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Appointment with Hepatologist on 12/5/13

Dec 26, 2013 - 13 comments

My husband saw his hepatologist for a routine follow up (labs, imaging, check up) earlier this month on 12/5/13.  His Ultrasound results were stable (no change, normal size, benign cyst unchanged, no sign of ascites, no sign of liver cancer).  Kidney function is good.  White count is good.  INR=1, Alb=3.6, Bili is good.  She gave him a MELD score of 6, which is about where it's been for the past five years.  Since he has Hep C and Cirrhosis, and has previously treated and failed 3 times (2007=Interferon and Ribavirin; 2010=Consensus Interferon and 1400 mg Ribavirin; 2012=Triple Tx with Incivek), the newly approved treatment meds are not for him.  She discussed the possibility of treating him with sofosbuvir, ribavirin, and interferon "off label", but with his recent diagnosis of serous retinopathy, there could be risk to treat with interferon again.  She also discussed the possibility of combining simeprevir and sofosbuvir, which would again be an "off label" treatment and would require special consideration for prior treatment failures with higher risk factors.  She seemed to feel that the best option might be to wait for sofosbuvir and ledipasvir combined with ribavirin, which she hopes will be approved about December, 2014.  In the meantime, his liver is still well compensated.  she will see him again in June, 2014, for another ultrasound, lab work, and ultrasound.  He is still on the UW's study radar to be called if any appropriate clinical studies come up in our area.  In the meantime, she is in communication with his retina specialist to see if he would advise or advise against another interferon based treatment (e.g. sofosbuvir, ribavirin, and interferon "off label") given his retinopathy.  If he advises against, then I think she plans to request special permission to consider treating with simeprevir and sofosbuvir "off label", but if she doesn't feel that will benefit him, if I'm understanding correctly, she will wait until sofosbuvir combined with ledipasvir is approved end of 2014.
Advocate1955

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Avatar universal
by stormy456, Dec 28, 2013
Hello, my friend!

I was glad to read this post, so happy that your husband is stable.  When I saw the news about the new treatments, I immediately thought about the two of you.  While it's disappointing that the sofosbuvir tx isn't a fit for him, they're making such tremendous headway, and quickly, that I feel quite certain that you'll find the right one, and soon.  Your hepatologist sounds like a rock star.

Hope all is well with you, and that 2014 is the year of the cure for you and everyone.

Stormy

Avatar universal
by Advocate1955, Dec 28, 2013
Hi Stormy,
She is a rock star!  She tried Consensus Interferon with him before it was FDA approved!  She is assertive and aggressive about treating, and we like that!  
She feels confident that either she will try something "off label" for him during 2014, or there will be something new (all oral) either a trial or something new approved by the end of 2014 for him.
We love her.
Advocate1955

Avatar universal
by nan535, Dec 29, 2013
Hi Advocate
Glad to hear your husband has been stable for so long.  That is amazing.

As you may know from my prior posts, my husband unfortunately has recurrent Hep C and bile duct blockages post-transplant that have now caused cirrhosis of the new liver.   He has been having bouts of HE again which is the most difficult to deal with.

His hepatologist plans to start him on Solvaldi plus Ribavirin for 24 weeks. They are submitting the paperwork now to his insurance company and hopefully treatment will begin in late January.

Just wondering if this is not an option for your husband and if not, why not?

All the best for a happy and healthy New Year for us and our husbands!   ;-)

Nan


Avatar universal
by Advocate1955, Dec 29, 2013
Hi Nan,
Sovaldi with Ribavirin would be off label for my husband.  He is Genotype 1, and right now Sovaldi and Ribavirin without Interferon is not approved for Genotype 1.  She did mention the possibility of treating off label.  Did your husband's hepatologist give you an idea of the likelihood of success using that combo, and is your husband a G 1?

Best wishes for a Happy New Year!

Advocate1955

Avatar universal
by nan535, Dec 29, 2013
Thank you for the Happy New Year wishes.

My husband is genotype 1a and treated with triple treatment for 5 weeks before having to stop treatment because he became very anemic and needed several blood transfusions. Apparently  this 24 week treatment is approved for those that are interferon ineligible. I'm not sure why he is considered ineligible for it (perhaps because he is post-transplant and had such a poor response to interferon previously).

