Prevent HIV with just four pills?

Can you prevent HIV with only four pills?

PrEP (pre-exposure prophylaxis) is the term used for methods to prevent disease transmission before contact with the disease actually occurs.

In HIV, PrEP centers around taking an oral medication daily, in conjunction with condom use, to prevent infection by the virus that causes AIDS.

In studies, PrEP seems to be quite effective in decreasing HIV transmission in men who have sex with men (MSMs).

A new drug trial is now suggesting that PrEP might be just as effective taken only right before, and in the immediate two days following, sexual activity.

Truvada (photo courtesy of Jeffrey Beall)

Truvada (photo courtesy of Jeffrey Beall)

The drug trial is called IPERGAY, and it uses the drug Truvada® as PrEP (Preexposure Prophylaxis) against HIV. The main difference between IPERGAY and other PrEP studies is that in the other studies Truvada® (a combination of emtriciabine and tenofovir) is given as a once-daily dose. It needs to be taken every day, and it is strongly suggested that condoms be uses in conjunction with the drug.

In IPERGAY, the Truvada® is given only around the time that sex takes place. It’s not given as a regular daily dose that is taken independent of whether the patient has sex. So the Truvada® in IPERGAY is more of an “as needed” pill.

Their dosing schedule is:

Two pills taken anywhere from 2 to 24 hours before anal penetrative sex. Then one pill taken 24 hours after that. And a final pill is taken 24 hours later, and that’s the complete sequence.

One problem with the standard PrEP routine is that the medication is expensive and would be more expensive if it needed to be taken daily versus just taking it sporadically. Of course, that would be dependent upon how frequently the patient engaged in sex.

AIDSMap is reporting that IPERGAY has been so successful that, while the trial will continue, the control patients will be invited to start on Truvada® just as the experimental group is doing. While AIDSMap hasn’t linked to the data (I’ve emailed IPERGAY to try to get the information directly from them), it is obviously good enough to close the control arm of the research (the controls are those who are not taking the test drug and are receiving a placebo instead.)

In other words, the sporadic use of Truvada® as described is so effective at preventing HIV infections that it would be unethical to allow the control patients to continue to go without it. When I get hard data on the study, I’ll post that.

These results could be a very good thing, or not. I have a few concerns with the IPERGAY dosing philosophy.

First, Truvada® as PrEP has been available in the US for some time, but very few men are taking it.

A survey done about a year ago, asked men who have sex with men (MSMs) why they weren’t using PrEP. A significant number said that they didn’t want to take a pill a day — that it was inconvenient. Remember, getting someone to take a single pill once a day is fairly easy and convenient for most people. Taking pills on an erratic schedule, however, is difficult for a lot of people. As a consequence, often doses get missed. Sometimes people just stop the medication entirely. Thus,Truvada® taken every day for life is easy. Truvada taken only right before you have sex, and two days following, is more sporadic, and thus potentially more difficult for patients to remember.

Something that might work better would be an implantable form of Truvada®. Basically, a small reservoir of the medication, inserted in the skin every three months by the doctor. That would coincide with the quarterly HIV testing, other testing and follow up that is recommended when on PrEP. Also, it would make it impossible for the patient to miss doses. The dose is automatically released daily.

Next, with the use of on demand when sex occurs only type of dosing we might encounter the Viagra® problem.

Many commercial health insurances will only permit patients to receive a limited number of Viagra (often only 3) per month. Above that, the patient has to pay for additional pills out of pocket. I’m almost certain, with the high cost of PrEP, insurance companies would ration the number of pills that they’d pay for per month. If that’s the case, then many patients would not take them as directed and would take one or two around the time of intercourse instead of following the prescribed dosing. Either of the above could lead to failure of the medication to protect against acquisition of HIV.

Then we have the Hobby Lobby decision form SCOTUS.

One can imagine right-wing religious corporations fighting against paying for any form of PrEP, simply because the(ir) Bible is against same-sex sexual relations. So far, I haven’t seen any instances of that happening with PrEP (or antiretrovirals), but it seems like it could be a real possibility to me.

