What to expect from appointment with Hepatologist?

[Anand]

Hello Mike,

the fact that you are in a happy place<almost> gives me hope because we had/have similar HVC profile.  About that later.

In 1987 I had a heart attack followed by heart bypass surgery and blood transfusion. It was suspected the blood supply was contaminated with hepatitis C (HVC).  My blood was tested to have HVC antibody in 1993 and confirmed to have HVC in 1995. In 2006 the Gastroenterologist (GE) told me that there are some promising drugs in the pipe line that have higher cure rates and will be available in about 10 years.  After the blood test he said that I have nothing to worry until then.  Fast forward to 2014.

I moved to a new state and consulted a new GE and tested my blood. Now to our profile similarity. I have HCV for 27 years, my HCV is 1a, my VL is 2.427 million IU/ml. My abdominal ultrasound showed only mild diffuse fatty infiltration of the liver without evidence of hepatic lesions.

I have an appointment with a hepatologist of repute, in the second week of April and I could use some advise of what to expect.

I am grateful to Lucinda and others for their empathy and moral support. thanks

Anand

[jberlin]

Arnand,

I expect and hope that your new MD will set you up to get treated with one of the triple therapy regimens out there.  The drugs are here, the treatment very tolerable and cure rates above 80%.  It is time!  Let us know what transpires.

Good luck.
jack

[iana5252]

Moderators Note: This thread was originally started on http://forums.hepmag.com/index.php?topic=1210.

[Anand]

Jack,

will do.

Anant

[Mike]

Hi Anand,

I would talk to the MD about new treatments. The SOC for type 1a is SOL+INTF+RIBV x 12 weeks, though the insurance companies are balking at the costs of the Solandi, which received FDA approval December 6th, 2013.

There's some new antiviral combinations that are currently in phase III clinical trials that might be available (FDA approval) in the next 6 months or so. These combinations don't include INTF, which a lot of folks don't tolerate well (myself included).

When I talked to my GI in December 2013, my decision boiled down to (1) SOL+INTF+RIBV x 12 weeks, which gave me the highest chance for success; (2) SOL+RIBV x 24 weeks, which had a lower chance of success or; (3) waiting for the next wave of antivirals to be approved (avoiding the INTF) or going off-label.

I told my GI to see if I could get approved for the Solvadi and would take it from there.

I was approved in late December 2013, and, since it was approved, and my insurance would probably change next year, with no gaurentee the cost all oral medication for type 1a would be approved in 6-9 months, I decided to move forward.

I would recommend discussing the 3 options I mentioned with your MD and move forward accordingly. Once you decide, have your MD call in the prescription and see if it is approved.

Hope this helps.

Best wishes, Mike

[Anand]

HI Mike,

thanks for the info.

 In my earlier post there is a factual mistake as pointed out by my wife.  I trust her memory more than I do mine.  In 2006 my Gastroenterologist said that there is intense research going on for cure for HepC and in about 10 years there is likely to be a cure with much higher cure rate than ones existed then.

Hope to see very soon that you leave our ranks and join the ever increasing cured group.

Anant

[jberlin]

Anand,

Your Doc in 2006 was correct, except it came in May 2011 with the 2 protease inhibitors approved then by the FDA [VICTRELIS (boceprevir) & INCIVEK (telaprevir)].  That shortened the average treatment by half and more than doubled the cure rate from 40% to over 80% (Geno 1). -jack

[Anand]

Hi Jack and mike,

Thank you guys for sharing your experiences with respect to HVC treatments.  I was wondering what are the long term effects or damages of the side effects themselves. These powerful medicines  do get rid-off HVCs <grateful for that>, but  they put kidneys and other vital organs under stress. Any permanent damages there. Since I had heart attack some 27 years ago I always consider my heart is my Achilles heel. I do pride myself that I have taken care of my heart by my disciplined diet and exercise  all these years.  Again thanks to all the bloggers that I learned a lot and more prepared to face to what is coming next.

