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news.Boehringer Ingelheim has released VERxVE study results evaluating once daily Nevirapine extended release (XR) formulation (400mg QD) Viramune which demonstrated that the drug is non-inferior to the currently used twice daily immediate release (200mg BID) Viramune (IR) through 48 weeks.
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According to Boehringer Ingelheim’s VERxVE randomised study 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.
VERxVE trial showed a median baseline viral load of 4.7 log 10copies/ml for both arms (XR and IR). Demographics, other disease characteristics and length of exposure to study drug were also similar between arms.
Boehringer Ingelheim is working with regulatory authorities to make the Nevirapine XR formulation available as soon as possible.
Joseph Gathe, lead investigator of the VERxVE study, said: “Like the Arten trial, the VERxVE trial demonstrates the efficacy and safety of the combination of Viramune with Truvada.”
Klaus Dugi, corporate senior vice president of medicine at Boehringer Ingelheim, said: “We are very pleased with the VERxVE results as they confirm Viramune as a choice in antiretroviral therapy.
“We are confident that the extended release formulation, once approved, is expected to enable HIV patients and their physicians to choose a tolerable treatment option with a favourable lipid profile.
“This development is particularly important as it is expected to give patients the convenience of a once daily antiretroviral drug that does not carry food or drink restrictions.”