Promising HIV Preventative Failed, It Turns Out, Because Patients Were Not Taking It

By Veronique Greenwood | March 12, 2012 12:03 pm

Last April, we reported on the failure of Truvada, an oral anti-HIV pill, to prevent infection in African women. The results of the trial were disappointing, and surprising, because Truvada had been found to prevent infection in 90% of gay men who took it religiously. We pointed out at the time that the researchers had yet to analyze blood samples they’d taken from the women in the study. Those samples would show whether the women had been taking the drug as prescribed, which would suggest that its failure was due to some biological factor, or whether they had been failing to take the drug.

It looks like it’s the latter. This week, the NYTimes reports, the researchers announced at an AIDS research conference in Seattle that of the women who got infected, only a quarter of them had any Truvada at all in their blood.

The fact that nonadherence, rather than biological factors, caused the drug fail is important to know. Truvada might one of a large number of therapies that can help if taken properly but meet with clear failure when they are not. Antibiotics for tuberculosis, for example, are very effective if a regimen is completed, but patients frequently fail to take all the pills, because they start to feel better or because they just forget, something we can all sympathize with. These failures result in prolonged illness and in the creation of multidrug-resistant tuberculosis strains. For that reason, one of the most important breakthroughs in tuberculosis treatment in recent decades is making patients report to clinic to take their pills while a nurse or doctor is watching.

Why the women were not taking Truvada is the next puzzle the researchers will have to investigate. Could it be that stigma of AIDS makes having a bottle of anti-HIV medication around the house socially awkward? Or did these healthy women not have a strong enough impetus to take the drug? As the example of tuberculosis shows, getting people to take medication—especially, perhaps, medication that’s meant to prevent infection rather than cure it—can be as big a hurdle as developing a drug that works in the first place.

CATEGORIZED UNDER: Health & Medicine
  • Windygirl

    They need to make these drugs implantable.

  • njem

    This seems like “social science fail” in the experiment design. From what I understand, most women contract HIV from bi or gay male partners with whom they are monogamous, but who are themselves *not* monogamous — the men are usually cheating on the women. These women don’t expect to be in danger from their husbands or boyfriends — and even if they do expect danger, admitting it could increase their danger. Most of these male partners — even the ones who actually are cheating — would be mightily offended at the suggestion that they’re untrustworthy. In nearly every culture on this planet, women have the role of mediators within a family; it’s their job to smooth over or anticipate interpersonal problems that could threaten relationships. Why would anyone expect women to do something that’s going to cause so much friction and possible violence?

    This might be useful for women who are in the sex worker field, especially if they can’t control their condom use, or women who know their partners are infected. But in any other case, asking a woman to take Truvada is like asking her to put her relationship in jeopardy. Given that, what outcome did the researchers expect?

    They need to come up with a delivery mechanism for this drug that’s discreet. Maybe an under-skin implant or something. Pills are a bad idea.

  • rabidmob

    Side effects?

  • Tony Mach

    HIV/AIDS is not a pure medical problem, it is in large parts a social problem. We as a society must tackle this problem, we need better education – not only for this problem.

  • Scott

    I have worked in international public health before and the problem with the noncompliance starts with the women’s lack of education. Even if you implement an education program alongside, you may still not ensure compliance. Once you’ve lived with seeing the world in a non-scientific way for a long time, no amount of medical jibber jabber will displace other beliefs. It’s not impossible, but it requires some experimentation with the women to find what kind of motivation will get them to take the medicine.

  • Wil

    I work in the medical field. My professional life is a roller coaster of highs, such as the development of incredible new drugs and sophistocated medical devices, and lows, such as patients allowing themselves to be obese, not exercising, not doing their therapy, taking recreational drugs or becoming an alcoholic, not taking their therapeutic drugs, not following doctor’s orders, and other similar things.

