By Benjamin Ryan
Personal choices and public health can find common ground in the pre-exposure prophylaxis?
"The PrEP is not a silver bullet."
If you talk to a long list of researchers and advocates of HIV on the controversial pill to prevent HIV Truvada, you will hear a handful of them spontaneously literally uttering this phrase.
Provide drugs to HIV-negative people is not intended as a panacea that will put aside all other methods of prevention, an expert says. And only time will tell if the pre-exposure prophylaxis (PrEP, in English) will really help inhibit the HIV epidemic in the US, particularly among gay men.
Succeed at the public health level depends on whether Truvada ends in medicine cabinets of a critical mass of people at high risk of contracting HIV, and if they finish adhering well to the daily regimen.
it's been over two years since Truvada, a pill that include antiretroviral tenofovir and emtricitabine, common in HIV treatment was okay for use as a preventive virus. Rivers of ink have been spilled in recent months 12 on the apparent warm capture of PrEP. But recent evidence suggests that PrEP is finally starting to become popular among gay men and a flourishing revolution may be upon us.
What is already abundantly clear is that providing drugs to HIV-negative people with a drug that can have as much as 100 percent efficacy in preventing HIV can be a powerful transformation at the individual level. Dozens (almost all of them gay men) who shared their stories for this article under be taking PrEP, many described a personal and sexual renaissance that caused a change in life like for the first time, they found what is sex without fear.
"The PrEP made me feel good about being gay," says Evan (one of which preferred to use only his first name), a sex professional full-time 22 years who lives in Washington, DC "Growing being gay is still very difficult. The first thing we learn about our sexuality is that some people do not like us, and that we probably contrairemos HIV. Taking PrEP allowed me to enter my sexuality and feel powerful. "
The PrEP, he adds, "led me to accept all gay men as potential friends, sex partners or partners of independent life of their HIV status."
Quentin Ergane, 38, who works as a caregiver in a home for adults with mental illness in Seattle, it may be the perfect candidate for PrEP. Despite being very familiar with the alarmingly high rates of HIV among their African-American male friends who have sex with men (MSM, in English); despite having seen his father, his favorite cousin and best friend all die from causes related to AIDS; despite a paralyzing fear of becoming HIV-positive; and despite knowing that condoms could help protect him, he uses just indiscriminately since their domestic partnership ended in 2009.
"Leaving a period of 10 years without using condoms and now that you are single have to go back to use them, I just did not have the feeling that I was approaching anyone," Ergane says, adding that the decrease in pleasure during sex is another factor, if less important, contributing to their contempt for the latex which is a common refrain among gay men.
"Not always occurs to me in the heat put on a condom," he says. "Also, this attitude is very unnatural. People really disrupt your privacy, your connection, your passion, your everything, and then put a condom and expect things to go back to the same level? "
After starting with PrEP earlier this year, "I finally felt free," he says. "For the first time since I was a kid, I know that my sexuality is not the cause of my death."
When gay men describe not use condoms despite intentions to do so, they will generally use language suggesting it was an accident largely beyond their control ". It was a slip" Some might even describe as an extracorporeal mental state "I realized that my compatibility with the use of condoms had changed."
Critics may argue that this amounts to a juggler parental trick to divert justifiable blame for failing to develop a rational process. However, as John Guigayoma, a boy of 28 years of San Francisco, can attest, sex has a powerful ability to go over such reasoning. As Ergane, Guigayoma found that sexual behavior was going against HIV prevention practices he was teaching - and which, in his case, he was also teaching others. Despite working in a health education provider, he used condoms sporadically as he struggled with the shame and guilt to lead a sex life that was making it incredibly unhappy, confused and lost.
"I felt I could not trust myself and there was something wrong with me," says Guigayoma. "That only added to all my own shame: I'm not doing what I should be doing."
