European Union - During 2002, the European Medicines Agency (EMEA) requested the marketing authorisation holders for all licensed antiretroviral medicinal products in Europe to conduct a retrospective review from clinical trials and post marketing data in HIV patients with hepatic impairment and/or HBV/HCV co-infection, with the aim to review pharmacokinetic and safety data, and propose measures to improve the availability of relevant data from these patients.
After an assessment of initial responses in April 2004, marketing authorization holders jointly established the HIV/Hepatitis Co-infection Cohort Collaboration (HIVCO) to plan how to obtain information on the hepatic safety of highly active antiretroviral treatment (HAART) in co-infected patients. At the CHMP and Pharmacovigilance Working party meeting in June 2005, the CHMP endorsed the HIVCO proposal to use the ongoing Study on Data Collection on Adverse Events of Anti-HIV Drugs for the evaluation of liver related death in co-infected patients.
Reference: EMEA public statement. 5 August 2005. EMEA/CHMP/249537/2005 on http://www.emea.eu.int
Spontaneous monitoring systems are useful in detecting signals of relatively rare, serious and unexpected adverse drug reactions. A signal is defined as "reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously. Usually, more than a single report is required to generate a signal, depending upon the seriousness of the event and the quality of the information". All signals must be validated before any regulatory decision can be made. |
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