A pill a day to prevent HIV? Could it be “that” easy?

I’ve written previously about pre-exposure prophylaxis (PrEP) for preventing HIV (here and here, as well).

For those unaware, PrEP makes use of an antiretroviral pill called Truvada® (a combination of tenofovir and emtricitabine), along with safer-sex practices (e.g., condom use), to vasty decrease the risk of contracting HIV. PrEP is something that HIV negative people use.

Several studies were done using PrEP in different populations (men who have sex with men (MSM), women, sex workers, partners in zero-discordant couples (one member of the couple HIV positive the other HIV negative)) in several countries on different continents. The results were published in a number of papers, several of which are listed in the previous articles I did on PrEP linked above. In brief, most of the studies showed a dramatic decrease, by 92%, in the transmission of HIV when this drug combination was used along with safer-sex practices.

AIDS-HIV activist dispenses awareness information near Yoyogi Park, popular with teens and young adults on Sept. 18, 2009 in Tokyo. 20-30 year-olds have the highest rate of HIV in Japan. cdrin / Shutterstock.com

AIDS-HIV activist dispenses awareness information near Yoyogi Park, popular with teens and young adults on Sept. 18, 2009 in Tokyo. 20-30 year-olds have the highest rate of HIV in Japan. cdrin / Shutterstock.com

The Food and Drug Administration approved this drug for PrEP in 2012 in the United States. Earlier this year, the US Public Health Service (USPHS), in conjunction with the Centers for Disease Control, (CDC) released guidelines for the use of PrEP. The guidelines were formulated by members of the USPHS, CDC, doctors who treat HIV patients, researchers, HIV patients and others. The guidelines provide criteria for determining when PrEP should be used.

• Provide clear criteria for determining a person’s HIV risk and indications for PrEP use.
• Require that patients receive HIV testing to confirm negative status before starting PrEP.
• Underscore importance of counseling about adherence and HIV risk reduction, including encouraging condom use for additional protection.
• Recommend regular monitoring of HIV infection status, side effects, adherence, and sexual or injection risk behaviors.
• Include a providers’ supplement with additional materials and tools for use when prescribing PrEP.
[. . . ]
For sexual transmission, this includes anyone who is in an ongoing relationship with an HIV-positive partner. It also includes anyone who 1) is not in a mutually monogamous* relationship with a partner who recently tested HIV-negative, and 2) is a
• gay or bisexual man who has had anal sex without a condom or been diagnosed with an STD  in the past 6 months; or
• heterosexual man or woman who does not regularly use condoms during sex with partners of  unknown HIV status who are at substantial risk of HIV infection (e.g., people who inject drugs or have bisexual male partners).

The USPHS, CDC, et al. said that, “[t]he new federal guidelines recommend that PrEP be considered for people who are HIV-negative and at substantial risk for HIV.”

The recommendation is that PrEP should be considered for use in people who are at a substantial risk for HIV.

On July, 11th the World Health Organization (WHO) came out with its opinion on using PrEP. Its report looked at several different groups: MSMs, serodiscordant couples, prison populations, transgender women and others. Here’s what the WHO said about MSMs and PrEP:

Among men who have sex with men, PrEP is recommended as an additional HIV prevention choice within a comprehensive HIV prevention package (strong
recommendation, high quality of evidence).

The parenthetical phrase “high quality of evidence” refers to the validity, and sometimes amount, of research on the topic.

The WHO is essentially saying that it recommends that all MSMs take tenofovir-emtricitabine, and use safer-sex practices, to help prevent them from getting HIV. The USPHS/CDC said that PrEP with Truvada® should be “considered” while the WHO the “considered” to an outright recommendation.

You can access a copy of the full guidelines (free) here: (184 pages), and an overview (8 pages) here.

One concern that some have raised is whether people on PrEP may stop using condoms (thinking they’re fine simply taking the drug). Some people and organizations came out against using PrEP for just that reason, characterizing it as a “party drug.” There was also some Internet-shaming going on against men who were using PrEP.

Of course, if people did stop using condoms, that would increase their risk for other sexually transmitted infections (STIs), and their risk to contract HIV. Two studies (one cited in the longer WHO report, linked above) show that this doesn’t seem to be true. One study showed that all men enrolled in one PrEP trial increased their use of condoms over what had been their baselines before enrolling in the study.

Another point raised was that there are side effects that can occur when someone takes a medication. The same holds true for PrEP. The WHO study concludes from studies that side effects from taking tenofovir-emtricitabine were low, rarely serious, often remitted over time or after a hiatus from the drug.

