New HIV prevention tool is effective; implementing ‘PrEP’ remains a challenge

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January 6, 2011
By: Chuck Colbert/TRT Reporter

The results of a groundbreaking HIV prevention study are indeed encouraging. Men who had sex with men (MSM), taking oral antiviral medication daily, decreased their HIV risk by almost half compared to those taking a placebo pill.

And yet health care providers, public health officials, and community activists readily acknowledge that the spreading word – getting accurate information out  – among populations at risk won’t be easy.

What’s next with the use of pre-exposure prophylaxis, or PrEP, as a new HIV prevention tool?

A panel of experts addressed the challenge recently at the Boston-based Fenway Health Center, during a community forum, held on World AIDS Day, Dec. 1. The forum drew with more than 50 people.

Gay and bisexual men, particularly men of color who have sex with men, are “bearing the brunt of the disease,” said panel participant Gary Daffin, executive director of the Multicultural AIDS Coalition, a non-profit organization based in Boston’s Jamaica Plain neighborhood.

“Disparities, denial, and dollars” Daffin said, summarize his primary concerns about the new prevention tool.

PrEP “is an intervention that requires [folks] to know about HIV,” he explained. “They know that it’s transmitted in their community, but they don’t think it will happen to them. They deny their own personal risk, particularly young black gay men” and other populations.

PrEP “also requires you to disclose to your [primary] care giver your risk,” Daffin said. “You have to acknowledge with the current regimen: ‘I am a man who has sex with men and that I have to take this pill every day,’” although some men may be inclined to take a “drug holiday,” which “we know from the study that’s not something people can do and still be protected.”

Indeed, sticking to the daily medication regimen is paramount.   Study participants taking medication daily had a 44 percent lower rate of HIV infection compared with those in the placebo group, the study found.

Better yet, participants who reported “high adherence” – taking at least 90 percent of the medication – their protective effect against infection surpassed 70 percent.

And for study participants with medication levels detected in their blood, risk of infection decreased by more than 90 percent.

_The New England Journal of Medicine_ was the first to report about the new HIV prevention study, which tested the use of a daily tablet containing two widely used HIV medications, the antiretroviral drugs emtricitabine and tenofovir.

The full article, “Preexposure Cheomoprophylaxis for HIV Prevention in Men Who Have Sex with Men,” is available at www.nejm.org/doi/full/10.1056/NEJMoa1011205 <http://www.nejm.org/doi/full/10.1056/NEJMoa1011205>.

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.

A total of 2,499 gay and bisexual men, other MSM and transgender (male-to-female) 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 Fenway Institute, along with the San Francisco Department of Public Health, was one of two U.S. sites that enrolled study-volunteer participants. Additionally, there were nine international sites in Brazil, Ecuador, Peru, South Africa, and Thailand.

The iPrex study is the first evidence that oral PrEP prevention reduces HIV infection in people at increased risk. An earlier study, CAPRISA 004, found that topical PrEP, a microbicide, protected at risk women.

The name iPrEx comes from the Spanish _Iniciativa Profilaxis Preexposición_ or Prexposure Prophylaxis Initiative in English.

During the community forum, Dr. Kenneth H. Mayer, MD, a principal investigator on the study and an author on the journal article, gave an over view of the results.

Dr. Mayer co-chairs the Fenway Institute and is its medical research director.

The iPrex “Achilles heel,” he said, is non-adherence to the daily pill regimen and the other components of the PrEP HIV- prevention protocol.

Still, other challenges remain. “Pockets of populations at risk are difficult to reach,” said Robert Pomales, executive director of health policy and partnerships at the Latin American Health Institute.  Among Latinos, for example, 20 percent of people who show up at health clinics are uninsured, 50 percent are undocumented, and 70 percent live below the poverty line, he said. “These factors make it difficult for clients to access an intervention.”

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In making PrEP available, Pomales asked, “How do we prepare to implement without increasing [such] disparities?”

The cost of the medication is yet another concern.  “Who’s going to pay for the drugs?” asked Daffin.

The cost of one Truvada pill is $30. While physicians can write prescriptions for the antiviral medication, it’s not clear if third-party health insurance companies will pay for it. “That’s a gray zone,” Dr. Mayer said.

Still, “Who is going to pay for the public health [education] campaign?” asked Daffin, who also sees the potential for a right-wing backlash.

“Society is not all of a sudden going to embrace gay sex,” he said. Social conservatives might well say:  “’No we are not giving these gay people drugs so they can go out and have more sex.’”

Yet for all their apprehensions, panelists voiced hope the iPrex study would help save lives.

“I’ve been waiting for this news for two-and-a-half decades,” said Rhoda Johnson-Tuckett, manager of the Boston Public Health Commission’s education and outreach office. “I am very, very happy.”