EMEA statement on use of antiretroviral treatment in HIV-patients with hepatic impairment and/or HBV/HCV co-infection

Two public statements, were published on the EMEA website on Friday, 5 August 2005.

Both statements relate to research initiated by the European regulatory agency in response to safety and toxicity concerns from the long-term use of antiretrovirals in combination therapy. The research has been a unique collaborative response between the companies, independent investigators and the community, and has produced some of the most solid data on this aspect of HIV management.

It has included international cohort collaborations including the D:A:D study and more recently has started to look at implications for patients coinfected with HIV and hepatitis.

These statements were based on the Oral Explanations presented at June meeting of the CHMP and the conclusions reached.

Statement on use of antiretroviral treatment in HIV-patients with hepatic impairment and/or HBV/HCV co-infection

During 2002, the EMEAs Committee for Proprietary Medicinal Products (CPMP) requested the Marketing Authorisation Holders (MAHs) 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 to propose measures to improve the availability of relevant data from these patients. The focus on this issue provided new information which has been incorporated into the relevant sections of the Summary of Product Characteristics of antiretroviral products, the enrolment of co-infected patients in ongoing and planned clinical trials, an improved surveillance of hepatic safety in these patients and the planning of epidemiological studies.

After an assessment of initial responses by CPMP in April 2004, the MAHs jointly established a Steering Committee (HIV/Hepatitis Co-infection Cohort Collaboration- HIVCO), to set up a plan on how to obtain information on the hepatic safety of highly active antiretroviral treatment (HAART) in co-infected patients, which reported in March 2005. At the CHMP1 and Pharmacovigilance Working party meeting in June 2005, the preliminary assessment of this response was discussed and the Marketing Authorisation Holders made a presentation of their data and proposals. The conclusions from this meeting were formally adopted by the CHMP in its July 2005 meeting.

The CHMP endorsed the proposal of the HIVCO committee that the D.A.D. Study2 should be used for the evaluation of liver related death in co-infected patients, which the Marketing Authorisation Holders also have committed to support for three years.