Continuing PrEP discusion

[Guest ChrisW]

I was pretty moved that a public official disclosed there health status for the sake of the community. PrEP isn't for everyone but as sexually active men who have sex with men its something we should all consider.

 

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

[rvwnsd]

The CEO of Chicago House, who happens to be an Episcopal priest, beat him to it:

 

http://myprepexperience.blogspot.com/2014/08/episcopal-priest-and-ceo-of-chicago.html

 

 

There are several good reads on My Prep Experience. It even has a section on insurance plans' coverage procedures:

 

http://myprepexperience.blogspot.com/p/truvada-track.html

[manTOman]

Hey Chris,

Is it mandatory to get screened for STDs in order to continue PREP prescription, and how often is this done? Monthly?

Another issue I have is that if someone tells me they're on PREP, I have to take their word for it, not only that they're actually on it but that they take it every day.

To me that is as bad as believing someone when they say they're negative. That's why I'm sticking with a condom.

[rguer]

Hey Chris,

Is it mandatory to get screened for STDs in order to continue PREP prescription, and how often is this done? Monthly?

 

You must have an initial HIV test; Truvada alone is not appropriate for treatment of an existing infection, so they need to know you're not already seropositive. That's a quick blood test, takes half an hour or so to get the results. After you're on Truvada, the period between tests seems to vary by location. The manufacturer recommends at least every 90 days; some prescribers initially required restesting every 30 days, but that seemed to be counterproductive.

 

http://www.towleroad.com/2014/04/medi-cal-increases-accessibility-of-truvada-eliminates-monthly-hiv-testing-requirement.html

http://www.hivplusmag.com/opinion/2014/04/29/factually-deficient-screed-prep-harms-efforts-prevent-new-infections

http://www.aidsmap.com/Efficacy/page/1746573/

 

Another issue I have is that if someone tells me they're on PREP, I have to take their word for it, not only that they're actually on it but that they take it every day.

To me that is as bad as believing someone when they say they're negative.

 

Yes, it is just as bad. But look at the name - Pre-Exposure Prophylaxis. Someone who is already infected is not "pre-exposure". PrEP is intended to protect the person who is taking it from becoming infected. If you want that protection, take it yourself.

 

That's why I'm sticking with a condom.

 

Condom use is good. Using condoms and Truvada is better if you're in a high-risk group. A professional like Killian James might use condoms every time, and never have condoms break (because he knows how to use them) but in the general population there is not 100% adherence.

[rguer]

but nothing is getting through latex when used properly.

 

The CDC says "condoms may not fully protect you from getting herpes". I think that's also true for HPV.

 

Truvada does provide some (about 36%) protection against herpes infection. That's another reason to take it if you're sexually active, even if you're using condoms.

 

http://www.cdc.gov/std/herpes/stdfact-herpes.htm

http://www.webmd.com/hiv-aids/news/20140630/hiv-prevention-drug-truvada-might-lower-genital-herpes-risk-too

 

I did not find any studies showing that Truvada reduces HPV risk, but the HPV vaccine is very effective.

[+ Funguy]

The CDC says "condoms may not fully protect you from getting herpes". I think that's also true for HPV.

 

Truvada does provide some (about 36%) protection against herpes infection. That's another reason to take it if you're sexually active, even if you're using condoms.

 

http://www.cdc.gov/std/herpes/stdfact-herpes.htm

http://www.webmd.com/hiv-aids/news/20140630/hiv-prevention-drug-truvada-might-lower-genital-herpes-risk-too

 

I did not find any studies showing that Truvada reduces HPV risk, but the HPV vaccine is very effective.

 

One of the reasons condoms do not "fully" protect you from contracting HPV is that there is a lot of genital contact prior to putting on the condom. Same with herpes.

 

Yes, the HPV vaccine is very effective and highly recommended.

[rvwnsd]

A couple of days ago I discussed PrEP with my doctor and then reviewed my insurance company's protocol for receiving approval for coverage.

 

My doctor stated that the protocol is an exam and initial set of blood work, including an HIV test, to determine whether the patient is a candidate for the drug. Obviously, the patient must be HIV -. However, he also needs to have good kidney and liver functionality. He then needs to have follow-up blood tests every three months to ensure 1) he remains HIV -, 2) his kidney and liver functionality remains good and 3) there are no other adverse effects that can be revealed in blood work and/or a general examination.