Sarit Golub, MD, PhD, a psychologist at Hunter College in New York City who is studying the use of Truvada for gay men, says the biggest benefit of PrEP is that it "separates the act of HIV prevention act of the meeting potential ", allowing the rational mind to run the show.
"I can not trust myself to use condoms," Ergane says, "but I can trust myself to take this pill every day."
"The PrEP helped me take control," says Guigayoma, which started with Truvada a year ago. Reducing your risk of HIV with drugs gave him the chance to take stock of your life and take better care of yourself holistically. Part of this process was to forgive to prefer sex without latex. "Perhaps there is nothing wrong with me," he explained. "Maybe this is just the way I want to live my sex life." Such sexual life includes an increased risk of sexually transmitted infections compared to those who are faithful to the condom. Activists of PrEP believe that those taking Truvada following the advice for Disease Control Center (CDC) and doing tests for STI at least twice a year will lead to earlier diagnosis and subsequent treatment will compensate for the absence of latex. However, these realistic attitudes toward condoms are causing grave concern and even anger among some in the gay community.
"It is not surprising that people think I'm irresponsible," says Guigayoma. "But it is more responsible to recognize the reality of our sexual life and provide people with options that they can work with than dictate a particular pre-intervention tactics."
Okay to treat HIV since 2004, Truvada has a long history of supporting the notion that monitoring is generally safe and well tolerated, and that doctors can easily monitor any development of renal dysfunction or reduction in bone density - the two major side effects of long-term use. The issue of drug resistance can be uncertain, however.
Research do iPrEx study showed that no one who contracted HIV during the study developed drug resistance. But most of the participants were tested for HIV every month, as anyone who keep the minimum requirements for the CDC PrEP will receive only quarterly HIV tests - giving the virus more time to mutate itself.
Another concern is that PrEP can lead gay men to increase their sexual risk-taking, a phenomenon known as risk compensation. The argument is usually framed as an either / or between Truvada and condoms - take the pill, release the latex - although in reality overlap in use seems common. Such rigid and dualistic thought fit with the popular speech that "condoms failed" with gay men - a defeatist claim that failure to recognize that without the latex HIV rates are likely to be catastrophically worse.
Other elements typically overlooked in this debate are the many behavioral practices that gay men also use to reduce the risk of HIV, and which can factor in risk compensation, such as: "seroposicionamento", in which the HIV-positive partner is on position passive or below; "Serotriagem" in which men try to have sex with the same serostatus partners; favoring oral sex instead of anal sex; or by the partner who is over (active partner) remove the member before ejaculation.
None of PrEP studies showed no risk compensation of evidence. In fact, both the placebo phase and in the open-label extension of the iPrEx volunteers, all of whom received risk reduction counseling, tended to have a less risky behavior. But as the gay world begins to discover PrEP, a different story can begin to emerge.
In an interview in the winter, Robert M. Grant, chief researcher, doctor and Master of Public Health, university professor at the University of California, San Francisco, was firm in saying that Truvada does not lead to risk compensation. But when summer came he recognized that he was beginning to hear anecdotes about otherwise.
Those who were looking for that story did not have to go far to find the boy's unofficial poster PrEP: Damon Jacobs, a therapist in Manhattan who won the title in recounting their experiences with Truvada in dozens of media outlets. Uncontrolled in their enthusiasm for this form of HIV prevention, he has not had remorse about having changed the inconsistent condom use for a life almost completely free of latex since it started PrEP.
This has not proved the shortage of people sharing their own experiences with PrEP for this article who reported engaging in varying degrees and different types of risk compensation. Some took Truvada with the clear purpose of opening condoms. Quentin Ergane, for example, is now enjoying outdone most often during sex. However, both are having fewer sexual partners lately.
Time will tell how common the risk compensation will become. A crucial question is whether those who took greater risks also take their medicine. A compensation combination of widespread risks and irregular adherence to PrEP could push HIV rates in the wrong direction. And if the risk compensation among people taking Truvada influence similar behavior in others, HIV rates could increase among non-users of PrEP.