    It can be very disappointing to see a drug company spend tens or hundreds of millions of dollars developing a breakthrough new medicine, and then watch patients who are given it, not take it because they “don’t feel like it”. Sometimes a person can think “Sheesh, why bother? Let the jerk die then”.

  • Curtis

    Too bad the drug can’t simply be pumped into the world’s water supply. Would be nice if someday no one even needs the drug because, like smallpox, there is no longer anyone who carries it.

  • Christine Vargas

    I agree with Tony Mach. HIV/AIDS is a social problem. But the lack of education is a problem. Many people enjoy talking about several topics, but when the topic of getting tested for STDs or HIV/AIDS comes up not many people feel freely to speak on the topic. Many people are open to speak about sex and sex is used as a promotional vehicle on TV, movies, online etc, but why are so many people shy when speaking about visiting the doctors office to get tested? There are many taboos on the topic.

    I thought you all might find this informative. http://worldlylivingnow.wordpress.com/2012/03/13/how-many-more-innocent-children-have-to-die/

  • Katherine

    While I think the point about stigma is good, a description of the side effects might help explain some of the problems with medication adherence. (Many researchers and advocates prefer to use “adherence” which suggests the doctor and the patient are a team treating the disease instead of “compliance” which suggests the patient is subordinate to the doctor in managing their own body.)

    Medication adherence is complicated and difficult: it involves issues of cost, access, stigma, time, scheduling, and managing side effects. That’s why medications in clinical trials are generally compared on intent-to-treat (who got what medication) not adherence or compliance (who took what medication) because an effective medicine is only effective if people can stand to take it. As scientists have discovered, blaming people who don’t take the medication is myopic, ignores contextual factors, and impedes medical progress.

    Using the example in the article, side effects do help explain early discontinuation of TB medication–there can be severe gastrointestinal effects. People who miss their medications aren’t always just forgetting, they may be dealing with daily vomiting or other effects that can be hard to manage.

  • christine

    It would probably be easy to shake our head at these women, but, if I am frank with myself, I think I would probably lapse as well. These are healthy women who are simply not expecting to become HIV positive any more than you are I are expecting to become HIV positive. If there are any side effects whatsoever, they are probably thinking that the actual disadvantages outweigh the theoretical disadvantages. Let’s be honest – how many of us have faithfully adhered to our fish oil pill regime? I doubt that more education is what is needed, either. Highly educated people make very poor decisions when the long term effects are uncertain. That is human nature.

  • John

    I am tired of the “better education” meme.
    We need people to use the one proven effective preventative method – which most people on earth know about – condoms.

  • John

    In addition, study after study has shown that only about 50% of patients take their medication for anything – from high blood pressure to diabetes. Patients are more likely to take meds for acute conditions with ill effects – for example, taking antibiotics for a strep throat. For prevention, or illnesses with no ill effects, such as high blood pressure, the incidence of taking meds is even lower than 50%.

  • Kayla R.

    Christine-
    If you doubt that more education is what is needed, what exactly in your opinion would help these women see their error?

    If it is as you say, and even highly educated people make poor decisions when the long term effects are uncertain, then wouldn’t you agree that at least in terms of those effects, they are NOT highly educated (in other words, people make poor decisions when they are not well educated about the consequences of those decisions)? So then, shouldn’t it follow that education about the consequences of not taking the pills faithfully should be improved?

    The statement that making poor decisions in the face of uncertainty is “human nature” is actually in SUPPORT of better education.

  • Arakiba

    Their men didn’t want them or let them take the medicine, maybe?

  • Geack

    @2 NJEM,

    Your assumption about “bi or gay male partners” doesn’t apply in Africa, where most HIV transmission is through hetero sex.

  • R2

    @2,15

    Does it actually apply anywhere? MSM to Women, not just among MSM. The whole downlow thing seems a bit scarce on the evidence and high on the homophobia.

  • Geack

    @16,

    What’s MSM?

  • Lena

    Geack, MSM is an acronym for “Men who Sleep with Men”.

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