Wednesday, the Centers for Disease Control and Prevention
(CDC) and the University of Washington released data gleaned from two African
studies, namely "Partners PrEP" and "TDF2." The studies indicated that
antiretroviral drugs (ARVs) taken daily by uninfected individuals--an approach
known as PrEP, or pre-exposure prophylaxis--can reduce HIV acquisition through
unprotected heterosexual sex by 62-73 percent, according to Partners PrEP, and
nearly 63 percent, according to TDF2. The two drugs tested as PrEP were
tenofovir (manufactured by Gilead Sciences and sold as Viread) and tenofovir
plus emtricitabine (also manufactured by Gilead Sciences and sold as Truvada).
As the news came across the wires, widespread HIV/AIDS community support followed. AVAC, Project Inform, the San Francisco AIDS Foundation and many other advocacy groups as well as the leadership of the International AIDS Society heralded the results. Wednesday's PrEP lovefest mirrored the community's reaction to the results of "iPrEx" or the "Pre-exposure Prophylaxis Initiative," supported by the U.S. National Institutes of Health (NIH) and the Bill & Melinda Gates Foundation. The iPrEx results established that men who have sex with men and transgender women who take PrEP are, on average, 44 percent less likely to contract HIV; they were 73 percent less likely to do so if they took daily PrEP 90 percent of the time. It was also announced Wednesday that iPrEx will continue a placebo-less extension of the trial to study those who remained negative.
The results of Partners PrEP, TDF2 and iPrEx are critical indications that HIV can be successfully prevented with biomedical intervention--to a degree. But it is important to note PrEP offers various levels of reduced risk of HIV infection that are contingent on adherence. And that a range of 44-73 percent reduction in new HIV infection rates will not result in population level impact on the overall rate of new HIV infections. It's also important to keep in mind that a fourth clinical trial FEM-PrEP, failed to find any benefits among African women at risk for HIV. Therefore, PrEP should not be considered a prevention panacea but rather, a potential harm reduction strategy.
By comparison, consider the results of another recently completed treatment-as-prevention efficacy trial--a trial known as HPTN 052. The results from this trial were so compelling they were released by the HIV Prevention Trials Network in May 2011, years before results had been expected.
As the news came across the wires, widespread HIV/AIDS community support followed. AVAC, Project Inform, the San Francisco AIDS Foundation and many other advocacy groups as well as the leadership of the International AIDS Society heralded the results. Wednesday's PrEP lovefest mirrored the community's reaction to the results of "iPrEx" or the "Pre-exposure Prophylaxis Initiative," supported by the U.S. National Institutes of Health (NIH) and the Bill & Melinda Gates Foundation. The iPrEx results established that men who have sex with men and transgender women who take PrEP are, on average, 44 percent less likely to contract HIV; they were 73 percent less likely to do so if they took daily PrEP 90 percent of the time. It was also announced Wednesday that iPrEx will continue a placebo-less extension of the trial to study those who remained negative.
The results of Partners PrEP, TDF2 and iPrEx are critical indications that HIV can be successfully prevented with biomedical intervention--to a degree. But it is important to note PrEP offers various levels of reduced risk of HIV infection that are contingent on adherence. And that a range of 44-73 percent reduction in new HIV infection rates will not result in population level impact on the overall rate of new HIV infections. It's also important to keep in mind that a fourth clinical trial FEM-PrEP, failed to find any benefits among African women at risk for HIV. Therefore, PrEP should not be considered a prevention panacea but rather, a potential harm reduction strategy.
By comparison, consider the results of another recently completed treatment-as-prevention efficacy trial--a trial known as HPTN 052. The results from this trial were so compelling they were released by the HIV Prevention Trials Network in May 2011, years before results had been expected.
HPTN 052 showed that when people living with HIV (the study
consisted of primarily heterosexuals) were given ARVs and were sufficiently
adherent to reduce their viral load to undetectable levels for a minimum of six
months--there was a 96 percent reduction rate of HIV transmission to their
HIV-negative sex partners. Now we're talking potential for population level
change.
Some groups cited PrEP's efficacy as critical proof that
treatment as prevention works, leveraging that notion to further justify the
need for universal access to treatment for people living with HIV. It's smart
to leverage PrEP data as further proof that treatment can serve as prevention.
Every additional piece of scientific evidence indicating treatment reduces the
spread of HIV is further ammo in our fight against the virus. But frankly, the
results of HPTN 052 offer sufficient, and arguably more compelling,
justification for universal access to care. HPTN 052's results informed the new
goal of putting 15 million people living with HIV/AIDS into care by 2015; a
goal announced at the United Nations' high level meeting on HIV/AIDS this past
June.
It must be acknowledged that treatment as prevention in people without HIV and treatment as prevention in people with HIV are very different things.
The results of HPTN 052 suggest that treatment may be a more effective form of prevention when given to people with HIV rather than to people who don't have the virus. Comparing the outcomes of the five aforementioned studies, it appears that administering ARVs to people with HIV rather than those without the virus offers a substantially higher rate of reduction in new HIV infections.
Treatment as prevention among people without HIV exposes healthy people to the side effects of drugs they don't have to take to stay well and survive. Treatment as prevention in people with HIV exposes people living with a disease to side effects of drugs that are, in most cases, necessary to prevent sickness and death. Obviously, we'd rather cure AIDS and should invest heavily to do so; until we have a cure, shouldn't we pursue a prevention path that has the upshot of keeping the people who are taking the drug alive as opposed to giving those drugs to people who don't need them for survival?
