HIV-1 patients with an undetectable viral load can switch to VIRAMUNE® regardless of their CD4 count
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
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 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.
Boehringer Ingelheim
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.
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