Boehringer Ingelheim initiates new HIV/AIDS Trial for extended release formulation of Viramune®

Ingelheim/Germany, 12 February 2008 – Boehringer Ingelheim announced today that it has initiated and begun enrollment of patients in the VERXVE trial, which will compare the efficacy and safety of a new extended release formulation of Viramune® (nevirapine), a non-nucleoside reverse transcriptase inhibitor (NNRTI), dosed once daily (QD) with the currently approved Viramune ® given twice daily (BID). The trial stands for Viramune Extended Release compared to Viramune® and will involve all in all approx. 1000 patients in 18 countries in Europe, North and South America, South Africa and Australia. Nevirapine will be combined with a background regimen consisting of tenofovir and emtricitabine (Truvada®). 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 Arastéh, 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 of the trial will be virologic response, i.e. suppression of virus load to < 50 copies/mL, after 48 weeks. It is a double-blind study comparing nevirapine 400 mg extended release formulation, given as one pill once a day, to the currently approved nevirapine regimen, given as one 200 mg tablet twice daily.

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.