 

The insurance company requires a prior authorization in order to cover the drug. Before authorizing, they require the pre-medication blood work and certification from the primary care physician that the patient has undergone sexual health counseling and instructions on the correct use of the drug. (My doc said that his chat about the importance of using condoms in addition to PrEP and the instruction that the drug must be taken every single day without fail is sufficient) They will approve the drug for six months and then renew the authorization for another six months if the follow-up blood work is performed.

[Steven_Draker]

However, he also needs to have good kidney and liver functionality. He then needs to have follow-up blood tests every three months to ensure 1) he remains HIV -, 2) his kidney and liver functionality remains good and 3) there are no other adverse effects that can be revealed in blood work and/or a general examination.

 

Good point, rvwnsd.

 

For more details on weighing risks of TDF/FTC PrEP side effects in people without HIV: http://www.companyofmen.org/showthread.php?99844-Weighing-Risks-of-TDF-FTC-PrEP-Side-Effects-in-People-Without-HIV

[Steven_Draker]

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

 

There are several flows with that article, the first one being the link about "condom failure rate" redirects to "birth control", "contraception" and "unintended pregnancy" page which is hardly useful when talking about gay men.

 

 

From AVERT:

 

Are condoms effective at preventing HIV and sexually transmitted infections (STIs)?

 

Studies into the effectiveness of condoms have shown that if a latex condom is used correctly every time you have sex, this is highly effective in providing protection against HIV.

 

The evidence for the effectiveness of condoms is clearest in studies of couples in which one person is infected with HIV and the other not (discordant couples). In a study of discordant couples in Europe, among 123 couples who reported consistently using condoms, none of the uninfected partners became infected. In contrast, among the 122 couples who used condoms inconsistently, 12 of the uninfected partners became infected. A recent review of 14 studies involving discordant couples concluded that consistent use of condoms led to an 80% reduction in HIV incidence.

 

In addition, correct and consistent use of latex condoms can reduce the risk of other STIs, including chlamydia, genital herpes, gonorrhea and syphilis.

 

The male latex condom is the single, most efficient, available technology to reduce the sexual transmission of HIV and other sexually transmitted infections.

 

How often do condoms fail?

 

“The main reason that condoms sometimes fail is incorrect or inconsistent use, not the failure of the condom itself”

 

There is no one answer to this, as different studies have shown different results. Many studies of condom effectiveness have counted how often women have become pregnant when their partners have used condoms for birth control. This "failure rate" includes cases where the couple did not use a condom every time they had sex, or they did not use the condom correctly. Some studies have included the times the condom was torn accidentally by people using it.

 

The main reason that condoms sometimes fail to prevent HIV/STI infection or pregnancy is incorrect or inconsistent use, not the failure of the condom itself. Using oil-based lubricants can weaken the latex, causing the condom to break. Condoms can also be weakened by exposure to heat or sunlight or by age, or they can be torn by teeth or fingernails. Also, remember to check the expiry date of your condom!

 

How often do condoms break or slip off?

 

A large body of research in the United States has shown that rates of breakage, caused by fault in the condom itself, are less than 2 condoms out of every 100 condoms. Studies also indicate that condoms slip off the penis in about 1-5% of acts of vaginal intercourse and slip down (but not off) about 3-13% of the time.

 

Various studies have shown that knowledge and familiarity with the use of condoms reduce the likelihood of condom breakage and slippage during sex. A major factor that can lead to a condom breaking or slipping off during sex is it's size, as this can affect how easy it is to put on and how likely it is to stay on. Different sizes of condoms are available, and it is important to make sure that the condom being used is the correct fit.

 

source: http://www.avert.org/condoms-effectiveness.htm#sthash.f4xL6Rmx.dpuf

[rguer]

My doctor stated that the protocol is an exam and initial set of blood work, including an HIV test, to determine whether the patient is a candidate for the drug. Obviously, the patient must be HIV -. However, he also needs to have good kidney and liver functionality. He then needs to have follow-up blood tests every three months to ensure 1) he remains HIV -, 2) his kidney and liver functionality remains good and 3) there are no other adverse effects that can be revealed in blood work and/or a general examination.

 

I misspoke - Truvada for PEP requires only an HIV test; Truvada for PrEP requires the additional steps you describe.

