Rectal microbicides – can we make them and will people use them?

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Ian McGowan, MD, PhD, FRCP Microbicide Trials Network/University of Pittsburgh The results of the CAPRISA-04 and iPrEx studies have demonstrated that topical or systemic use of antiretroviral agents can significantly reduce the risk of HIV acquisition associated with unprotected vaginal or anal sexual intercourse. However, the effect size in these studies was relatively modest and product adherence was generally poor. These observations suggest the need for new approaches to HIV prevention, especially for high risk MSM. Rates of lubricant use are high in MSM practicing receptive anal sex. Consequently, the development of an antiretroviral rectal microbicide gel may provide a safe and effective means of preventing HIV infection with an intervention that is likely to have high acceptability among the target population. The goal of this lecture is to describe the challenges and progress in the development of rectal microbicides for HIV prevention. Biography A native of England, Dr. McGowan obtained his medical degree from the University of Liverpool in the United Kingdom, where he also completed postgraduate training in Internal Medicine, Infectious Diseases and Gastroenterology. Between 1989 and 1991, he was a Fellow in Sexually Transmitted Diseases and HIV Medicine at the Middlesex Hospital in London. During this period he received a scholarship from the UK Medical Research Council that allowed him to obtain a PhD in mucosal immunology from Oxford University. In 1994, Dr. McGowan left the U.K. for a Post-Doctoral Fellowship in Digestive Diseases at the David Geffen School of Medicine, University of California Los Angeles (UCLA), where he was subsequently appointed Professor of Medicine and Co-Director of UCLA’s Center for Prevention Research. Between 1997 and 2002, Dr. McGowan held a number of senior positions in the pharmaceutical industry, including as a Director of Clinical Research at Gilead Sciences, where he was responsible for the Phase II/III clinical development of the antiretroviral drug tenofovir disoproxil fumarate (Viread®). Dr. McGowan joined the University of Pittsburgh in September of 2007 where he is currently a Professor of Medicine in the Division of Gastroenterology, Hepatology and Nutrition with a joint appointment in the Department of Obstetrics, Gynecology and Reproductive Sciences at the University of Pittsburgh School of Medicine. In addition, Dr. McGowan is Co-Principal Investigator of the University of Pittsburgh-based Microbicide Trials Network (MTN), an HIV/AIDS clinical trials network established in 2006 by the National Institute of Allergy and Infectious Diseases, part of the U.S. National Institutes of Health (NIH). As Co-Principal Investigator of the MTN, Dr. McGowan is intimately involved in the oversight and leadership of a major global effort to design and implement an expansive portfolio of clinical trials of candidate microbicides at research sites in seven countries and three continents. In addition to his MTN responsibilities, Dr. McGowan has received over $20 million in independent funding from the NIH to develop rectal microbicides for HIV prevention. More recently, he has received funding from the Bill and Melinda Gates Foundation to evaluate a slow release injectable NNRTI (TMC278 LA) as a potential agent for HIV prevention. Dr. McGowan is a Fellow of the Royal College of Physicians, the Royal Society of Medicine, and a member of the American Gastroenterology Association, and the Society for Mucosal Immunology. He is a reviewer for several high-profile scientific and medical journals, including Science, AIDS, Gastroenterology and PLoS Medicine, and serves on the editorial board of Sexually Transmitted Infections. Dr. McGowan has served as a consultant for the U.S. Centers for Disease Control and Prevention and the World Health Organization, and served as Chair of the U.S. Food and Drug Administration Antiviral Drug Advisory Committee. He currently serves as Chair of the Microbicide Advisory Committee for the Population Council. View webcast