Opinion Piece on Truvada

[+ quoththeraven]

I know, yet another link to an article (in this case an op-ed) on Truvada use. Never let it be said I haven't posted links looking at all sides of the issue.

 

False prophets: Questioning the crusade for a new gay equality (NY Daily News)

 

(Yes, I know, the NY Daily News doesn't have the reputation of other news outlets, but this think piece is more nuanced than is the norm with the Daily News.)

 

An excerpt:

 

Do we really want to mass-medicate an entire generation of gay men? Until we know more, that has to be bad medicine and bad policy.

 

With treatments that make HIV no longer the death sentence it once was, and a younger generation dangerously ignorant of that grim era, condom adherence continues to decline.

 

In this light, Truvada seems like a triumph of technology over human nature.

 

But PrEP was never intended as a community-wide cure-all — but rather to complement more conventional prevention strategies.

 

Treating Truvada as inevitably universal erases the incentive for remaining both negative and med-free.

 

It’s like offering insulin to the obese — rather than fresh vegetables and a gym membership.

 

Telling people — particularly younger ones — that they’re destined for drugs just encourages them to get there faster.

 

Finally, for Truvada to truly equalize gay men, it would have to reach those in the community who need it most — the poor and minorities.

 

Free PrEP would help — but who’ll pay for the education and maintenance programs to ensure rigorous Truvada adherence, assuming any program can really do so?

 

And with lax adherence, PrEP could actually end up causing more infections than it prevents.

 

Also, gay porn star, public intellectual, and Truvada skeptic Conner Habib is writing an article on the experiences of men in San Francisco with Truvada/PreP. (I ran across the article because he tweeted a link to it.) It'll be out sometime early next year. So we have that to look forward to.

[+ Gar1eth]

I know, yet another link to an article (in this case an op-ed) on Truvada use. Never let it be said I haven't posted links looking at all sides of the issue.

 

False prophets: Questioning the crusade for a new gay equality (NY Daily News)

 

 

 

 

(Yes, I know, the NY Daily News doesn't have the reputation of other news outlets, but this think piece is more nuanced than is the norm with the Daily News.)

 

An excerpt:

 

Do we really want to mass-medicate an entire generation of gay men? Until we know more, that has to be bad medicine and bad policy.

 

With treatments that make HIV no longer the death sentence it once was, and a younger generation dangerously ignorant of that grim era, condom adherence continues to decline.

 

In this light, Truvada seems like a triumph of technology over human nature.

 

But PrEP was never intended as a community-wide cure-all — but rather to complement more conventional prevention strategies.

 

Treating Truvada as inevitably universal erases the incentive for remaining both negative and med-free.

 

It’s like offering insulin to the obese — rather than fresh vegetables and a gym membership.

 

Telling people — particularly younger ones — that they’re destined for drugs just encourages them to get there faster.

 

Finally, for Truvada to truly equalize gay men, it would have to reach those in the community who need it most — the poor and minorities.

 

Free PrEP would help — but who’ll pay for the education and maintenance programs to ensure rigorous Truvada adherence, assuming any program can really do so?

 

And with lax adherence, PrEP could actually end up causing more infections than it prevents.

 

Also, gay porn star, public intellectual, and Truvada skeptic Conner Habib is writing an article on the experiences of men in San Francisco with Truvada/PreP. (I ran across the article because he tweeted a link to it.) It'll be out sometime early next year. So we have that to look forward to.

 

I like what the excerpt said except about the insulin and overweight people. I understand the point. But insulin is often medically necessary whether we 'executive cut' ( formerly known as 'portly until we probably let it be known to suit designers that we weren't fond of the term) guys lose the weight or not.

 

Gman

[+ quoththeraven]

I like what the excerpt said except about the insulin and overweight people. I understand the point. But insulin is often medically necessary whether we 'executive cut' ( formerly known as 'portly until we probably let it be known to suit designers that we weren't fond of the term) guys lose the weight or not.

 

Gman

 

It's an imperfect (and somewhat fat-shaming) analogy. It would have been better if he'd written "offering insulin to those with diabetes" (or the pre-diabetic). I am overweight and at risk for diabetes, but my fasting glucose levels (and a1c, when anyone's bothered to measure it) have always been fine, and my nutrition is pretty good.