Anant

[Mike]

This is my second time in treatment and I've had no long term side effects, Mike

[jberlin]

Anand,

Given your medical history, I would strongly urge the newest of the triple therapies, as Mike said (SOL+INTF+RIBV x 12 weeks) - Less side effects and half the time, therefore 12 interferon shots instead of 24....  The expected outcomes are pretty close as well, but insurance may push because of costs.

Let us know what you are told by the MD and what you decide to do! 
Good luck,
jack

[Anand]

just saw my Hepatalogist who is different from the GI doctor whose prescription for blood work yielded my HCV profile.

 WE <my wife, the doctor and I> had a good discussion.  He was concerned that the side effect from Pegs+ Riba, especially the possible trigger of anaemia might jeopardise my already weakened heart <from my heart attack in 1987>.  He is going to consult my cardiologist.  He suggested that  the new would-be-available Gilead product LDV/SOF will be a better choice.  LDV(Ledipasvir)/SOF is being priority-reviewed by FDA due to its potential benefits that are head and shoulders above the currently available combos. It is likely to be available in October 2014.  He said that I have waited for 27 years;  why not 6 more months.

I am scheduled to see him in the first week of June.  Meanwhile I am to have endoscopy and a more powerful ultra-sound image of my liver and a new VL number among other blood numbers.  He was not satisfied with my earlier ultra-sound of my liver.  Armed with all the results we hope to arrive at an educated treatment.

Mike,  I am looking forward to your EOT VL number.  Congratulations. Anand

[Marysee]

Anand, sounds like he is a very thoughtful Dr. And is taking all of your history into consideration. Let us know what you decide.

[Anand]

Mary,

Where are my manners? I should have acknowledged your blog. sorry.

  Looks like I am slow walking to my probable treatment in October 2014 when the FDA approved Sofosbuvir/Ledipasvir combination will be available for the public.   I will know for sure after my appointment with my Hepatologist in the first week of June.  Mean while the blood test was normal for alpha Fetoprotein, a tumor marker.

There is one more blood test for usual RBC, WBC etc and HepC viral load before my June appt.  My upper endoscopy showed no varices indicating there is no scarring of the liver. I have one more abdominal sonogram with Doppler of the lower abdomen.

Glad to know about your final stages of your treatment and we are all pulling for you.  Anand

[Marysee]

Anand,  Thank you so much for the reply. Good luck with your future apps.

[Anand]

Hi Lucinda,

I have some questions/enquiries about the Gilead's press release that includes ion-1 to ion-3 clinical trial results. You gave me the web site.  It is too long and incidentally how did you shrink that into an icon?

       Please refer to the table that summarizes the results in the first page.
1) In the heading " study Population...and SVR12 rates: Does SVR12 rate indicate 12 weeks after the EOT( VL =0)?

 2) There are two places the results of GT 1 Treatment-naïve are given; One at the beginning and one at the end and they are identical except for SOL/LDV duration.  But the cure rates are different. Can you elaborate?

3)Since I am treatment-naïve and will the duration of treatment be 8 weeks or 12 weeks?

4) If I have liver fibrosis, do I need RBV with SOL/LDV. I am not averse to using RBV
in combination with SOL/LDV since the side effects especially anemia is practically
nil right.  I have a few more questions which I will write in my next blog as I have to leave soon for an appointment. Thanks.  In haste Anand

[Anand]

Hi Lucinda,
 continuing from my previous post;  Please ignore the first question 1 as I understand now.

5) I assume You are part of ion-1 or ion-2.  Since you are treatment-experienced and had experience with RBV with both interferon and SOL/LDV How will you classify and compare the side effects from RBV ?  Are they included in the two books that you authored. Sorry I am being intrusive. If you do not want to answer; I will understand.

I suggest that you write another non-fiction titled "Biography of Hepatitis C" the sub-title should be about its epitaph. I am violating my own edict that one should not give un-solicited advice. Oh well. Were there any placebos in ion-1,2 or 3  trials?

