[Ip-health] Chronic hepatitis C treatment outcomes in low- and middle-income countries

George Carter fiar at verizon.net
Thu Sep 13 13:49:55 PDT 2012

Thanks for posting this meta-analysis showing people in developing nations respond as well to Hep C (HCV) therapy as cohorts in developed nations. No real surprise. 

Given this reality, and the fact that there is a drug currently in the hands of BMS that, with a drug in the even more vile hands of that monstrosity of greed, Gilead, in early studies showed rates of up to 100% sustained viral response (SVR) among hard-to-treat genotype 1 HCV infected individuals (and I'm one of those), isn't it about time Cipla or some company or GOVERNMENT took these drugs away from these two companies and started clinically evaluating them and making them available for pennies per patient per year?

Instead of allowing the situation to persist where they are NOT studied at all, due entirely and for no other reason than greed? Gilead has made it clear it would prefer to corner the market with their own version of the BMS drug and will wait, letting millions of us suffer and die while a CLEAR AND PRESENT CURATIVE TREATMENT IS AT HAND.

And the wait could be even longer as some of the newer oral agents are failing in clinical studies.

So Gilead has moved on from committing economic genocide among people with HIV to murdering millions of us with HCV. Unless we can afford the ransom they demand--and the have the luxury of the time it will take to develop these two new drugs?

The new drugs that need to be liberated from being held hostage are daclatasvir and GS-7977. See, e.g., http://www.hepmag.com/articles/hepatitis_dectatasvir_7977_2501_22276.shtml 
"kept hepatitis C virus (HCV) undetectable for four weeks after treatment in 100 percent of people with genotype 1 infection and 91 percent of people with genotype 2 and 3 infection..."

How can we get these drugs manufactured and available for human beings and not these criminal, murdering profiteers, these pirates of conscience looting the ship of state and human health?
George M. Carter

On Sep 13, 2012, at 12:12 PM, Joanna Keenan-Siciliano wrote:

> In case you missed it, please see the link below to the first article that
> systematically assesses Hepatitis C treatment results outside developed
> countries, published in the July issue of WHO Bulletin: "Chronic hepatitis
> C treatment outcomes in low- and middle-income countries: a systematic
> review and meta-analysis."  The study shows that outcomes in low- and
> middle- income countries are just as successful as in developed countries,
> lending further support that treatment should be prioritized. ....

...meanwhile in other news...
Bristol-Myers Ends a Hepatitis C Project

Published: August 23, 2012

Bristol-Myers Squibb said Thursday that it was discontinuing development of a hepatitis C drug that it had acquired in a $2.5 billion deal, after nine patients in a clinical trial had to be hospitalized and one of them died.

The company suspended testing of the drug on Aug. 1, after one patient in a midstage clinical trial experienced heart failure. At that time, however, there was still some question of whether the drug, known as BMS-986094, had caused the problem.

But Thursday evening, the company said that initial patient had died and that eight other patients also had to be hospitalized. Two of them remained hospitalized.

“While the cause of these unexpected events, which involve heart and kidney toxicity, has not been definitively established, the company has determined that it is in the best interest of patients to halt development of BMS-986094,” the company said in a statement.

The scrapping of the drug is a big setback for Bristol-Myers in the heated race to develop a combination of pills to treat hepatitis C, a viral infection that can cause liver scarring and liver cancer.

Current treatment now involves up to a year of weekly injections with alpha interferon, which causes severe side effects. The hope is that combinations of pills that work by different mechanisms could eradicate hepatitis C without the need for interferon. So companies are scrambling to assemble the components of such an all-oral regimen.

Bristol-Myers paid $2.5 billion in January to acquire Inhibitex, which was developing the drug that became known as BMS-986094. Bristol-Myers hoped to combine that drug with daclatasvir, another hepatitis C drug that it is continuing to test in clinical trials.

One question is whether the troubles with BMS-986094 will extend to other drugs in its class, known as nucleotide polymerase inhibitors.

Last week, Idenix Pharmaceuticals said the Food and Drug Administration placed a hold on a trial of its nucleotide polymerase inhibitor, IDX184, because of the heart failure case in the Bristol-Myers trial. Idenix said it had not seen any cardiac toxicity with its drug.

Gilead Sciences also has a drug in that class that it obtained by acquiring Pharmasset for $11 billion, though that drug, GS-7977, is somewhat different chemically.

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