Who would find a daily pill to prevent HIV “too inconvenient” to bother?

Much of the information presented here is from “AIDS 2014″ International AIDS Conference taking place in Melbourne, Australia.

iPrEx OLE
iPrEx was one of the studies done on using the PrEP (Pre-exposure Prophylaxis) drug combination of tenofovir-emtricitabine. iPrEx OLE was an extension of that study.

IPrEx OLE is unusual in a couple of ways. In general, most research trials enroll a number of patients. About 50% of the enrollees are randomly assigned to be given the study drug, the other 50% get a placebo. Almost always, neither the patients nor the investigators know which patients are getting the drug and which are getting placebo.

In iPrEx OLE there were two important differences. About 1700 participants were enrolled worldwide. These were either men who had sex with men (MSMs) or transgender people who had sex with men. All participants were allowed to choose which arm of the study (medication or placebo) that they wanted to be in. About 75% chose to take PrEP and the remaining 25% chose to not take PrEP. So all of the volunteers and investigators knew who was getting the drug and who wasn’t. So they weren’t blinded to that fact.

Researchers monitored how frequently the participants used condoms. Interestingly, the non-PrEP group began to use condoms more frequently than they had before enrolling in the trial. And the group that was taking PrEP? They started using condoms more frequently, as well. So both those taking tenofovir-emtricitabine and those not taking the drug increased condom use. So, in spite of fears to the contrary, it seems that those who use PrEP also increase condom use, not decrease condom use as was hypothesized.

Researchers also found that the people who chose to try PrEP and took it on a regular basis (if not daily, as directed) had the following characteristics:

  • They tended to be older (not necessarily much older) than those who didn’t take PrEP.
  • They had more schooling.
  • They had a history of having more sexual partners.
  • They had a history of having had either herpes, syphilis of both.
  • They had a higher incidence of having been receptive to anal intercourse (they bottomed) without condom use.

Data from this, and a previous study showed that “effective” PrEP use was defined as volunteers taking their antiretroviral combination 4 or more days per week. So, even when patients didn’t take PrEP daily, as they should, most took it frequently so that they had high enough blood levels of the drug to prevent infection.

One other interesting fact. Investigators asked those who chose not to take PrEP, why they made that choice. About 50% said that they were worried about side effects of the drug. 14% said that they preferred other methods or prevention (e.g., condoms) — though the question remains, why did they prefer other methods? And about 25% said that taking a daily pill was too inconvenient.

After having seen the history of HIV/AIDS as it occurred I’m amazed that people would think that a single daily pill, that can prevent a terrible disease, would be “too inconvenient.” I can only imagine what those lived (or died) through the three decades when HIV was virtually unstoppable, would have given to have had access to an “inconvenient” medication like this.


Mark Thoma, MD, is a physician who did his residency in internal medicine. Mark has a long history of social activism, and was an early technogeek, and science junkie, after evolving through his nerd phase. Favorite quote: “The most exciting phrase to hear in science... is not 'Eureka!' (I found it!) but 'That's funny.'” - Isaac Asimov

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  • docsterx

    As I’ve written before, this is a blog post on a site that is not science-oriented. My post is not meant to be a primer on biostatistics, research protocols, drug studies. Readers who are interested in those subjects can find that information elsewhere. Not only didn’t I discuss bias, I didn’t discuss risk reduction, relative risk or other statistics tools that were used. I’ve found in the past that readers here seem to prefer not to be confronted with excessive definitions, statistics/mathematics. For those readers who would like more information I usually provide one or more links either to the original article or to discussions of the original article. If readers access those links, they can usually find the more detailed information that they are looking for.

  • docsterx

    Guest, this is the iPrEx OLE study.

    From the study data:

    “. . . drug levels varied by site [country where participants were living]: the
    proportion of participants with detectable drug in their blood varied from 83%
    in the USA to 62% in Ecuador, and in every country except the USA, adherence
    was better than it had been in the original iPrEx RCT.”

    “PrEP had no significant efficacy in people who
    took fewer than two doses a week [ i.e. only took 1 dose or fewer doses on average per week]. However, the efficacy of PrEP was 84%
    in people who took 2-3 doses a week [instead of the recommended 7 doses per week] – there was only one infection in this group – and no infections at all were seen in people taking at least four doses a week.

