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Viramune (nevirapine) Extended Release Once Daily Study
  Feb 12, 2008
Press announcement from Boehringer Ingelheim
Boehringer Ingelheim announced today that it has initiated and begun enrollment of patients in the VERXVE trial which will evaluate the efficacy, safety and pharmacokinetics of a once-daily nevirapine extended release formulation versus twice-daily VIRAMUNE, was announced today.
The VERXVE study, which stands for a randomized, double blind, double dummy, parallel group, active controlled trial to evaluate the antiviral efficacy of 400 mg QD neVirapine Extended Release formulation in comparison to 200 mg BID neVirapinE immediate release in combination with Truvada in antiretroviral therapy naive HIV-1 infected patients, will enroll approximately 1,000 HIV-positive treatment-naive patients from planned sites in 18 countries. Recruitment is planned throughout 2008. Results will be available in 2010.
"Viramune dosed twice daily is proven to be an effective, tolerable and durable treatment option with a favourable lipid profile. The VERXVE study is an important trial as it is in the patients' interest to reduce the pill burden in HIV/AIDS as much as possible and we expect that the efficacy and safety will be the same in this simplified treatment regimen," said Dr Keikawus Arasteh, Director of the department Infectious Diseases and Gastroenterology at the Auguste Victoria Hospital Berlin and lead investigator at Epimed, Society for Epidemiological and Clinical Research, Berlin.
The primary endpoint is virologic response at 48 weeks, defined as a viral load of less than 50 copies/mL prior to Week 48 and without subsequent rebound or change of antiretroviral therapy by Week 48. Secondary endpoints include other efficacy endpoints, safety and pharmacokinetic parameters.
Patients will be randomized to receive either 400 mg of the nevirapine extended release formulation once daily or 200 mg of VIRAMUNE twice daily, after a 14-day lead in period in which all patients will receive 200 mg of VIRAMUNE once daily. The current VIRAMUNE CD4+ cell initiation criteria are being applied to both arms of the study. All patients will also receive the fixed dose combination of tenofovir and emtricitabine. Patients will be treated for up to 48 weeks with an extension through 144 weeks.
VIRAMUNE is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. Some adverse events with VIRAMUNE can be life-threatening. For your reference, below please find the full Prescribing Information and important VIRAMUNE safety information.
About Viramune
Viramune is a product of original research done at Boehringer Ingelheim. Viramune was the first member of the non-nucleoside reverse transcriptase inhibitor (NNRTI) class of anti-HIV drugs. Viramune is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on one principal clinical trial that demonstrated prolonged suppression of HIV-RNA and several smaller supportive studies. Studies have also shown that patients switching to Viramune from a PI-based regimen demonstrate an improved lipid profile while maintaining viral suppression. The most clinically important adverse events associated with Viramune are rash and hepatic events, which have included fatal cases. Any patient can experience hepatic events; however, female gender and higher CD4+ cell counts at initiation of therapy place patients at greater risk. Women with CD4+ cell counts >250 cells/mm3 are at the greatest risk. By application of the Viramune CD4+ guidelines the risk of hepatic events can be dramatically reduced. Viramune should not be initiated in adult females with CD4+ cell counts greater than 250 cells/mm3 or in adult males with CD4+ cell counts greater than 400 cells/mm3 unless the benefit outweighs the risk. The greatest risk of severe rash and hepatic events occurs in the first six weeks of therapy. It is essential that patients be monitored for these reactions at all times, and intensively during the first few months of therapy. Viramune should be discontinued and not restarted following severe hepatic, skin or hypersensitivity reactions.
Boehringer Ingelheim
Boehringer Ingelheim is committed to the research and development of novel antiretroviral agents. Apart from Viramune (nevirapine), Aptivus (tipranavir) is a new non-peptidic protease inhibitor, approved for combination antiretroviral treatment of HIV-1 infected adults that are highly pre-treated with virus resistant to multiple protease inhibitors. The company is committed to improving HIV therapy by providing physicians and patients with innovative antiretrovirals.
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