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Post Info TOPIC: Compassionate access to new hepatitis C drugs an "emergency" for European patients


Guru

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Compassionate access to new hepatitis C drugs an "emergency" for European patients
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Yes, that`s true, Malcolm, it would be a very difficult decision to make when doctors themselves don`t know what the risks would be for these patients.  As mentioned in the article, drug companies had no choice but to test new drugs for HIV on the sickest people first, but that doesn`t happen with new HCV drugs, no doubt because the drug companies want to be able to demonstrate the most promising looking results.

The patient and their doctor would both have to be prepared to step into unknown territory but I`m sure many people who would fit into the categories for `compassionate access` are desperate enough to think it was a risk worth taking.



__________________

Jill 

(71 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 



Guru

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Hi Jill,

I agree that patients should have some input about potentially dangerous new treatments. One of the problems is that not enough cirrhotics are included in the Clinical Trials, prior to FDA and other approvals.

Incivek and Victrelis are good examples. To my knowledge, no patient died during the Trials prior to approval. It is a fact that cirrhotics will have more severe adverse effects to these drugs. Since approval, additional safety warnings have been required for both drugs. The Incivek rash and Victrelis anaemia are bad enough, but there have been 4 deaths from Incivek and 1 from Victrelis. The deaths were all in cirrhotics, and acute liver and renal failure were responsible.

In this context, it is difficult for doctors to give full, informed advice to cirrhotics in regard to the new DAA's.  How can we expect patients to fully understand the risks?  If I was an otherwise healthy, well compensated cirrhotic, would I risk unknown side effects from an untried DAA, or use the Victrelis triple where the Sx are at least known.  It's not straightforward.



__________________

Geno 1b, IL28B CT,  x3 prior relapser,  ex-cirrhotic, 75 yo, did 48 weeks with Victrelis/Peg./Riba.  VL 1.28m at start, UNDET. at 8 ,12 ,16 ,24 ,30  and 48 weeks.  EOT 15 Feb 2013 , UNDET. at EOT + 28 weeks. SVR!  Still Undet. at EOT +5 years

Malcolm



Guru

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That is good news, and I agree it should be a risk measured by the patient. :D



__________________

Genotype: 3b

VL.�over 15, 000 000

Failed TX 2014: Interferon/Riba.

Cured using Sof/Dak combination.

I can eat cake again! <3 



Guru

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Compassionate access to new hepatitis C drugs an "emergency" for European patients

European governments must move quickly to ensure that compassionate use arrangements are put into place to allow access to new hepatitis C drugs for people with cirrhosis, advocates and doctors said at the 48th International Liver Congress Amsterdam.

However, clear differences in opinion emerged between patients and doctors regarding who should make decisions about acceptable levels of risk to patients during a symposium on compassionate use organised by the European Liver Patients Association.

Full article...

http://www.aidsmap.com/Compassionate-access-to-new-hepatitis-C-drugs-an-emergency-for-European-patients/page/2643212/

 



__________________

Jill 

(71 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 

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