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Post Info TOPIC: Updated introductory statement of When and In Whom to Initiate Therapy, from AASLD


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RE: Updated introductory statement of When and In Whom to Initiate Therapy, from AASLD
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This topic is annoying. I find it incredible that AASLD recommendations need to be put in boxes like 'Class 1, Level A'. Why the hell can't they just say all patients with chronic HCV need to be treated- period!

Over here, we don't have the Sovaldi or Harvoni problem. They aren't available.

For some bizarre reason, Olysio has been approved and is on our PBS (that means it's free). Geno 1 patients are trying to get Rx with Olysio/Peg/Riba for 24 or 48 weeks but Hepatologists are not keen to prescribe it.

Here in Queensland, Victrelis is still being used. It's safety profile is well known, and the new stopping rules are applied. ( Stop Rx if VL >1,000i.u./ml at week 8).

Just looking at the figures, here are my views on the potency of the DAA's ( 0= worst, 10= best): Sovaldi-8

                                                                                                                                     Olysio-5

                                                                                                                                    Incivek-6

                                                                                                                                   Victrelis-5

Vertex has stopped making Incivek, so I imagine that's no longer an option in the USA. The AASLD did not recommend the Victrelis triple in the second last set of Guidelines, so I guess that's off the table as well. I know someone in South Africa who has just started 48 weeks of Peg/Riba, as Victrelis is not available. It's a mad, sad world.

                                                                                                                                



__________________

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

Tig


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I'm not aware of there being a stop order on Victrelis prescriptions in the USA Isis. I've been trying to determine that since you mentioned it but I'm unable to find any current updates on it. It's still actively written in locations outside the USA and the most recent FDA update is listed as Feb 2014. Even if it is available stateside, I imagine it's not a real popular topic of conversation in most GE or Hepa offices right now! 

Tig

@Malcolm, any thoughts?



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Tig

66 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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Tig56 wrote:

______________________________________________________________________________________________________________

 I wonder what the insurance providers response would be right now if a request was made to treat with the IFN/RIBA and either Victrelis or Olysio protocols was made? Would they approve it or are they in a deny everything mode right now? As promising as the new protocols are right now, the massive wave of financial confusion crashing across their introduction seems to be stronger than the drugs themselves... no

 


I wonder that also, Tig.  Don't the protocols specifically exclude Victrelis?  But the Interferon combos are still listed (as is the S/O combo).  When combined with Sovaldi the Interferon combo doesn't even cost much less than Harvoni.  AASLD needs to provide more updates.  Maybe December or January?

I must say that I am disappointed the AASLD has not taken a stronger leadership position independent of financial considerations.  The relationship between the medical profession, the insurance industry, and Pharma has become so closely intertwined that it is getting hard to tell who makes the medical decisions anymore and whose interests are being protected.  The AASLD is  probably concerned about the lack of available resources within the medical community as well--not enough specialists and too many patients.  Rather a mess for the time being.  



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.

Tig


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Sadly, until Interferon backbone treatment protocols are eliminated from the list of options, there will continue to be physicians and providers (insurance companies), that are going to recommend it as a first line treatment. In many parts of the globe, they are all that's available and will be for a long time. The fact that those protocols under some circumstances continue to provide 80% +\- success rates across some genotypes and at significant cost savings, looks pretty good to these same providers. Unfortunately it appears that the harsh side effects and the length of time these treatments require mean very little to them. I wonder what the insurance providers response would be right now if a request was made to treat with the IFN/RIBA and either Victrelis or Olysio protocols was made? Would they approve it or are they in a deny everything mode right now? As promising as the new protocols are right now, the massive wave of financial confusion crashing across their introduction seems to be stronger than the drugs themselves... no

Tig



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Tig

66 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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The AASLD's recent position statement includes the following :

Our recent addition to the Guidance prepared by a committee of leading liver experts from AASLD and The Infectious Diseases Society of America (IDSA) proposed that the sickest patients be treated first, but all patients who receive advice from their doctor to take newest medications should not be denied. The decision across the board should be in the hands of the clinician and the patient to make the decision. Unfortunately payers across America are denying treatment when a doctor has prescribed it for their patient. We adamantly disagree with this decision.

Our Guidance is not intended to be used by payers to deny access to treatment. In no way does this position contradict the evidence evaluated to produce the Guidance and the recommendation made in the Guidance to treat the sickest first, but recognizes need to treat all.

http://www.aasld.org/aboutus/publicpolicy/Pages/aasldhcvposition.aspx

 

The prioritization of patients language is what the payers will rely on.  Interesting that the AASLD hasn't given any guidelines for tx duration or whether Interferon tx should still be considered.  I would think most physicians in clinical practice will reject prescribing Interferon tx now although the AASLD guidelines have not been updated to reflect this change yet.  As to duration of tx the product labeling approved by the FDA will probably govern.  I'm almost afraid to see what the AASLD suggests on these points.  

 



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.



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Thanks Jill

Read through the link and seems that AASLD is re-emphasizing the high priority patients so the Insurance industry doesn't turn a blind eye to treating them. Unfortunately that leaves out way to many other HCV patients.

matt 



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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 



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Sadly, too little too late for most of the F-0s to F-2s who want tx now.  The AASLD's Guidelines gave the insurance companies the ammunition they needed to deny claims.  Triaging patients is a difficult task to be sure but it didn't need to come to this.  I can easily see this situation lasting a year or two and the reverberations potentially much longer. 

It reminds me a bit of the Hurricane Katrina situation.  So much devastation was preventable if the government had acted to protect the people sooner. With HCV tx the government was too busy protecting corporate interests.  



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.



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WHEN AND IN WHOM TO INITIATE HCV THERAPY

Recommendations for Testing, Managing, and Treating Hepatitis C

The introductory statement of When and In Whom to Initiate Therapy has been revised to reiterate that treatment will benefit almost all patients in all stages of chronic infection and that urgent initiation of therapy is needed in patients with certain conditions.

Successful hepatitis C treatment results in sustained virologic response (SVR), which is tantamount to virologic cure, and as such, is expected to benefit nearly all chronically infected persons. Evidence clearly supports treatment in all HCV-infected persons, except those with limited life expectancy (less than 12 months) due to non-liver-related comorbid conditions (See Unique Patient Populations). Urgent initiation of treatment is recommended for some patients, such as those with advanced fibrosis or compensated cirrhosis (see Table 1).

 http://www.hcvguidelines.org/full-report/when-and-whom-initiate-hcv-therapy



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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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