HIV Preexposure Prohylaxis -- Only $12,000 per person, per year
November 23, 2010 12:13 PM Subscribe
An article published in the New England Journal of Medicine online edition today announced study results that the use daily of antiretroviral medicine reduced rate the acquisition of HIV infection. The New York Times coverage highlighted the result that the preexposure prophylaxis protected more than 90% of study participants who took the medicine every day, as prescribed. An editorial in the NEJM noted, however, that compliance was problematic, with only 44%of study participants protected overall.
From the NEJM editorial: “The overall reduction in HIV incidence in the FTC–TDF group was less than 50%. Although increased medication adherence would raise this degree of protection (along with the risk of potential side effects), what is the likelihood that such a regimen could be accomplished in an implementation program that lacks the intense reinforcement of adherence counseling provided in the context of a clinical trial? How can medication-use fatigue be mitigated over potentially many years of daily therapy?”
As noted in the NYT, one major question hangs over this debate: who will pay for the drug?
"In the United States, Truvada, made by Gilead Sciences, costs $12,000 to $14,000 a year. In very poor countries, generic versions costs as little as 40 cents a pill.
Globally, only about 5 million of the 33 million people with AIDS are on antiretrovirals, and, in an era of tight foreign-aid budgets, that number is not expected to rise quickly. Hundreds of millions of Africans, eastern Europeans and Asians are at risk and could benefit from prophylaxis, but that would cost tens of billions of dollars."
In an article in the Washington Post about the response to the epidemic, the authors note that aid from wealthy countries for HIV treatment is declining, and less than half of infected patients are covered by current funding levels.
The LA Times article also notes the worrying result that drug resistance was seen in participants that began the study with undetected HIV.
From the NEJM editorial: “The overall reduction in HIV incidence in the FTC–TDF group was less than 50%. Although increased medication adherence would raise this degree of protection (along with the risk of potential side effects), what is the likelihood that such a regimen could be accomplished in an implementation program that lacks the intense reinforcement of adherence counseling provided in the context of a clinical trial? How can medication-use fatigue be mitigated over potentially many years of daily therapy?”
As noted in the NYT, one major question hangs over this debate: who will pay for the drug?
"In the United States, Truvada, made by Gilead Sciences, costs $12,000 to $14,000 a year. In very poor countries, generic versions costs as little as 40 cents a pill.
Globally, only about 5 million of the 33 million people with AIDS are on antiretrovirals, and, in an era of tight foreign-aid budgets, that number is not expected to rise quickly. Hundreds of millions of Africans, eastern Europeans and Asians are at risk and could benefit from prophylaxis, but that would cost tens of billions of dollars."
In an article in the Washington Post about the response to the epidemic, the authors note that aid from wealthy countries for HIV treatment is declining, and less than half of infected patients are covered by current funding levels.
The LA Times article also notes the worrying result that drug resistance was seen in participants that began the study with undetected HIV.
The Obama Administration has not seen fit to continue with adequate funding either for the PEPFAR program (one of the Bush Administration's few successes) or for HIV/AIDS funding at home.
While this is no doubt good news (with the caveats listed above), the benefit that it will have for people who cannot afford the costly medication remains to be seen.
posted by blucevalo at 12:43 PM on November 23, 2010
While this is no doubt good news (with the caveats listed above), the benefit that it will have for people who cannot afford the costly medication remains to be seen.
posted by blucevalo at 12:43 PM on November 23, 2010
I can't help but think that if your life decision are such that taking $12,000/year in drugs (some with side effects) is a rational decision to avoid catching HIV, the solution is not the antiviral drugs, it's to change whatever is horribly wrong with your lifestyle.
