By: Chuck Colbert/TRT Reporter
More than 25 years into the HIV/AIDS pandemic, statistics of HIV rates of infection are shocking:
• “Every ten minutes, someone in the Untied States gets infected with HIV,” cautions HopeTakesAction.org, a website seeking volunteers to participate in a clinical vaccine trial to prevent infection.
• Sixty-three percent of all HIV/AIDS cases nationwide are among gay and bisexual men, with HIV infection rates rising among men who have sex with men, according to Fenway Health, a-state-of-the-art facility, providing comprehensive medical care to the LGBT community of Greater Boston.
• The Centers for Disease Control and Prevention estimate that close to one in five gay and bisexual men in 21 major US cities are infected with HIV, and half of them do not know it. Apparently, some younger gay and bisexual men either don’t remember the early years of AIDS or have a sense it won’t happen to them. Among older men, another attitude has set in: “No-big-deal, it’s-a-chronic-treatable disease, like diabetes. “It’s very interesting,” said Ronn Bill, research coordinator at The Fenway Institute, who has worked on a number of HIV clinical trials. “Some men are very conscious and practice safe sex. Others have to be convinced the epidemic happened, and they are at risk.” “There seems to be a perception, at least in some parts of the community, that HIV is not a problem and that why do we need to be involved in HIV prevention and research,” said Marcy Gelman, associate director of clinical research at Fenway Institute. Still, “It’s well documented that men of color is a particularly concerning community” among MSM (short form for men who have sex with men), she said recently during a wide ranging interview. In fact, men of color MSM “may well be at higher risk and have higher rates of infection that is even know about.” The bottom line, Gelman explained, “HIV rates of infection are the same as they were ten years ago.” That’s the grim news. And yet there is plenty of promise in no small measure thanks to biomedical research at Fenway.
Indeed good news broke recently on one HIV/AIDS battleground – a new prevention approach called Pre-Exposure Prophylaxis or PrEP. On Nov. 23, The New England Journal of Medicine reported the results of a new study showing that individuals at high risk for HIV infection who took a single daily tablet containing two widely used HIV medications, the antiretroviral drugs emtricitabine and tenofovir, experienced an average of 43.8 percent fewer HIV infections than those who were assigned to take a placebo pill.Manufactured by Gilead, Truvada is the brand name of the antiretroviral pill, which combines emtricitabine and tenofovir also known by the initials FTC and TDF respectively.
The Fenway Institute, along with the San Francisco Department of Public Health, was one of two US sites that enrolled study-volunteer participants. There were nine international sites in Brazil, Ecuador, Peru, South Africa, and Thailand. The study, called iPrEx, is the first evidence that the PrEP approach reduces HIV infection in people at increased risk.
The name iPrEx comes from the Spanish Iniciativa Profilaxis Preexposicion or Prexposure Prophylaxis Initiative in English.
“Today’s announcement marks a tremendous step forward,” said Dr. Kenneth H. Mayer, MD, a principal investigator on the study and an author on the journal article. Mayer is co-chair of Fenway Institute and medical research director. “It’s now possible that within the next few years, we can significantly reduce the number of new infections,” he explained in a press statement. “For more than 15 years, the rate of new infections in the U.S, has been stuck at about 56 thousand per year. Globally, there are more than 2.5 million new HIV infections per year. There has been no downward movement in this number; which has meant that we desperately needed a new approach.”
A total of 2,499 gay and bisexual men, other MSM and transgender women at high risk of HIV infection participated in the six-country, four continent iPrEx study. All study participants received a comprehensive package of prevention services designed to reduce their risk of HIV infection throughout the trial, including HIV testing, intensive safer sex counseling, condoms and treatment and care for sexually transmitted infections. The U.S. National Institutes of Health sponsored the iPrEx study through a grant to the Gladstone Institutes, a non-profit independent research organization affiliated with the University of California, San Francisco. The Bill & Melinda Gates Foundation provided additional support. More hope is on the way from two other battlefronts in the global fight to stop HIV/AIDS. The gold standard in fighting any disease, of course, is a vaccine to protect against infection. Currently, no HIV vaccine has been fully developed. But Fenway Health is one of nearly two-dozen clinical trial sites nationwide seeking participants in a second phase vaccine study. As Dr. Mayer explained, “A vaccine tricks the immune system into having a good response to an infecting agent.” But before a the federal Food and Drug Administration will license any vaccine, it must pass three phases of testing in human beings. A Phase II study requires hundreds of participants to test the safety and various doses of the vaccine, usually lasting 12 to 18 months. Circumcised, HIV-negative MSM who are between the ages of 18 to 45 years old areFenway continued
eligible to participate, as well as male-to-female transwomen who also meet the study criteria. Participants cannot get HIV from the vaccine. Volunteers can expect to receive a total of four shots (vaccine or placebo), a physical exam and blood tests, with follow up visits including an interview, HIV test, and risk-reduction counseling. For more information see: www.hopetakesaction.org, www.stand4love.org, or call Fenway at (617) 927- 6450.
