In 2012, the Food and Drug Administration approved the pill Truvada to be used as pre-exposure prophylaxis, or PrEP. Study results released the previous year indicated that taking Truvada daily would lower risk of HIV-infection by over 90 percent, even as much as 99 percent when patients strictly adhered to the regimen.

But since that recommendation was issued, relatively few prescriptions for Truvada, manufactured by Foster City-California-based Gilead Sciences, have been issued as prevention. New York Times reported May 14 that, as of September, just more than 2,300 prescriptions for Truvada as prevention had been reported by Gilead.

The drug has furthermore been greeted with uncertainty and controversy, as some commentators and community members predicted widespread PrEP use would lead to sexual irresponsibility. Gilead also has put little money into marketing Truvada's prevention capabilities.

But this past week federal officials put more weight behind Truvada when the Centers for Disease Control and Prevention ( CDC ) May 14 issued a recommendations to physicians that it be used to try to stem new HIV infections, which still number about 50,000 a year. The CDC also delineated which patients would most benefit from Truvada.

In a May 18 statement, Jim Pickett, director of prevention advocacy and gay men's health at AIDS Foundation of Chicago, said of the guidelines, "While they are geared towards clinicians, we think they will be extraordinarily helpful in our education and advocacy efforts. They will be especially important for medical providers who are not familiar with HIV or HIV meds and now have increasing numbers of HIV-negative patients approaching them about PrEP."

Service providers and policy advocates maintain that Truvada is not a license for LGBT individuals to carry on with behaviors they know to be unsafe, as some fear. Instead, they say it fits into a changing landscape of HIV prevention, one that is indeed more complex but, at that same time, may just offer protection for populations that still are becoming infected every year.

"This is one piece of the puzzle," said Kristin Keglovitz Baker, associate medical director at Howard Brown Health Center. "It's not the answer. But it's one piece, that if we get it in the right hands, in certain communities and groups, it can have a pretty large impact."

CDC guidelines

In the CDC's release of the PrEP guidelines, Jonathan Mermin, M.D., director of CDC's National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, said, "While a vaccine or cure may one day end the HIV epidemic, PrEP is a powerful tool that has the potential to alter the course of the U.S. HIV epidemic today. These guidelines represent an important step toward fully realizing the promise of PrEP. We should add to this momentum, working to ensure that PrEP is used by the right people, in the right way, in the right circumstances."

By May 16, 82 health-advocacy organizations signed onto a statement in support of the new guidelines. Among the local organizations taking part were AIDS Foundation of Chicago, HBHC and Test Positive Aware Network. According to Pickett, the organizers planned to allow additional signatories even after the initial posting.

The statement took aim at Michael Weinstein, president of Los Angeles-based AIDS Healthcare Foundation, the most vocal of Truvada's critics, who earlier in the spring called the medication a "party drug."

"Weinstein continues to make assertions that are not grounded in scientific evidence," said the statement. "We reject statements from all quarters that add to the deep stigma attached to HIV and that erect barriers between people and what they can use to support their health."

Ready for change?

Weinstein's comments nevertheless point to how controversy about Truvada is largely not because of questions about the drug's safety or efficacy. Rather it stems from fear that the community might abandon its longtime advocacy for condoms as the primary means of protection.

"It upends decades of messaging that says, 'just wear a condom every time,'" said Pickett, who runs the blog "My PrEP Experience" for AFC. "In the context of people dying left and right, which people my age and older remember very well, wearing a condom to save yourself and our community made sense every timeit's an incredible game-changer."

Condom-focused messaging, he noted, has not stemmed new infections. "We've been relying on condoms as the main prevention tool for the past 30 years. Condoms clearly have not been enough to end the epidemic. … Condom use has been low. Lack of condoms are why we have 2 million new infections on the planet every year, and 50,000 infections in the United States."

PrEP also has the capability of shifting dynamics in responsibility as well, Pickett said. "A male or female who is receptive has complete control over this intervention. There is no need for negotiation. The other tools that we havecondoms, or just not fuckingrequire negotiation, and we know that men and women aren't always able to be empowered, and have the sex that they want to have, with the people they want to have it with."

Damon Jacobs, a New York City-based licensed marriage and family therapist who takes Truvada and has been one of its most outspoken advocates, added, "Change is good, but people don't like change, even when it's good change. … But when it comes to saving our lives in our community, I'm disappointed by what I perceive to be such a continuous brick wall, especially with the science and the information that has become available."