"The PrEP works if you take", according to researcher Robert Grant.
In fact, no one in the iPrEx study or in your open-contracted HIV while taking Truvada four or more days a week. But even if Truvada offer a type of protection "bulletproof" we do not know if it will reduce the 50, 000 new cases of HIV hell-bent on consist in the United States each year.
The key to the success of PrEP spread tailored, according to Anthony Fauci, MD, director of the National Institute of Infectious and Allergic Diseases, is that the field of public health stop "to cheat saying HIV is a 'equal opportunity employer'. "
Approximately two-thirds of HIV infections in the United States are transmitted through gay sex. In fact, the group of men who have sex with men (MSM, in English) is the only category of risk that recently did not change the scenario: while heterosexuals and injection drug users have seen rates fall in recent years, the rates among gay and bisexual men only increased, especially among young people.
This does not mean that all gay men should start taking a blue pill every day. There is still a big risk spectrum within the community. Take into account the estimate maybe less than 2,5 percent of sexual encounters between men involves a partner ejaculate inside the rectum on the other - the act is by far the most likely to transmit the virus.
Arguably the most effective way to increase the power of PrEP is to aim in HIV-negative men who are not using condoms consistently, and especially those that lie under where the partner ejaculates inside them. (This demographic priority would exclude men in a monogamous relationship or with other HIV-negative man or with an HIV-positive man who has suppressed the virus and is in regular care with HIV.)
"My focus is not to help and concerned about gaining access to PrEP," said Jim Pickett, advocacy director of prevention in the Chicago AIDS Foundation.
With this priority in mind, resultados July the open phase of the iPrEx are encouraging: those most at risk of contracting the virus were both more likely to follow PrEP and were more likely to join. However, the overall adherence was dramatically lower among younger participants.
Hopefully, the benefits of PrEP will extend to individuals taking Truvada. According to Demetre Daskalakis, MD, Master in Public Health, new health care commissioner of Prevention and Control of AIDS Center at Office of the City of New York, "PrEP, if given the correct population at risk, not really only HIV prevention but is specifically acute HIV prevention. "
In fact, during the first six to twelve weeks of infection - a known period as acute phase - viral loads shoot, which makes it much easier transmission of HIV. During this phase, one may feel perfectly fine and continue to engage in the kind of high-risk sex as exposed to the virus in the first place, thus helping the virus way through its "network of sexual contacts." So ultimately PrEP can operate as a cutter wire breaking current.
How to take the PrEP to a critical mass, much has been made of estimate manufacturer of Truvada, Gilead Sciences, that only around 2,300 people are taking PrEP. But this data have many limitations that are often neglected: it only reflects data September 2013; he was shot down only 55 percent of US pharmacies; and it excludes the thousands who are taking PrEP through studies.
Many health care providers who were contacted for this article reported that since the media buzz began in 2013, they have seen a swing 2, 5 20 or even times in prescriptions.
"We have had a tremendous increase in interest," says C. Bradley Hare, MD, director of services for HIV prevention and care at Kaiser Permanente Medical Center in San Francisco, where 250 patients are on PrEP compared 40 years ago. "It has grown and maintained in the last year."
Because candidates for PrEP choose not take it? For starters, there is the possibility of barriers to safe (though in PrEP are generally covered), concerns about side effects (founded or unfounded), a lack of desire to take medicine every day, and fear of being stigmatized as a person promiscuous doing unprotected sex. But the biggest blockade for gay men could be their own lack of information that PrEP could benefit them personally.
Daskalakis recently published a study with gay men meeting points in the city of New York, which found that the 80 percent who were candidates for Truvada, over three-quarters did not think they ran sufficient risk to use PrEP.
But perhaps the strongest case for PrEP is not necessarily done the context of anonymous meetings. Research critically neglected suggest that gays are many more likely to use condoms in a chance encounter and that between one third and only above two-thirds transmissions between men occurs with their primary partners. In other words, a lot of guys are contracting HIV valentines, not sexual encounters.
