Monitoring while waiting for new tx?

[WyoSue]

I saw my gastroenterologist on July 11. He recommended I wait for the new all-oral, interferon-free treatment expected to be FDA-approved and available in early 2014. I agreed to wait. At the time, I didn't think to ask about any monitoring I might need while waiting. When checking out, I was surprised to see there was no return visit scheduled.
A little background: I was dx with chronic HCV geno2 in Nov. by primary-care doc, who referred me to this gastro doc. Gastro doc did an ultrasound in Dec. and complete hepatic panel, including viral load  test. VL is high at 8.7 million. I estimate I've had HCV 35 years now.
Initially, I told gastro doc I wanted to go forward with SOC treatment for geno2s, then changed my mind after learning about the possible side effects. To complicate matters, I also have been dx with rheumatoid arthritis. Interferon treatment is not recommended for people with autoimmune disorders, as these can become much worse during treatment. So, for me, it makes sense to wait for an interferon-free treatment.
Here's my question: should my liver function be monitored while waiting for treatment? If yes, how? Regular liver panel blood tests? Regular ultrasounds? I asked the gastro doc about a liver biopsy, and he replied "Since you have decided to treat, a biopsy is irrelevant."
I don't have a great deal of faith in this doc and would like to hear from others who are waiting for the new treatment. What are others docs recommending in the way of monitoring while waiting?

[WyoSue]

Thanks for sharing your experience and thoughts. Sorry to hear you failed your first treatment. The "sick as a dog" stories I'm hearing were a big factor in my decision to wait for the new meds. I presume you are, too? I hope they deliver an SVR to both of us and everyone else who is waiting for them.
Best wishes!

[WyoSue]

Thanks for sharing your experience and success with the new tx. It's very encouraging, and I'm happy for your SVR. Yay!
Live long and prosper!

[WyoSue]

Thanks to everyone who responded. It was difficult to choose between Can-do-man's and HectorSF's as the best answer. You both basically confirmed what my gastro doc was trying to tell me - that a biopsy or more lab tests would not alter our current plan of treatment, which is now waiting for the new geno2 interferon-free regimen expected to be available in early 2014.  And I like Can-do-man's advice: "...worrying about ups and downs with blood test would just add to ones stress level... " Stress is a killer, too.
I'm not going to push for a biopsy. My doc said there's no indication of cirrhosis on my ultrasound or other blood tests, and I'm getting tired of getting poked.
The reason I don't have complete faith in my gastro doc is because he gave me a clearly wrong answer regarding one of my RA meds -- methotrexate. When I saw him the first time, he told me to keep taking the drug, but my rheumatologist and primary care doc emphatically told me to stop taking the drug! Methotrexate injures the liver. It is dosed weekly instead of daily so your liver can heal in between doses. I can't imagine why my gastro doc would tell me to keep taking it, unless he was unaware of the dangers (as I was until recently).  So, I went with 2 out of 3 doctors' recommendations, and stopped taking methotrexate.
Oh well, everyone makes mistakes, and there's only 2 other gastro docs in town, and my primary care doc says this guy is the best of the three.  So, I roll the dice and hope this doc can help me beat this virus.
Thanks for the great advice, folks. I feel very grateful to have found this group. It's been a tremendous source of information and encouragement. All the best back at ya.

[mzkity]

I agree, I would want the biopsy. Although the main thing that you should address Sue, is whatever issue you have with your doctor. I'm not sure of what it is but since you have time maybe just look around. Good luck biker mama!!! :).   Kitty

[Willy50]

I find myself falling most within what Cando and Hector said.

I DO think that it is important to know one's stage in most circumstances and monitor it.... but in this case the wait should be so very slight as to make it irrelevant.
well......
not actually so......

For if one was in an advanced stage, where some might get their knickers in a twist to treat.... in this circumstance I would feel that it might become even more important to WAIT.

Cirrhotics have a tougher time with treatments and run a far greater risk of having complications with treating or with other extrahepatic issues becoming worse.  I believe the newer treatments will be safer for cirrhotics or people with other accompanying extrahepatic issues

I believe the FDA review for Sofosbuvir is due in very early December of this year; the drug may be approved in just over 4 months (aug, sept, oct, nov. =4 months)  

Any possible advancing cirrhosis issues would likely be weighed against waiting for a easier, safer, treatment which should be approved well within 6 months.
I see no reason why you cannot simply trust your doctor and wait.

For what it's worth I am currently taking one of the new drugs (sofosbuvir w/ gs5885 and RBV) and it has been highly efficacious, minimum sides other than my riba.
Also FWIW, I was diagnosed w/ high liver enzymes 10 years ago; over 100 ALT (in 2003) and this past summer ALT 150, and yet my April 2013 biopsy revealed a stage 2 fibrosis.  : )  

best,
willy

[ppmguy]

             no body is is debating the issue of when to tx.  i think everybody is in agreement that wyosue should wait.  the only thing im concerned with is finishing the diagnostic phase.  
          

[jules2551]

I dont think that waiting six months for the new drugs to come out would make much difference since you said you have had it probably for 35 yrs.  What is done is done.  You do need to have abiopsy through to see what stage/grade your liver is in.  That is something you definitely want to know what you are dealing with.  I was not dx until sept 2012 and couldnt start tx until july 2013 due to other issues.  S waiting 5-6 months, with the new orals, should not make a difference.  Unless you are cirrhotic which is more difficult to treat.  But you should push your dr for a biopsy...blood work wont tell you much other than what Hector and Cando said.  Best of luck and let us know how you are doing!

