Activists and public health professionals took to the stage during the opening plenary of the Research for HIV Prevention (HIVR4P) conference yesterday to challenge U.S. government research agencies and demand support for short-acting, user-controlled methods for HIV prevention. The U.S. National Institutes of Health (NIH) is soon to announce its funding for prevention research, which will indicate the priorities for HIV prevention research for the next several years.
Just before Tony Fauci, M.D., director of the NIH's National Institute of Allergies and Infectious Diseases (NIAID) took the stage to deliver his address to the crowd, several dozen people filed on the stage with signs that read: "Whose choice, our choice?" and "Dear NIAID, Fund Microbicides NOW!"
Just before speaking, Jim Pickett, chair of International Rectal Microbicides Advocates (IRMA), stepped to the mic and asked the audience whether he could take just two minutes of their time, and he began to speak from a prepared statement.
"We are here because previous calls to ensure that NIAID and USAID continue to support research on microbicides that are short-acting and user-controlled have been totally ignored, given the vast majority of feedback they themselves solicited last year," said Pickett. IRMA, along with the AVAC, released a report earlier this month that developed out of a Freedom of Information Act (FOIA) request to analyze public comments given to NIAID about funding priorities for HIV prevention. Their report found that 79% of comments expressed a desire to see prevention research support a range of options to hopefully come to market, including microbicides. Advocates told TheBody in March 2018 that they feared NIAID was going to drop its support for microbicide trials, a point Pickett reiterated on stage.
"NIAID is about to issue its funding opportunity announcement (FOA) that will indicate priorities for the next HIV prevention network," he told the HIVR4P audience. "They have a chance to clarify that they respect what women, gay men and other men who have sex with men, researchers, and other stakeholders have been demanding: choices that aren't all long acting or systemic. We are here to ensure that research serves the people with products they want, not simply what those in power want to develop."
According to AVAC, in 2016 total global investment in microbicide research and development came to $167 million, of which $97 million came from the NIH -- nearly 60% of the total. Advocates worry that any reduction in support from NIH for research for products such as rectal douches or lubricants with a preventative drug would greatly challenge the development of products they see as having the potential to be just as effective in preventing HIV as daily pre-exposure prophylaxis (PrEP) in pill form and some of the other more systemic options in development (such as long-acting injectables).
"We have been preaching that one size does not fit all in HIV prevention for quite some time, said Lilian Benjamin Mwakyosi, M.D., a young physician and advocate from Tanzania. "It is high time that we invest in the options that people desire, which include microbicides and other non-systemic options."
I spoke to Carl Dieffenbach, Ph.D., director of the Division of AIDS within NIAID, at the conclusion of the plenary session to get his response to the activists' requests. He said that although he couldn't speak to the specifics of the upcoming FOA until it is made public, nothing has changed in his approach to HIV research at the Institute.
"Nothing has been taken out of the pipeline, and we continue to support all types of microbicide research from systemic to short acting," he said. "But we're not going to take things forward that don't have a level of efficacy. You need to have biological plausibility. At the same time, if we're going to truly impact the epidemic, there has to be somebody that is willing to advance that product through an appropriate clinical program."