In 2013, Jacobs started a Facebook group, "PrEP Facts: Rethinking HIV," to talk about its benefits. "There was no Facebook group in the world where anyone in the world could go and just learn the facts about PrEPlearn the facts, see the data, ask the questions and get responses," he said. The group now has 2400 members.

Throughout his thirties, Jacobs was diligent about using condoms. "I came of age in the late 1980s and early 1990s, when knowing people with AIDS meant losing people with AIDS," he said. But after a significant relationship dissipated, and he got involved in dating and cruising again, he found that many men were weary of condoms, and he gradually became weary of using them as well.

"I began to think, 'If I became HIV-positive, it wouldn't take me out,'" Jacobs added. "My perception shifted from 'if I become infected' to 'when I became infected.' I knew that was the kind of thinking that ultimately did lead to an infection."

Shortly after the results from the iPrEX trials were released, and, at the time, suggested that PrEP reduced the likelihood of infection by 92 percent, Jacobs asked his doctor to be put on the medication. He has been taking it ever since.

"The main thing about it for me is, just taking a pill every day," he said.

Taking Truvada

Taking even one pill every day, however, can be a tall order for many patients, for myriad reasons.

Often, the large expense is foremost among them. A yearly regimen of Truvada costs about $13,000, and requires a commitment to regular HIV and STD screenings as well as follow up visits. Those will often be covered by insurance and Medicaid, and Gilead has offered assistance to some users to help cover co-pays and deductibles, but for many patients, even what's left over might be insurmountable costs.

"Insurance and paymentthat's the concern I hear the most," said Keven Cates, manager of emerging HIV prevention interventions at HBHC. "That's obviously going to be a huge barrier to accessing care, so working with patients to address and manage that has been a huge challenge."

Among the reported side effects of Truvada taken for prevention have been headache, stomach pain and weight loss, according to Gilead.

Keglovitz Baker said patients have sometimes declined Truvada because they are hesitant about a relatively new drug, know they will have difficulty adhering to the daily regimen, or simply don't see themselves as being at serious risk for infection.

Other patients, she added, are afraid of stigmathey fear that, should friends or family find out they're taking Truvada, they'll think they're HIV-positive.

That was the reaction that Curtis E. Lewis, a 22-year-old student who lives in Northwest Indiana, got from some of his friends when they found out he has been using Truvada. "I had to tell them that wasn't why I was taking it," he added.

Lewis has been a participant in Project PrEPare program at the Ruth Rothstein Center at John Stroger Hospital, a research project studying PrEP as part of a sexual health regimen for young men and trans girls. He said that he became aware of Truvada after seeing statistics that showed he had "a triple risk" of becoming infected with HIV: "I'm African American, I'm male and I'm gay."

Lewis has been on PrEP for about 11 months. He said the only side effect he ever experienced was some nausea that "was only temporary and very, very mild."

Since he started participating in the study, Lewis has been extremely conscientious about his sexual behavior, not only adhering to his medicine, but thinking through his choices and practices more. PrEPare's programming, he noted, "emphasized their whole goal was to make us cognizant about not putting ourselves at risk."

The possibility of patients who are more thoughtful about their sexual behavior has been a benefit from the advent of PrEP, Keglovitz Baker said. Some patients who'd never heard of PrEP had declined prescriptions for various reasons, but suggested their friends look into it.

"One of the most valuable tools is the conversation emphasizing that [taking this pill] doesn't need to be forever," she added. "I think the 'forever' is what worries many people. We say, 'Maybe this is something for you right now, and we're going to check in regularly to make sure.'"

SIDEBAR

CDC issues

PrEP guidelines

The Centers for Disease Control and Prevention on May 14 issued guidelines suggesting that healthcare providers prescribe pre-exposure prophylaxis, or PrEP, for persons who are at high risk for HIV.

According to a statement, the new guidelines offer providers information on identifying who might be eligible for PrEP, providing monitoring and support as patients take the medication, and counseling patients on drug adherence and risk reduction strategies.

The CDC recommends PrEP for the following individuals:

Anyone who is in an ongoing sexual relationship with an HIV-infected partner;

A gay or bisexual man who has had sex without a condom or has been diagnosed with a sexually transmitted infection within the past six months, and is not in a mutually monogamous relationship with a partner who recently tested HIV-negative;

A heterosexual man or woman who does not always use condoms when having sex with partners known to be at risk for HIV, and is not in a mutually-monogamous relationship with a partner who recently tested HIV-negative; and

Anyone who has, within the past six months, injected illicit drugs and shared equipment or been in a treatment program for injection drug use.

See www.cdc.gov/hiv/prevention/research/prep/index.html .