Jules

[ppmguy]

           two things jumped out at me!   35 years of hep c and no biopsy.  the other thing is HCC.  

[can-do-man]

Exactly Hector, makes no sense to me. And I agree that her doctor seems to be on top of things........ Hope your doing well guy.

[HectorSF]

Here's my question: should my liver function be monitored while waiting for treatment?
The so-called laboratory test do not indicated you liver function. Only if you have cirrhosis would that be an issue.

Unless you have a platelet count under 100,000 and abnormal total bilirubin, creatinine or INR do you have to worry about complete cirrhosis. Besides the only treatment is the treatment you are going to do in 2014 so what difference would it make if you found out you had cirrhosis now? It would make no difference in what you are going to do.

If yes, how? Regular liver panel blood tests? Regular ultrasounds?
AST and ALT only show the damage the hep C is doing to your liver not how damaged your liver is. Only a biopsy can tell you that.

Ultrasounds are for detection liver cancer. If you don't have cirrhosis you have nothing to worry about. Besides women only develop liver cancer 1/3 as much as men.

The bottom line is you are going to treat in 6 months and liver disease is a slow moving disease so nothing is going to change in the next 6 months so I don't see any advantage to worrying about things that you can do nothing about.

I am not sure why you don't trust your doctor? Everything he/she has told you is accurate and true. Treating with a doctor you don't trust is never a go idea. If you can find someone as knowledgeable that you trust you should treat with them. You don't want to not following directions when treating and loose your chance for curing your hep C.

Personally I would wait for the new Gilead treatment as cure rates are the highest they have ever been for any group of people with hepatitis C. Even if you were to have cirrhosis the treatment is effective and since you can't take interferon there is no other treatment available. Waiting 6 months or so will make no difference in the stage of your liver disease.

You might be interested in data from the FISSION trial of Gilead's therapy for genotype 2s that should be available in early 2014.

About FISSION
"In FISSION, treatment-naïve HCV genotype 2 and 3 patients were randomized (1:1) to receive either 12 weeks of sofosbuvir 400 mg once daily plus RBV (1,000 or 1,200 mg/day) (n=256) or 24 weeks of peg-IFN (180 μg/week) plus RBV (800 mg/day) (n=243). Overall, 20 percent of patients had compensated cirrhosis (advanced liver disease) and 72 percent had genotype 3 infection.

The SVR12 rates in patients receiving sofosbuvir plus RBV (for 12 weeks) were 97 percent for genotype 2 patients (!)
(SVR rates don't get any higher than this.)

The SVR12 rates in patients receiving peg-IFN plus RBV (for 24 weeks) in this study were 78 percent for genotype 2 patients.

Three patients (1 percent) receiving sofosbuvir discontinued treatment due to adverse events compared to 26 patients (11 percent) receiving peg-IFN/RBV."

I have been taking this same treatment for 45 weeks now and side effects are minimal compared to interferon based treatment. You will only need to treat for 12 weeks.

Good luck.
Hector

[can-do-man]

Well maybe I am missing something but could someone tell be just what they would be monitoring and for what? If these new drugs are approved which is 5 months out just what could be done. Most people wait that long before they even start treatment once they have decided to treat.

As for a biopsy for genotype 2 that is going to treat that hasn't been recommended for years unless someone really just wants to know. A complete CBC will give insight to a doctor if one seems to be cirrhotic. And even then I have not seen where it changes how one will treat with these newer meds......... Just my opinion.

[ppmguy]

          if you have had a previous biopsy, i would say you dont need one.  personally i would want to know.  i would also want to continue with normal routine for bloodwork.  the new txs are still 8 or 9 months away an d still not approved.  
          i have auto immune problems also(ms) and pretty severe arthritis.  i have been on interferon for 7 of the last 12 years and no more sx than what others post here.    
         i do agree that waiting is best.  barry

[arri078]

yes your liver functions should always be monitored!!!   Why would a liver biopsy not be done?  That is usually the first thing ordered.  This is to see what "stage" your liver is at.... basically to see if any damage is done and THEN to proceed with treatment or wait.
I have been diagnosed for over 10 years... also geno 2.  I tried the first tx, ... Sick as a dog.. reduced my viral load to the hundreds, but did not work.   That was 7 years ago.   My Dr.  suggested to wait for the new TX also.   I continue to have my liver levels checked every six months and also a liver ultrasound every year.   The liver biopsy was done within 6 months of finding out I had hep C.  My viral load is also 38 million...Always has been crazy high... Follow your gut, Personally  I would want to know the biopsy result... A less than 1 is great!!! as a result.  My first GI just retired and he relied faithfully on the blood tests... I now see his partner who does not have complete faith in the blood tests... So to each his own for the Doctors and to each his own for the patient.  I don't know if this helped.   But I felt I should tell my experience.

[rivll]

If the reports are correct, the drugs will be available shortly after the first of the year so you really do not have long to wait.
I was geno 2 and treated with them and have svr. Very effective for our genotype and relatively easy treatment.
All the best

[can-do-man]

Since you have decided to wait I don't see where regular monitoring would be of any use... As soon as the new drugs are approved I would contact my doctor and get the process started, as for his statement that since you have decided to treat a biopsy is irrelevant for type 2's that has been the norm for many years.......... Good luck