I think too many people have drunk the proverbial Kool-Aid on PrEP. Think about this:
Currently, there are 33.3 million people estimated to be living with HIV worldwide. To date, only 6 million of those people have access to ARVs. This means the bulk of the remaining 27.3 million people are headed toward near-certain death. Some of them quite rapidly.
HPTN 052 suggests that if we could achieve universal testing and access to care for all people living with HIV, we could reduce individual viral loads around the world and therefore lower the global "community viral load." By doing so, we could reduce the overall potential HIV transmission risk around the world significantly. If we could test and treat every positive person--and, admittedly, there are many significant issues to address in order to make universal access feasible, not the least of which is the challenge of paying for ARVs for tens of millions of people for the rest of their lives or until there is a cure--would we really need PrEP? Would we really need to give medications to people who don't have a disease?
I can hear the gasps already. (Especially from those who are funded to administer, study and sell PrEP...and those who manufacture and invest in it.)
But when you pit the prevention potential of universal access to care against the concept of PrEP, there seems no question to me about which approach is likely to save the most lives while preventing the most new cases of HIV most quickly and efficiently.
Therefore, especially in a time of limited resources, shouldn't we invest in a strategy that will save lives and stop the spread of AIDS while sparing healthy people the side effects of ARVs?
I want to be crystal clear: I support the notion of PrEP as a tactical tool for certain populations. All biomedical options that can work should be understood and added to the HIV prevention tool kit. We need every arrow possible in the quiver in our fight against AIDS.
PrEP could be a powerful form of harm reduction if made available to people most at risk for HIV, especially those who have no access to other forms of protection, like condoms and clean needles and injection equipment. PrEP could be helpful in situations in which condom negotiation is not possible, allowing PrEP to join the ranks of vaginal and rectal microbicides--other biomedical prevention tools being studied and developed. PrEP could be valuable for women who wish to conceive naturally and not risk contracting HIV. I would love to see PrEP adopted globally as part of a comprehensive prevention plan and given to people at high risk for HIV, who, again, are not able to get or use alternate tools, people like: sex workers; injection drug users; women and men in abusive relationships who don't have the power to advocate for their sexual health; and married people whose husbands and wives are being unfaithful and having unprotected sex.
But if we cannot find the political and financial capital to get ARVs to the 27.3 million people living with HIV who desperately want and need them, how are we going to secure the political and financial capital to get ARVs to millions of HIV-negative sex workers, drug users and other disenfranchised people in exceptionally compromised positions?
Unfortunately, PrEP will probably remain in the domain of the haves, not in that of the have-nots. Treatment as prevention is not going to be a reality for disenfranchised HIV-negative people at risk. PrEP will be for rich, HIV-negative people in the United States and other developed nations, gay and straight, who would rather take a pill and weather its side effects than use a condom.
PrEP is the viral equivalent of the birth control pill for people who can afford it. Price won't be an issue. To wit: Just before seeking FDA approval for Truvada as PrEP in April, Gilead jacked up the price of the drug by 7.9 percent.
I find it disconcerting that so many HIV treatment activists today, many of whom are living with HIV themselves, are wildly supportive of a prevention modality that has no benefit to people living with HIV other than arguably allowing HIV-positive people to have unprotected sex with HIV-negative people with a reduced risk of transmitting HIV, a risk that would be reduced further if the positive person was on treatment themselves. And especially when all activists could be advocating as vociferously for universal access to care for all people living with HIV; a prevention modality that has the added benefit of saving tens of millions of lives while stopping the spread of AIDS dead in its tracks.
The PrEP data has unleashed an ocean of press releases. I'd like to see the same volume of press releases come over the transom focused on issues like raising the U.S. debt ceiling, finding ADAP funding, protecting Medicaid and Medicare budgets, finding resources to implement the National HIVAIDS Strategy, supporting America's financial commitment to the President's Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund to Fight AIDS, Tuberculosis and Malaria and defending the perimeter of the Affordable Care Act.
Given the efficacy of treatment as prevention for people with HIV as established in the HPTN 052 study, I have to again ask: In a time of limited resources, how can we afford to invest in PrEP? Do we need to spend millions of dollars on drug trials and feasibility studies for PrEP? Wouldn't the world be better protected and more lives saved if that money instead was dedicated to increasing access to care for people with HIV?
Make no mistake: PrEP is a profit-driven sex toy for rich Westerners, disguised as a harm-reduction and prevention tool for disenfranchised people at risk for HIV.
And it's coming to a drugstore near you soon.
Some groups cited PrEP's efficacy as critical proof that
treatment as prevention works, leveraging that notion to further justify the
need for universal access to treatment for people living with HIV. It's smart
to leverage PrEP data as further proof that treatment can serve as prevention.
Every additional piece of scientific evidence indicating treatment reduces the
spread of HIV is further ammo in our fight against the virus. But frankly, the
results of HPTN 052 offer sufficient, and arguably more compelling,
justification for universal access to care. HPTN 052's results informed the new
goal of putting 15 million people living with HIV/AIDS into care by 2015; a
goal announced at the United Nations' high level meeting on HIV/AIDS this past
June.
It must be acknowledged that treatment as prevention in people without HIV and treatment as prevention in people with HIV are very different things.
The results of HPTN 052 suggest that treatment may be a more effective form of prevention when given to people with HIV rather than to people who don't have the virus. Comparing the outcomes of the five aforementioned studies, it appears that administering ARVs to people with HIV rather than those without the virus offers a substantially higher rate of reduction in new HIV infections.