So while the IPERGAY trial is good news to an extent (that people who diligently take their PrEP as directed are protected against HIV), there may well be some downsides to look out for.


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

Share This Post

  • xelle cunninghem

    earn $100 a day at bit.do/neopera

  • AleishaHansfordsyd

    my boyfriends sister just got a fantastic green Kia Rio Hatchback by working part-time from a home pc… see it here…….>> -> INCREASE YOUR EARNINGS!! <-

  • Kenster999

    That’s a shame it’s a hassle. But I’m glad at least you finally got it squared away! That’s not the case with me, because Kaiser simply doesn’t take co-insurance — look how easy, there’s nothing to discuss!

  • The main issue with these kind of programs from the manufacturers is getting them and your insurance company on the same page. I use a similar program from Teva for my meds, and after multiple calls with each side saying yeah they’ll handle it, it finally took me getting frustrated and putting the rep from Teva on a conference call with me and the rep from my insurance company so we could all get on the same page together.

  • sayencrowolf

    As someone who’s written about PrEP and Truvada since well before it was approved (and been in two NIH sponsored trials), I can tell you that it works. I have a very active sex life, condoms aren’t always present, and I’ve yet to miss a dose of taking it daily. Still negative as of yesterday’s test.

    The side effects are no more severe than any drug that’s on the market: yes, this-that-or-the-other-thing CAN happen, and as soon as it happens in more than one patient it has to be reported as a possible side effect. For me, the worst I’ve ever had happen is muscle fatigue: the same feeling I get after working out. My solution to it is to take my daily dose before bedtime and I sleep right through it.

    Once I finished the last trial, I went on Truvada full time as a patient. I see my doctor every three months to renew the prescription and get my checkups and that’s that. California as I recall as done away with the quarterly checkins altogether on a case-by-case basis. The total cost for me is zero, and sadly this is not a well publicized fact as it’s available for anyone (http://www.truvada.com/truvada-patient-assistance). My insurance picks up the majority of the expense, and Gilead pays the rest. They will also absorb the cost 100% for anyone who doesn’t have insurance.

    We probably won’t see any of the data from the IPERGAY study anytime this year, as they’ve noted in their press releases it won’t be seen publicly until 2015. The CDC sent out their response to the IPERGAY study reports as of yesterday (http://content.govdelivery.com/accounts/USCDCNPIN/bulletins/d97a26), and they say the same thing that I feel as well as the author of this article: on the surface it looks great, but there’s a lot of questions that need to remain answered. The DSMB unblinded the data, but I’m sure that in order to preserve the continuity of the trial, they didn’t give that access to the study directors – yet.

    Personally, I don’t know of any real world scenarios where an intermittent dose would be preferred as opposed to taking it daily, but that’s just me – a guy who’s not a medical professional. Cost effectiveness? Sure, but I’m not out to save my insurance company any money. My being on PrEP is about maintaining my current HIV status. Condom use has decreased considerably – myself included – and PrEP is slowly changing the thinking of them being the only protection against HIV.

  • Kenster999

    Gilead offers a $200 per month co-pay to anyone who asks — it’s not income tested. I heard they recently upped it to $300 per month but haven’t verified that. Of course, your provider needs to accept it; some like Kaiser don’t accept any co-insurance.

  • Julien Pierre

    Atripla is a 3-drug combo, Truvada is 2 drugs.

