title: Once-a-day (QD) vs. twice-daily (BID) nevirapine as simplification in PI-treated patients after 2 mos. of BID induction.
abstract: To assess the efficacy and the tolerability of once-daily (QD) versus twice-daily (BID) nevirapine (NVP)-based highly active antiretroviral therapy (HAART) in virologically suppressed, HIV-positive patients switched from protease inhibitor (PI)-based HAART. Eligible patients were enrolled in the multicenter trial if HIV RNA levels were <50 copies/mL for ³6 months prior. Patients were switched from a PI to NVP 200 mg BID for 2 months, and then randomized to continue with that regimen (group A) or NVP 400 mg QD (group B) for a further 10 months. Virological efficacy (primary endpoint) and tolerability/toxicity were evaluated according to an intention-to-treat analysis. A total of 126 patients (63 per group) were enrolled. Withdrawals from the study (any reason) numbered 15 in group A and 14 in B, virological failures numbered 5 and 2, respectively, and there were 4 cases of adverse events in each group (all p = NS). Mean alanine aminotransaminase (ALT) and gamma-glutamyl transpeptidase (γ-GT) level increases were significant for the whole cohort (33.2±22.9 to 43.3±29.1, p < 0.001; 57.3±72 to 109±131 U/L, p < 0.0002, respectively), but there were no differences between the two groups. Apparently, no significant differences between the QD and BID NVP groups were found, in terms of virological failures or tolerability/toxicity. The switch to NVP may be safely pursued with a QD schedule.
authors: Foundation IRCCS Policlinico San Matteo Hospital, Infectious Diseases, Pavia, Italy. rmaserati@smatteo.pv.it
authors: Renato
authors: R
authors: Maserati
authors: Micaela
authors: M
authors: Brandolini
authors: Annamaria
authors: A
authors: Cattelan
authors: Anna
authors: A
authors: Orani
authors: Laura
authors: L
authors: Sighinolfi
authors: Massimo
authors: M
authors: Andreoni
authors: Alessia
authors: A
authors: Uglietti
authors: Giovanni
authors: G
authors: Guaraldi
authors: Giovanni
authors: G
authors: Sotgiu
mesh_terms: D000293:Adolescent; D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects* / Q000379:methods*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D019829:Nevirapine / Q000008:administration & dosage* / Q000009:adverse effects*; D016896:Treatment Outcome; D019562:Viral Load; D055815:Young Adult; D005723:gamma-Glutamyltransferase / Q000097:blood
chemical_list: D019380:Anti-HIV Agents; D019829:Nevirapine; D005723:gamma-Glutamyltransferase; D000410:Alanine Transaminase