 

Not all insurers require pre-authorization.

[rguer]

From AVERT:

 

Are condoms effective at preventing HIV and sexually transmitted infections (STIs)?

 

Studies into the effectiveness of condoms have shown that if a latex condom is used correctly every time you have sex, this is highly effective in providing protection against HIV.

 

The evidence for the effectiveness of condoms is clearest in studies of couples in which one person is infected with HIV and the other not (discordant couples). In a study of discordant couples in Europe, among 123 couples who reported consistently using condoms, none of the uninfected partners became infected. In contrast, among the 122 couples who used condoms inconsistently, 12 of the uninfected partners became infected. A recent review of 14 studies involving discordant couples concluded that consistent use of condoms led to an 80% reduction in HIV incidence.

 

12 out of 122 is more of a failure rate than I like. It's the failure rate with actual compliance that counts, not the failure rate in a perfect world where everyone uses a condom every time and the condom never breaks or slips.

 

The goal is risk reduction. Both condoms and PrEP reduce risk.

[Steven_Draker]

12 out of 122 is more of a failure rate than I like. It's the failure rate with actual compliance that counts, not the failure rate in a perfect world where everyone uses a condom every time and the condom never breaks or slips.

 

In a perfect world there would be NO STIs and no condoms. :-)

 

But more importantly, it isn’t about the failure of condoms themselves to prevent STIs, it’s about the failure of people to use them!

 

 

Now, how effective are condoms?

 

How effective are condoms? That varies due to a number of factors. Some are described above. If the condom isn’t used correctly, is damaged, tears during sex, the protection afforded is very low.

 

But if condoms are used correctly, how effective are they?

 

If we just look at data that is concerned with condom use to prevent STIs (and not focus on condom use to prevent pregnancy) the data shows a fairly wide range of efficacy. The reasons for that include the following.

 

Much of the data is based on self-reporting from volunteers in the studies. So the accuracy of that information depends on how truthful the subjects in the study are. One study showed that men who reported that they used condoms might only use them about 60% of the time. Another study that quizzed men who reported using condoms found that, at times, they may have used condoms incorrectly >40% of the time. So the data from similar studies may differ solely because of the accuracy of the people involved in the study.

 

Another point that can add to different efficacy rates is that many of the parameters in various studies differ. Some studies are done using male-female couples having penile-vaginal intercourse only. Others are done on man who have sex with men (MSMs) who have penile-rectal intercourse. Other studies include both groups. A few look at how much knowledge the couples have about condom use; many don’t look at that at all. A few studies looked at serodiscordant (one member HIV positive, one HIV negative) couples. Some look at only how well condoms protect against just HPV or just syphilis or just hepatitis. Others looked at how well condoms protect against viral STIs but not STIs caused by other organisms. Therefore, the data can be bewildering unless the methods of the individual study are reviewed as well as the numbers.

 

Because of the above, and a few other reasons, some the information that I present below is drawn from the World Health Organization (WHO), National Institutes of Health and the United Nations, which looked at large number of condom studies. In additions, there are also some individual studies with interesting and somewhat unsettling information included.

 

First, let’s look at condoms to stop the heterosexual transmission of HIV

 

In heterosexual serodiscordant couples:

 

...

 

So consistent condom use did reduce HIV transmission, but only between about 80% to 87%. And the reduction in risk could be as low as 35-60%.

 

A word about efficacy vs. relative risk reduction. Relative risk reduction is reduction in the absolute risk based on some intervention (e.g., using condoms), expressed as a percentage of the whole exposed group before the intervention.

 

But efficacy is the extent to which something is effective in meeting its objectives under ideal conditions. Ideally, the intervention would be 100% effective.

 

 

Condom use among MSM/gay men

 

The fastest-growing subset of HIV cases in the US is found in young MSMs (teens through twenties), especially in African-Americans. How well do condoms protect them?

 

The data from Alberta reported by Genuis (massive promotion of condoms followed by upsurges in gonorrhoea and chlamydia) are mirrored in Spain. Spain, together with Greece, stands out as the European country with the highest levels of condom use among young people, with 90% of sexually active young people reporting using a condom the last time they had sexual intercourse. Nevertheless, the rates of sexually transmitted infections (STIs) are increasing year after year, despite more than a decade of intensive official educational campaigns transmitting the message to young people that condoms and only condoms are the magic bullets to prevent all STIs and unintended pregnancies.