The transmission window seems to be generally open when there is a need to show confidence and experience intimacy in a new relationship leaves the side of condom - before the men had been tested for HIV and discussed monogamy.
Unfortunately, one unpublished study led by professor of psychology and public health at New York University, Perry Halkitis, PhD, Master of Public Health, found that young MSM in romantic relationships were less likely to see the use in taking PrEP despite not using condoms.
On the other side of the coin are recent findings of a published study recently co-authored by Kristi Gamarel, PhD at Brown University and Sarit Golub of Hunter College who studied MSM adult men in the City of New York - a set of older men with me'dia age of 32 years - that estavm in stable relationships in which the two were HIV negative. When men cited privacy as the reason they had sex without a condom with their partners, the likelihood that they express interest in PrEP rose to 55 percent. Those who reported having sex without a condom with someone other than your partner were also more likely to say they would use PrEP.
And must be taken into consideration that HIV affects black MSM more disproportionately: They comprise about one-fifth of all infections annually in the United States. Young black MSM are at risk particularly higher. An alarming 12 percent young black MSM in Atlanta contract the virus each year.
The key to engage this demographic population, said Phil Wilson, founder and CEO of the AIDS Institute in Negros, is to use targeted efforts for equal.
"Someone comes up with a tennis or a rap song or a T-shirt and is popular in the Bronx," says Wilson. "Four days later is the posters in Watts and Compton. So there are mechanisms in vogue that are used every single day to reach young black men. "
Unfortunately, trying to get Truvada usually mean battle with primary care physicians who refuse to prescribe a recipe with which they are unfamiliar with which they believe will lead to risk compensation, and which they erroneously consider highly complex to monitor security.
Part of the problem stems from Gilead decision not to announce the Truvada as PrEP. Instead, the company makes modest donations to community groups, universities, and public health agencies which take some slack to educate the public and doctors. This stands as a stark contrast to dissemination of birth control in 60 years, when GD Searle & Company sent an army of "Minute Men" clinical doctors to promote contraceptive Enovid.
"In some cases, because the gay sex be so stigmatized, it is leading doctors to make inappropriate judgments," says Jose Zuniga, PhD, Master of Public Health and president of the International Association for AIDS Care Providers.
Until recently, the clinic Kaiser Permanente in San Diego called for those looking for PrEP sign a form that warned, "At any time, the Contractor may consider stopping the PrEP if there is continuing evidence of risky sex or is positive for DST's." No matter that both have sex without a condom as sexually transmitted diseases on the list of what makes someone a candidate for PrEP first.
Lisa, a woman of 34 years living in a big city on the East Coast that are wanting to conceive of their HIV-positive boyfriend first asked her gynecologist about PrEP.
"So I told her that my partner was HIV positive, the look that woman gave me was disgusted size," Lisa recalls. "She talked to me like I was an irresponsible person and the scum of the earth."
As is apparently highly common, medical Lisa said she consulted a doctor of infectious diseases, who then told her that he did not seek HIV-negative people and that she was looking for his first doctor, subjecting her to months of back and forth as she sought a doctor who sympathized with PrEP. "It was so humiliating," Lisa said.
Daskalakis, in turn, fears that experiences like Lisa mean that medical specialists will become the large group who prescribe Truvada and that ordinary doctors will do tests to select potential candidates for PrEP.
Promising efficacy data aside, worrying findings emerged in open phase iPrEx: participants took four or more tablets per week just 33 percent of the time and joined daily 12 percent of the time. Fortunately, it seems the MSM taking Truvada can lose up to TRE doses a week and probably remain fully protected. It is estimated that even taking the pill only twice a week reduces the risk of HIV 76 percent.
