The United States finds itself in a strange position this World AIDS Day. It is the only country where a once-daily pill to prevent HIV, a combination of emtricitabine and tenofovir disoproxil fumarate (Truvada), has been endorsed by the government for that use and is widely available. Yet just last week, the U.S. Centers for Disease Control and Prevention (CDC) reported that only 3 in 10 Americans with HIV have the virus under control.
While the rest of the world studies the merits of Truvada for PrEP, or pre-exposure prophylaxis, here in the United States uptake of the medication has been slow. In some urban, gay communities, men have taken to shaming other men who take it, calling them “whores.”
The groups most at risk for contracting HIV in America are African-American men who have sex with men and African-American women. HIV disproportionately impacts both groups. Although blacks are a racial minority, black men who have sex with men only trailed white men who have sex with men by 600 infections in 2010, according to the CDC. Almost half of new infections in this group — totaling nearly 5,000 new cases — were among people ages 13 to 24.
Dr. Chris Beyrer, president of the International AIDS Society, told Healthline that the racial disparity in new infections persists despite the fact that black men have fewer sexual partners, are less likely to mix drugs and sex, have lower rates of substance abuse, and are more likely to use condoms than their peers.
“There’s not enough sophistication in thinking about what sexual risk really is about in an epidemic context,” Beyrer said. “Most of what you will see negative about PrEP are people thinking about individual level behaviors, such as, ‘What’s wrong with these young gay men having unsafe sex?’ All these things in their minds as to why HIV rates are higher are not in fact supported by the data.”
The problem, Beyrer said, is that the virus is so common in some communities that the transmission risk is very high every time someone has a sexual encounter. He said that’s why prevention methods like PrEP, in addition to condoms, are so badly needed.
“There is no controversy in the scientific community,” Beyrer said. “Everybody understands that we now have established efficacy. Now it’s more about how do we implement this, how do we use it, how do we get it out there. That’s the challenge.” Truvada is already commonly prescribed to treat existing HIV infections.
Truvada Does Not Lead to More Risky Sex
Much of the opposition to PrEP has come from Michael Weinstein, head of the Los Angeles-based AIDS Healthcare Foundation.
Study after study has shown that PrEP needs to be taken daily, as directed, in order to work. Some studies have shown that when taken as directed PrEP can reduce infection risk by as much as 100 percent. But other studies, such as iPrEx, only showed it to be effective at preventing HIV infection 44 percent of the time. Larger doses of the drug found in the blood were linked to a greater prophylactic effect.
Weinstein has argued that men who have sex with men do not take the pill as directed. He has also speculated that PrEP will cause so many people to have sex without condoms that it will cancel out any positive impact on disease prevention.
But in Europe, two clinical trials are underway that already appear to disprove those ideas. The first, called IPERGAY, includes six study sites in France and one in Canada. The trial closed its randomized phase in October after showing that PrEP even works when taken “on demand.”
In the study, participants took two Truvada pills 24 hours before sex and one pill each day for the two days following sex. The study was conducted by French national AIDS research institute ANRS. Everyone in the study, including those initially given a placebo, also received repeated HIV tests, condoms and lubricant, and treatment for other sexually transmitted diseases. About 400 people were enrolled in the trial when the randomized phase ended.
In England, the PROUD study of PrEP among 545 gay men in London, Brighton, Manchester, Birmingham, Sheffield, and York was designed to test whether those on PrEP stop using other prevention measures, such as condoms. A U.S. trial has already shown that men who have sex with men are not more likely to engage in riskier sexual activity while taking PrEP than they were before they started taking the drug.
In October, the PROUD researchers decided to offer Truvada early to those who had been placed in the placebo arm of the trial. The drug proved effective beyond the threshold required to keep the study going; the drug was so effective that it would have been unethical not to provide it for all participants.
Why Isn’t HIV in the U.S. Under Better Control?
Even with PrEP, the state of the HIV epidemic in the United States is bleak. Although 86 percent of people with HIV in the United States have been diagnosed, only 40 percent are in care. Even more shocking is that less than one-third are virally suppressed. When someone with HIV has an undetectable viral load, their chances of passing along the disease are drastically reduced.
In an interview with Healthline, Dr. Rafael Mazin of the World Health Organization said stigma surrounding homosexuality may be preventing some people from accessing care. He said that’s another reason why it’s so important that PrEP not be labeled an intervention primarily for gay men.
“Being out sometimes constitutes a protective factor for that person,” Mazin said. “That person is empowered to take control of his sexuality and his life so he can make more informed decisions and seek self-care. A person who is closeted perhaps is protected against stigma, yes, but at the same time it may be a factor of larger exposure of risk.”
He also said that American prudishness has quashed healthy, open discussions about sex.
“We have failed in promoting practices that are positive in terms of sexuality,” Mazin said. “We live in this dichotomy where we think things that are healthy are tasteless … People have sex because it feels good, it’s a pleasant experience, and we have forgotten that in our approach to prevention.”
Mazin said he sees gay communities pulling together, especially in places like South America, to demand access to PrEP and to HIV treatment in general.
China May Be Ready for the PrEP Revolution
In the United States, Truvada costs about $1,200 per month. Outside of G-8 countries, the medication is less expensive.
However, some countries do not have approval processes in place for using Truvada as a prevention tool. It is already being prescribed off-label as a sort of boutique treatment in some South American countries and in South Africa.
The British government has begun the process of reviewing PrEP for inclusion in the country’s national health plan. A decision could take 10 months or more, Beyrer said. If the U.K. approves Truvada as PrEP, it will become the first country in the world where anyone can get the drug for free, Beyrer pointed out.
PrEP is badly needed in nations where HIV has surged, such as China and Russia, Beyrer said. In addition to very high infection rates among men who have sex with men, the commercial sex industry in China has exploded.
He noted that China could easily absorb the cost of PrEP and use it to beat back the HIV epidemic before it gets out of control. Research has already shown that female sex workers in China are open to PrEP.
“China embraced needle exchange, took methadone to scale, and never have been squeamish about condoms,” Beyrer said.
He hailed Wu Zunyou, who heads the Chinese government’s HIV program, as a “dynamic leader” who could make a PrEP rollout happen.
With activists around the globe pushing for greater awareness of HIV and its treatments, word will only spread.
HIV-positive activists Josh Robbins, Maria Mejia, and Alex Garner discussed their roles as advocates during a Healthline-sponsored Google+ Hangout today – view it here. Tomorrow, Healthline will honor influencers in HIV activism, treatment, and prevention during a multiplatform social media awards celebration.