    This 100% efficacy translates into a minimum efficacy of 86% if the statistical uncertainty of the result is taken into account.”

    Also,

    “Professor Robert Grant, commenting on this [compliance with suggested drug dosing], said: “If people were at higher risk they took more PrEP and adhered to it better. I think this
    contradicts previous assumptions that people together enough to use PrEP
    would already be managing risk in other ways: it shows that people who
    are at risk can take reasonable and appropriate decisions on their own
    behalf.”

  • Julien Pierre

    trinu,

    I think you are confused. nicho was talking about people looking to get infected, ie. ” bug chasers”. Not about people who know they are positive and concealing their status.

    The bug chaser phenomenon exists, but I think it’s a very limited one, and should be treated as a mental health problem, not as a criminal issue. I have encountered some online, and they are open about asking to become infected. They aren’t going to get it from me. They might get it from someone else who complies with their requests, and in that case, they would be fullfilling their own wish.

  • Julien Pierre

    Unfortunately, PrEP is not a vaccine, so I don’t think the concept of “herd immunity” applies. You need a never-ending of supply of pills for PrEP to continue to work.

    Also, as far as the threat of HIV being non-existent, there are still 35 million people living with HIV worldwide. Not all of them are aware they have it, and not all of them are on treatment with a suppressed viral load.

    With no vaccine and no cure, I don’t think we will get to a world where the threat of HIV is non-existent.

  • Julien Pierre

    Isn’t there an alternative to Truvada for you if you can’t tolerate the side effects ? I wouldn’t put up with daily nausea. Fortunately, I tolerate Truvada very well. I don’t take it as PrEP either.

  • EvaKJones

    uptil I saw the draft 4 $5514 , I be certain
    that…my… cousin woz like actualey bringing home money parttime online. .
    there dads buddy has done this for only fourteen months and just cleared the
    dept on there appartment and purchased a great Fiat Multipla . read the article
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  • MPetrelis

    One of the issues I’m promoting as I campaign for San Francisco Supervisor for District 8, which includes the Castro, is pressuring AIDS Healthcare Foundation to stop lying about Truvada. Check out my campaign site about my recent effort involving that nonprofit:

    https://www.facebook.com/petrelis4supe8

  • Guest

    We need to know more about HIV/AIDs. For people living with HIV/AIDs, I would like to suggest __ PositiveChat.com __, a safe and private place to meet someone in the same boat for support, date and love.

  • http://heimaey.us/ heimaey

    I think that is much less popular than it used to be, but yes, scary indeed.

  • Indigo

    There’s a lot of potential in that development even if the behaviors are a little puzzling. The easy expression “too inconvenient” covers a multitude of peccadilloes and shouldn’t be taken too literally. Lazy is as lazy does, after all. That’s not really surprising.

  • SuperGuest

    Dr. Thoma states above “most took it frequently so that they had high enough blood levels of the drug to prevent infection.” Actually, according to the study, only a third of participants in the PrEP group took the medicine frequently enough for those blood levels. “One third” is quite a bit different than “most”. Compliance was “inconvenient” even for most of the PrEP users in this study. Not just those electing to be in the non-PrEP group. The majority of those electing to take PrEP (for free) did not take it effectively. For someone as myself who thinks PrEP has great potential, this is a huge concern. PrEP can be a useful tool, but the media reports of the research around it are often exaggerated or misrepresented.

  • Wilberforce

    Thank you. I’ve also learned from experience that condoms work, at least they have for me.
    It makes all this chatter offensive. We already know how to stop hiv. But we refuse to set adult standards in the community, and we give a pass to the nut jobs who make endless excuses for irresponsible behavior.

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  • WilmRoget

    We’ve already seen that the “official” standards for testing to ensure compliance are being loosened.

  • WilmRoget

    They knew they were in a study, and that they would be tested to see if they sero-converted. Take that element of ‘checking up on you’ out of it, and see what happens.

  • http://heimaey.us/ heimaey

    That’s why I go to a gay doc.