The medication involved needs to be taken daily. Some fear that people won’t adhere to a once-daily dosing schedule. That may happen and could increase the risk that HIV may become resistant to this antiretroviral drug combination. However, many of the participants adhered well to their daily dosing. Some others did not. Some of the data showed that even with less than ideal adherence to the medication, protection against HIV transmission was still relatively good.

The cost of the medication is high. Yet almost all health insurances are willing to cover the cost. Their feeling seems to be that, as expensive as it is, it’s less expensive than paying for triple antiretrovirals, hospital admissions, physician specialist consults and other medications necessary to treat complications of someone with HIV or AIDS. Additionally, the manufacturer of the drug has a patient-assistance program available for those who are uninsured and may not be able to pay for the drug.

The recommendations from the WHO and the USPHS/CDC require that those people who get started on PrEP be followed regularly. They are not just given an infinite supply of the drug. They have to see their doctors regularly, be tested for HIV, have other tests done to be monitored for side effects from the drug, have counseling, etc.

PrEP is not just the drug; it’s a program to reduce the spread of HIV.

If you’re not taking PrEP and are sexually active, you at least owe it to yourself to discuss the topic with your doctor. Even if you’re in a monogamous relationship, there may be the possibility that your husband, or you, may have an extramarital affair at some time.

If you want more information on HIV or PrEP you can contact the CDC 1-800-CDC-INFO or call your state HIV/AIDS hotline.


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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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  • Rambie

    The study shows that PrEP users are no less like to skip using condoms as those not on PrEP. There are some on PrEP who openly continue to bareback and remain HIV negative, so condoms alone are a valid protection against HIV as is PrEP alone. Taken together it’s as close to 100% you can get.

    With the rising rates on HIV in the young gay community, we know that people don’t always use condoms. So PrEP can be a second line of defense.

  • NCMan

    so, if the prep users also used condoms, you have no way of knowing which is providing the protection.

  • Rambie

    Latest study shows 100% efficacy of PrEP. Note that those on PrEP are encouraged to continue use condoms and if the report is right, users of PrEP are indeed no less likely to go without condoms as those not on PrEP.

    http://dish.andrewsullivan.com/2014/07/22/100-percent-efficacy/

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  • Rambie

    There are some wrong numbers being tossed around. Condoms alone are 97% effective IF USED RIGHT to prevent STDs which include HIV. Truvada alone is also into the mid-90%’s zone at only HIV prevention, again IF USED RIGHT.

    Combined, it’d put the protection up into the 99 percentile.

    The problem is not everyone uses condoms “right” 100% of the time.

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  • countervail

    Yes, time will tell. The problem mostly to my mind is PRep is being promoted as some kind of 100% effective resistance. People want a simple answer, but HIV prevention is complicated. The drug company’s marketing seems complicit in trying to make PReP a simple, easy, 100% effective (when taken as directed) answer, like a daily vitamin. Even in PeP studies I’m reading about, the issues are very complicated and people still become infected. I just think the emphasis should still be on sexual safety first – safe sex, condoms, monogamy after testing, etc. – and then MAYBE PReP for those individuals whose lifestyles make it more likely to become infected. I can’t be the only one frustrated by the libertine attitude of gay men and their right to have as much irresponsible sex as they choose.

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  • trinu

    Unfortunately all I can tell you is that men in both groups were also advised to use condoms. They did look at condom usage enough to find out that during the trial men used condoms slightly more than they had before but I don’t remember seeing any data comparing men on placebo using condoms 100% of the time to men on truvada using drugs 100% of the time, just that the placebo and treatment groups had similar levels of condom usage.

  • Hue-Man

    or “men having hetero sex with women” – the basis for the uncontroversial recommendation to mutilate the genitals of all newborn human males.

  • NCMan

    ” the pill is just a way to make it even smaller”

    That’s my question. How much smaller? Is it enough smaller to justify the cost and possible effects. That’s the answer I can’t seem to find anywhere. Is there really any reason for someone who practices safer sex 100% of the time to take this drug?

  • trinu

    That was compared to placebo. Condoms alone are 90-95% effective, provided they’re used properly (ie make sure they’re the right size, pull out before you take off the condom, and use a condom made from either latex or polyurethane). So as long as you practice safer sex 100% of the time your chances of getting infected are pretty small, the pill is just a way to make it even smaller. Either way, you should still get regular tests because prophylactic doses of the drug are lower than the doses used to treat an actual infection.