Treatment as prevention among people without HIV exposes healthy people to the side effects of drugs they don't have to take to stay well and survive. Treatment as prevention in people with HIV exposes people living with a disease to side effects of drugs that are, in most cases, necessary to prevent sickness and death. Obviously, we'd rather cure AIDS and should invest heavily to do so; until we have a cure, shouldn't we pursue a prevention path that has the upshot of keeping the people who are taking the drug alive as opposed to giving those drugs to people who don't need them for survival?
I think too many people have drunk the proverbial Kool-Aid on PrEP. Think about this:
Currently, there are 33.3 million people estimated to be living with HIV worldwide. To date, only 6 million of those people have access to ARVs. This means the bulk of the remaining 27.3 million people are headed toward near-certain death. Some of them quite rapidly.
HPTN 052 suggests that if we could achieve universal testing and access to care for all people living with HIV, we could reduce individual viral loads around the world and therefore lower the global "community viral load." By doing so, we could reduce the overall potential HIV transmission risk around the world significantly. If we could test and treat every positive person--and, admittedly, there are many significant issues to address in order to make universal access feasible, not the least of which is the challenge of paying for ARVs for tens of millions of people for the rest of their lives or until there is a cure--would we really need PrEP? Would we really need to give medications to people who don't have a disease?
I can hear the gasps already. (Especially from those who are funded to administer, study and sell PrEP...and those who manufacture and invest in it.)
But when you pit the prevention potential of universal access to care against the concept of PrEP, there seems no question to me about which approach is likely to save the most lives while preventing the most new cases of HIV most quickly and efficiently.
Therefore, especially in a time of limited resources, shouldn't we invest in a strategy that will save lives and stop the spread of AIDS while sparing healthy people the side effects of ARVs?
I want to be crystal clear: I support the notion of PrEP as a tactical tool for certain populations. All biomedical options that can work should be understood and added to the HIV prevention tool kit. We need every arrow possible in the quiver in our fight against AIDS.
PrEP could be a powerful form of harm reduction if made available to people most at risk for HIV, especially those who have no access to other forms of protection, like condoms and clean needles and injection equipment. PrEP could be helpful in situations in which condom negotiation is not possible, allowing PrEP to join the ranks of vaginal and rectal microbicides--other biomedical prevention tools being studied and developed. PrEP could be valuable for women who wish to conceive naturally and not risk contracting HIV. I would love to see PrEP adopted globally as part of a comprehensive prevention plan and given to people at high risk for HIV, who, again, are not able to get or use alternate tools, people like: sex workers; injection drug users; women and men in abusive relationships who don't have the power to advocate for their sexual health; and married people whose husbands and wives are being unfaithful and having unprotected sex.
But if we cannot find the political and financial capital to get ARVs to the 27.3 million people living with HIV who desperately want and need them, how are we going to secure the political and financial capital to get ARVs to millions of HIV-negative sex workers, drug users and other disenfranchised people in exceptionally compromised positions?
Unfortunately, PrEP will probably remain in the domain of the haves, not in that of the have-nots. Treatment as prevention is not going to be a reality for disenfranchised HIV-negative people at risk. PrEP will be for rich, HIV-negative people in the United States and other developed nations, gay and straight, who would rather take a pill and weather its side effects than use a condom.
PrEP is the viral equivalent of the birth control pill for people who can afford it. Price won't be an issue. To wit: Just before seeking FDA approval for Truvada as PrEP in April, Gilead jacked up the price of the drug by 7.9 percent.
I find it disconcerting that so many HIV treatment activists today, many of whom are living with HIV themselves, are wildly supportive of a prevention modality that has no benefit to people living with HIV other than arguably allowing HIV-positive people to have unprotected sex with HIV-negative people with a reduced risk of transmitting HIV, a risk that would be reduced further if the positive person was on treatment themselves. And especially when all activists could be advocating as vociferously for universal access to care for all people living with HIV; a prevention modality that has the added benefit of saving tens of millions of lives while stopping the spread of AIDS dead in its tracks.
The PrEP data has unleashed an ocean of press releases. I'd like to see the same volume of press releases come over the transom focused on issues like raising the U.S. debt ceiling, finding ADAP funding, protecting Medicaid and Medicare budgets, finding resources to implement the National HIVAIDS Strategy, supporting America's financial commitment to the President's Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund to Fight AIDS, Tuberculosis and Malaria and defending the perimeter of the Affordable Care Act.
Given the efficacy of treatment as prevention for people with HIV as established in the HPTN 052 study, I have to again ask: In a time of limited resources, how can we afford to invest in PrEP? Do we need to spend millions of dollars on drug trials and feasibility studies for PrEP? Wouldn't the world be better protected and more lives saved if that money instead was dedicated to increasing access to care for people with HIV?
Make no mistake: PrEP is a profit-driven sex toy for rich Westerners, disguised as a harm-reduction and prevention tool for disenfranchised people at risk for HIV.
And it's coming to a drugstore near you soon.
Regan on:
I find this editorial disappointing, and to be honest, insulting. I am not a "rich Westerner," nor do I use PrEP as a "sex toy." As the HIV negative partner in a serodiscordant relationship, I use PrEP as part of a prevention strategy, in close collaboration with my physician.
I'd invite everyone to read my own story regarding PrEP, either in the July/Aug issue of Positively Aware at http://issuu.com/positivelyaware/docs/positively_aware_july_august_2011-clickable or at the LifeLube Blog at http://lifelube.blogspot.com/2011/05/i-havent-given-up-ive-taken-charge-one.html?zx=8d0afa9380b64464 .
Ironically, a commenter at the latter blog suggested that I offer the article to Poz for publication. I'm glad Positively Aware asked permission to print it first.