  • Shella Morris

    I Never believed i was ever going to be HIV Negative again,Dr Molemen has given me reasons to be happy, i was HIV positive for 2years and all the means i tried for treatment was not helpful to me, but when i came on the Internet i saw great testimony about Dr on how he was able to cure someone from HIV, this person said great things about this man, and advice we contact him for any Disease problem that Dr Molemen can be of help, well i decided to give him a try, he requested for my information which i sent to him, and he told me he was going to prepare for me a healing portion, which he wanted me to take for days, and after which i should go back to the hospital for check up, well after taking all the treatment sent to me by Dr Molemen, i went back to the Hospital for check up, and now i have been confirmed HIV Negative, friends you can reach Dr Molemen on any treatment for any Disease he is the one only i can show you all up to, reach him on (drmolemenspiritualt[email protected]) or call him on +2347036013351, Facebook page on (https://www.facebook.com/Dr.MolemenHerbs) Website at (http://drmolemenspiritualtemple.webs.com), God Bless you for your Good Work Sire

  • Shella Morris

    I Never believed i was ever going to be HIV Negative again,Dr Molemen has given me reasons to be happy, i was HIV positive for 2years and all the means i tried for treatment was not helpful to me, but when i came on the Internet i saw great testimony about Dr on how he was able to cure someone from HIV, this person said great things about this man, and advice we contact him for any Disease problem that Dr Molemen can be of help, well i decided to give him a try, he requested for my information which i sent to him, and he told me he was going to prepare for me a healing portion, which he wanted me to take for days, and after which i should go back to the hospital for check up, well after taking all the treatment sent to me by Dr Molemen, i went back to the Hospital for check up, and now i have been confirmed HIV Negative, friends you can reach Dr Molemen on any treatment for any Disease he is the one only i can show you all up to, reach him on ([email protected]) or call him on +2347036013351, Facebook page on (https://www.facebook.com/Dr.MolemenHerbs) Website at (http://drmolemenspiritualtemple.webs.com), God Bless you for your Good Work Sire!

  • Rambie

    Did you not even read the article?, the people taking PrEP *increased* their condom use too.

  • Mike_in_the_Tundra

    My doctor has done a lot of studying in order to better serve his gay patients. He does a really good job, but he could use a vocabulary lesson. I mentioned topping, and his face went blake. He got a quick lesson in tops and bottoms. He then asked me if all gay guys wanted to be tops.

  • Freday63

    I lost my first partner to AIDS in 1991. I entered into a relationship with an HIV positive man in 1993 who has since passed. In the years since, being selective, responsible and consistent with condom use has served me well. I see no reason to risk my liver so some CEO can buy a new Rolls or Lear Jet.

  • NCMan

    if a man doesn’t want to support a child for 18 years, he could use condoms instead of relying on women to be the responsible party for birth control.

  • http://heimaey.us/ heimaey

    That’s very Larry Kramer panicky. Remember when he was scared about the super-virus 10 years ago? Didn’t happen. That scenario is unlikely. Not impossible but unlikely.

  • nicho

    I worry that the casual and laissez faire attitude developing around PrEP and Truvada is going to produce a Truvada resistant strain.

    Most viruses are pretty crafty, and HIV is craftier than most. Also, there is the phenomenon that, thinking they are protected, PeEP users will take greater risks. Studies have shown that people who are on statins have increased their total caloric intake and their intake of fat, while non-statin users have not. And I shudder to think of the results of meth combined with PrEP.

  • John-Manuel Andriote

    Your point is well taken, that to prevent potential HIV infection the “inconvenience” of a daily pill should be easily overcome. But remember: Even people who are already infected with HIV often forget to take their medications if they are on them (a high proportion of those with known infection are not on medication at all as fewer than one in three have suppressed virus). Not only that, but issues related to depression, substance abuse, a chaotic lifestyle–or just plain running out of pills–also prevent full treatment adherence. So it’s important to remember there are other reasons besides resisting the “inconvenience” that people–not only those with or at risk for HIV, but people in general–often fail to take the medications that can literally save their lives.

  • http://heimaey.us/ heimaey

    Yeah, I worry about the side effects. I wonder if yours are worse because you’ve been living with HIV for a while, but I don’t know if that’s true or not. I think your voices are important and I’m still kind of undecided but mostly because I’m not sure it’s just not big pharma looking for more money.

  • http://heimaey.us/ heimaey

    My doctor told me to contact him only if I bottomed and a condom broke, not if I topped. The risk is there but it’s so low.

