48‐week efficacy and safety of transitioning virologically stable HIV‐1 patients from nevirapine IR 200 mg BID to nevirapine XR 400 mg QD (TRANxITION)

Abstract

7‐11 November 2010, Tenth International Congress on Drug Therapy in HIV Infection, Glasgow, UK

Considerations on the New Nevirapine

“…At 48 weeks, virologic response was achieved in 262 of 295 patients treated with NVP-XR and 131 of 148 patients treated with NVP-IR (88.8% vs 88.5%, 0.3% difference; 95% CI: À6.1-6.7). 6 Again, NVP-XR was noninferior to NVP-IR treatment, and this outcome was further supported by consistent results from time to loss of virologic response and snapshot analyses, as defined by the US Food and Drug Administration (FDA).…”

“…Results from 24 weeks of follow-up have recently been published 5 and 48-week results were presented at the 10th International Congress on Drug Therapy in HIV Infection. 6…”

“…Also, liver transaminase elevation was seen in 4 patients taking NVP-XR (1 patient had hepatitis C infection and discontinued participation and 3 patients continued in the study; Tables 1 and 2). 6…”

Nevirapine once daily: pharmacology, metabolic profile and efficacy data of the new extended-release formulation

“…The TRANxITION trial [49], an openlabel, 2:1 randomized, parallel group study, demonstrated the non-inferiority of switching HIV-1-infected patients from NVP IR based regimen to NVP XR based regimen (Table 1).…”

HIV-Infektion

“…Daher sollten Frauen mit CD4 + -Zellzahlen > 250/µl und Männer mit einer CD4 + -Zellzahl > 400/µl in der Initialtherapie kein Nevirapin erhalten [26]. Die Darreichungsform mit verzöger-ter Freisetzung erlaubt eine 1-mal tägliche Einnahme und ist seit 11/2011 in Deutschland verfügbar [2,15].…”