 

Education about condoms and successful compliance with their use by young people is not decreasing STIs in these two countries. In fact, the reverse is true. As condom use increased, so did rates of transmission of STIs.

 

Condom use in adults and young adults.

 

Now, how about condom use in adults and young adults:

 

The main problem with condoms is that average people, particularly aroused youth, do not use them consistently, regardless of knowledge or education. Although condoms offer some protection against discharge related infections such as chlamydia and gonorrhoea, protection is usually compromised by compliance issues, incorrect use, or mechanical failure.

 

In theory, condoms offer some protection against sexually transmitted infection; practically, however, epidemiological research repeatedly shows that condom familiarity and risk awareness do not result in sustained safer sex choices in real life. Only a minority of people engaging in risky sexual behaviour use condoms consistently. A recent study found that less than 8% of couples discordant for herpes used condoms for each sex act, despite ongoing counselling. Even among stable, adult couples who were HIV discordant and received extensive ongoing counselling about HIV risk and condom use, only 48.4% used condoms consistently. Irregular use of condoms will not provide sustained protection against sexually transmitted infection.

 

The relentless rise of sexually transmitted infection in the face of unprecedented education about and promotion of condoms is testament to the lack of success of this approach. In numerous large studies, concerted efforts to promote use of condoms has consistently failed to control rates of sexually transmitted infection—even in countries with advanced sex education programmes such as Canada, Sweden, and Switzerland. In my home province of Alberta, rates of chlamydia and gonorrhoea have tripled since 1998 despite ubiquitous “safer sex” education. The ongoing assertion that condoms are “the” answer to this escalating pandemic reminds me of Einstein’s words, “The definition of insanity is doing the same thing over and over again and expecting different results.”

 

Reports of diminished rates of sexually transmitted infection as a result of widespread condom use in countries such as Thailand and Cambodia are reinforcing the focus on condoms as the primary strategy. Careful scrutiny of the data, however, suggests that changes in sexual behaviour (fewer partners, less casual sex, and less use of sex workers) after mass educational campaigns rather than widespread condom use by ordinary citizens was instrumental in reducing infection rates.

 

It appears that people don’t want to use condoms in spite of education. In fact, a few countries tried providing free condoms to their citizens. Briefly, the use of condoms skyrocketed. But in less than two years, the increase diminished to back to near baseline levels of use. The investigators inferred that perhaps condoms were a novelty or fad and once that wore off, people were no longer interested in using them.

 

So, technically, this isn’t the failure of condoms themselves to prevent STIs, it’s the failure of people to use them (or to use them correctly.)

 

 

In a study done for the United Nations on reduction of HIV transmission done on heterosexuals, gays and bisexuals:

 

According to a meta-analysis commissioned by UNAIDS, condom use is 90% effective in preventing transmission, and condom use has been a key element in reductions in HIV prevalence in many countries. [AUTHOR’S NOTE: This meta-analysis and the data upon which it was based were done years before PrEP was available as a possible alternative. That is, no head-to-head study of PrEP v. condoms could be done at that time.]

[. . . ]

But, where the epidemic is largely heterosexual and widespread, evidence on the effectiveness of condom programs has been more mixed and less clear. In Uganda, while it is clear that condoms have played a role in lowering infection rates, reducing the number of sex partners appears to have played at least as large a role. In other words, condoms should not be seen as distinct from other strategies but as an integral part of comprehensive strategies that also counsel abstinence and reducing the number of sexual partners.

 

Interestingly, another similar study, not a meta-analysis, done in 2005, showed that HIV rates were successfully reduced by 82% by condom use. Again, this study used gays, bisexuals and heterosexuals as subjects.

 

So, where does this leave us? How effective are condoms in preventing STIs?

 

Condoms do provide protection from infection with STIs.

 

As described above, it is difficult to show the exact efficacy because of the factors previously described (correct use of the condom, methodology of the studies, etc.) It seems that much of the data shows that, with correct and at least very frequent use, condoms may be able to decrease transmission of STIs by somewhere around 80-90% depending on the physical characteristics of the STI in question.

 

Can condoms help to protect against getting an STI like HIV? Yes, if they are used and used correctly.