I will try to find the info about this option that I saw. I would think given your husband's prior response, he too may be considered interferon ineligible.  As for the likelihood of success, I believe it is about 70%.  Our thinking is even if he should fail this treatment, he will be undetected for 6 months and that will being him closer to the new combo pill treatment expected by Dec. 2014.  The trials on that one show a 90+ SVR rate.

All the best,
Nan




Avatar universal
by nan535, Dec 29, 2013
Found it!

http://www.lifebeyondhepatitisc.com/2013/12/new-hepatitis-c-drug-approved-fda-sovaldi-sofosbuvir-gilead/
"Gilead states that Sovaldi (Sofosbuvir) can be considered for (CHC) chronic hepatitis C patients with genotype 1 infection in combination with ribavirin for 24 weeks for those patients who are interferon ineligible."

Avatar universal
by nan535, Dec 29, 2013
Hi Again

My husband is not HIV infected but there was a trial called PHOTON-1 which treated HCV infected patients who were also infected with HIV
http://www.gilead.com/news/press-releases/2013/11/gilead-announces-phase-3-results-for-an-alloral-sofosbuvirbased-regimen-for-the-treatment-of-hepatitis-c-in-patients-coinfected-with-hiv

In the trial, 76 percent (n=87/114) of genotype 1 HCV treatment-naïve patients receiving 24 weeks of an all-oral, interferon-free regimen of sofosbuvir plus ribavirin (RBV) achieved a sustained virologic response 12 weeks after completing therapy (SVR12). Patients who achieve SVR12 are considered cured of HCV infection.

I think these results are why they have also stated that that Genotype 1 chronic hep C patients who are ineligible for interferon can be considered for the Solvaldi + Ribavirin treatment for 24 weeks.

A  76% cure rate sounds pretty good to me and worth a try.

Nan

Avatar universal
by Advocate1955, Dec 29, 2013
Thanks for all the info Nan.  If he fails with the sofosbuvir plus ribavirin treatment, would he still be able to attempt the sofosbuvir ledipasvir combo when if/when it becomes available?

Advocate1955

Avatar universal
by nan535, Dec 29, 2013
I asked his doctor that question and she said yes he would be able to attempt the sofosbuvir.ledipasvir combo  as there would be no resistance like there was with the Incivik.
I hope I'm saying that right. ( Hard to keep all the terms right but I think you know what I mean.)

Nan

Avatar universal
by nan535, Dec 30, 2013
Found a little more info on results of the PHOTON-1 trial. (Sovaldi + Ribavirin for 24 weeks)  I think these results are even more encouraging for gt 1a patients (like our husbands). One  difference however is this trial was for treatment naive patients.  My husband was not a null-responder, he was undetected at Week 4 with triple treatment but had to quite at Week 5, so I'm hoping that bodes well for success with this treatment.

http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/sovaldi/sovaldi_pi.pdf

"In subjects with HCV genotype 1 infection, the SVR rate was 82% (74/90) in subjects with genotype 1a infection and 54% (13/24) in subjects with genotype 1b infection with relapse accounting for the majority of treatment failures.

SVR rates in subjects with HCV genotype 1 infection were 80% (24/30) in subjects with baseline IL28B C/C allele and
75% (62/83) in subjects with baseline IL28B non C/C alleles."

Nan

Avatar universal
by Advocate1955, Dec 30, 2013
Thanks for all the additional info Nan.  I will definitely ask his hepatologist about this.  If there are no resistance issues, then it seems like a good idea to try SOF and RBV off label to give his liver a break, if nothing else, and then if he relapses to do SOF and LED when it becomes available.  Since my husband now has serous retinopathy, I have a feeling that his retina specialist and his hepatologist will decide no more Interferon for him.
Let me know what you, your husband, and his doctor decide.
Advocate1955

Avatar universal
by nan535, Dec 30, 2013
One last comment - Hector was on this treatment for 48 weeks pre-transplant. He is gt 1b. Unfortunately, he relapsed
post treatment. I asked his advice and he said my husband should go for it for the very reason you wrote - to give his liver a break (hopefully, permanently). He also said he was never anemic while on treatment which was a big concern for us given his prior reaction to triple treatment.
I will definitely keep you posted on how things go.

Nan

Avatar universal
by Advocate1955, Dec 30, 2013
OK, thanks Nan.  I agree, especially given your husband's particular circumstances of being post transplant with Cirrhosis in new liver and Hep C.  Any break that you can give the new liver and any chance of treating the Hep C is a good thing.
Advocate1955

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