 

I also disagree with his opinion that it's wrong and messed-up to compare the considerations that go into deciding whether to take Truvada to the decisions women made and still make regarding the birth control pill. From the point of view of morality, whether taking using it makes one a slut/wh0re/pick your pejorative term, and its use as an alternative to condoms, the comparison is relevant.

[+ quoththeraven]

And here's another one. This one's by J. Bryan Lowder of Slate and is titled "Twenty-One Attempts at Swallowing Truvada"

 

http://www.slate.com/blogs/outward/2014/12/05/truvada_the_gay_community_and_fear_considering_the_meanings_of_condoms_and.html

 

An excerpt:

 

When I came out to my mother, the first thing she said (after indicating that my effeminacy had already tipped her off) was that she feared my getting AIDS. To her credit, this fear came from a place of benign stereotype rather than bigotry, but still, not the ideal way to react to someone’s coming out. And yet, I do not recall being upset by this focus on disease then, nor am I particularly bothered by it all these years later. After all, my mother was not wrong that, the world being what it is, my orientation toward men brought the threat into my life in a statistically significant way. In that, her fear was based in fact.

 

Gay sex and HIV/AIDS have been grim dance partners since 1981. When I began waltzing men to bed in 2006, my moves conformed, with the instruction of my first real boyfriend, to the choreography, marked out in fear, by the generation of gay men before me. This never struck me as an imposition—there’s plenty of freedom within form.

 

I want to think more about the utility of fear.

[+ quoththeraven]

More on Info on Truvada and HIV Transmission Risks of Various Acts

 

Whee, I'm clearing out my e-mail inbox! Here's two more articles on Truvada I ran across via links on Twitter, which I then e-mailed to myself. One's a general reporting piece in the San Francisco Business Times that cites efficacy levels of 90% but mentions that a subgroup of a survey group also self-reported using condoms less:

 

http://www.bizjournals.com/sanfrancisco/morning_call/2014/12/hiv-aids-prep-truvada-condom-gilead-gild.html

 

And a HuffPo piece by San Francisco Supervisor Scott Wiener, who is on Truvada:

 

http://www.huffingtonpost.com/scott-wiener/coming-out-of-the-prep-closet_b_5832370.html

 

He addresses the condom issue this way:

 

Condoms remain critically important for HIV-prevention efforts, but they have their limits, as demonstrated by the continuing new infections after 30 years of robust prevention efforts. Only one in six gay men uses condoms consistently and effectively enough to be fully protected from HIV. For those who do use them consistently, condoms offer significant protection but have a failure rate, and condom usage among gay men reduces HIV risk by 76 percent, not 100 percent.

 

Given the challenges many gay men have with consistent condom use as well as the continued risk of HIV transmission even for those who use condoms, PrEP provides a powerful additional level of protection. It's not a question of either condoms or PrEP. It's about both important tools.

 

I'd recently seen the statistics he cites on overall condom failure rates, which surprised me, elsewhere. If you look at the rest of the rates calculated for failure of contraceptive methods (which for condoms is also a general failure rate irrespective of whether they're used for contraception or STD prevention), the only methods with failure rates less than 1% are those that require physician or other practitioner involvement - IUDs and the like, basically. The rest have high failure rates that I'm very suspicious of; I used two of the methods (the pill and condoms) consistently for many years without any failures, and the failure rates I'd seen cited (not by the CDC, though) when I was using those methods were far lower -- something in the 90% range for the pill (98-99% with perfect adherence) and in the low 90% range for condoms. I think the CDC is extrapolating the worst real-world failures across all usage, not just some usage. In other words, as to the Pill, for example, assuming every user will slip up and skip a pill here or there.

 

I've also never seen the statistic that condom usage reduces the risk of HIV transmission among gay men by 76%, not 100%. As far as I know, condom usage reduces the risk of HIV transmission the same irrespective of gender or orientation; what matters is the risk associated with the sex act at issue, and I thought the reduction was closer to 100% than 76%. So I'm puzzled.