 

Are they being used frequently and correctly? No.

 

source: http://americablog.com/2014/05/well-condoms-actually-work-tricky-question.html

[manTOman]

Don't want to start another PREP thread, and it definitely falls under a continuing discussion...

 

Recently an escort who advertises as safe only, told me in an email that he doesn't mind BBing, but that he's always safe since he's on PREP.

Is this a new "safe"? It's like revisiting the term "sexual relations" from the Clinton era.

 

On the other hand, I also applaud his honesty, since I know that many escorts keep such info hidden.

 

So is this a deal breaker for you guys? What's the difference between him and a guy who lies about it? And he is taking some precautions, even though I'm personally uncertain of efficiency of his "safe" practices.

Call me archaic, since I'm still a firm believer of traditional methods, and in no way am I considering forgoing a condom regardless of what any guy tells me, but I was a bit dumbfounded by his honest belief that he wasn't putting himself at risk at all.

 

Sorry to bring this back, but it's a really intriguing topic, and it keeps popping up.

[armadillo]

Truvada is a step in the right direction. I just hope the disease does not become drug resistant, and come back with stronger strains. That's what going on with Tuberculosis.

 

****Everyone should continue to practice safer sex****

[Steven_Draker]

Since you cannot control what an escort do with every client or in his personal life, you have to assume that every sexual partner you're with may be a carrier of a sexually transmitted infection. Some may not even know it.

 

It doesn't matter what an escort tells you, you need to protect yourself and take things seriously regarding your health.

 

Don't hesitate to discuss openly safe sex practices and require the protection level that feels right for you, manTOman.

 

“No one can take better care of you than you yourself.”

 

[armadillo]

""Does PrEP protect against other STIs besides HIV?

 

No, PrEP does not protect against other STIs. PrEP only reduces your risk of getting HIV.""

 

http://men.prepfacts.org/the-questions/

[manTOman]

Just to make clear I'm not debating if I should trust the guy or not. As a matter of fact I do trust that he's on Truvada. I don't know if he takes it every day as he should, but even if I knew that was the case, I would still warp it up. I'm not on it, and probably even if I was I would still wrap it up. I just like myself that much.

 

Armadillo, I'm afraid too, that the pill is getting abused by both the porn industry and escorts, and that the virus might mutate and then we'll be back to square one. And since it doesn't do anything to other STIs, it might bring more of all that fun stuff back into vogue. However, we as humans love to fuck things up, and have gotten pretty good at it throughout history, so that's not going to change anytime soon.

 

I am just surprised that the BB situation has changed that much in such a short time.

[rvwnsd]

...Not all insurers require pre-authorization.

 

True, but many do. United Healthcare, which is the largest single health insurance carrier in the US, and Aetna both require a prior authorization. Given the wording of their policy (which repeatedly references Truvada used alone, not in conjunction with other anti-virals for the treatment of HIV, and not for PEP) I suspect they require the prior authorization to make sure the pre-treatment blood work and exams have been administered, not because they intend to deny coverage. The last thing they want is a patient who has undetected kidney disease taking Truvada and developing kidney failure.

[rguer]

""Does PrEP protect against other STIs besides HIV?

 

No, PrEP does not protect against other STIs. PrEP only reduces your risk of getting HIV.""

 

http://men.prepfacts.org/the-questions/

 

Well, that depends on who you ask. Some studies show a reduced risk of contracting HSV-2. Not a huge reduction, but non-zero.

 

http://www.hivplusmag.com/prevention/2014/07/02/study-truvada-prep-shown-lower-herpes-infection-rates

http://www.medicaldaily.com/combination-drug-hiv-prevention-could-also-treat-herpes-who-really-benefits-291020

http://annals.org/article.aspx?articleid=1884529

 

Also, there's this on the web site you cited: "This website was supported by funding from Gilead Sciences, Inc. Gilead is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need. Gilead’s portfolio of marketed products includes the only complete treatment regimens for HIV infection available in a once-daily single pill and the first oral antiretroviral pill available to reduce the risk of acquiring HIV infection in certain high-risk adults."

 

The FDA doesn't like manufacturers to make off-label claims for prescription drugs. Gilead itself couldn't say that Truvada helps prevent HSV-2 without getting into trouble, and funding a program that makes that claim wouldlook suspicious.