Dear Reagan,
I follow news on 'hiv cure' everyday, and on Wednesday, just 1 day after the most significant hiv cure news of the last several months was announced (that over $70 MILLION will be given for cure research in a 5 year plan), all the sudden comes another "huge study" sponsored by a pharmaceutical company.
If it weren't for you and your above post, I don't know how alone I would have felt in my dismay.
And this isn't the 1st time a 'huge study' was 'revealed' about 'prevention', 'vaccine', and anything EXCEPT the word 'cure' by Big Pharma within hours after significant cure news.
These drug companies must spend a fortune on controlling the 'buzz' about the promising cure research.
It's so sickening that I can barely take it, yet thankfully there are humans with conciouse such as yourself and the hundreds of scientests who haven't been drinking and selling the kool-aide, who are in this fight for reasons that I think any person should be in it for - to make those who are sick, healthy, to HELP those less fortunate, to CURE this most deadly infectious disease of our time once and for all.
I'm sure like clockwork, the next significant 'hiv cure' news will be followed by a "major" study release from a Pharma group - we need to Call Them Out - We need to shine light to how they'd rather spend millions to suppress the knowledge about the real and present hope for a cure, than throw a penny towards research that would save millions of lives and livelihoods.
Having been diagnosed almost a year ago, and as someone who found much to be stunned and sad about with regards to the communities ties with Pharma, I consider this site and you HEROES. I thank you with from the bottom of the heart, and know that I and countless others greatly appreciate all you have done and continue to do - we need you!!
Best,
Stephan
Regan, you are correct on all points, but you are still arguing apples and oranges. who exactly has proposed shifting money away from prevention efforts aimed at the poor in favor of prevention efforts aimed at the rich, and where have they done so?
by all accounts, there is already an underground movement using PrEP...Sean Strub has openly admitted to giving PEP "starter kits" to sexually active MSM's, which of course also easily function as PrEP kits, yet he also declares that approving PrEP will lead to more deaths via A) diminished resources for those who cant afford/access it, B) more people having raw sex, and C) people creating drug-resistant virus via sub-optimal PrEP (or PEP).
what often seems unsaid in these blogs is that many prevention activists feel that their efforts at encouraging condom usage will be diminished and demoralized by the example of well-to-do partiers having raw sex on blue pills.
that may very well be so, but you still certainly don't have the right to thwart the introduction of a new prevention modality simply because you feel it will make your own job harder. the rich will always have it easier than the poor, and epidemiology and public health are not the ideal places to fight that inequality beyond direct health consequences.
if some official proposes taking money away from prevention efforts aimed at the poor in favor of funding PrEP, then i could see the outrage being justified...but until then, the attacks on PrEP have a distinct air of sexual fundamentalism about them.
"we only JUST got everyone acknowledging the need for condoms, what does PrEP do to our efforts?!"
i'll tell you. PrEP points to the strategic error of accepting the sexual limitations of condoms decades ago, even as condoms were adopted as, essentially, "the new normal" when it comes to sex.
having failed to effectively lobby for improvements in condom concept, design and manufacturing over the last 25+ years, no one should be surprised that there's a bum's rush toward prevention paradigms that do not depend on crippled sexual sensation.
your own column on this topic recently proffered the theory that "condoms would be more accepted if people knew how to put them on faster". this is nominally true, but it is HARDLY the biggest obstacle to condom acceptance. the elephant in the HIV-prevention room remains that, for a great many people, condoms simply suck real badly.
THAT problem needs fixing, and it has nothing to do with PrEP...which only a few will ever afford.
Regan, your skepticism is appropriate. AIDS has indeed made strange bedfellows out of AIDS activists and the Pharma lobby. Hope mongering of this type serves the drug houses at the expense of the community.
What happened to AIDS PREVENTION MODELS? CONDOMS WORK! RECKLESS BAREBACKING IS WRONG. Still people forget or forsake the use of CONDOMS and that should be front line prevention tools for men and women. PrEP in a relationship used regularly sounds like reckless behavior.
Actually chemoprophylaxis (a new word that covers PrEP and treatment as prevention) has probably already helped to deprive prevention education of funding. With budgetary constraints, it's easier for health departments to shift the responsibility for prevention services to those entities that pay for drugs, which will be insurers whether private or Medicaid/Medicare
Oral PrEP has no place as a public health intervention. It just does not work well enough. The costs extend far beyond the price of the pills. People taking Truvada will need to be monitored for toxicity, adherence and importantly to detect infection. We certainly can’t be confident that all of this will happen and so there will be predictable consequences. Since adherence cannot be assured it’s certainly possible that implementing PrEP as a public health intervention may result in an increase in infections, and some will be with resistant virus.
Regan’s view of PrEP as a harm reduction strategy is brilliant. Condoms are much more effective, cheaper and safer. But for whatever reason there are people who will not use them. Viewing PrEP as a harm reduction strategy means that we support people who for whatever reason make a more dangerous choice. Just as we support the provision of sterile needles to people who use drugs intravenously.
From all the experience we have gained regarding the toxicities of antiviral agents and how long it can take before some are recognized, it’s bewildering that the adverse effects of Truvada are being downplayed.
Prevention education with continuing support for condom use already receives meagre support. It may have been further damaged by the way PrEP has been promoted which generally manages to remain completely silent about the efficacy of condoms,
Jeton,
You write:
"Sean Strub has openly admitted to giving PEP "starter kits" to sexually active MSM's, which of course also easily function as PrEP kits, yet he also declares that approving PrEP will lead to more deaths via A) diminished resources for those who cant afford/access it, B) more people having raw sex, and C) people creating drug-resistant virus via sub-optimal PrEP (or PEP)."
