Sustained Suppression of Viral Replication

1997; Oxford University Press; Volume: 175; Issue: 4 Linguagem: Inglês

10.1086/514002

1537-6613

Menno D. de Jong, Stefano Vella, Andrew Carr, Charles A. Boucher, Allison Imrie, Martyn A. French, Jennifer Hoy, S. Sorice, S Pauluzzi, Francesco Chiodo, Gerrit‐Jan Weverling, Marc van der Valk, Ph. J. Frissen, H Weigel, Robert H. Kauffmann, Joep M. A. Lange, Rosa Yoon, Mauro Moroni, E. Hoenderdos, G Leitz, David A. Cooper, D. B. Hall, Peter Reiss,

HIV/AIDS Research and Interventions

High-dose nevirapine treatment has been reported to confer sustained antiretroviral effects, despite a rapid development of resistance. The use of this strategy was evaluated in 20 previously untreated human immunodeficiency virus type 1 (HIV-1) p24 antigenemic persons with CD4 cell counts between 100 and 500/mm3. Treatment consisted of 400 mg of nevirapine, after a 2-week lead-in dose of 200 mg. Rash was the most frequently reported adverse event, occurring in 25%. While sustained declines in p24 antigen levels were observed in the majority, serum HIV-1 RNA load and CD4 cell counts returned to baseline values within 12 weeks in virtually all subjects. The resistanceconferring tyrosine-to-cysteine substitution at reverse transcriptase position 181 was detected after 4 weeks in most subjects. These observations suggest that plasma drug levels attained with highdose nevirapine were not sufficient to inhibit nevirapine-resistant virus, although they were ∽2-fold higher than reported IC50 values of resistant virus.