Norfolk, Va. Richard V. Homan, MD, President and Provost of Eastern Virginia Medical School (EVMS) and Dean of the School of Medicine, along with Alfred Z. Abuhamad, Chair and Professor of EVMS Obstetrics and Gynecology, announced today that CONRAD, a leading reproductive health-research organization at the school, will receive up to $80 million over the course of five years from the United States President's Emergency Plan for AIDS Relief (PEPFAR) through the U.S. Agency for International Development (USAID). The awards will fund three areas of HIV prevention research including: licensure and implementation of tenofovir gel, development of novel on-demand and longer-acting microbicide leads, and development of objective measures of product adherence for vaginal and rectal microbicides.
Globally, 35.3 million people are currently infected with HIV, and in South Africa, prevalence of HIV has increased from 10.6% in 2008 to 12.3% in 2012. Young, single women account for the highest rate of new infections, and condom use in South Africa has fallen in all age groups. The need to develop and implement prevention options for those at highest risk of infection continues to be a top public health research priority. The U.S. Congress recently approved legislation to extend PEPFAR, a foreign aid program to combat AIDS worldwide.
CONRAD Scientific and Executive Director Gustavo Doncel, M.D., Ph.D. said, "We are deeply grateful to USAID for their continued support, and to PEPFAR and the U.S. Congress for making HIV prevention a priority. These awards coincide with World AIDS Day and reflect the unwavering commitment of the American people to support the fight against the AIDS epidemic worldwide. The funds will support multi-faceted research and allow us to advance and develop a variety of prevention products which include on-demand and long-lasting options for different women's needs. We plan to incorporate input on user preferences early in the product development process and develop objective measures of adherence to enable a more accurate evaluation of the new microbicides. Developing products that women want to use as opposed to have to use is key to the successful assessment and implementation of HIV prevention strategies, especially in young women who are most at risk for HIV infection."
Tenofovir gel was the first product to provide proof of concept that a vaginal gel used before and after sex could reduce HIV-1 and HSV-2 infections. A confirmatory study of tenofovir gel called FACTS 001, sponsored by CONRAD and funded by USAID, the South African government and the Bill and Melinda Gates Foundation, is currently ongoing and if the results again show protection, the gel has been fast tracked by the FDA for regulatory approval.
Other products in CONRAD's pipeline include a fast-disintegrating vaginal tablet and two vaginal rings that have the potential to be effective for up to three months. One ring in testing contains tenofovir plus a contraceptive called levonorgestrel, a combination that has the potential to provide triple protection against unintended pregnancies and HIV and herpes. Safety, pharmacokinetic and pharmacodynamic studies will begin in 2014.
Using this funding, CONRAD will continue development of new microbicide products that are more potent, acceptable, discreet, and longer acting to improve adherence and effectiveness. In addition to advancing clinical development of the current pipeline, CONRAD also will explore new formulations consisting of antiretrovirals displaying different mechanisms of action.
Adherence, or regular and consistent use of a product, has been shown to be problematic in various HIV prevention trials. Adherence is conditioned by socio-behavioral, biologic and environmental factors and without consistent use, it is extremely difficult for researchers to gauge true product effectiveness. In light of this, CONRAD will continue development and validation of biomarkers for measuring adherence and its possible use in alternative trial designs.
"We are very proud to continue supporting CONRAD's excellent work," said USAID Program Officer Lee Claypool, PhD. "Together with our partners in the private sector and participating African governments, I'm very optimistic that we will continue to forge new ground in HIV prevention."
|Contact: Annette Larkin|