    Truvada $1412 for a 30 day supply at Costco pharmacy. About $47 a pill.Or $4165 for a 90 day supply, about $46/pill.

    http://www.costco.com/Pharmacy/drug-results-details-price?storeId=10301&catalogId=10701&langId=-1&searchKeyword=truvada&drugId=3283&drugName=TRUVADA&drugSearch=headerDrugSearch&isPharmacy=true&encodedDrugName=TRUVADA

  • Julien Pierre
  • UncleBucky

    Just a small thing: Should this be specified as for MSMs only, or for ANYONE who has sex more than with one person? Just asking. It seems that a really important aspect of this is that HIV can be transmitted in almost any gender combination, no? :)

  • Unfortunately, most people do not get regularly tested for STIs unless they have a specific concern of infection, or a new partner. Even those people who do get tested regularly generally only get it done during their yearly physical. Something that healthy, well-feeling, people all too often put off. I don’t know what the recommendation is for testing with Truvada, but most medications that have liver or kidney contraindications suggest testing at most at three month intervals.

    The ultimate trick around all STIs has always been to get healthy people to take the risks of their actions seriously.

  • Gilead refers to a passage in the Bible, mentioned as a place that would be in modern day Jordan where a type of tree had healing properties. Thought likely to be the mastic tree, which is known to have antibacterial and antifungal properties.

  • Rambie

    Agreed, it’s another arrow in our quill to fight HIV. It’s not for everyone but I’m glad Truvada is out there.

  • It’s not a connection. It’s just two weird names.

  • docsterx

    Sure. That’s why the recommendation is to take daily PrEP and use a condom. Problem is, condom use is down in many instances (especially young gay males and black gay males.)

  • docsterx

    There are researchers working on an anti-HIV vaccine. But no one seems to be able to come up with something that i.es effective. And the vaccine research has been going on for decades.

    I’ve been hoping that the push to develop Ebola vaccines might stimulate more research into an HIV vaccine. Maybe sone of the techniques used to produce drugs like ZMapp and Tekmira-Ebola might prove useful in the hunt for an HIV vaccine.

  • docsterx

    While your point about the hassle of blood tests, UAs and doctor visits is valid, people who aren’t taking PrEP should be getting blood tests, seeing the doctor, etc. to make sure that they haven’t picked up HIV, hepatitis or another STI.

    As for side effects, IPERGAY never got back to me re: my questions about their data. I’d like to know how many patients experienced side effects, how severe they were, etc.

  • GarySFBCN

    Holy crap – it is another tool to fight HIV infections and that is a good thing. I understand all of the concern, but overwhelming evidence is that it works and most do not have side-effects.

    Again, it is a good thing, and, as with most things in life, there are some risks.

  • docsterx

    I think that’s always a realistic possibility, especially when people who are on daily PrEP skip doses. That’s one of the reasons I think some kind of depot injection/implant would work. It dispenses drug regardless if the patient remembers or forgets.

  • docsterx

    Many of the insurance companies have it on formulary. So it should only require a copay for many people.

  • docsterx

    That could be a good idea. But the current recommendation (though that is for Truvada®) is to get tested for HIV (and other STIs as appropriate) get counseling, get next Rx, etc. every three months. If those same guidelines are required for the medication you mentions, I can imagine a lot of guys skipping the three month visits.

  • docsterx

    I don’t get the connection between Gilead and IPERGAY.

    Many health insurances have Truvada® on formulary. So it should be covered. May require a copay and a prior authorization. I’ve heard that a number of health insurance companies are willing to pay for it rather than pay for a lifetime of taking 3-4 antiretrovirals/day, hospitalizations, viral load testing, CD4 counts, etc.

  • Rambie

    I hope there is a vaccine for HIV soon, but big pharma makes more off treatments than vaccines.

  • Anybody else kinda weirded out by the fact they’re calling this trial IPERGAY and the drugs are made by a company named Gilead?

    In any case, as many have noted (1) we’re talking powerful drugs with potentially serious, maybe even life-threatening side-effects, (2) available at a price that makes it clear that only the wealthy will be able to afford these drugs on a regular basis.

  • nicho

    PrEP can prevent infection

    It may prevent HIV infection. However, there are a lot of other things out there that it will not protect from in sex without condoms. There are some really nasty strains of drug-resistant STDs going around, and there are fewer and fewer drugs to combat them. Doctors are really having to pull out all the stops in order to get a handle on this. One doc told me he has had several patients who needed months and months of powerful antibiotics. A couple of people needed to be hospitalized.