  • WilmRoget

    And again, the flaw in these studies remains – condom usage conceals the actual effectiveness of Truvada.

    “I can only imagine what those lived (or died) through the three decades
    when HIV was virtually unstoppable, would have given to have had access
    to an “inconvenient” medication like this.”

    Well, as a person living with HIV, who has lived through the three decades when HIV was virtually unstoppable, I am convinced the PrEP is a foolish risk backed by shoddy science and careless rationalizations. Of course, I’ve been on Truvada for years, and found that the toughest side effects did not show up for more than a year. But the daily nausea is a challenge I would forgo, if my body weren’t home to a rather nasty virus. And I would love for my kidneys not to be damaged from the med, so that I could use aspirin or NSAIDS when my arthritis acts up. Of course, I am grateful that Truvada is helping keep my viral load undetectable, and I want other people to have that option 5, 10, 15 years from now – so I worry that the casual and laissez faire attitude developing around PrEP and Truvada is going to produce a Truvada resistant strain.

    And I don’t think that it is a coincidence that PrEP steps into the spotlight at the same time so many advocates and individuals have largely given up on trying to curb unprotected sex, bare-backing.

  • nicho

    Well, when the man is on the hook for 18 years of child support eating into his salary that’s a huge hunk of money. To commit him to that against his will and without his informed consent is basically larceny. It should be illegal.

  • http://www.rebeccamorn.com/mind BeccaM

    Well, that might’ve been the answer ‘too inconvenient’ — but it’s also just one particular elicited response which may or may not accurately convey the actual reasons which are likely to be far more complicated and involve questions like:

    – How often am I going to have sex anyway? (And how much will I admit to…?)
    – What are the side-effects and is the Pharma company being honest about them? (Remember the miracle drug Thalidomide?)
    – How expensive is this going to be anyway?

    Human decision making is never so cut-and-dried as being exactly what they’ll say when asked, “Why don’t you want to take this pill every day for the rest of your sexually active life?” Nor will everybody be honest and forthright about the real reasons.

  • Mike_in_the_Tundra

    That is really just an anti-gay rule. A lot of gay men are going to know their HIV status, and most straight men will not know their status. Also, the tests on donated blood are very effective at detecting HIV.

    This can sometimes be carried to an extreme by Red Cross representatives. I had a very odd incident about 15 years ago, and perhaps it was because of the nurse not understanding the situation. I had to have surgery, and the surgeon recommended having two pints of my own blood on standby. He sent me to a Red Cross donation center. The nurse asked me if I had ever had sex with a men. I said yes, and she told me I couldn’t donate to myself. I left and contacted the surgeon. He was eventually able to straighten things out.

  • http://wicca.com/celtic/wicca/wicca.htm Colin

    Taking a daily pill to prevent the plague inconvenient ? That tells me that many have become too comfortable with this monster being around.

  • trinu

    That’s a pretty common perception. The FDA bans monogamous gay men from donating blood because of the supposed HIV risk, but they allow promiscuous heterosexuals donate.

  • trinu

    I really don’t see how that follows. In one case we would be talking about knowingly exposing your partner to a disease, in the other we would merely be talking about a woman’s right to do with her own body as she wishes (not that I morally condone going off the pill without informing your partner, I just don’t think it should be illegal).

  • trinu

    That wasn’t the case here.

  • nicho

    Oh, many of them are doing it quite openly. Following your logic, we should arrest women who go off the pill without informing their partner.

  • http://musephotos.wordpress.com/ GarySFBCN

    Many have no idea that they are infected with HIV.

  • trinu

    I know this is unpopular, but people who do that should be arrested. If they’re having sex without telling their partners about their HIV, they are not getting informed consent.

  • Hue-Man

    They assume wrong: CDC says if a male has vaginal sex with an HIV+ female partner, his infection risk is 4 in 10,000 exposures. http://www.cdc.gov/hiv/policies/law/risk.html

    As I’ve mentioned before, this is the risk exposure that has been justified for circumcising all males worldwide.

  • http://musephotos.wordpress.com/ GarySFBCN

    I agree. And taking it a step further, I’m wondering if there would be greater adherence and less stigma among young men who have sex with men (or any “target population”) if PrEP was a global strategy for everyone at risk,

    And at some point, we could see something similar to the dynamics involved with “herd immunity” – creating a world where the threat from HIV is almost non-existent.

