European Commission approves label change for Boehringer Ingelheim's Viramune; US FDA updates on Pradaxa

The European Commission has approved an update to the Summary of Product Characteristics (SmPC) for independent German drug major Boehringer Ingelheim’s 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-naive patients, the firm noted.

“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 Jurgen Rockstroh, a professor at the University of Bonn, Germany, adding: “Prescribing physicians will now no longer have to apply the CD4 count threshold when switching patients to a lipid-friendly regimen containing Viramune.”