 

Despite the information from the earlier article, Wiener is right to say that there is evidence that there's some research that shows Truvada users may have increased adherence to condom usage, not less, most likely due to the education efforts that go hand in hand with the periodic HIV/AIDS testing that's required for Truvada use, since it's not helpful anymore if someone becomes HIV positive and his antigen level is detectable. I don't remember which article it is, but I'm pretty sure one of the articles I posted earlier reports this.

 

Finally, to keep this all in perspective: an unattributed but apparently authoritative chart listing various types of exposure and the risk of transmission per 10,000 associated with them that Conner Habib tweeted along with the message: "Almost NO sex acts have a high risk for HIV transmission. So chill out, and for the ones that do, use a condom."

 

https://twitter.com/ConnerHabib/status/541430685412499456/photo/1

 

The only exposures with a greater than 100 out of 10,000 risk of transmission are blood transfusions, with a risk of around 90%, and receptive anal intercourse, with a risk of around 1.5%. I imagine that some would like to reduce the risk to zero, and Truvada use in addition to condoms may come close to achieving that, but as a statistical and philosophical matter, it's probably impossible and irresponsible to definitively state that an act involves zero risk of anything no matter how many prophylactic steps are taken.

[jakeleyman]

Could I ask two questions related to this subject:

 

1. Is there any more recent credible study on obtaining HIV from oral sex?

 

2. Would beginning PrEP after exposure to oral sex with an HIV postitive person reduce the possibility of infection or is PrEP only a treatment prior to exposure?

 

Thanks

[Rudynate]

Could I ask two questions related to this subject:

 

1. Is there any more recent credible study on obtaining HIV from oral sex?

 

2. Would beginning PrEP after exposure to oral sex with an HIV postitive person reduce the possibility of infection or is PrEP only a treatment prior to exposure?

 

Thanks

 

There is also post-exposure prophylaxis, for people who have had high-risk sexual exposures, health-care workers who've been accidentally exposed on the job and transfusion exposures. It used to be fairly arduous, involving taking a high-intensity anti-viral combination for 6 weeks or so. As with so many things antiviral, it is probably easier than it used to be.

[corndog]

https://twitter.com/ConnerHabib/status/541430685412499456/photo/1

 

The only exposures with a greater than 100 out of 10,000 risk of transmission are blood transfusions, with a risk of around 90%, and receptive anal intercourse, with a risk of around 1.5%. I imagine that some would like to reduce the risk to zero, and Truvada use in addition to condoms may come close to achieving that, but as a statistical and philosophical matter, it's probably impossible and irresponsible to definitively state that an act involves zero risk of anything no matter how many prophylactic steps are taken.

 

I find this part very interesting, and very hard to believe. If you assume for the moment that typical homosexual men have unprotected anal intercourse 10,000 times in their lives, this statistic seems to suggest that only 1.5% would contract HIV. I believe that most gay men have significantly less than 10,000 risky sexual experiences, and substantially more than 1.5% of gay men have contracted HIV, especially at the height of the epidemic when safe sex wasn't understood. As the OP mentioned, this information is unattributed. I'm very skeptical of its veracity.

[+ quoththeraven]

Could I ask two questions related to this subject:

 

1. Is there any more recent credible study on obtaining HIV from oral sex?

 

2. Would beginning PrEP after exposure to oral sex with an HIV postitive person reduce the possibility of infection or is PrEP only a treatment prior to exposure?

 

Thanks

 

Rudynate is right about post-exposure prophylaxis, which IIRC is a combination drug that may include the constituents of Truvada. I seem to recall its test results aren't quite as good as Truvada's is for PrEP. You should find more information if you do an internet search for post-exposure prophylaxis.

 

As for the risks of contracting HIV from oral sex, I'm not aware of any studies, but I do know that there have reportedly been a few confirmed cases. See the following post of mine from this past June and the links therein:

 

http://www.companyofmen.org/showthread.php?99018-Is-the-increase-in-bareback-porn-changing-the-way-clients-view-escorts&p=913007#post913007

[+ quoththeraven]

I find this part very interesting, and very hard to believe. If you assume for the moment that typical homosexual men have unprotected anal intercourse 10,000 times in their lives, this statistic seems to suggest that only 1.5% would contract HIV. I believe that most gay men have significantly less than 10,000 risky sexual experiences, and substantially more than 1.5% of gay men have contracted HIV, especially at the height of the epidemic when safe sex wasn't understood. As the OP mentioned, this information is unattributed. I'm very skeptical of its veracity.

