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Once-a-Day (QD) vs Twice-Daily (BID) Nevirapine as simplification in PITreated patients after 2 mos. of BID induction

Maserati, Renato and Brandolini, Micaela and Cattelan, Anna Maria and Orani, Anna and Sighinolfi, Laura and Andreoni, Massimo and Uglietti, Alessia and Guaraldi, Giovanni and Sotgiu, Giovanni (2011) Once-a-Day (QD) vs Twice-Daily (BID) Nevirapine as simplification in PITreated patients after 2 mos. of BID induction. Current HIV Research, Vol. 9 (3), p. 166-173. ISSN 1570-162X. Article.

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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 ≥6 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.

Item Type:Article
ID Code:6652
Uncontrolled Keywords:HIV, antiretroviral therapy, therapy switch, nevirapine, adverse events, once-daily, HIV/AIDS therapy, BID NVP, hepatitis B, CD4+ T cell
Divisions:001 Università di Sassari > 01 Dipartimenti > Scienze biomediche
Publisher:Bentham Science
Deposited On:23 Nov 2011 10:54

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