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Hep C Discussion Forum -> General Discussion -> Frquency of VL testing on treatment
Post Info TOPIC: Frquency of VL testing on treatment
Mugsy


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Frquency of VL testing on treatment
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http://www.oregonlive.com/health/index.ssf/2014/07/oregon_moves_closer_to_limitin.html

 

Here's an article from the July 14th Oregonian about the proposed limiting of Medicaid patients access to Sovaldi. The article brings up many good points.

 

Sorry  wrong thread



-- Edited by Mugsy on Friday 15th of August 2014 06:25:19 PM

__________________

62 y/o F     Genotype 1b  for 40+ years    cirrhosis    Started Harvoni  on 11/23  for 12 weeks       UND  12/22/2014     Ended treatment on Feb 15th.

12 week's EOT viral load      <15 
Isiscat2011


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Gator Man wrote:

If prescription prices ever get out of the stratosphere, maybe we will see more individualized therapy for each patient, evaluating each patient's stage and severity of liver disease prior to deciding tx duration. Until then, your "bitter" conclusions about what to do with these drug addicts appears to be correct.

_________________________________________________________________________________________________________

I think we are already there.  Prescription prices have gone out of the stratosphere but instead of individualized therapy to maximize SVR rates the solution is minimizing tx durations and rationing.  The new AASLD guidelines actually spell out who gets the tx and who doesn't.  

Rationing makes a certain kind of sense--much like cannibalism does if you are stranded and starving on a desert island and your mates start dropping dead-- but it is nonetheless a repugnant idea.  

 



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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.
Isiscat2011


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mallani wrote:

The next step will be 8 weeks for Rx-naives, like it or not. If cirrhotics only get the same as non-cirrhotics, why bother with biopsy or Fibroscan?

As side effects are so mild, who needs a Hepatologist? Let GP's take care of these drug addicts. So what if we need to retreat some. THAT'S being bitter!

 You got it, Malcolm.  Now you are thinking like an American policy maker!  lolol

 

 



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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.
Gator Man


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mallani wrote:

 

I don't understand this, and that annoys me. With SOC and the antiprotease triple, a RVR was a great indicator of the likelihood of SVR. It should be the same with Sovaldi.

Now it seems everyone gets 12 weeks, like it or not and best of luck. The VL then becomes pointless, until the EOT +12 or 24 weeks.

The next step will be 8 weeks for Rx-naives, like it or not. If cirrhotics only get the same as non-cirrhotics, why bother with biopsy or Fibroscan?

As side effects are so mild, who needs a Hepatologist? Let GP's take care of these drug addicts. So what if we need to retreat some. THAT'S being bitter!

I think the ultimate unanswered question is whether longer tx spans, 16, 20, 24 weeks or more, would have made a difference for those that relapsed at EOT +12 with the S/O or S/O/R combo? I don't think this question has been addressed in any of the clinical trials. Continuation of tx with a reasonable chance of success for "problem " cases, seems like a much better option than kicking the can down the road for the next approved DAA combo. Plan B can always be another drug in the future, once it is clear that is not the length of tx that is responsible for relapse.

If prescription prices ever get out of the stratosphere, maybe we will see more individualized therapy for each patient, evaluating each patient's stage and severity of liver disease prior to deciding tx duration. Until then, your "bitter" conclusions about what to do with these drug addicts appears to be correct.

Clearly those decisions need to be made by a physician well versed in the current Hep C horizon. I for one, need my Hepatologist.



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Geno 1b, compensated cirrhotic, 54 yo, prior null responder. Pre tx VL approx 595,000, tx with Sovaldi/Olysio (no Riba) started 1/8/14. VL 40 @ 2 weeks, UND @ 4 weeks. Still UND @ EOT + 1 year.

Gator Man SVR12, Dragon 0, Final Score.
mallani


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I don't understand this, and that annoys me. With SOC and the antiprotease triple, a RVR was a great indicator of the likelihood of SVR. It should be the same with Sovaldi.

Now it seems everyone gets 12 weeks, like it or not and best of luck. The VL then becomes pointless, until the EOT +12 or 24 weeks.

The next step will be 8 weeks for Rx-naives, like it or not. If cirrhotics only get the same as non-cirrhotics, why bother with biopsy or Fibroscan?

As side effects are so mild, who needs a Hepatologist? Let GP's take care of these drug addicts. So what if we need to retreat some. THAT'S being bitter!