I also worry that if lots of people do this, it'll ruin the antivirals for use against other viruses. AIDS evolves extremely rapidly and I suspect drug resistance does not work in the same manner that it does with other things, but other viruses are likely to be more like bacteria in this respect - where incautious use of antibiotics can lead to them becoming useless.
posted by Mitrovarr at 12:49 PM on November 23, 2010
I also worry that if lots of people do this, it'll ruin the antivirals for use against other viruses. AIDS evolves extremely rapidly and I suspect drug resistance does not work in the same manner that it does with other things, but other viruses are likely to be more like bacteria in this respect - where incautious use of antibiotics can lead to them becoming useless.
posted by Mitrovarr at 12:49 PM on November 23, 2010
Yeah, and antiretrovirals have nasty side effects. I wouldn't want to take them every day.
posted by Mental Wimp at 12:52 PM on November 23, 2010
posted by Mental Wimp at 12:52 PM on November 23, 2010
I suspect the nasty side effects are a big part of the reason people drop out of the study. 44% compliance is not that unusual. Lots of daily-use drugs have high dropout rates in real life use - SSRIs and statins to name two.
posted by mskyle at 12:56 PM on November 23, 2010
posted by mskyle at 12:56 PM on November 23, 2010
If we are talking about rational decisions, perhaps the more rational decision is to make the dimes-a-day generic versions more available in the United States.
People like unprotected sex. I don't think that's going to change.
posted by adipocere at 1:10 PM on November 23, 2010
People like unprotected sex. I don't think that's going to change.
posted by adipocere at 1:10 PM on November 23, 2010
If the studies results can be duplicated in the larger population this is incredibly good news. The $12,000 a year cost for the medication today is because there really aren't that many people in the grand scheme of things taking this drug. As a result the millions of dollars spent on R&D have to be paid for from a relatively small number of monthly sales. If Gilead suddenly sees a massive uptick in the number of scripts for Truvada by a factor of 10 or 100 the cost should be able to be lowered by a similar factor.
Yes the patent protections are in place and they could continue to charge the same amount of money, but can you imagine the outcry and the pressure that would be applied?
If the cost dropped to $2000 a year and was covered by insurance with the patient responsible for only a small copay each month you would think that given the opportunity most people in that group would go on the drug.
The million dollar questions are whether the at risk population can get access to proper testing before going on the medication, access to medical care to write the script both initially and every few months, appropriate blood tests to verify compliance and to check for side effects AND most importantly whether they can actually take the pill every single day. The study paid people to take the medication, handed them the drug for free, gave them testing and other care and yet many participants didn't (couldn't?) comply.
posted by cmj at 1:18 PM on November 23, 2010
Yes the patent protections are in place and they could continue to charge the same amount of money, but can you imagine the outcry and the pressure that would be applied?
If the cost dropped to $2000 a year and was covered by insurance with the patient responsible for only a small copay each month you would think that given the opportunity most people in that group would go on the drug.
The million dollar questions are whether the at risk population can get access to proper testing before going on the medication, access to medical care to write the script both initially and every few months, appropriate blood tests to verify compliance and to check for side effects AND most importantly whether they can actually take the pill every single day. The study paid people to take the medication, handed them the drug for free, gave them testing and other care and yet many participants didn't (couldn't?) comply.
posted by cmj at 1:18 PM on November 23, 2010
I can't help but think there's a risk that this sort of thing could lead to HIV becoming resistant to these antivirals, and then absolutely decimating all of the people who think they're immune and are thus not taking precautions.
posted by Mitrovarr at 1:21 PM on November 23, 2010
posted by Mitrovarr at 1:21 PM on November 23, 2010
I can't help but think that if your life decision are such that taking $12,000/year in drugs (some with side effects) is a rational decision to avoid catching HIV, the solution is not the antiviral drugs, it's to change whatever is horribly wrong with your lifestyle.
The NYT article says the side effects were primarily just nausea and/or dizzyness.
If you happened to be in a segment of the population where 7% of your likely sex partners are HIV+ then perhaps this isn't such a nutso thing to take. The article says that in countries where a generic is available - which I assume means places where they're breaking patent protection - the cost is closer to $0.40 a pill. One hopes we'll see more sensible prices as time progresses.
Even if you're not breaking patent, there's segments of the population who could be greatly helped by this. Anyone receiving a blood transfusion, for example, particularly people who for whatever reason might need to get a lot of transfusions over time.
posted by phearlez at 1:47 PM on November 23, 2010
The NYT article says the side effects were primarily just nausea and/or dizzyness.
