HIV prevention drug Truvada focus of controversy
The drug Truvada is increasingly being used as PrEP, to prevent HIV transmission. But some gay activists worry there will be negative fallout.
By: Paul Hunter Feature reporter, Published on Sun Nov 23 2014
Len Tooley remembers anxiety-filled days as his next HIV test approached, time spent racking his brain, trying to recall if he'd done
something against his better judgment that could have exposed him to infection.
Tooley, 33, is a sexually active gay guy living in downtown Toronto. As someone who works as an HIV educator, tester and counsellor
and did a master's degree in public health focused on gay men and HIV, he understood the importance of using a condom during sex.
He just wasn't, he readily admits, perfect at it.
"We all want to mitigate risks in our lives," he says. "But it's not as easy as it looks on paper."
So two years ago, he convinced his doctor, after a thorough assessment, to provide him with Truvada, a drug already being used to treat
people who are HIV-positive and one shown to be highly effective at preventing the transmission of HIV.
Some consider it a revolution in protection against HIV, but it has also led to some polarizing debates in the world of AIDS activism.
Last week, the AIDS Healthcare Foundation (AHF), based in Los Angeles, rolled out print ads in seven U.S. markets challenging the
Centers for Disease Control (CDC) on its recommendation of the drug.
Known as PrEP, which stands for pre-exposure prophylaxis, Truvada stops infection if it is taken properly before exposure. James Wilton,
co-ordinator of biomedical science of HIV prevention at CATIE, a leading Canadian source for HIV information, says there is "a lot of
evidence . . . that PrEP taken consistently and correctly can reduce risk of transmission by over 90 per cent."
Truvada, taken as a daily pill, continues to be studied and will be the focus of a year-long clinical trial just getting underway at
Toronto's St. Michael's Hospital.
"The drug prevents HIV from being able to replicate in your body," explains Tooley, who remains HIV-negative. "So, if you're exposed
to HIV and the drug is in your system, the virus can't replicate enough to get a foothold in your immune system."
Truvada has been approved by Health Canada as a treatment for HIV but not as PrEP to prevent its transmission. It is not illegal for
doctors to provide it for that use by writing what is called an off-label prescription. It costs between $800 and $900 a month, or
about $30 a pill.
Tooley considers himself fortunate he has a drug plan that pays for Truvada and a gay family physician accustomed to dealing with HIV
issues. He must still have regular testing for HIV because if he did become positive, the virus could quickly adapt and become
resistant to the drugs he is taking.
"PrEP is one part of what I really consider a huge change in the way that we look at, understand and address HIV," says Tooley, the
co-ordinator of community health-promotion programming at CATIE.
"Nobody is saying we should give up condoms and PrEP is the only option. But what we are saying is that PrEP is effective and it is an
option and it is important to acknowledge that."
Awareness of PrEP has been growing, especially since it was approved in 2012 in the United States and endorsed by both the CDC and the
World Healthy Organization. The CDC recommended PrEP for as many as 500,000 high-risk American men who have sex with men. Information
provided by Gilead Sciences, Truvada's manufacturer, shows that 3,253 unique individuals began taking the drug as PrEP in the U.S.
between Jan. 1, 2012, and March 31, 2014. That number comes from a survey of 55 per cent of the nation's retail pharmacies.
No numbers are available in Canada, but Dr. Darrell Tan, who will lead the St. Mike's demonstration project, says the use of PrEP in
Toronto "is not widespread but it is definitely increasing."
Gilead has not made an application to Health Canada for approval of Truvada as PrEP.
On Halloween, the AIDS Committee of Toronto (ACT) rolled out an education campaign about PrEP, visiting several clubs in Toronto's Gay
Village around Church and Wellesley Sts. to promote conversations about what it calls "an important new prevention tool." It also
posted an extensive information package on its website
"It's very much the hot topic in the HIV-prevention community," says Chris Thomas, an ACT spokesperson involved in community education.
"I don't think we so much encourage it as we make known what the reality of using it is. I think we see it as a strategy that you can
use to reduce your risk of contracting HIV. It's not something where we are going to put all of our eggs in the basket. We continue
to encourage the use of condoms and other types of safe sex practices."