In this perspective, there is hope that the first findings of an ongoing study of PrEP use in the real world among MSM and transgender women in San Francisco, Washington, DC, and Miami. Within one month of the study, the participants were adhering to four or more times per week at rates 92 percent 90 percent and 73 percent their respective cities. The daily adherence, however, was only a respective 66 percent, 45 percent and 19 percent. And if this study follow the trends of the open phase of the iPrEx, adherence rates may fall over time.
Michael Weinstein, president of AIDS Healthcare Foundation (AHF), media adviser in opposition citations to PrEP, insists, "There is no evidence in the scientific literature that PrEP is a successful approach to public health." He points to the fact that poor adherence has pulled down the effectiveness at the population level, and then it shows the average data risk reduction as failures. The media campaign "Facts Prep" opposes PrEP as an intervention in public health for these reasons.
But another way to look at a median efficiency of 44 percent is to say that if you give PrEP to a good number of gay men at high risk, HIV rates decrease.
These data are also close to the reduction about 60 percent in woman's risk of transmission to man that male circumcision confers. Research is beginning to show that the massive campaign to circumcise African men are not only connected to reduce HIV among circumcised men, but also among women. Which brings us back to the point of Daskalakis that PrEP can prevent people from effective way to transmit HIV to others, to keep people who are having sex at high risk of contracting HIV in the first place.
The Weinstein final argument is that the dominant prevention approach should focus on promoting the use of condoms along with the treatment and diagnosis of HIV-positive people, and that PrEP should be reserved for "special cases."
In fact, Recent research suggest that having an undetectable viral load makes it virtually impossible for people living with HIV transmitting HIV. But poor adherence to antiretroviral also pulls down the effectiveness of population-level "treatment as prevention" (TASP in English): A estimated 75 percent of Americans treated for HIV is actually a fully suppressed virus.
Another way to look at this is that only 40 percent of all Americans diagnosed with HIV are in treatment and only 30 percent are virally suppressed. Recognized, give medications to individuals with HIV is a much more objectified way to contain the transmissions to give Truvada to HIV-negative people in the hope of preventing any HIV that they can find. But all things considered, PrEP is still being kept in a much higher standard: the grip is always factored in the debate about his worthiness as that element is largely ignored when discussing the TASP. Moreover, only a minority of MSM apparently consistently adheres to condoms.
"There is one person I know who thinks that PrEP is perfect or that compliance is a critical issue," says Mitchell Warren, executive director of the group support global HIV prevention (HVAC, in English), which added that adherence is critical to all forms of risk reduction of HIV.
"If there was a perfect intervention, we would prefer," he says. "But in 2014 the best approach is a Patchwork approaches good, but not perfect. Why would we want to give up any of them does not make sense to me. "
By the Numbers
Considering the effectiveness Prep
In the experiment iPrEx with MSM and transgender women who were the first to demonstrate the effectiveness of Prep 2010, the group given Truvada had a reduction of infection by HIV 44 percent rate compared with the placebo group.
Only 51 percent of participants assigned to take Truvada in iPrEx detected the drug in their systems, but they had a reduction of HIV 92 percent rate compared with those with no detectable drug. The American Center for Disease Control and Prevention (CDC) incorrectly the consistent use of Truvada reduced the risk of HIV in "to 92 percent." The data is not the upper limit of risk reduction of Truvada with perfect grip; it represents a risk reduction of average among those taking absolutely no drug.
A specific modeling (Called regression analysis) based on the data iPrEx designed to take Truvada seven days a week reduces the risk of HIV 99 percent. The real data, researchers estimate could be between 96 percent and greater than 99 percent.
Na placebo free phase iPrEx researchers analyzed the data with what is called stratified analysis, which allowed the evaluation of them reflect more directly the fact that, as early in the iPrEx, nobody contracted HIV while taking Truvada four or more days a week: they designed to adhere to the regime that offers favorably 100 percent efficacy. A drawback of using this different way of statistical analysis was a range of broader estimates: they could only speculate with confidence that the efficacy was nothing less than 86 percent.