If you happened to be in a segment of the population where 7% of your likely sex partners are HIV+ then perhaps this isn't such a nutso thing to take. The article says that in countries where a generic is available - which I assume means places where they're breaking patent protection - the cost is closer to $0.40 a pill. One hopes we'll see more sensible prices as time progresses.
Even if you're not breaking patent, there's segments of the population who could be greatly helped by this. Anyone receiving a blood transfusion, for example, particularly people who for whatever reason might need to get a lot of transfusions over time.
posted by phearlez at 1:47 PM on November 23, 2010
phearlez: If you happened to be in a segment of the population where 7% of your likely sex partners are HIV+ then perhaps this isn't such a nutso thing to take.
Unfortunately, I suspect the demographic of people most in danger of catching it from that 7% are going to be some of the least able to afford prophylactic retroviral drugs.
I guess I can see a couple of good uses for this - people who might be exposed by blood transfusions or people who have a long-term partner with HIV. But for the most part, if you are at significant risk for HIV you probably should stop what you're doing. Even if you were magically immune to it (this only provides significant resistance) you will just accumulate and serve as a junction point for the other STDs or blood-borne diseases, which is neither good for you nor a responsible thing to do to other people.
posted by Mitrovarr at 4:43 PM on November 23, 2010 [1 favorite]
Unfortunately, I suspect the demographic of people most in danger of catching it from that 7% are going to be some of the least able to afford prophylactic retroviral drugs.
I guess I can see a couple of good uses for this - people who might be exposed by blood transfusions or people who have a long-term partner with HIV. But for the most part, if you are at significant risk for HIV you probably should stop what you're doing. Even if you were magically immune to it (this only provides significant resistance) you will just accumulate and serve as a junction point for the other STDs or blood-borne diseases, which is neither good for you nor a responsible thing to do to other people.
posted by Mitrovarr at 4:43 PM on November 23, 2010 [1 favorite]
One of the absolute trainwrecks about the way drugs on patent vs generics work is that often, if the patented product was made affordable to the masses, the increased usage would make it more profitable for the innovator despite the reduced consumer cost. I can't believe I'm the only person in the Citadel of Big Pharma who has worked this out, but I'm only using arithmetic, not the calculus that comes into play when insurance company formularies are considered.
(Admittedly, I have a horse in this race, but my horse doesn't have a special department charged with making you retroactively not our customer should you become sufficiently ill.)
posted by Kid Charlemagne at 4:47 PM on November 23, 2010
(Admittedly, I have a horse in this race, but my horse doesn't have a special department charged with making you retroactively not our customer should you become sufficiently ill.)
posted by Kid Charlemagne at 4:47 PM on November 23, 2010
Would people really be willing to take antiretrovirals every day regardless of the cost when it only gives a 50% reduction in risk? I mean, I guess some would, but it doesn't sound too appealing to me.
posted by markr at 7:53 PM on November 23, 2010
posted by markr at 7:53 PM on November 23, 2010
Would people really be willing to take antiretrovirals every day regardless of the cost when it only gives a 50% reduction in risk? I mean, I guess some would, but it doesn't sound too appealing to me.
Given good compliance, it was shown to be a 90% reduction in risk. Why bother throwing around hypothetical numbers when we have a clinical trial that conclusively provided us with real ones?
posted by schmod at 8:17 PM on November 23, 2010
Given good compliance, it was shown to be a 90% reduction in risk. Why bother throwing around hypothetical numbers when we have a clinical trial that conclusively provided us with real ones?
posted by schmod at 8:17 PM on November 23, 2010
"From the NEJM editorial: The overall reduction in HIV incidence in the FTC–TDF group was less than 50%."
posted by markr at 8:47 PM on November 23, 2010
posted by markr at 8:47 PM on November 23, 2010
Would people really be willing to take antiretrovirals every day regardless of the cost when it only gives a 50% reduction in risk?
Those who took the drug every day saw a 90% drop.
posted by Marlinspike at 10:46 AM on November 24, 2010
Those who took the drug every day saw a 90% drop.
posted by Marlinspike at 10:46 AM on November 24, 2010
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