The three-day starter kits I provide to be used as an emergency intervention buys an individual a couple of days' time, to see their doctor and assess their risk, to prevent sero-conversion. Their efficacy for use as Prep is not established and I think it is irresponsible to imply otherwise.
Your summary of my concerns about Prep is also inaccurate, but readers can review the posts on my blog at poz.com to understand my point more clearly.
I did, however, feel the need to correct the implication that a three-day ART "starter kit" is effective for use as Prep.
It may not be Kool-Aid, but Hofman seems to be drinking something. Of course "levels of reduced risk of HIV infection ... are contingent on adherence" From abstinence to condoms to Truvada, all HIV prevention methods are contingent on adherence (duh!). Hofman is right to re-direct our attention to HPTN 052 and to push hard for treatment as prevention. She is right to argue for "universal testing and access to care for all people living with HIV." But she is absolutely wrong to imagine that it can only be one or the other. That the drug companies are making a killing with these expensive meds in not a good reason to oppose their use or to distort the facts of their efficacy.
Hofman's claim that "FEM-PrEP, failed to find any benefits among African women at risk for HIV" is a blatant mis-statement of fact, and I suspect that it is deliberate (in other words, a lie). The FEM-PrEP study was halted because the researchers realized that they had failed to design an experiment that would have a clear result. Why? Because they couldn't tell whether the women in the study were taking their medicine or not. The reason other trials have shown "a range of 44-73 percent reduction in new HIV infection rates" is the same - the research subjects were not following the protocols, but the researchers were not fully able to determine who was and who was not taking their meds. And for a physician (Dr. Sonnabend) to write that "Oral PrEP has no place as a public health intervention. It just does not work well enough." is tantamount to malpractice. He knows better.
I hope some smart PhD candidate is already conducting a study similar to Partners PrEP, TDF2, iPrEx and FEM-PrEP, but in which the research assistants actually watch the study participants take their meds. Then the researchers will know what level of adherence they really got. When that smart PhD candidate announces the results of the study, and the level of protection for those who adhere to the protocol is as high or higher than with condom usage, what will Hofman, Sonnabend and Strub say then? Probably what Lunceford says - "BAREBACKING IS WRONG" - which is just a slightly more liberal version of what the abstinence-only crowd says. Such is the current state of our community "leadership."
Until all "33.3 million people estimated to be living with HIV worldwide" are getting ARVs (and taking them as directed), there will be a need for PrEP. For Hofman, or anyone, to stand in the way of a person taking responsibility for their own health in the way they deem best for them is offensive. For her and others to argue against access to PrEP is an outrage. And she is working against it, in spite of her disingenuous statement that "We need every arrow possible in the quiver in our fight against AIDS." The contempt that drips from her closing statement that "PrEP is a profit-driven sex toy for rich Westerners" belies her true intent and her true motivation.
Thanks to Literski and Ademaj for providing honest, well-reasoned rebuttals. "The attacks on PrEP have a distinct air of sexual fundamentalism about them."
This is really good news.
as a positive person of close to 30 years who has had two serodicordant long term 5-10 years i can say that no drugs are needed.
safe sex, condoms and common sense work every time.
it is not sex-negative to say that more, and more expensive drugs are needed. simply follow basic safe sexy guidelines...and have Very Hot Sex.
Very.
a condom never stopped me from truly enjoying my partner in a loving and very sexual way.
Even if you are a poor easterner, you are capable of reading that Regan Hofmann clearly states......
"I want to be crystal clear: I support the notion of PrEP as a tactical tool for certain populations. All biomedical options that can work should be understood and added to the HIV prevention tool kit. We need every arrow possible in the quiver in our fight against AIDS.
What is insulting about her statement?
Without specific mention of your particular circumstance, I believe the editor considers your situation a certain population that benefits from a PrEP regimen.
I believe in more options. The concept of PrEP is exciting, although not perfect. Treatment is not perfect either.
I believe there are reasons why PrEP results have been less than we would expect. As someone from a poor community of color, I can tell you what people do with resources they manage to get -- they sell them. Or what about passing that Truvada on to a lover or friend or family member who IS living with HIV?
Taking an HIV regimen and deciding to give it to a positive person or to an HIV-negative person -- I think the choice is obviously to provide antivirals to the positive person. But that's not how research works. I want to know what works whether or not ADAP and others will provide it. I believe we need research.
Regan's arguments are very rational, and I appreciate her passion. But the title is not rational. Following a madman to your death? I think not. I say, "Gimme a P! Gimme an r! Gimme an E, P, yay!" Go, team!
With love (and I hope, kindness), Enid, Positively Aware
i've been hiv positive for fifteen years due to a blood splash while working as a nurse. if this had been available then i might not be positive now.i do have a problem with it being casually used for ppl who just dont want to be safe. you have to have half a brain to think it should not be used at all, but you also have to use your common sense look at the issues from different views and work it out. ppl always push what will be most likely to put money in their pockets. if the drug companies want to get involved, please by all means, help. give meds to ppl who already have hiv. that is if you really want to fix the problem.