 

I think it's bad practice not to include an attribution, but I'm less skeptical of those statistics (particularly since Habib has an academic background and interest in science and his boyfriend is a medical practitioner) than I am of the ones in the article on Truvada on condom failure and HIV prevention rates. I have a link to another article about Truvada and HIV/AIDS risk lurking in my e-mail inbox (which is currently a disaster) that includes some specifics about the riskiness of various sex acts t hat I will post here eventually. I read it long before I saw Habib's tweet, so I can't tell you how much its statistics line up with these statistics, but I remember the general gist as to relative risk was the same.

[rvwnsd]

Could I ask two questions related to this subject:

 

1. Is there any more recent credible study on obtaining HIV from oral sex?

 

I have not read any studies that address acquiring HIV from oral sex. However, as part of my volunteer work at the local LGBT community center I routinely hear talks from sexual health educators and researchers. Not one has heard of a documented case of HIV transmission via oral sex. All have said it is theoretically possible, but the evidence at hand indicates it is improbable.

 

2. Would beginning PrEP after exposure to oral sex with an HIV positive person reduce the possibility of infection or is PrEP only a treatment prior to exposure?

 

Thanks

 

To expand upon Rudynate's and quoththeraven's replies, PrEP refers to Pre-Exposure Prophylaxis, meaning it needs to be taken before engaging in the activity that could expose you to HIV. PEP refers to Post-Exposure Prophylaxis, meaning it is taken after engaging in the activity that could have exposed you to HIV. At the last sexual health talk I attended, someone asked about the efficacy and danger of routinely taking PEP. The physician explained that PEP is intended for emergency situations, not for routine use. He went on to explain that someone who routinely needs to take PEP might want to consider taking PrEP.

 

PrEP requires pre-prescription blood work, including an HIV test with negative results, and is taken every day. Recent studies indicate that PrEP might be effective when taken on a one-off basis prior to having sex. PEP requires the first administration within one to seventy-two hours after potential exposure to HIV and is typically administered for four weeks.

[Rudynate]

but as a statistical and philosophical matter, it's probably impossible and irresponsible to definitively state that an act involves zero risk of anything no matter how many prophylactic steps are taken.

 

A biostatistician would call it a "non-zero, low probability."

[+ quoththeraven]

Here's the article I mentioned in my most recent post. It's by a physician about what he tells his patients who are HIV-negative gay men when they ask if they need condoms if they're on PrEP:

 

http://www.thebody.com/content/75205/do-hiv-negative-gay-men-need-condoms-if-theyre-on-.html?ap=2004

 

I expect that what he says will be controversial here, although he's clear that the riskiness of having condomless sex with men whose status is unknown and unknowable (otherwise known as casual sex) while on PrEP is unknown. Here's some excerpts:

 

We hear a lot about gay men not using condoms these days, but how many heterosexual men are using them if their female partners are on birth control? Are doctors counseling that all of their straight patients need to use a condom every time in every situation, now and forever? You know they're not. But that's the only message we've had for gay men for a long time. It's a message that was vital in the days when we had no other tools, had unreliable testing and did not understand transmission well. It's a message that saved countless lives. But now it's a message that pathologizes gay sex and fails to recognize that people are making reasonable and rational choices about risk. Now we have PrEP and treatment as prevention (TasP).

 

People want to know if using PrEP could actually allow them to go without condoms. They are looking to their doctors for guidance. If we sidestep the question by talking about STIs, then we leave people fumbling around to find their own way. PrEP opens the door to talking about situations where the risk of HIV infection will be so low that perhaps going without condoms is a reasonable choice.

 

If some people want to take PrEP and still use condoms, I salute their choice. They will be the safest among us. Some have likened this to using a belt and suspenders to hold up one's pants. I don't like this image because it implies that those who choose it are a bunch of nerds (see Urkel). I prefer the analogy of the use of seat belts and airbags in cars. Both are there to protect us, but they work in different ways to do so -- and outcomes are best when we use both modalities.

