Non-profit’s $300 hepatitis C cure as effective as $84,000 alternative

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steross

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Non-profit’s $300 hepatitis C cure as effective as $84,000 alternative

Exclusive: 71 million people stand to benefit from reduced price treatment for virus which can lead to liver cirrhosis, cancer and death

Julia Kollewe
Thu 12 Apr 2018 15.00 AEST Last modified on Fri 13 Apr 2018 09.55 AEST

An affordable hepatitis C treatment has been shown to be safe and effective, with very high cure rates for patients including hard-to-treat cases, in interim clinical trial results that offer hope to the 71 million people living with the disease worldwide.

The treatment is expected to cost $300 for 12 weeks, or $3.50 per day, in Malaysia, where trials were conducted along with Thailand – a fraction of the cost of other hepatitis C medicines produced by major drugmakers, which often run to tens of thousands of dollars.

The Drugs for Neglected Diseases initiative (DNDi), a not-for-profit organisation, is working with the Egyptian drugmaker Pharco Pharmaceuticals to bring a combination treatment of two hepatitis C tablets, ravidasvir (a new drug) and sofosbuvir, to countries that cannot afford to pay the high prices charged by US companies Gilead and AbbVie. This is taking longer than expected but has moved a big step closer with the latest results.

The interim results of the phase II/III trial of 301 people will be presented in Paris on Thursday. It has been funded by Médecins Sans Frontières, one of DNDi’s founding partners which also include France’s Institut Pasteur.

DNDi said 97% of patients were cured after being treated with the combination pill for 12 weeks. Even hard-to-treat cases such as people with HIV or liver cirrhosis showed very high cure rates, of 96% and 97% respectively.

Egyptian labourers queue for hepatitis C test. Egypt has the highest prevalence of hepatitis C infections in the world – 7% of Egyptians between the ages of 15 and 59 are infected with the virus. The epidemic started after government mass vaccinations were carried out with unsterilised syringes in the 1950s.

Hepatitis C is a blood-borne viral infection that can lead to liver cirrhosis, cancer and death. It affects more than 71 million people worldwide and causes 400,000 deaths a year. Although highly effective medicines have been available for several years, their high cost means that less than three million people are on treatment.

US drugmaker Gilead has lowered the price of its Harvoni tablet and other medicines in lower and middle-income countries, but it is still too high for governments to roll out mass hepatitis C treatment programmes.

Harvoni now costs about $48,000 for a 12-week course in Malaysia and $12,000 in Chile. Gilead’s previous Sovaldi treatment cost $1,000 a pill, or $84,000 over 12 weeks. Prices vary around the world and tend to be highest in the US.

Gilead has come under pressure from US rival AbbVie, which launched a new hepatitis C medicine, Mavyret, last year with a shorter, eight-week treatment course priced at $26,400.

Bernard Pécoul, executive director of DNDi, said: “The results indicate that the sofosbuvir/ravidasvir combination is comparable to the very best hepatitis C therapies available today but it is priced affordably and could allow an alternative option in countries excluded from pharmaceutical company access programmes.”

The treatment is expected to be available in Malaysia within one to two years. DNDi has also signed deals in Latin America to make it available for $500 for the 12 week course, with a provision to bring the price down to $300.

The trial using medicines produced by Pharco was run by DNDi and co-sponsored by the Malaysian Ministry of Health.

The medicine has also been tested on 300 patients in Egypt, who have different genetic characteristics, with a 100% cure rate. Further studies are being carried out in South Africa and Ukraine to cover all six genotypes of the disease.

DNDi has licensed rights for ravidasvir in low and middle-income countries from the Californian firm that developed it, Presidio Pharmaceuticals. The UK has an estimated 215,000 hepatitis C cases, while the US has 3.4m.

https://www.theguardian.com/science...as-effective-as-84000-alternative?CMP=soc_567
 

CocoCincinnati

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Sounds great but I'm always skeptical of dismissing R&D costs in discussions like this. Taking two existing drugs that somebody else created and running one trial with 300 people is a perfect way to keep costs down. From what I could gather from a very quick and very amateur google search, the Gilead treatment combines the sofosbuvir with ledispavir (which they developed) instead of ravidasvir. Gilead bought the company that developed Sofosbuvir for $11 Billion, I'm not sure how patent law works in such a case but where is DNDi getting the sofusbuvir, how much are they paying for it and who is funding it (and why).

It's easy to accuse the drug companies of greed and I'm sure there are probably plenty of cases where those accusations are deserved but I also believe it's not always a black and white issue. If this is proven effective for such a cheap cost, that's great. I just hope it doesn't effect the development of the next "sofosbuvir" because of fear of not being able to recoup the costs of it.
 

steross

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Sounds great but I'm always skeptical of dismissing R&D costs in discussions like this. Taking two existing drugs that somebody else created and running one trial with 300 people is a perfect way to keep costs down. From what I could gather from a very quick and very amateur google search, the Gilead treatment combines the sofosbuvir with ledispavir (which they developed) instead of ravidasvir. Gilead bought the company that developed Sofosbuvir for $11 Billion, I'm not sure how patent law works in such a case but where is DNDi getting the sofusbuvir, how much are they paying for it and who is funding it (and why).

It's easy to accuse the drug companies of greed and I'm sure there are probably plenty of cases where those accusations are deserved but I also believe it's not always a black and white issue. If this is proven effective for such a cheap cost, that's great. I just hope it doesn't effect the development of the next "sofosbuvir" because of fear of not being able to recoup the costs of it.
I believe sofusbuvir is generic. Much of what pharma puts out as patented medications now are combos of previously available meds or chemical cousins with slightly different effects.

