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Ute E. Schmidt
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55216 Ingelheim am Rhein
European Commission approves label change
For medical media outside the US only
Ingelheim/Germany, 16 September 2010 - Boehringer Ingelheim announced today that the European Commission has approved an update to the Summary of Product Characteristics (SmPC) for VIRAMUNE® (nevirapine) in the treatment of patients with HIV.
The label change means that HIV -1 patients with an undetectable viral load can switch to treatment with Viramune® regardless of their CD4 count.
A large body of clinical evidence demonstrates that the risk of hypersensitivity and/or hepatotoxicity in treatment-experienced HIV patients switching to Viramune® is not increased among those with an undetectable viral load (< 50 copies/ml) and CD4 counts above the gender specific CD4-thresholds identified for treatment-naïve patients 1-4.
“This is good news for all HIV patients looking to change their HIV treatments to a Viramune®-based regimen because of drug resistance, side effects or drug interactions,” said Professor Jürgen Rockstroh, University Bonn. “Prescribing physicians will now no longer have to apply the CD4 count threshold when switching patients to a lipid-friendly regimen containing Viramune®.”
The decision followed a positive recommendation by the Committee for Medical Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA) who reviewed the clinical evidence and approved the new wording in the Viramune® Summary of Product Characteristics.
This new label change is based on data from more than 12,000 patients, including a meta-analysis of randomised prospective studies, a retrospective analysis of a single centre HIV cohort and observational studies (EuroSIDA cohort, ATHENA cohort and multi-cohort studies). 1-4 These studies found that the risk of hypersensitivity and/or hepatotoxicity in patients with an undetectable viral load switching to Viramune® is not increased in patients with higher CD4 counts (i.e. above the gender specific CD4-thresholds: women more than 250 cells/mm³, men more than 400 cells/mm³).
Notes to Editors
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 and is indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents. 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. 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.
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 142 affiliates in 50 countries and more than 41,500 employees. Since it was founded in 1885, the family-owned company has been committed for 125 years to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2009, Boehringer Ingelheim posted net sales of 12.7 billion euro while spending 21% of net sales in its largest business segment Prescription Medicines on research and development.
Please be advised
This release is from Boehringer Ingelheim Corporate Headquarters in Germany. Please be aware that there may be national differences between countries regarding specific medical information, including licensed uses. Please take account of this when referring to the information provided in this document. This press release is not intended for distribution within the U.S.A.
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1. Mocroft A, Staszewski S, Weber R et al. Risk of discontinuation of nevirapine due to toxicities in antiretroviral-naive and -experienced HIV-infected patients with high and low CD4+ T-cell counts. Antiviral Ther 12 (3) , 325-333 (2007)
2. Wit FWNM, Kesselring AM, Gras L, Richter C, et al. Discontinuation of nevirapine because of hypersensitivity reactions in patients with prior treatment experience, compared with treatment-naive patients: the ATHENA cohort study. Clin Infect Dis 46 (6) , 933-940 (2008)
3. Kesselring AM, et al: Nevirapine Toxicity Multicohort Collaboration. Risk factors for treatment-limiting toxicities in patients starting nevirapine-containing antiretroviral therapy. AIDS (Phila) 23 (13), (2009) 1689-1699
4. Lazzari E de, et al. Hepatotoxicity of nevirapine in virologically suppressed patients according to gender and CD4 cell counts. HIV Med 2008; 9 (4): 221 -226