 

At this point, I think most people would agree that those in a long-term, stable monogamous relationship where both partners are the same serostatus do not need to use condoms. [i'm not so sure I agree with him there; the assumption that a relationship is monogamous and stable is sometimes just that, as is the assumption that in open or monogramish relationships any sex outside of the primary relationship that involves risk of HIV transmission will involve condoms.]

 

. . . .

 

That leaves the unknown partner, someone whose serostatus you cannot know for sure. I ask my patients to consider this scenario: You're on PrEP and a really hot guy comes up to you and says, "I really want to have sex with you, but you should know I recently became positive for HIV and I'm not on any medications yet and my viral load is pretty high." Would you have unprotected sex with this man?

 

Most of my patients immediately answer no (unfortunately too many would not even have sex with him, despite the fact that condoms would protect them, but we'll leave stigma to another discussion).

Some people say they aren't sure. A few have said they would only top that person without a condom (the risk from a single episode of insertive anal intercourse is 11 in 10,000 encounters -- you do the math).

A small number who are strong believers in the power of PrEP to protect them say they would still have unprotected sex, including receptive anal intercourse.

So we talk about these choices.

 

To those who say they would use a condom, I say that is the way they then need to handle every unknown hookup.

 

For those who say they would still have unprotected sex, I first say that I hope that PrEP will be as effective in this scenario as it was in studies overall. I then caution them that the data we have from studies have not proven that is true. The studies of PrEP have not looked at the HIV status and viral load levels of every partner of the study participants. We cannot say for sure that PrEP will work as well overall if one is constantly encountering partners with very high HIV viral loads. That is not to say for sure that it won't work, but we just don't know. People who are on PrEP and not using condoms with strangers are, in fact, experimenting with their own bodies. I am not saying that they are wrong or stupid or ill-informed, but they need to be aware that we do not know for sure that this will be safe.

 

From a link in the article, it's clear that the source of the chart showing the risk of HIV transmission per 10,000 exposures that Habib tweeted and I linked to is the CDC. So the author is using the same data regarding risk factors as the above-discussed chart.

 

BTW, I believe that conceptually, the 10,000 exposures could be those of a few people or 10,000 different people; what's measured is the risk of an HIV-negative person of any gender contracting HIV as a result of one instance of the specified act measured over 10,000 such exposures. So 134 out of 10,000 times (which it should be kept in mind is an estimate -- I don't know what the confidence level is, and I'm not sure the CDC knows, either), receptive anal sex will result in HIV transmission in the absence of any prophylaxis, etc or certainty of the other person's status. In other words, this measures both the likelihood that the other person has something to transmit and the actual occurrence of transmission. Transmission doesn't occur in every case in which the other person is HIV positive with a detectable viral load. The risk goes up if the other partner has an STI; the risk goes down if the other partner is HIV-positive with an undetectable viral load, etc., etc.

 

What gets overlooked in all the understandable and justified concern about transmission, and the gut response of those who lived through the time when HIV/AIDS killed many, many gay men, is that for transmission to occur (medical professionals on this forum, correct me if I'm wrong, but I'm pretty sure I've got this right), the virus has to get from one person's semen/precum/milk/vaginal lubrication/bloodstream (for expectant mothers) into another person's bloodstream. Just looking at the fluids that can harbor the virus is not enough. Mixing one person's semen with another's, or any combination of the above list of bodily fluids other than blood, isn't enough. That means transmission can only occur when there are unhealed cuts (could be microscopic, but there still have to be cuts), open sores, wounds, or the like.

 

Another thing that needs to be kept in mind (other than that the presence of other STIs greatly increases transmission risk) is that the real reason why men who have sex with men run a greater risk is the boomerang effect of versatility. A man can transmit the virus to a woman through vaginal or anal penetration if the virus is able to cross the blood/membrance barrier, but that woman can only transmit the virus if her partner (most likely a man, although there's at least one documented instance of woman-to-woman transmission) has a cut or some other mechanism for the virus to cross that barrier again. As the risk factors show, this is not as likely to happen whether we're talking about vaginal or anal intercourse. But if the virus is transmitted to a man during receptive anal sex, the person to whom it is transmitted can then turn around and transmit the virus when he tops, with the exact same risk rate. So versatility can, unfortunately, magnify the problem.

