Standard of Treatment

[doncheery]

Hello all.  A long time since i have posted or been at site for that matter.
I am Canadian. 9 weeks into a 12 week course of Harvoni. Fatigue headaches but manageable
I am considered treatment naive although did three weeks of Interferon back in 2012 before massive allergic reaction, . lol was not pretty.
Heavily cirrhotic. Fibrotic. Viral load 1.7 million when treatment started. Feel great for most part.
Here is the question
Is the American standard of care/treatment also 12 weeks for someone in my situation?  I have heard 24 weeks for cirrhotics with fibrosis in the States.
i have faith in my physician but with 19 pills left i would like some info upon which to base an argument if i feel i need an extension.   My viral load was 28 after four weeks. Apparently the criteria is 12 in the Staes after four weeks to suggest treatment effective. I was called borderline.

Thank you in advance for any replies


.  

[doncheery]

Thank you for the links   Much appreciated

[hepcandme]

Here's some thread links:

http://www.medhelp.org/posts/Hepatitis-C/Viral-Load-at-4-weeks/show/2563655#post_12578198

http://www.medhelp.org/posts/Hepatitis-C/4-weeks-week-viral-load-60-still-detected-worried-on-8-week-tx/show/2570043#post_12538430

http://www.medhelp.org/posts/Hepatitis-C/HARVONI/show/2555145#post_12448503

While we all love scientific data, those "difficult to treat" patients have a limited amount of data to share, as you pointed out

Plus, I think we all benefit from each experience. We are the vanguard of the new regimens

[pooh55811]

I have no idea which threads you are talking about.

Plus, I don't go by anything anyone says unless they can provide links to studies. And, if the studies were small, then the results are questionable. We all know the studies are cherry picked and do not represent the real world. If they are small studies, they represent the real world even less.

[hepcandme]

Hi Don

Yes, those seem to be the questions that are still a bit elusive because we don't have the data in significant numbers yet

I am a compensated cirrhotic on 12 weeks of treatment with Harvoni and Ribavirin

There are a couple of good threads here that discuss both the significance of VL and another long thread re: length of treatment

My take on these comments were:

1) don't worry about VL so much unless it climbs (mine was 84 at 4 weeks and less than 20 at 6 weeks. Some report being detected at EOT even with a small viral load

2) Length of treatment is more problematic - Pooh's post is a good one but you can tell we are all a bit concerned about the criteria for how long treatment should last. When I relapsed on Sovaldi/Olysio last year, I was told that I probably would have cleared if I had done 24 weeks

Some have fought for longer treatments and succeeded

I don't think that I could handle another 12 weeks of Riba but everyone reacts differently to treatment

Good luck and keep us posted

Pooh, You might provide those links to the threads I mentioned?

[doncheery]

I saw that. Same concerns. the main red flag seems to be the 28 viral load at 4 weeks.  That being said my physician is saying no more viral load tests until 12 weeks after com[completion.  Reasoning being is that even if detected now , it might not be in Sept. Also vice versa. Undetected now can show up detected  three months after completion.  .
I seem,  as he said to be a borderline case.  Wait and see.  Feel good now. This moment.  Grateful.  Be here. Now  Thanks again Pooh. You have been marvelous.    

[pooh55811]

When you read the part (further down) on length of treatment, you will see the results of the studies. In the one study that included Cirrhotics, there was no statistically significant difference in SVR for Cirrhotics versus Non-cirrhotics.  "There was no difference in SVR12 in those with cirrhosis (97%) versus those without cirrhosis (98%)" The study included 16% with Cirrhosis (which would be 138 people with Cirrhosis). I think my concern is that 138 people is not a large group of people. I am always concerned when the studies include few people because the numbers can get skewed in smaller studies, simply because the sample group is small. If the studies included several hundred Cirrhotics  and came out the same, I would be more convinced. Plus, we all know that the real world numbers do not end up being as good as the study numbers.

[doncheery]

Thanks for response.  Just printed it off.  Hope you are well.  
Seem compensated.  All functions ALT etc normal.  Platelets were low but have been forever. They are rebounding.  No ascites,, varices or hep encephalopathy.  As to 28 viral load at 4 weeks it was discussed. he called it borderline.  I will read info you linked and see what it says.  If i feel it warranrs it I will make the call to him. Thanks again. Take care

[pooh55811]

Good to see that you are getting treatment. Here's wishing you SVR.

If you are well compensated, then 12 weeks is the recommended treatment for your status (classified as naive).

However, if you have any signs of  decompensated Cirrhosis (ascites, or esophageal varices, or hepatic encephalopathy, or edema, low platelets, or any other symptoms of decompensation) then you would do 24 weeks.

The thing that would concern me, if I was you, is the VL of 28 at 4 weeks, especially considering your cirrhosis. It would be worth discussing with your doctor.

http://hcvguidelines.org/full-report/initial-treatment-hcv-infection#genotype1a-text

http://www.hcvguidelines.org/full-report/unique-patient-populations-patients-decompensated-cirrhosis

Wishing you the best.