An effective and safe HIV vaccine may well take years. Because of its “potential impact on the lives of millions of people, Dr. Mayer said, “it’s important to continue doing vaccine work.” Meanwhile, biomedical research employing microbicides holds out hope at the same time providing important tools in reducing HIV transmission. Currently, Fenway researchers are undertaking two microbicide trials. One clinical study examines the safety of a tenofivir gel used rectally in men and women. The other clinical trial is testing the safety of a rectal microbicide among MSM, particularly young men of color who are disproportionately affected by HIV.
The rectal microbicide clinical trials comes on the heels of promising CAPRISA trial results that were announced this summer in Vienna during the international AIDS conference. The microbicide, a vaginal gel containing tenofovir was found to be 39 percent effective in reducing a woman’s risk of becoming infected with HIV during sex and 51 percent effective in preventing genital herpes infections in the women participating in the trial.
Sponsored by the United States Agency for International Development, Family Health International, and the South African Department of Science and Technology, the study included 980 HIV-negative women in South Africa. “It’s the first time in many, many years that we have had a positive result in biomedical HIV prevention research,” said associate director Gelman. For MSM, unprotected, receptive anal intercourse is high-risk sexual behavior associated with HIV infection. The hope with rectal microbicides is that they too, will prove to be safe and effective in reducing HIV transmission. So, what motivates volunteers to participate in clinical trials? In a word, “altruism,” said Jim Maynard, Fenway Institute’s associate director of community engagement. Sometimes, “volunteers lose a friend to HIV,” he explained. “They want to be part of something to find a cure and elevate the problem of HIV/AIDS in the community,” explained Coco Alinsug, recruitment manager at Fenway Institute. For others, he said, a small monetary compensation provides motivation. For yet others, “One partner is HIV-positive and the other is negative,” Alinsug, said.
“There are lots of personal reasons.” While some study volunteers contact Fenway on their own, the organization recruits other participants through a variety of venues, including college fairs, gay bars, public sex areas and private parties. Fenway also relies upon social networking media, namely Facebook, Twitter, MySpace, Craig’s List, Manhunt, gay. com, and Adam4Adam, among others.
What say Fenway Institute staff members who coached and counseled local iPrEx participants and volunteers in other trials? “My experience is that people came to like, depend, and enjoy the counseling sessions,” said Chris Chianese, a PrEP trial coordinator. Some had never come into Fenway before or had never been asked anywhere about sexual risk. “All of a sudden they are required to come in once a month,” he explained. “Their mind is at a place where they are constantly being asked about sexual risk and what puts them at risk for contracting HIV and sexually transmitted infections.” That line of questioning “affects people’s behavior and thinking,” Chianese said. “In working with people for an extended period of time, you don’t always see results during the day-to-day routine.” Then, “one day you are taken by surprise with a piece of knowledge someone never had before.”
Vanessa Marquez, a clinical research nurse associated with the iPrEx and microbicide trials, said her most important take-away lesson about the AIDS epidemic is “learning it’s real” and “not just a story on CNN.” She added, “It becomes more real when you see how many people it takes, not just one person, not just my doing this, but encouraging other people to come onboard and stay the course.” Keep in mind: “People who are infected need medication now for treating HIV. People look wonderful, not like we saw in the early years,” said Ronn Bill.
That’s because of advances in treatment and medication. Meanwhile, Fenway Institute’s research efforts continue — all aimed at trying to help prevent infection in the first place.
“When you become HIV-infected, medical treatment is for life,” added associate director Gelman.