  • NCMan

    I’m sorry to be so picky, but are you saying that the drug plus condoms is 85 – 95% MORE EFFECTIVE than condoms alone? Because, that’s what I’m trying to find out. Or, if the drug plus condoms is 85 – 95% effective, then what is the rate of effectiveness for condoms alone?

  • trinu

    It’s around 85-95% reduction, with a greater benefit if you take the pill everyday as prescribed (you’d be surprised how many men skipped doses in the trials). My comment about monogamy was directed mainly at people who constantly raise the “people cheat” argument; also note that HIV can have a window period (during which you can have the virus and test negative) of up to six months so if you enter into a monogamous relationship and decide to get tested and stop using condoms keep that in mind.

  • NCMan

    well, if you’re in a monogamous relationship and both are negative, the risk of being infected is absolutely ZERO. You’re talking about the risk based on behavior. I’ve asked whether using the drug provides significant benefits over condom use to justify the cost and side effects. How much better are the results of Prep with condoms over condoms alone?

  • trinu

    That would depend on what your risk is. If you’re in monogamous relationship and you and your partner have both tested negative, that risk is obviously small, but if you’re promiscuous or in a serodiscordant relationship then it’s larger. We don’t know a lot about the long term side-effects in part because the drug is relatively new and most of our data on it comes from using it as part of a cocktail to treat HIV, but when used as a treatment instead of a prophylactic, doctors tend to prescribe higher doses, so the long term side-effects of PrEP may be milder but it’s too early to know for sure.

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

    Well… seems to me the real answer, eventually, will be in an HIV vaccine. There are several problems with this WHO recommendation, most of which you brought up, Mark:
    – Expense
    – Side-effects, many of which are not trivial
    – Convincing people to both practice safe sex and take this drug every day

    The biggest problem of all is those who are most at risk are also those who are most likely not to be able to afford the drug (no money, uninsured, etc.), unable or unwilling to deal with regular monitoring and treatment for the potentially life-threatening side-effects if they do occur, and not be the sorts to be able or willing to follow the discipline of daily meds and safe sex only practices.

  • NCMan

    is the difference significant enough to justify the cost and the side effects?

  • trinu

    PrEP with condoms was more effective than with condoms alone. Using it without condoms is a good way to accelerate the evolution of multi-drug-resistant HIV.

  • NCMan

    Does the data show that Prep plus 100% use of condoms is more effective than 100% condom use alone? Or, is Prep just for in case you don’t always use a condom?

  • Rambie

    I agree, not everyone is as compliant on medications any chronic condition. Doesn’t mean it shouldn’t be available to those that will. Truvada isn’t new, it’s been on the market for years as one of many anti-HIV drugs. One of the two drugs was developed back in 1985 as an anti-Hep B drug. So the side effects are pretty well established.

  • trinu

    Yes, but diabetes doesn’t evolve into low-carb resistant diabetes when people are less than rigorous with their diet.

  • Rambie

    It’s hard to get people with diabetes to stop eating sugary candy too. Doesn’t mean we shouldn’t develop other treatments does it?

  • Rambie

    I wasn’t disagreeing with you, as I said, time will tell. The cases I read were to study the normal day-to-day habits of the participates. Some of whom were pretty unsafe in their sexual activities.

    Again, time will tell.

  • pipslvr

    This one is easy.

    The reason why PrEP study subjects can categorically be determined to be HIV negative is because they did not develop HIV antibodies. HIV antibodies are present in an infected subject usually 1 month after infection, in very rare cases all the way to 6 months. If you test negative on an HIV antibody test you were negative for sure 6 months ago and before that.

    The case of the baby or anyone who becomes infected is different because they will test positive on an antibody test for the rest of their life, regardless whether there is virus or not. In these cases someone needs to agree on what being cured means and how to determine that.

  • Indigo

    Good point but then they’re uncertain what “gay” might mean in some contexts and fearful of using trigger words that upset those who seek to be upset about something they don’t understand.

  • Indigo

    Does Hobby Lobby get another exemption for meds they don’t approve of?

  • nicho

    It’s still a struggle getting people to use condoms.

  • nicho

    Interesting that they don’t include “women who have sex with men.” A lot of women have contracted HIV because they had sex with man who was HIV positive — and the woman didn’t know it. This is extremely prevalent in communities where a lot of men are closeted or bisexuaal and have sex with men before going home to the wife/girlfriend and kids.

  • nicho

    I agree. You’re very well informed, very compliant with safe-sex practices, and the drug, despite its known (and still unknown) side effects, can make you even safer. But not everyone is that careful or compliant. They may take the drug – or not — or maybe just take it the day they plan to go to the sex club for an all-night party.

