07/22/10

PRN Reports: New Once-daily Extended-release Nevirapine is Non-inferior to Twice-daily Formulation

Today in a latebreaker session the 48 week results from the VERxVE study were presented by Anne-Marie Quinson of Boehringer Ingelheim Pharmaceuticals. This was a safety and efficacy study of 400mg QD nevirapine extended-release formulation (Viramune XR) compared with the 200mg bid nevirapine immediate-release (Viramune IR) in ARV treatment-naïve, HIV-1 infected patients. Viramune XR has the advantage of once-daily dosing, which may lead to improved compliance with antiretroviral therapy.

The study design was a double-blind, double-dummy, non-inferiority study with 1:1 randomization to Viramune XR or Viramune IR after 14-day Viramune IR lead-in 200 mg QD dose. For all patients the background regimen was emtricitabine/tenofovir (FTC/TDF) fixed-dose combination. A total of1011 patients were randomized & treated.

The primary endpoint of sustained virologic response at week 48 was achieved by 76% of patients on Viramune IR and 81% on Viramune XR. Discontinuations were similar in both groups (19.2% Viramune IR compared with 16.6% for Viramune XR) and the two formulations appeared to have similar tolerability and safety with adverse events similar for Viramune IR (8.3%) and Viramune XR (6.3%). Viramune XR also demonstrated a similar lipid profile to that of Viramune IR.

These data suggest that Viramune XR shows non-inferiority to Viramune IR and, if FDA approved adds another once daily antiretroviral treatment HIV-infected patients.

Reference:

Gathe, et al. Comparison of 48 week efficacy and safety of 400 mg QD nevirapine extended release formulation (Viramune XR) versus 200 mg BID nevirapine immediate release formulation (Viramune IR) in combination with Truvada® in antiretroviral (ARV) naïve HIV-1 infected patients (VERxVE). Presented July 22, 2010 at the XVIII International AIDS Conference, Vienna, Austria. Oral Abstract THLBB202.

Source: Reporting from Vienna, Austria for PRN News: Anita Radix MD, MPH and Susan Weiss FNP, AAHIVS