 

Finally, the PARTNER study showing no transmissions among serodiscordant couples not using condoms when the HIV positive partner has an undetectable viral load suggests treatment itself is a form of prevention. While the results of all studies have confidence rates of less than 100%, a well-done random study of 700 couples is large enough to yield good results. The real question is how likely viral loads are to fluctuate under treatment (I think the answer is not a lot) and if they do fluctuate (most likely due to lack of adherence), how soon will that be detected? If those under treatment have undetectable viral loads and don't transmit HIV without condoms, what is the problem with the use of Truvada in these circumstances? The real risk is with people who haven't been tested and/or whose HIV status is unknown or unknowable who engage in activities with a high(er) risk of transmission.

[+ quoththeraven]

A biostatistician would call it a "non-zero, low probability."

 

Yes. And from a statistical standpoint, I'm not sure anything that can be shown to be a theoretical risk can be ruled out as zero probability. That was my point. But the risk may be so vanishingly low, or can be shown not to exist for practical reasons, that the risk can be assumed to be zero. Just don't expect a statistician (as opposed to, say, a medical professional) to endorse that conclusion, as there's always a confidence rate of less than 100%.

 

Just in case anyone's wondering, while I'm not a statistician by trade, I used statistical packages like OSIRIS and SPSS during my college days to conduct public policy research. I still remember most of the basics.

[Rudynate]

Yes. And from a statistical standpoint, I'm not sure anything that can be shown to be a theoretical risk can be ruled out as zero probability. That was my point. But the risk may be so vanishingly low, or can be shown not to exist for practical reasons, that the risk can be assumed to be zero. Just don't expect a statistician (as opposed to, say, a medical professional) to endorse that conclusion, as there's always a confidence rate of less than 100%.

 

Just in case anyone's wondering, while I'm not a statistician by trade, I used statistical packages like OSIRIS and SPSS during my college days to conduct public policy research. I still remember most of the basics.

 

I read an article just yesterday, summarizing the results of that one large study of Truvada as PrEP. They said that, among the group who took the drug at least 4 times/week, there were no seroconversions, for an infection rate of substantially zero. I have been dithering about this for a year and a half and I have decided to opt in. I emailed my doc yesterday and am going in today for the baseline testing.

[+ quoththeraven]

Reposting on this thread to say that I've since learned that those exposure statistics (risk of contracting HIV out of every 10,000 exposures) are based on data regarding or assuming the other person is HIV positive. Also, to repeat, the chart is from the CDC. Note that the riskiest activity is direct blood-to-blood transfer (aka blood transfusion). In a world where 95% confidence intervals are considered sufficient, any given sex act, engaged in once, isn't associated with a high degree of risk.

[Guest]

A study just came out in JAMA a week ago in which they gave PrEP to a large group in Africa, and they found it useless, but the compliance was pretty low. For PrEP to work, it really has to be taken pretty religiously.

[+ quoththeraven]

Here's a link to a well-written and well-reasoned critique of the ethics of PrEP trials:

 

The Cost of Science: Knowledge and Ethics in the HIV Pre-Exposure Prophylaxis Trials, Cindy Patton and Hy Jin Kim, published online in Bioethical Inquiry in 2012

 

Overall, this is a critique of the ethical decisions behind the trials, not primarily the validity of the results, although questions are raised about the applicability of the main study, iPrEX, to populations in the US when so much of the study was conducted elsewhere. In the course of demonstrating that the 44% reduction shown in the iPREX results is marginal because it's not that much of an improvement over placebo, in large part because the seroconversion rate over the study period wasn't that high to begin with, the paper examines the statistics about risk:

 