  • nicho

    It’s like the Low-T scam. A growing trend over the last few years has been to tell men they had low testosterone and that they needed testosterone replacement therapy. It’s really a disaster. There has been little independent research into testosterone replacement ,and what there is is disturbing. They’re not sure of the reference ranges. They’re kind of meaningless at this point. Also, testing for testosterone depends on so many factors — time of day, time of month, time of year — so that results are unreliable. Add to that the fact that the testing itself is unreliable. Researchers sent the same sample to 20 different labs and got wildly different results. Also, they don’t have good data on the outcomes.

    Add to that the fact that most men — over 60 percent — have cancer cells in their prostate. Most of those men will never experience prostate cancer that necessitates treatment. What’s there will remain subclinical and non problematic. However, loading themselves up with testosterone will feed those cells and cause some serious issues.

    But Big Pharma is making a ton of money off of it.

  • nicho

    Well, Mark, from your lips to Big Pharma’s ears. And it’s not even an implantable. Now in the pipeline and ready to make its debut is a twice-a-year injection to prevent HIV transmission. Coming from a Pharma giant. It’s going to leave Truvada in the dust as a preventive.

  • WildwoodGuy

    For a 3-months supply by mail-order… just for comparison:

  • Somewhere in the range of $1,300 for 30 day supply. The company does offer copay assistance for anyone unable to afford it, and even assistance for people with no insurance at all, but in a quick search I was unable to determine exactly how much. The company probably determines on a case by case basis. I’ve read stories of people getting it paid for entirely, between the company and insurance, and other stories about people still having to shell out >$500 a month, despite their coverage. Just more examples of how there are no equal rights in health care. I would encourage anyone who was considering it to shop around for better prescription coverage, and definitely contact the company (Gilead) about any assistance they can provide.

  • Ummmm…I would also note that those pills cost something in excess of $1000.00.

  • Shouldn’t there be a really serious concern about drug resistance with this kind of therapy? Which is why groups like the WHO recommend a comprehensive public health approach for HIV treatment rather than this kind of an individualized therapy approach. Studies have shown that a majority of HIV positive people already have varying amounts of drug resistance, and some drugs have already been taken off the market because they’re no longer significantly effective. I get that the whole point in using multiple drugs is that often when one may not be entirely effective, the other may be, thus still offering the goal of full suppression of viral replication, but over the long term this does not seem to be the ideal solution for preventing HIV infection. But a stop gap that will need to be constantly updated.

  • Of course, even the more mild side effects, which pretty much every single antiretroviral drug seems to have – nausea, diarrhea, and headaches – can be enough to put one off sexual activity, if only momentarily. Then there’s the long term concerns, like lactic acidosis, impaired lipid metabolism, and renal dysfunction, that require regular monitoring of anyone taking them. It’s often not just the inconvenience of taking a regular pill that discourages people from continuing a therapy, but also the hassle of blood tests, urine analysis, and regular doctors visits to make sure the pill isn’t harming them in ways that are not readily apparent.

  • nicho

    As with all drugs, there are side effects with Truvada, some of them serious. Anyone considering long-term use of Truvada — or any other drug — should check them out and decide whether condoms might pose less of a risk to your overall well-being. Ironic that two of the side effects are impotence and loss of interest in sex, along with things that are of more concern.

    http://www.rxlist.com/truvada-side-effects-drug-center.htm

    Be very afraid when Big Pharma is pushing pills at you.

  • S1AMER

    Short term, this is probably wonderful, medically speaking. We’ve got enough data to make a convincing case that PrEP can prevent infection and save lives.

    Longer term, though, the search for an effective vaccine MUST continue. So there’s a problem if widespread use of Truvada diminishes urgency (and therefore funding) in the search for avaccine.

© 2018 AMERICAblog Media, LLC. All rights reserved. · Entries RSS