While some herald PrEP as a huge breakthrough in the fight against the spread of HIV, there are dissenting voices, the loudest of which
likely belongs to Michael Weinstein, president of L.A.'s AIDS Healthcare Foundation.
Weinstein has dismissed Truvada as a "party drug" and called it a "public health disaster in the making." Then came last week's ads
in the form of an open letter to the CDC titled: "What If You're Wrong About PrEP?"
In the letter, the AHF challenged the CDC's recommendations as a public health strategy because of "consistently bad adherence by
study subjects."
Not only does the AHF fear the pills will not be taken properly, but it is also concerned that PrEP will create a culture in which men
who have sex with men will move away from using condoms, and that that will lead to an increase in other sexually transmitted infections.
"Men would prefer to have sex without condoms," Weinstein said in an interview last week. "That's a given. So if you give people a
get-out-of-jail-free card, they're going to use it. You can actually do harm by discouraging some people who are currently
protecting themselves from not using condoms."
Weinstein said PrEP, if not adhered to correctly, will give men a false sense of security and they'll engage in unsafe sex.
"We felt the warning had to be put out there."
Some in the HIV-prevention community have dismissed Weinstein as a pariah, an attention-seeking contrarian interested mostly in
promoting himself and his foundation. A recent New York Times article suggested Weinstein's "vociferous opposition to PrEP has
made him perhaps the most hated man in the AIDS business."
The paper quoted one veteran activist saying, "I consider him a menace to HIV prevention."
"Prevention is a thankless job," counters Weinstein. "But it's a moral responsibility."
The ACT info package reinforces that PrEP is "added protection" and "encourages guys to continue using condoms in addition to taking PrEP."
Thomas says that in his work with ACT, his experience is that men using PrEP are not taking more chances with their sexual health.
"In terms of it fostering a risk-infused environment, that's not something that we've seen immediately. The people who are interested in
PrEP are extremely conscious of their health. They are fantastic stewards of their own well-being. This is may be one of the reasons why
they are interested or using PrEP in the first place."
Against that backdrop of differing views, Dr. Darrell Tan is about to begin a trial at St. Michael's to clinically assess PrEP, a study
that will coincidentally address concerns raised in the AHF open letter.
Over the next year, 50 Toronto men who have sex with men with follow a regimen of PrEP, and Tan, an infectious diseases physician and
clinical scientist at the hospital, will monitor their adherence to the drug and whether it changes their aversion to sexual risk.
He'll also look at whether any of the subjects develop a resistance to the drug.
"There has continued to be some debate about PrEP . . . " he says. "There are a lot of concerns that people have about whether it is
a good thing to do or not.
"To base policy decisions on speculation about how people will or will not behave in the future is not the ideal route to go. I think
we really need to collect the data to answer those important, realistic questions."
Tan says that the HIV infection rate among gay men in Toronto is about 17 to 18 per cent and that, he says, "rivals what we see in the
hardest hit countries of Africa.
"Clearly, it's a problem and we have to do something about it. It really speaks to the need for new interventions."
"I think that at a population level, (PrEP) has the potential to be a game-changer. I think the other way to look at it is at the individual
level. Every single infection that is prevented is a game-changer for that individual."
Tooley agrees that it is important to raise questions and have frank discussions, but he is concerned that a letter like the one published
by the AHF might discourage some men from pursuing a protection option that could be perfect for them.
"Unfortunately, we are still living in a world where HIV transmission still happens," he says. "It's a reality and for guys who are at
risk of HIV, I think it would be a real shame for them to not consider PrEP because of a letter written by the AHF."
Tooley, who spoke to the Star as an individual who has made his life in HIV prevention rather than as a representative of CATIE, says his
use of a pre-exposure prophylaxis has "profoundly impacted my sense of well-being.
"It's given me a level of confidence and security that was a pie-in-the-sky dream before and that is a pretty significant thing for a
young gay man who grew up in the shadow of an epidemic that wiped out a lot of people in the community before he really got into that
community.
"I wouldn't necessarily go so far as to say that PrEP a game-changer for the HIV movement, but in some ways for me, it's been a personal
game-changer," continues Tooley. "If you look at the stories of people who use PrEP, that's not an uncommon thing and that's a really
hopeful thing."
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Source: Toronto Star
"Reproduced with permission - Torstar Syndication Services"
Toronto Star
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