There is no reason to accuse drug companies of greed. Look at profit margins and ROE vs R&D costs for pharmaceutical industry vs other creative industries and you can decide for yourself if the special patent rights they lobby so hard to obtain are greed or not. And, don't forget, some clearly non-greedy entity created the ravidasvir.

If you lived in the third world and had a life-threatening disease and the company that owns the US patent for a drug wants to charge a lifetime of income from you for it I suspect that your concerns about their R&D costs for theoretical future drugs vs taking a cheaper alternative would dwindle quite a bit.

Nobody is talking about importing this drug into the US if it might break US law. This is about saving hundreds of thousands of lives elsewhere.
 

CocoCincinnati

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If you lived in the third world and had a life-threatening disease and the company that owns the US patent for a drug wants to charge a lifetime of income from you for it I suspect that your concerns about their R&D costs for theoretical future drugs vs taking a cheaper alternative would dwindle quite a bit.
I don't doubt that at all but that's kind of the problem. If nobody was concerned about R&D costs, the life saving medicine might not exist in the first place. As I said, if this works and saves lives, that's great, just pointing out that some people (not you) don't seem to understand that R&D costs can play a huge part in the high price of some drugs. Probably not needed in this thread though so I'll leave it alone.
 

steross

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I don't doubt that at all but that's kind of the problem. If nobody was concerned about R&D costs, the life saving medicine might not exist in the first place. As I said, if this works and saves lives, that's great, just pointing out that some people (not you) don't seem to understand that R&D costs can play a huge part in the high price of some drugs. Probably not needed in this thread though so I'll leave it alone.
I suppose it is a good ethical discussion.

There are 71 million people with Hep C. So, at the $84000 cost for the drug that Gilead charges they theoretically could make $5.9 trillion dollars. Obviously, not realistic. And, in some countries they lowered the cost some, but still were in the tens of thousands for treatment therefore making it mostly impossible to use.
They made a gamble. They could have priced the drugs at say $10000 in the US/UK/Aus and at $5000 in poorer and treated a lot of people and made half a trillion dollars. Instead, they priced it as high as possible to make the 1st world treat only the wealthy/well insured (UK has drastically rationed) figuring they can later lower the price and then pull in more people (ignoring the 400K dying from it each year).

So, seeing a need, a non-profit comes along and figures out a way to get around the desire for high profit in order to help people in poor countries. If the drug companies would have priced a bit more reasonably, probably never would have happened. Altruism and capitalism can (and should) go hand in hand. That is how I see this, not as some drug company working hard for years only to have their idea stolen.
 

ksupoke

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I don't doubt that at all but that's kind of the problem. If nobody was concerned about R&D costs, the life saving medicine might not exist in the first place. As I said, if this works and saves lives, that's great, just pointing out that some people (not you) don't seem to understand that R&D costs can play a huge part in the high price of some drugs. Probably not needed in this thread though so I'll leave it alone.
It’s my understanding that actual R&D costs are not the major costs they have to recoup, that would be the unbearable regulatory costs the gvt(s) artificially create. I read somewhere that it costs roughly a billion dollars to get a drug to market and the figure is inflated by as much as 50-70% by unnecessary regulation.
edit:
Sorry, what I read was evidently over 10yrs old, in the last 10 yrs that figure has increased by more than 2x.
https://www.scientificamerican.com/article/cost-to-develop-new-pharmaceutical-drug-now-exceeds-2-5b/
 

StillwaterTownie

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Drug companies spend much more on advertising than on research and development. Those drug ads you see on TV that spend much time warning of side effects, such as cardiac arrest and thoughts of suicide cost a fortune. So much for R&D.
 

CocoCincinnati

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It’s my understanding that actual R&D costs are not the major costs they have to recoup, that would be the unbearable regulatory costs the gvt(s) artificially create.
Good point, I personally was already considering the regulatory costs to be part of the development but it's good to mention it.
 

ksupoke

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Good point, I personally was already considering the regulatory costs to be part of the development but it's good to mention it.
Here are some pretty good articles on Drug development and costs as well as government involvement.
One item to note: the riskiest time for a new drug is the early research stage - unlike a new business venture where 95% fail to make the 1st year the numbers for new drugs are more like fractions of a % - 1 in several thousand even make it to the point where they go for fda approval - so who is the largest investor in the riskiest stage - that would be the taxpayer (mainly through the NIH). The pharma co's and VC's typically don't get involved until most of the risk is gone - in VC parlance that means they participate in the mezzanine round, that is patently unfair to the taxpayer and great for the VC's and pharma. By doing it this way, pharma in particular has been able to use funds that, by all rights, should go to research for products they will ultimately make substantial profits on, and use them for, and to, consolidate the industry, which has had the, unintended, effect of stalling or even eliminating research in some areas.

https://www.ncbi.nlm.nih.gov/books/NBK50972/
https://www.thebalance.com/who-funds-biomedical-research-2663193
https://www.fool.com/investing/gene...f-developing-an-fda-approved-drug-is-tru.aspx

Take the gvt out of research all together let the private sector take all the risk since they will see all the 'financial' benefits, eliminate all unnecessary steps in the approval process the process is overly burdensome to the point that you can lose a substantial amount of your patent period during your approval process, you can shorten the ttm by 30-50% or more and the development costs by at least that much, drug companies have patent(s) that have market value longer so they and the investor are 'whole', costs to consumers can be reduced that means taxpayer gets a benefit by not having our money risked on a fraction of a % chance and we gain the benefit of lower costs that we subsidize through various health programs, product gets to market sooner meaning more patients earlier more than offsetting the lower cost again meaning the co and the investor are made whole.


The problem is the behemoth that is the federal bureaucracy behind everything simply feeds on itself so eliminating or even reducing its involvement is tantamount to sorcery in Salem.
 
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