Most people have no idea what the "normal" rate of infection is among highly sexually active men who have sex with men (MSM) who have unprotected sex in a context in which HIV prevalence is already well-established. In fact, it is almost impossible to know prevalence or new infection rates with any precision, since no one knows how many men are having sex with men, how many new men join this group each year, nor how many of these men are engaging in sexual practices that could result in HIV transmission. As suggested in the previous section, no one should be shocked that PrEP works to some degree, but the efficacy of PrEP is heavily dependent on whether an individual takes a high enough dose consistently. But "to some degree" is a fairly low success rate on which individuals might base decisions about how to avoid contracting HIV. The marginal utility of PrEP is fairly unimpressive; this can be seen if one looks closely at the actual study results. In the iPrEX placebo group, the infection rate was 5.2 percent over the study period (144 weeks), or about 1.9 percent per year [footnote and citation omitted] -- only slightly higher than the 1.6 percent rate typically used by modeling teams as an estimate of annual risk for "high risk" gay men [citation omitted]. The iPrEX treatment group's seroconversion rate was 2.9 percent over the same time frame, or about 1.05 percent annually. Those averted infections would certainly add up at the level of whole populations, but in everyday terms, the touted 44 percent reduction (the difference between the non-annualized figures of 5.2 percent and 2.9 percent) actually only amounts to less than one person in 100 per year.

 

The above not only confirms that it's impossible to know prevalence or new infection rates with any precision, which is my problem with the study discussed in this thread: http://www.companyofmen.org/showthread.php?102784-The-Puzzling-Link-Between-HIV-Diagnoses-And-Craigslist, but it suggests that PrEP may not make that much of a difference at the individual level. The study goes on to outline the side effects and concludes:

 

If one wanted to put all of these numbers into a package that might be useful to an individual who was consideringi PrEP, one might say that, of every 100 people taking PrEP, less than one per year will have avoided contracting HIV, while between 10 and 12 of these 100 individuals (98 of whom would not have contracted HIV even without PrEP) will have experienced a worrisome symptom, some of which (5.5 and 3.5) will turn out to be indpendent of Truvada but assessing the cause of this symptom will require aditonal medical investigation by their doctros. Of course, a person would have to read widely to gather sufficient information to make a choice in this way.

 

The side effects may ultimately prove lower in well persons, or the next round of studies might find that less toxic anti-virals have the same marginal utility as Truvada. But as long as Truvada remains the new standard of care in PrEP, or unless the FDA allows new side-effect labeling for the use of PrEP in HIV-negative persons, clinicians will have to help their patients make sense of the current consumer warning ....

 

In addition to questioning the ethics of treating HIV negative persons to prevent further infection at the expense of their HIV positive partners who were not receiving any treatment (the design of the PARTNER study, conducted in various African countries), the study challenges the assumption that educating men on condom usage has failed as a way of avoiding HIV infection:

 

The most compassionate argument for use of a mildly toxic drug as a means of preventing HIV in seronegative men, and one premise of the iPrEX trial, is that gay men are either collectively experiencing condom fatigue or individual men are simply unwilling to practice safe sex. In research ethics terms, this is an assertion that the standard of care for gay men's sexual health promotion -- education, community development, counseling, condom availability -- has failed in general, or that specific kinds of gay men ("high-risk") are recalcitrant to those longstanding and effective health interventions. This is important because researchers must show why a new intervention need not be compared with the current standard but can instead be tested against a placebo or "treatment-as-usual" scenario. Assessment of the ethics of using a placebo is more complicated in cases where a behavioral intervention is compared to a drug, and while trials of this kind are not unknown, they usually involve adding an enhancement onto an existing treatment or intervention for people who already have a condition or disease, not replacing a successful health promotion strategy with drugs for people who are well. Whether they found themselves required to offer counseling, condoms, and support to research subjects because it would be unethical to only offer them drugs, or whether the researches actually designed the study to compare behavior-change intervention with placebo to behavior-change intervention with drug, is unclear. The research reports suggest that the former is the case, since there is no attention to measuring inter-site fidelity in the administration of behavior-change activities [citation omitted].... Thus, given the questions the MSMGF findings raise about whether gay men are getting much support in their efforts to reduce risk ... it is hard to judge whether the trail subjects had previously received sufficient education and support to judge them recalcitrant to safe-sex advice [citation omitted]. In fact, the descriptors of the men in the study and the criteria used to recruit them suggest that they are a lot like the men who responded to the MSMGF survey, and not "recalcitrant" or "fatigued" but simply unsupported.

 

I have no way of knowing if she's right about that or not. That would require, among other things, an examination of the conduct of the studies that have shown non-usage of condoms by men who have sex with men. But her point is well-taken.

 

That doesn't mean Truvada is useless or that no one should take it. But it does put a somewhat different spin on its usefulness than the raw data might suggest.