  • nicho

    One sad cohort in that group are the guys who are looking to be infected. That’s a minority, but it’s very scary. As one young guy explained it gleefully online “Now, I don’t have to get tested every six months and I don’t have to use condoms.”

  • nicho

    That’s plausible, but you’d think they would still want to prevent what little transmission there is. In fact, that sort of transmission is more tragic. Any young gay man today who is having unprotected sex knows exactly what risk he is taking — unless of course he’s been living in a cave (and gay men simply will not live in caves). The wife or girlfriend of a guy she thinks is (a) heterosexual and (b) monogamous is unaware of her risks.

  • http://musephotos.wordpress.com/ GarySFBCN

    Everything I’ve read indicates that overall HIV transmission rates are coming down. The only group that shows an increased rate of infection is young men who have sex with men.

  • http://musephotos.wordpress.com/ GarySFBCN

    I believe their justification can be found in the WHO press release: “Young MSM” was the only demographic group that showed increased rates of infection. All other groups showed decreases (I think the time period was 2000-2011).

  • nicho

    I’m still not sure why they don’t recommend this for “women who have sex with men.” People assume that men having heterosexual sex can’t be infected with HIV, when they’re probably at risk. The husband or boyfriend hitting the baths or the pickle park on the sly is probably not taking the best precautions. Or the older man boinking the elderly next door lady may also be getting it on with prostitutes.

  • http://parkandbark.wordpress.com/ Houndentenor

    I remember reading Gabe Rotello’s book when it came out. It gave me a better understanding of epidemiology overall and why HIV transmission rates were not coming down. On an individual level this is not going to work for everyone. On a larger scale, a significant reduction of transmission of HIV among the most sexually active people (or others at risk) would have a dramatic effect on the population at large.

  • nicho

    Why people do or do not take necessary medication is problematic and should be studied more. A recent study among heart patients showed that if the color or shape of the pill changed, a significant number of people would stop taking their meds. If the color changed, 34 percent would stop taking it, and if the shape changed, 66 percent would stop taking it. And this was among people who had previously had heart attacks and the drugs were designed to prevent another heart attack.

    http://www.washingtonpost.com/national/health-science/if-color-or-shape-changes-patients-more-likely-to-stop-taking-much-needed-drugs/2014/07/14/60e687f4-0b8c-11e4-8341-b8072b1e7348_story.html

    I’m guessing the compliance rate is lower when the drug is preventative, rather than therapeutic. But even with therapeutic drugs, people will stop taking them once they feel better, which is why a lot of people stop taking antibiotics before the infection is completely beaten down — leading to drug-resistant forms of disease.

  • http://musephotos.wordpress.com/ GarySFBCN

    In general, I think PrEP is good strategy for many. I’m concerned about Gilead’s price gouging on Truvada as well as their Hep C ‘cure’.

    But I have to ask: How is this data valid if participants were allowed to choose “medication or placebo” ?

    And because the conclusions reports on “behavior” beyond the medication use, and that undoubtedly relied upon self-reporting by participants, reviewing incidence of non-HIV STD infections among study participants and comparing that with baseline STD infections rates in a similar population would be more assuring.

    That said, while I know that STDs can have life-long affects and can sometimes be life-threatening, the need to discuss condom use in a study of HIV prevention medication efficacy is nothing more than a distraction to satisfy the ‘slut-shaming’ crowd.

  • nicho

    Most people — not just young men — are lousy at dealing with probability and relative risk.

  • http://heimaey.us/ heimaey

    Men are weak.

  • percysowner

    In the straight world women have to (are currently permitted to) do this to prevent pregnancy and they too forget or can’t be bothered. So it’s sort of a human thing. Part of the issue may be that the guys are younger. When you get older you suddenly have to take pills for blood pressure, or cholesterol so throwing in one more pill is no big deal. I had an underactive thyroid, so I was taking pills daily anyway. Tossing in BC with thyroid made it easier to remember both.

  • NYMama

    Young men don’t seem to be very good at risk-benefit analysis. Perhaps this is why there are no oral contraceptives for men–and why many women say they’d still use birth control even if there were.

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