Thank you Regan, for bravely taking a stand where others have been afraid to. You deserve to be commended for speaking out against this deceptive "prevention strategy". Prep is not a realistic means of reducing the cumulative number of HIV infections. Even the most optimistic estimates of its effectiveness show it to be LESS preventative than condom usage. Unless there is some sizable group of people with money to burn who realize they're at risk but choose the danger of HIV over the annoyance of condoms, unless it is used as a seemingly redundant addition to condoms to further reduce risk or unless we literally start spiking the water supply so that we may drug those who don't know they're at risk or don't have the means to protect themselves, prep simply will not decrease the number of infections in any population. If it is used to replace more effective means of prevention, prep will almost certainly lead to an increase in new infections and a rise in resistant strains. All the ad-hominem attacks from the pro-prep crowd that this is a "moralistic" opinion do not change this obvious reality. What I find disturbing is the tenacity with which the prep crowd goes on the attack. They do not simply disagree, they suggest that the opinion of a respected physician and freethinker is "malpractice". They intentionally conflate the provision of pep starter kits as hypocrisy. They ignore the statistical realities of this drug or refuse to extrapolate those realities to a population wide basis. Then, they endlessly accuse their opponents of being "anti sex", all the while failing to conjure any convincing explanation as to what prep actually brings to the table. These are not legitimate arguementatative tactics, but they are evocative, and they are convincing to the populations they are intended for. Perhaps it is time that our side begins to ask WHY they're so wrapped up in a prevention strategy that doesn't work as well as existing methods.
Good points here. For me, personally, as long as we continue to ignore the inclusion of scaling up access to HIV-tests, I do view this PreP as a big bone for "AIDS, Inc." that includes pharma but also the big-player AIDS organizations. The current system seems to have a strangle-hold on options, creativity and empowerment, often needing the "tale of the victim" to keep funded. Now, if we were to go full-bore with all the technology and unleash all the compassion, than perhaps PreP would be a vital piece, but it's just that - a piece of the puzzle. Without fundamental changes to the incredibly-screwed-up testing that is controlled by zealots who are driven by a fundamentalist ideology as rigid as any religious conservative when it comes to testing, we are destined to fail.
I cannot thank you enough Regan for this article and all of your posts.
I must say that the conference and what I consider an effective pharma ploy of 'treatment is prevention' motto has made me so disheartened and quite frankly shocked - considering that this is the year of the HIV cure (groundbreaking research, the 1st person who may have been truly cured, scientific leaders with promising cure strategies, etc.).
As I search google news everyday for 'hiv cure', I have found that the media's coverage of this most significant news in on the topic of HIV/AIDS - the cure developments, are greatly UNDER-COVERED, while pharma company press releases are picked up by thousands of outlets on 'major studies' that always point to more people taking meds - which is great - yet the CURE is much more significant and newsworthy by any standard.
For example, just this evening I saw this article appear, with a title that literally made my jaw drop...
"HIV Cure: 'Educate the Healthy' Rather Than 'Heal the Already Dead'" - the article covers what all the media seems to be covering from the conference - this soundbite: 'treatment is prevention'.
This in my opinion is nothing short of criminal, in the wake of the cure efforts and the most promising cure research in the history of the epidemic!
As a community, we should be OUTRAGED, and demand that attention be given to the most logical prevention and treatment measure to ever end this epidemic (which is now feasible) - the CURE!
I'm a PR director of an online business and know what it looks like when a story or angle is being pitched within a particular topic/subject matter - and I have no doubt that the pharma companies are pitching their products and spending millions to suppress the cure's media attention.
This is the Fight of our lives and the true fight of HIV today.
Prep is a morally bankrupt prevention paradigm. How many people languished on waiting lists while the publicly funded CDC spent public monies demonstrating this counterproductive sex toy? How many people died? How many people with HIV needed that truvada?
in reply:
Dr. Sonnabend: the rise of the chemoprophylaxis paradigm was inevitable with the emergence of effective treatment cocktails and the relationship between viral load and infectiousness. the hostility to the "Test And Treat" paradigm across the blog pages of POZ and other venues carried some of the same visibly convoluted motivations as the hostility that PrEP currently enjoys here...so i thank you for tying them together again under the banner of "chemoprophylaxis".
I notice that your tone varies a bit here, and it leaves me to wonder exactly how you feel about needle-exchange programs. after all, such programs support individuals who are making choices you feel are dangerous...and you already object to giving the same support to those who "for whatever reason" decline to use condoms. well, it's the same reason that promotion of PrEP has downplayed condoms: people who would rather swallow a pill of dangerous medication rather than accept the crippled sexual sensation afforded by condoms have already made their choice clear.
one can fight this choice, or ignore this choice, or take this choice it into account when redesigning and rethinking prevention strategies. 30+ years into this plague, i'm suggesting the last option.
To Sean Strub: nowhere do i pretend to declare what modalities of PrEP are "effective" or not. what i wrote is that you give out 3-days-worth "PEP starter kit" packets of medication (Truvada?) to individuals. You have never written of auditing these packets or the people you have given them to so as to ensure usage per your exact stated intent. Whether or not taking Truvada for 3 days would effectively prevent HIV-infection during some typically risky exposure at any point during those 3 days, I have only ever read of people using 1 or 2 or 3 Truvada tablets in non-controlled settings via POZ.com and the HIV-press...for almost a decade now. What is new is that all of these PrEP studies apparently relied on continuous usage of PrEP for much longer periods. none tested the "weekend partier" modality that the HIV press has described in terms of "underground" use for years.
in light of this, it's fanciful to presume that none of your "starter kits" have been used in this fashion, unless you're actively and invasively auditing these recipients regularly somehow.
in regards to your (and certainly others') recent postings on PrEP, i stand by my description of "an air of sexual fundamentalism"...which i found disappointing, given some of your other expressed thoughts, such as the "5 things about HIV they're Not telling you" interview you did with Mark S King.
To John Eisenhans: thank you. i appreciate the statement "...to stand in the way of a person taking responsibility for their own health in the way they deem best for them is offensive", especially given that this sentiment was often expressed here at POZ in opposition to the Test And Treat model...ie, that Test And Treat gave short-shrift to HIV+ people doing what is best for their own health in favor of doing what is best for Society's health. amazing how quickly the shoe teleports to the other foot, eh?
