Cirrhosis w or w/o Decompensation - HCV Trial results

[nan535]

http://www.clinicaloptions.com/Hepatitis/Conference%20Coverage/London%202014/Highlights/Capsules/68.aspxSummary of Key Conclusions

For those who have Hep C related cirrhosis with or without decompensation, these are the promising interim results of multicenter, open-label, randomized phase II trial :
Source: 2014 Annual Meeting of the European Association for the Study of the Liver*


        Robust on-treatment efficacy observed with sofosbuvir + ribavirin through 24 weeks in HCV-infected
        patients with portal hypertension with and without hepatic decompensation
        High rates of virologic suppression (93% to 100% at Week 24) regardless of liver disease severity
        Decrease in necroinflammation with normalization of ALT
        Improvements in albumin levels and platelet count
        Resolution of ascites and hepatic encephalopathy
        Sofosbuvir + ribavirin well tolerated through 24 weeks
        Low rate of treatment discontinuation due to adverse events (AEs) (4%)
        No worsened or new-onset hepatic decompensation

This provides hope for those of you who have decompensated cirrhosis. My husband is on this treatment (10th week)
Has portal hypertension and hepatic encephalopathy.  Platelet count is up to 240 from 145.  Inflammation of his liver has been reduced as evidenced by normalization of AST, ALT and Billirubin. He, unfortunately, is still having frquesnt episodes of hepatic encepahlopathy but this study is giving us hope that that will improve in the next few weeks.
Most importantly, he is UND for the HCV.

Nan

[nan535]

My husband unfortunately has experienced way too many episodes of HE over the last three and a half years (pre and post transplant). Some episodes  were mild while others have been very severe.  Of everything he has gone through, I think HE is probably the worst thing.  At its worst, he was uncommunicative and unaware of his surroundings.  Some signs of advanced HE are trembling hands, confusion, forgetfulness, handwriting changes, increased irritability, and loss of appetite. It is not a good idea for anyone who is experiencing these symptoms to drive.

This is a link to a very good webinar on HE which took place the other night.
I think it is worth the time for those who suffer from HE or who care for someone who has these terrible episodes.
http://he123.liverfoundation.org/resources/webinars/diagnosing-and-treating-he/

Chris - how advanced is your liver disease?  HE is one of the signs  of advanced liver disease. I hope you are being seen by an experienced hepatologist. If not, you probably should find one soon.

Nan

[ChrisDDD]

Hi.  Do you mind telling me what symptoms your husband was having with the hepatic encephalopathy?  Less than a year ago I was put on Lactulose, but wasn't told why except having constipation issues.  I remember my GP asking me now that I'd been on the Lactulose, was I noticing any improved mental functioning, better memory, more clear-headed, much less brain fog, and ability to interact with people (I'd feel so embarrassed because sometimes I'd be at a party or whatever and I could not for the life of me remember what people were talking about, what I was talking about, their names, etc.)  The Lactulose did really help, but the brain fog feels like it's getting worse again.  Is that Hepatic Encephalopathy?

[nan535]

Wish I could say it was "they" who figured it out but the truth is it was me...

[Livelife777]

OMG.     So happy to hear they finally figured out what was causing the awful  HE episodes.     You both deserve a break.     Hope you have smooth sailing from here on, and may your journey be easier to complete.   Can't believe you were not told this.    At least it's good knowledge to share with future treaters,  as they can be spared having to go thru this......      Kim

[nan535]

Are you taking Xifaxin to control the HE?  If so, you should consider  stopping.
My husband took it for the 10 1/2 weeks on this treatment. Just found out he should not have been taking it. I called the Sovaldi hotline for help and the nurse told me he should not be taking Xifaxin with Sovaldi because it is an antibiotic based on rifampin. So I stopped it and the HE episodes that he has been having all these weeks have finally stopped.  Praise God. Unbelievable!
So he only takes lactulose now 3X a day.

Nan

[nan535]

The most important  thing is to kill that virus before transplant.  
It's a wonderful thing that you have the opportunity for  a treatment that you will be able to complete and hopefully, get you in better physical shape before your transplant.  What an amazing difference that would have made for my husband had he been able to clear the virus before transplant. I will be praying for SVR for you in the near future.

Nan

[heart_in_the_keyes]

I will be on the Sovaldi/Riba for  24 weeks ...so far doing great...

I have HCV, HE and Cirrhosis with decompensation Stage 4.

Think I will kill this HVC beast.

Now if they could only do something for the decompensation so I won't have to have a transplant because even with the a success on Sovaldi/ Riba will still have to have transplant.  Ugh.

[nan535]

These findings are just preliminary. We will have to wait to find out if the participants reach SVR or not.

I think the important thing they wanted to show with these results is that the participants (some with decompensated cirrhosis) were able complete 24 weeks of Sofosbuvir + ribavirin safely.

Only 4% discontinued treatment due to adverse events and none of the participants decompensated on treatment or worsened if already decompensated.  

This is in contrast to the triple treatment (with Incivik) my husband tried pre-transplant. He had decompensated cirrhosis at the time. He lasted only 5 weeks on treatment and ended up with ESLD (end stage liver disease). He also came very close to kidney failure. In other words, the treatment worsened his condition.  

This did not happen to any of the participants in this trial who were able to complete 24 weeks on treatment and have shown improvement in their
liver function.

The icing on the cake will be to see how many will actually achieve SVR.

Nan

[Upbeat]

Thanks for posting.

I am into week 13 of this protocol.  Geno 1b   compensated cirrhosis and HCC.  Big improvment in my AST and ALT  also platelets seem to be abit better.  This study points out the improvment in liver functions however there is no mention of SVR.  I guess we can be happy for the improved liver function even if no SVR is obtained

[nan535]

The link in the above post was broken.

http://www.clinicaloptions.com/Hepatitis/Conference%20Coverage/London%202014/Highlights/Capsules/68.aspx

Main interim Findings of this trial
    High rates of virologic suppression attained in CTP A and CTP B groups
     through first 24 weeks of sofosbuvir + ribavirin
    Slower response in CTP B group but exceeded 90% by Week 8
    No patients experienced virologic breakthrough during treatment

Primary Endpoint will be SVR 12