European Medicines Agency welcomes continuation of D:A:D study

The European Medicines Agency (EMEA)The European Medicines Agency (EMEA) has welcomed the commitment of the sponsors to continue the D:A:D study at least until 2012. This ensures that the study, which was started on the initiative of the EMEA in 1999, will remain one of the most powerful pharmacovigilance tools to monitor the long-term safety of antiretroviral medicines.

D:A:D (Data Collection on Adverse Events of Anti-HIV Drugs) is a prospective study based on multinational cohort collaboration, which includes data from 33,308 patients in 11 ongoing HIV cohorts in Europe, Australia and the United States of America.

The D:A:D study was started in response to a request from the EMEA to all marketing authorisation holders of antiretroviral medicines. It set out to conduct a collaborative review of the cardiovascular safety and metabolic and body composition changes possibly associated with HIV treatment. The scope of the study was extended in 2005 to also investigate liver-related safety.

Although marketing authorisation holders of antiretroviral medicines contribute to the funding of the study, it is run in scientific independence. This is ensured by an independent scientific steering committee, which takes all scientific and procedural decisions, and by the so-called HAART Oversight Committee, which administers funds for studies, follows their progress and ensures their completion and reports regularly to the EMEA. The Oversight Committee includes also representatives of academia, patient organisations, the EMEA and the USA Food and Drug Administration (FDA).

Due to its large size and long follow-up, the D:A:D study has had a pioneering role in drug safety, helping to address existing and new emerging safety concerns, as well as to learn more about HIV infection itself. This is likely to serve as a model for future collaborative observational studies that will analyse the safety of whole therapeutic classes of medicines.

During the January 2009 meeting of the EMEA's Committee for Medicinal Products for Human Use (CHMP) representatives of the HAART Oversight Committee and the steering committee presented the achievements made over the last ten years and the plans for the study’s continuation.

The study now monitors all authorised antiretroviral medicines. In addition, the marketing authorisation holders for any new antiretroviral medicines authorised in the future will be required to take part in the study. D:A:D will continue to explore cardiovascular and liver-related safety. An association between antiretroviral combination therapy and myocardial infarction was identified in 2003. Further follow-up established that this was mainly explained by cumulative exposure to protease inhibitors. More recently an association with the recent use of abacavir and didanosine was found and is being further investigated.

The study will also be expanded to consider whether antiretroviral medicines affect the risk of contracting non-AIDS defining cancers and endstage kidney disease, as well as to examine patterns of causes of death over time and laboratory markers of liver and kidney function.

The results from the first ten years of the study have shown that the benefit-risk balance of antiretroviral medicines remains strongly positive and that the overall mortality of HIV-infected patients has dramatically declined since the introduction of highly active antiretroviral therapy (HAART).

1. More information about the D:A:D study is available at: http://www.cphiv.dk/DAD/tabid/57/Default.aspx
2. The EMEA published statements on results from the D:A:D study in April 2003 (http://www.emea.europa.eu/pdfs/human/press/pus/238303en.pdf) and August 2005 (http://www.emea.europa.eu/pdfs/human/press/pus/24902205en.pdf).
3. In 2008, the EMEA issued a press release on abacavir and a potential increase in the risk of heart disease as a follow-up to a signal detected in the D:A:D study. The press release is available at: http://www.emea.europa.eu/humandocs/PDFs/EPAR/Kivexa/14288808en.pdf
4. This press release, together with other information on the work of the EMEA, can be found on the EMEA website: www.emea.europa.eu

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