A Pill a Day to Keep HIV Away?

Results are due soon from several recent clinical trials in which once-a-day anti-retroviral pills were used as a shield against infection. But even if the method works, can it do more harm than good?

What if there was a pill you could take once a day to keep from contracting HIV? That idea may not be as crazy as it sounds.

In countries around the world, scientific studies involving thousands of participants are looking at whether a person who does not have HIV can take a once-a-day, anti-retroviral pill to keep from getting infected with the virus during sexual encounters. A growing number of scientists, activists and government officials are anxiously awaiting the results of seven clinical trials. Below the radar, excitement is bubbling and experts from community organizations, the Centers for Disease Control and the White House are quietly discussing the best ways to roll out this so-called pre-exposure prophylaxis—known as PrEP—if it works.

“We are embarking on a national dialogue about a national HIV/AIDS strategy,” says Jeffrey Crowley, who was appointed head of the National Office of AIDS Policy earlier this year. He spoke to a gathering of several hundred attendees interested in PrEP at the National HIV Prevention Conference in Atlanta earlier this week.

“The president articulated three HIV/AIDS goals, and the first was reducing HIV incident. [PrEP] could be an important piece of that issue, but we need to maintain a balance of being excited about it while also being cautious.”

Even as interest grows, this experimental treatment has been saddled with controversy. Around the world, 33 million people live with HIV/AIDS, 1 million in this country, and globally, the majority of those infected don’t have access to lifesaving treatment. So is it fair to use desperately needed medication for prevention rather than to save lives? Also, if the drug is used incorrectly, the virus could become “resistant” to it. In other words, it could stop working.

“These are my two big anxieties,” says Dr. Connie Celum, a professor at the University of Washington and the principal researcher on a PrEP trial being conducted in Kenya and Uganda. “First, are we taking away resources from treatment if we use the medication for prevention? And the second is about resistance. Yes, there’s a lot of promise, but we have to be realistic that there’s still a lot of work to be done.”

Some study results are expected later this year, and if the medication does work, it could be a boon for HIV prevention. A new way to prevent the spread of HIV is desperately needed. During the Bush years, there was no wide-ranging, coordinated effort to prevent the spread of HIV in the U.S. Though the federal government vowed to cut the rate of new infections in half by 2005, the number has remained constant. Recent, adjusted estimates place new infections at 56,000 per year—actually an increase from previous numbers.

African Americans account for half of people living with HIV in the U.S.—510,000—and nearly half of new infections. One of the key ways to curtail the spread of HIV is through comprehensive sex education. But that effort has been hampered in the U.S.—and around the world—by American policies that have tied funding to the teaching of abstinence only, both in the U.S. and in nations around the world.

As far as PrEP, studies of monkeys have shown promise, and, in theory, the idea should work. Anti-retroviral drugs have prolonged the lives of people living with HIV/AIDS, and the medication is given to people—mainly health care workers and victims of sexual assault—who have been exposed to HIV to reduce the risk of transmission. And giving anti-HIV medication to pregnant women can prevent the passing of the virus from mother to child.

“This isn’t a radical idea,” says Dr. Celum. “There’s a rich history of using prophylaxis to prevent infection, including HIV infection.”

Still, at Sunday’s crowded session, enthusiasm about PrEP was tempered with caution. Experts warn that even if the studies prove positive, the medication will not be 100 percent effective—probably closer to 60 percent. In comparison, condoms are much more effective when used correctly and consistently according to many studies. This means PrEP would be a supplement, used with another form of protection, rather than a substitute.

Another issue: cost. Currently, anti-retroviral medication runs approximately $750-$1,000 per month for one person taking a daily dose, explains Kevin Farrell, executive director of the Center for HIV Identification, Prevention and Treatment Services in Los Angeles. Activists wonder if access to an expensive medication would be reserved only for the wealthy—creating a kind of prevention apartheid, a situation of haves and have-nots.

And even if it were affordable, would people be able to stick to a drug regimen for years and years? Would anyone even want to? Does it make sense, for example, for a woman who has an occasional sexual encounter to take an anti-AIDS pill every day? Experts say that PrEP is probably best for those at highest risk of contracting the virus. They point to what is called sero-discordant couples—which means a relationship in which one partner is HIV positive and the other isn’t. PrEP might be especially beneficial for a heterosexual discordant couple who wants to have a child.

Another idea, and one that is being studied more thoroughly in one of the experimental trials: Could PrEP be made more convenient? Would this prevention regimen be more attractive if the anti-retroviral medication could be used intermittently? What if you could take the medication before a sexual encounter—a kind of party pill? But activists worry about the political fallout of this scenario.

“When we think about PrEP, there’s a high risk for demagoguery about this issue,” says Crowley. “My nightmare is the cable-TV talk shows. I can hear in my head people saying. ‘This is just another way to let those irresponsible homosexuals have sex.’ We have to be conscious of the political risk.”

Craig Washington, prevention program manager of AID Atlanta, puts it more bluntly. “I think it should be countered as flawed and specious when arguments like ‘Ya’ll can’t give them PrEP because they’ll fly out the window and go have butt-naked sex all over the neighborhoods and schools’ are used to withhold PrEP. This propaganda will definitely be used around PrEP.”

As the debate continues, so does the research. Dorrington Poitier, a 37-year-old technical training manager, was part of a two-year PrEP study. The results will be out next year. “I was proud to tell people I was taking part in a study like this,” says Poitier. He took the pill once a day and says he suffered no side effects. He remains HIV negative.

“It was very important that I take away some of the stigma in the African-American community around clinical trials,” says Poitier, who lives in Atlanta. “And, ironically, one of my best friends was also going to participate in the study, but the day before we were supposed to start, he found out he was HIV positive. That gave me even more incentive to be involved.”

Dr. Kevin Fenton, the director, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, sums it up: “Nearly 30 years into this epidemic, we don’t have enough prevention technology to drive HIV incidence down. If we implement this strategy effectively, it would be an important expansion to the prevention toolkit.”

Linda Villarosa is a regular contributor to The Root.