(2005; 12 pages)
ATAZANAVIRRITONAVIR - Not to be coadministered with omeprazole
Europe. The European Medicines Agency (EMEA) has issued a public statement that warns physicians against the co-administration of atazanavir (Reyataz) combined with ritonavir (RTV) and 40 mg omeprazole, a proton pump inhibitor. This warning is based on the observations from a randomized, open-label, multiple-dose drug interaction study performed in healthy volunteers. The study demonstrated a 76% reduction in atazanavir area under the concentration curve (AUC) and a 78 % reduction in atazanavir trough plasma concentration (Cmin) when atazanavir/ ritonavir (300/100 mg) was coadministered with omeprazole 40 mg. The exact mechanism for this interaction is yet to be determined. In the meantime, physicians are advised not to co-administer atazanavir/ ritonavir (300/100 mg) with any dose of omeprazole or with any other proton pump inhibitor to avoid risk of reduction in the atazanavir exposure levels in these patients.
EMEA Public Statement, EMEA/CHMP/202649/2004, 21 December 2004. Available on the Internet at www.emea.eu.int