__________________

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
Fireman Rob


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And there are people that were UND at 4 weeks that relapsed. When UND takes place doesn't seem to make a difference for SVR rates which makes me wonder if it's primarily immune system dependent?



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Age 33, Male. GT-1 for ten years. Diagnosed in March, 2014.

Treated with Sovaldi/Olysio: SVR 24 on February 16, 2015!
Isiscat2011


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Hi Malcolm:

The question is:  Does when someone becomes UND predict outcome?  We have seen people here who were not UND at 4 weeks but who SVRd.  Is there any data available on this?   



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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.
misosoup


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I'm on Peg/riba/Sovaldi, and last week my GI told me they had decided not to test VL at 4 weeks anymore, and were considering not testing at all until 12 weeks post treatment. They had met with hepatologists and since there is no change in regimen based on VL, any tests before 12 weeks post are pretty pointless. They also mentioned a few cases they had of patients who were unnecessarily worried when they came back detected at 4 weeks, but undetected later on.

I was a little bummed out to hear that, I will likely ask for one at EOT just because. I don't have a copay if I go to a specific lab, so it's no big deal to me.

 

ETA: They did test CBC and metabolic panel at 2 weeks, and I do another (plus thyroid? Wasn't expecting that one!) at 6 weeks. I was told they like to check CBC twice during the first 6 weeks, just to keep an eye on it. I'll find out at my 8 week follow-up what's after that.



-- Edited by misosoup on Friday 15th of August 2014 04:15:12 AM

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27 F, genotype 1a, started riba/Pegasys/Sovaldi July 2014
Isiscat2011


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mallani wrote:

If it was me, I'd demand a 4 week, 8 week and 12 week VL. If the Hepatologist wouldn't do it, I'd get a referral from my GP. The cost of a private VL (with no refund) is $288 here. I'm not sure what it is in the USA or Europe.

 

The problem is there is no protocol for extending tx based on VL not being UND at 4 or 8 weeks.  That problem remains until it is rectified.  Also, the GP can't get an extension. The Hepatologist would have to be on board for this, and even then if the guidelines don't provide for an extension, the insurance companies may not pay.  

This is the US.  We have a long established tradition of throwing more money into getting worse results in healthcare.   I predicted this too and I fully expect to see more relapses and retreatments than necessary.  

Oh my...was that too bitter?  lol

 

 

 



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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.
Fireman Rob


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Hi Malcom,

That's about right in my case. My doc wanted to do a EOT, and 24 week after tx VL test only. I did manage to get a EOT plus 12 weeks test added to the schedule.  Apparently he's not aware of SVR 12 as the standard to meet? Two weeks of S/O to go. Interesting times!



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Age 33, Male. GT-1 for ten years. Diagnosed in March, 2014.

Treated with Sovaldi/Olysio: SVR 24 on February 16, 2015!
mallani


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Hi all,

There have been some posts regarding the frequency of Viral Load testing while on treatment.

Previously, this was well established. With Peg/Riba, a VL at 4, 12 24 and 48 if required) weeks was standard. With Incivek triple, 4, 12 and 24 weeks were standard, and for the Victrelis triple, 4, 8, 12 and 24 (or28) were the go. There were well defined Stopping Rules.

With the Sovaldi regimes, confusion reigns. With it's supposed rapid action and high cost, I've been waiting to see some guidance about VL testing and stopping. Obviously, this is not coming.

I've been following the AASLD HCV Treatment Guidelines. All editions, including the August one, have a section called 'Monitoring Patients'. It says 'Coming soon'!!

Most patients will become Undetected on Sovaldi, usually with 2-4 weeks. I thought this would be useful to know, so a 4 week VL should be standard. Not so, some Hepatologists don't seem to care. It's assumed that ALL patients will be Undetected by week 12, so a VL then isn't really necessary?? The only thing that seems to matter is the EOT + 12 week VL, so they can see who relapsed.

Some patients are going to need more than 12 weeks. In fact, the Geno 3's need 24 weeks if only on Sovaldi/Ribavirin. The AASLD Guidelines now state 'cirrhotics should have the same treatment as non-cirrhotics'?? This would worry me, particularly without VL testing to see whether an extension of treatment is indicated. I'm afraid the 'one size fits all 'prediction of mine has come true.

If it was me, I'd demand a 4 week, 8 week and 12 week VL. If the Hepatologist wouldn't do it, I'd get a referral from my GP. The cost of a private VL (with no refund) is $288 here. I'm not sure what it is in the USA or Europe.

I'll keep looking, but don't be surprised if your VL testing is pretty sparse.



__________________

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
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