To Andrew: putting aside your unsupported scientific assertions, i will clarify that Sean Strub's distribution of "PEP starter kits" is not hypocrisy, it is willful naivete given his surprising objections to PrEP. you do your own ad-hominem attacks no favors by decrying the purported ad-hominems of others, btw. would you like to just go ahead and call all vocal supporters of PrEP (and maybe chemoprophylaxis in general) "murderers for hire on the payroll of Big Pharma"? you're almost there, buddy...take the plunge. or, you could try to acknowledge that people can vehemently disagree with you without being "evil" for doing so.
to Stephan: i have never stopped screaming and hoping for a Cure at any point in the last 30 years...but as Ms. Hoffman's video interview with Kevin Frost (CEO, AMFAR) makes clear, it is not Big Pharma's interest to hunt a cure over treatment. moreover, it's not in Big Pharma's power to effect media coverage of efforts to find a cure for HIV. the biggest obstacle to such coverage is the long history of false hopes and false starts in the search for a Cure.
hopeless stories don't sell, and stories that don't sell don't get printed...unless one is writing for Pravda circa 1953. We are indeed in a different era now, medically speaking, but getting due media coverage of it will require clarifying the reality of this new era to media and broadcasting editorial boards.
"once bitten, twice shy"...Big Media has accumulated many dozens of such bites over the years. they wont just get over that instantly.
Jeton,
What "unsupported scientific assertions"? Do you mean my insinuation that prep could lead to a rise in resistant strains? What exactly do you think is going to happen once we start sloshing about in a landscape of incomplete cocktails? Do you think that the principles of evolution will put themselves on hold with this highly adaptable virus? Maybe you meant that my belief that it will result in more infections is "unsupported". I'd absolutely LOVE to understand what mental gymnastics lead you to believe that a less efficient prophylactic agent will lead to fewer infections. Calling this an "unsupported scientific assertion" is just another diversion to take away from the obvious, as is your reaction that I'm accusing you of being a "murderer for big pharma". So much of your tirade isn't even worth acknowledging, so I'll just cut to the chase and ask again-WHO WILL IT BENEFIT? HOW WILL IT LOWER THE RATE OF INFECTION? WHAT DOES PREP BRING TO THE TABLE? Until those questions can be answered in a reasonable way, with real world applications, I'm left to assume the prep has nothing to do with reducing infections and is, as Regan states, a sex toy for rich westerners.
Dear Ms. Regan Hofmann
as a Vietnamese newspaper, i've known that u came to VN, Hai Phong, Ngo QUyen Dist., Dong Khe ward. (My hometown). and u had a talk ab HIV and AIDS.
i have some questions, if possible, may you spend some few minutes to explain for me.
Thanks indeed!.
Khanh
Since you asked, Andrew, I'll tell you why I'm so interested in chemoprophylaxis (PEP and PrEP): if it had been available to me, I would not be HIV-positive. Doctors and other health professionals arguing against access to chemoprophylaxis particularly gall me. The fact is that health care professionals have been using chemoprophylaxis to protect themselves from infection for over a decade. They know from first-hand experience that it can be effective. Why is it not available to everyone? Because "it is not cost effective." In other words, it is available to health care professionals because their lives are more valuable than the lives of us ordinary folk (in the opinion of health-care professionals who control access, of course).
Is chemoprophylaxis just an expensive sex toy? Clearly some people see it that way. But not everyone can use condoms. What about the 50-something-year-old man who can barely manage to use his penis with the help of vitamin V? How is he supposed to use a condom as well? Not everyone finds sex with condoms satisfying. What about magnetic couples who long for the intimacy of natural sex? Perhaps you find sex with condoms perfectly acceptable - good for you. No one here is arguing against allowing you to have access to condoms. Some have made such arguments; how have you responded to them? You may feel that, in the the aforementioned cases, people should simply accept those limitations on their intimacy, their sexuality and their spiritual satisfaction. That is not your decision to make. Nor should it be the decision of the Regan Hofmanns or even Joseph Sonnabends. Take your anti-sex, anti-choice opinions and use them as your expensive sex toy.
Andrew, you have reached the limits of your argument. PrEP can effectively lower the rate of infection for people who are adherent to it (most common in the USA) and who don't use condoms...you would seek to punish or brainwash this sub-population towards your point of view, whereas i seek to control the infectiousness of this sub-population.
It is precisely the biological parameters of HIV that lead me to support PrEP, as it is well-known that the most infectious spreaders of HIV are those who are both newly infected and participating in highly active sexual networks. it seems many people don't want to hear harangues about condoms anymore...that this surprises anyone at all is telling. some of the Prevention community seems intent on making people fit their prevention models, rather than tailoring those models to real-world behavior.
I believe Regan's characterization of PrEP as a "sex toy" is intended to describe PrEP being used to enjoy FULL sexual sensation while also reducing the chance of infection...I haven't the foggiest idea how you could call PrEP a "sex toy" outside the Prevention context. i'd be surprised if you have any idea what you meant by that comment yourself.
I am not poz but had panic attacks from coming close to it. So, I can't know how it really is to be diagnosed. I think this mag is about the greatest good, saving the most lives. So there will be cries of "what about us?" whenever any plan that leaves anyone out comes up. I saw grafitti in a NY subway: "I love GRILS!" then: "It's GIRLS, idiot" then: "What about us GRILS?" It's lives versus pleasure, you can't misspell those.
The cost of Truvada PrEP.
I just saw a letter in the New England Journal of Medicine of April 7, 2011 in response to the iPrEx trial report.