  • WilmRoget

    well, when the PrEP fails, and someone contracts HIV, Gilead has another customer for life.

  • Henson

    That would be why the guidelines have PrEP as an addition to a safer sex toolbox, not the only tool. These people are not saying “Don’t use condoms.” They’re saying, “Here is this thing that works even better when you add it to condom use.”

  • http://heimaey.us/ heimaey

    I agree with you.

  • countervail

    Maybe they didn’t come into contact with the virus, or maybe they only had sex with people of undetectable amounts of virus. I just haven’t seen studies where people who took PReP where it was known where they were regularly in sexual contact with those of detectable levels of HIV continued to remain virus free after stopping PReP and no sexual conact with infected partners.

  • Rambie

    Could happen, but one of the cases I read had the participants stop PrEP for extended time and they still tested negative. Levels of Truvada were non-detectable in the tests as well.

    Still, time will tell.

  • Rambie

    Well, as they say, “You can lead a horse to water…” PrEP won’t protect against other STDs so condom use it still recommended but like everything in life, some people won’t listen. I think overall PrEP will help lower new HIV infections –if taken consistently– but we may see a rise in other STDs.

    Frankly, I’m more worried about the “taken consistently” side of the equation.

  • countervail

    Again, we just saw a case of a baby thought cured of HIV from aggressive antivirals redevelop the virus. The case studies that the PReP advocates are relying on lasted about that same amount of time. What’s to say PReP simply doesn’t mask the presence of the virus if you’ve come into contact with it. How do we know it simply keeps HIV from being detectable rather than protecting you from the virus?

  • Rambie

    The cost should also begin to drop in 2017 –at least in the US– as the patent on the two drugs in Truvada should end in 2017 and there are already companies making generics for export. They just can’t sell the generics in the US yet. /sigh/

  • Rambie

    I’m pretty strict on condom use and I’ve dated a HIV+ men before. In fact, I’m seeing one currently. His status is undetectable and we’ve –as I said– used safe sex practices but condoms aren’t perfect and we don’t use them for every aspect of our sex lives.

    I’ve still asked my doctor about PrEP and have had the HIV & Hepatitis-B tests completed — both came back Negative thank God. I have to see the doctor again before he’ll prescribe PrEP and I haven’t totally decided if I will get on it. However, even as fanatical as I am about condom use, sometimes one slips or, it breaks, etc. Combined with condoms, it should up the safety of preventing me getting HIV from my partner to 99.99% up from 97%-ish with condoms alone.

    The worst side effect –and happily the LEAST common– is a build up on toxins in your kidneys. PrEP users need to have blood tests to monitor this toxicity level (according to my doc) starting at about 1-month, 3-month, 6-month intervals. If toxicity levels remain stable then it’ll move out to once-every-6-months testing. Also routine STD tests will still occur.

    Is the additional 2 percentage points of protection enough to justify the costs of PrEP. Well, as John said in the article, it’s cheaper to be on PrEP than it is to be on the full spectrum on anti-HIV antivirals. My insurance is a HSA, so the first several thousand of prescription drugs and labs are all on me, then the insurance will kick in a percentage for the remainder of the year.

    (sorry for the WoT)

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

    Minor clarification: The WHO recommendations via their press release discusses ‘men who have sex with men’, not ‘gay men.’

  • trinu

    You say it doesn’t decrease condom use, but the study you cite is the placebo controlled PrEP study. Maybe the men didn’t stop using condoms because a.) they didn’t know they whether they were getting placebo or truvada, and b.) at the time truvada hadn’t been shown to be effective. Since neither of these will apply to men who decide to go on the drug, I see little reason not believe it will decrease condom usage, if it becomes popular. You can already see on certain corners of the internet, men talking about how they don’t intend to use condoms as often.

  • nicho

    If they want that “extra protection” and can afford the drug and are willing to risk the side effects, sure, why not. But the point is that recommending the drug universally won’t necessarily bring about the risk reduction people think it will. People are very bad at taking steps to protect themselves.

    More gay people — many more — men and women — will die from smoking next year than will die from HIV/AIDS. Those deaths are completely preventable and don’t need drugs to do it. All people need to do is stop smoking, but they don’t.

  • http://heimaey.us/ heimaey

    At least for them, though, they can maybe worry less?

  • nicho

    The problem is that the people who will be rigorously compliant are exactly the people whom don’t need the drug.

  • http://heimaey.us/ heimaey

    I like the idea in theory, I just worry it’s big pharma taking advantage of us.

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