INGELHEIM, Germany & VIENNA, Thursday, July 22nd 2010 [ME NewsWire]:
For medical media, outside the US only
(BUSINESS WIRE)-- Results from the VERxVE study presented today at the 18th International AIDS Society (IAS) conference in Vienna, Austria, show that once daily nevirapine extended release (XR) formulation (400mg QD) Viramune® is non-inferior to the currently used twice daily immediate release (200mg BID) Viramune® (IR) through 48 weeks.
VERxVE is a pivotal trial that compared the frequently prescribed lipid-friendly* antiretroviral Viramune® IR with once daily nevirapine (Viramune® XR.) At week 48, virologic response was 81% (409/505) for nevirapine extended release formulation compared with 75.9% (384/506) for Viramune® IR. There was an adjusted difference of 4.9% in favour of nevirapine extended release formulation (95% CI: -0.1%-10.0%), demonstrating non-inferiority.
The 400mg QD nevirapine extended release formulation (Viramune® XR) demonstrated adequate trough drug exposure through 48 weeks, and efficacy was consistent across gender, baseline viral load and country of origin. Both formulations demonstrated a similar adverse event profile and no new side effects were identified.
“Like the ARTEN trial, the VERxVE trial demonstrates the efficacy and safety of the combination of Viramune® with Truvada®,” said Joseph Gathe, Therapeutic Concepts, Houston, Texas, USA and lead investigator of the VERxVE study. “It confirms that this once daily combination is very efficacious and significantly increases HDL-c, the so-called good cholesterol.”
In the VERxVE study, 1,011 patients were randomized and treated. Median baseline viral load was 4.7 log10 copies/mL for both arms (XR and IR). Demographics, other disease characteristics and length of exposure to study drug were also similar between arms.
Viramune® increased mean absolute HDL-c from baseline (13.4 mg/dL for Viramune® IR and 11 mg/dL for nevirapine extended release formulation (Viramune® XR)). Mean increases in LDL cholesterol were 10 mg/dL in each of the treatment groups. The total mean cholesterol over HDL-c ratio decreased in both treatment groups by 14% in the IR group and 12% in the XR group.
“We are very pleased with the VERxVE results,” said Prof. Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim, “as they confirm Viramune® as a potent choice in antiretroviral therapy. We are confident that the extended release formulation, once approved, will enable HIV patients and their physicians to choose an effective, tolerable and durable treatment option with a favourable lipid profile. This development is particularly important as it will give patients the convenience of a once daily antiretroviral drug that does not carry food or drink restrictions.”
The adverse event (AE) profile of both formulations was similar: investigator defined drug-related AEs were observed in 19.8% of nevirapine extended release formulation (Viramune® XR), vs 24.3% for Viramune® IR. The overall rate of symptomatic hepatic events was 1.6% for the nevirapine extended release formulation (Viramune® XR) vs. 2.8% for Viramune® IR), while the rate of rash was 8.3% vs 8.8%, respectively, for nevirapine extended release formulation (Viramune® XR) and Viramune® IR.
Boehringer Ingelheim is working with regulatory authorities worldwide to make the nevirapine XR formulation available as soon as possible.
Please click on the link below to access ‘Notes to Editors’ and ‘References’:
http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2010/22_july_2010.html
* In clinical studies, VIRAMUNE has been associated with an increase in HDL- cholesterol and an overall improvement in the total to HDL-cholesterol ratio.
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Ute E. Schmidt
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