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Published on 22 September 2011

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Viramune® approved in EU for HIV-1 treatment


Viramune® (nevirapine) prolonged-release has received approval for use in the EU in combination with other antiretroviral medications for the treatment of HIV-1 infection.

EU approval for the use of one 400 mg tablet once daily for adults and adolescents – and for 50 mg and 100 mg strengths for once-daily treatment of children – is based on results from clinical trials confirming the significant therapeutic benefits of nevirapine when administered in a convenient once-a-day formulation.

The Viramune® XR™ single 400 mg tablet once daily was approved in the USA by the Food and Drug Administration earlier this year.

In clinical trials, the antiviral efficacy of Viramune® prolonged-release tablets was shown to be non-inferior to the older, twice-daily immediate-release (IR) 200mg tablet, with a safety and tolerability profile comparable to nevirapine IR.

“Nevirapine prolonged-release provides physicians and patients with a simplified, once-daily treatment while maintaining the high level of efficacy, comparable tolerability and favourable lipid profile already associated with the nevirapine immediate-release formulation,” said Dr Keikawus Arastéh, Director of Internal Medicine at Vivantes Auguste-Viktoria-Klinikum in Berlin, Germany.

“Switching therapies and a low pill burden can improve treatment adherence, which is often key to treatment success.”

Boehringer Ingelheim

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