The DAD Study and HIV Therapy – An Interview with Professor Peter Reiss
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Professor Peter Reiss, MD, PhD works jointly for the Department of Medicine, Division of Infectious Diseases and the Department of Global Health, both situated at the Academic Medical Center (AMC) at the University of Amsterdam. His focus is particularly related to the complications of HIV treatment, with the majority of his time dedicated to various clinical studies related to this topic as well as consulting at the AMC’s HIV clinic and teaching medical students. |
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| Dr. Reiss also serves on many international committees and study groups. Amongst his many roles, Dr. Reiss currently serves on the HIV Monitoring Working Group of Stichting HIV Monitoring (SHM) and acts as Principal Investigator for SHM in the DAD study (Data collection of Adverse events of Anti-HIV Drugs). We were fortunate to catch up with Dr. Reiss to discuss the DAD study further. |
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Can you explain how the DAD study started?
Peter Reiss: “The DAD study was started in 1999, a couple of years after protease inhibitors (ed: PI’s, an anti-HIV therapy) were introduced. It was found that PI’s were associated with a range of side effects including body fat distribution changes and increased blood lipid (incl. cholesterol) levels. For this reason an independent group of researchers were asked by the European Medicines Agency (EMA) to assess whether treatment with anti-retroviral drugs, including PI’s may be associated with an increased risk of cardiovascular disease, particularly heart attacks.”
“The study built on the experience of various cohort studies, including the SHM/ATHENA cohort study (ed: ATHENA is ‘AIDS Therapy Evaluation in the Netherlands’, the predecessor of SHM. SHM is still known by this name principally in international studies). It built on general cardiovascular studies, prospectively capturing information on cardiovascular disease in HIV-infected individuals. Funding for the study came from the pharmaceutical manufacturers of antiretroviral drugs through an independent oversight committee set up with guidance from EMA.”
Could you elaborate a little on SHM’s involvement?
Peter Reiss: “There are 11 cohorts participating worldwide and one principal investigator is involved for each cohort. I act as the principal investigator for the Netherlands SHM/ATHENA cohort, which is also represented by SHM’s Luuk Gras, who gives input regarding data analysis, and Mariska Hillebregt, who is responsible for the data management for SHM. It is important to realize that SHM provides one of the largest datasets to DAD.”
What results have been achieved so far with this study and what is the impact on the Netherlands?
Peter Reiss: “The first report of the study showed the increased risk of cardiovascular disease with combination antiretroviral therapy (cART). The study initially focused on cART, then on classes of drugs, and then individual drugs. A second report focused on protease inhibitors, and a third report on the drug abacavir. The findings from the DAD study to date have influenced treatment guidelines globally including of course the Netherlands. Of note, the group always continues to stress that any risk found for a particular antiretroviral within the study, when making treatment decisions in the individual patient always needs to be considered against the background risk of cardiovascular disease in that patient.”
What future developments are in store for DAD?
Peter Reiss: “The study originally focused on myocardial infarction and other cardiovascular conditions, but this was then broadened to include other conditions such as chronic liver and renal disease and cancer, and information on these studies will be published in the next year or two. The key focus remains what contribution a particular antiretroviral drug or combination of drugs has on these comorbidities in patients with HIV.”
What are your thoughts on SHM’s contribution to HIV care via studies such as the DAD study?
Peter Reiss: “In qualitative terms, SHM’s contribution of data to DAD and other studies is huge, often in the top three contributors of data. This contribution ultimately not only influences international guidelines but also guidelines in the Netherlands. SHM is in the unique position of being one of the only organisations that is studying, on a national level, a disease which remains lethal if left untreated. It involves following people under life-long care with increasingly complex medical conditions and definitely needs to be maintained as a successful model to accomplish pharmacovigilance. Who knows what we are in store for with respect to as yet unknown long-term complications of HIV treatment? In addition, maintaining adherence to treatment over the long-term could become a larger problem, which could result in emergence of more drug resistance, increased transmission of resistant HIV, etcetera. There could be a whole host of things. And what has been set up by SHM can also be used as a model for other diseases, such as viral hepatitis, which is a natural follow-on from working on HIV. Furthermore, other organisations in developing countries look at SHM for setting up their own HIV monitoring studies, for example, Curacao. So overall, SHM makes a major contribution to HIV care both nationally and internationally.”