The authors calculate that it would cost $400,000 a year to prevent a single infection.
I’m pleased that the calculations in my last post were correct. Truvada PrEP is associated with a very small absolute risk reduction (ARR) of 2.26%. The number of people who need to be treated to prevent one infection was 44 (it’s 1/ARR; I got 45).
The authors calculate that treating 44 people will cost $400,000 a year, and this does not even include the costs of regular monitoring.
From Sean Strub’s calculations (in his comment to my previous post) which included doctor’s visits and tests, the annual cost would be about $500.000.
These figures are based on drug costs in the US.
There definitely seems to be a perception that PrEP is for everybody; there even have been calls for its general implementation. These cost estimates alone would make it unfeasible as a public health measure but there are additional reasons, importantly its relatively low efficacy.
It's even probable that widespread and uncontrolled use of PrEP could result in an increase in new infections.
PrEP is a reasonable option for only a small number of individuals at high risk for infection who are able to be regularly checked for infection. I believe there is no disagreement about this; the controversy is only about its general use.
PrEP is not an appropriate public health HIV prevention intervention. I said this in my first post about iPrEx in November 2010
Drs Dong Heun Lee, M.D. and Ole Vielemeyer, M.D of Drexel University College of Medicine in Philadelphia are the authors cited.
Regan,
I totally agree with the points you make and made these same points to the pharmaceutical company at a dinner they put on and advertised as an "HIV and Aging" presentation where they "decided" to change the format to PrEP. I asked where the money for this to be distributed to the people who are mostly in the high risk areas are also those with NO MONEY to pay for it. I work in the HIV prevention arena and find that they have put way to much effort into something which, although it has been proven to work, is not something that people most at risk can afford.
And I also agree with your statements about those without HIV being the focus. It is like..if you already have it, we won't treat you but if you don't....let's make sure you have access to something which MAY decrease your chances of getting it....as long as we make money doing that. I don't see the drug companies saying they will provide it for those most at risk for free.
As a woman who is living with the disease in a state which has a waiting list and just applied to continue my ADAP, I am frightened that I will not be approved again and know that although I have insurance, I can't pay my co-pays and fear that even with help from the drug companies, I may not be able to continue with my life saving drugs and will have to quit work and school and become one who is living off the system. That is the risk here. If we can't get life saving medications, we will get sick. Then we are not able to contribute to the community in as many ways and we become a burdon. It is about choice...pay now for my copays or pay later for my illness which will inevitably happen.
Thanks for standing up and making your voice heard. From the bottom of my heart, I thank you for your unending work to help all of us.
John, stop with the ad-hominem attacks already, you're really not making a case for anything with them. If you sincerely believe that I'm "anti prep" because I'm "anti sex", I can't change your mind, but I do ask that you address what I'm saying on its merits, not what you think I feel. The reality is that it is an unworthy option, a waste of public resources and a potential minefield for public health. I'm opposed to prep because its a bastardization of the patent law system, because its going to result in more infections and because it distracts from the very real needs of those who have HIV, both in the developed and undeveloped world. I'm against prep because it has already demonstrated an unethical tendency towards experimenting on those in the developing world who will never benefit from its implementation, and because the long term manifestations of its rollout will likely be a catastrophic rise in new and resistant infections. In short, prep is the incarnation of everything that is wrong with our commercialized pharmaceutical industry. Finally, prep angers me because it distracts from the only things that will curb this epidemic, a cure or a vaccine.
You talk about serodiscordant couples. Read "the swiss statement", or any of the growing body of evidence in its heritage, and understand that any serodiscordant couple conscientious enough to benefit from prep will more likely benefit from the widespread implementation of HAART. Tell me why we're supposed to be drugging the seronegative under these circumstances?
You mention partners of "guys who can barely keep it up" as another beneficiary of prep. Since the very notion of condoms inexplicably offends you, I'll refrain from pointing out that female condoms would be an adequate alternative. Instead, I'm going to ask if you honestly believe that impotent, condom averse gentlemen not on treatment are really viable source of transmission? Seriously? Ok, fine, i'll bite. In public health though, the powers that be should always weigh the benefits of something against the downsides. This isn't "anti sex", its common sense, and a premise we are accustomed to in other realms of public health without screaming that people are "anti sex". Thalidomide is a great tool for preventing nausea, but we restrict it under this premise precisely because of its potential to cause birth defects. The five or so infections that may have allegedly been conveyed by these gents in the last decade almost certainly aren't going to stack up against the wave of drug resistance we'll face when prep becomes the hottest sex toy for the DDF bathhouse crowd, or the explosion of infections we'll see amongst those who give up condoms in favor of inconsistent pill usage.
Jeton, you make a point about prep being useful to a sub population of users who can remain adherent to an expensive pill, but not a condom. Its a complex arguement peiced together with big words, but it doesn't hold water. I'm inclined to ask who in the real world is going to go in for regular and consistent testing, endure copays of up to $200 a month, take their pills religiously, etc, but won't just use a condom or go in for pep when the time is necessary? You say you're interested in controlling the real world spread of this virus, but I ask you to apply this to a realistic scenario where it will do this, rather than condescend about whether or not I understand Hoffman's meaning of the phrase "sex toy". John tried but came up short. I suspect that your reluctance to do the same is because you fully understand that the number of applicable scenarios are vastly outnumbered by the damage prep will do.
John, you complain that chemoprophylaxis is used by healthcare professionals to protect them from HIV but withheld from the general public on grounds of cost effectiveness. The type of chemoprophylaxis you reference is Pep, not Prep. No one is disputing that "Pep" should be made available to everyone in need.