Since I will be wallowing in a state of purgatory until sometime in October when I hope to have my rendezvous with SOV/LDV, I will use my time to read your books.
  Thanks,  Anand

[lporterrn]

Hi Anand,
Regarding the hyperlink, there is an icon under the italics button where you can insert the link.
As foor your questions:
1) In the heading " study Population...and SVR12 rates: Does SVR12 rate indicate 12 weeks after the EOT( VL =0)?
Yes - SVR 12 is almost as good a predictor as SVR 24

 2) There are two places the results of GT 1 Treatment-naïve are given; One at the beginning and one at the end and they are identical except for SOL/LDV duration.  But the cure rates are different. Can you elaborate?
Two different studies - data are not rigid, they are more like guidelines

3)Since I am treatment-naïve and will the duration of treatment be 8 weeks or 12 weeks?
I am not sure, but I think the FDA will leave up to the prescribers to decide. Although there is not much of a difference between 8 and 12, I suggest that you plan on 12 weeks, and if it is only 8, then that will be a pleasant surprise.

4) If I have liver fibrosis, do I need RBV with SOL/LDV.
Same answer as above, but probably no ribavirin

I just saw #5 come in (I'll leave my answer to #1 since others may wonder. I was in one of the ION studies and let's put it this way, if you can do treatment without ribavirin, then do it. If you have to do ribavirin, it is doable, but I think it is a tougher drug to take than I had ever realized prior to taking it without interferon.

Thank you for reading my books, and I love the new idea, although I was thinking of writing something non-hep C-related.

[Anand]

Lucinda,

thanks.Anand

[Anand]

Hi Mike,

I was planning to post a different question until I saw your post on the new trials. Is it because FDA wants more data before approving SOF/LDV which is schedule to be approved in October?  That will throw a monkey wrench into the whole process.

Now to my other question, sometime back in one of your posts, you mentioned that there may be connection between Type 2 diabetes and HEP C.  Do you have any reference?  I was diagnosed with Type 2 diabetes about 7 years ago.  This surprised me since neither my mom and dad nor the siblings have/had diabetes. I put "had" as my parents are no more as well as some of my siblings.  Now when the virus departs from my blood stream after treatment will my type 2 diabetes also will be history. regards  Anand

[Mike]

Hi Anand,

The FDA fast tracked the approval of SOF/LDV because early clinical trials supported its efficacy in treating type 1a Hep-C, with much lower side effects compared with INTF-based treatments. Oftentimes, a new drug can take 3-5 years for approval in the general public once clinical trials have started. Sometimes, a new drug's (still under research)  benefits can be documented in a shorter period of time. If the drug appears safe, and offers great prognosis, the FDA will fast track it for general use, which is what happened here.

Below, is some research on Hep-C and diabetes. Basically, the liver helps regulate glucose levels in the body and Hep-C may interfere with this process. I, too, developed type II diabetes and I'm not overweight nor is there a family hx of it. A Hep-C infection may explain how I developed it. The research is  not 100% conclusive.

https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=5&cad=rja&uact=8&ved=0CF4QFjAE&url=http%3A%2F%2Fwww.medicalnewstoday.com%2Farticles%2F270094.php&ei=vSd9U8qtD8ObyASLsIJ4&usg=AFQjCNFjIv2XiSHVGsx9fLnh1fhgYm0cHQ&bvm=bv.67229260,d.aWw

Best wishes, Mike

[lporterrn]

Anand - Mike answered your question about the FDA - they pretty much have all the info they need, but the process is involved and rigorous.

The connection between diabetes and hep C has now been unconnected. However, type 2 diabetes is occurring among everyone at increasingly high rates in the U.S., probably diet-related.

[Mike]

Thanks for correcting me, Lucinda.

I meant to say the research is "not" conclusive regarding the link between a Hep-C infection and diabetes.

Mike

[Anand]

Hi Lucinda and Mike,

Thanks for being here. I just had a visit with my Hepatologist and we went through the recent blood work, upper endoscopy and ultrasound of abdomen area results. It looks like we have opened the proverbial Pandora's box. Endoscopy showed no varices <good news> but found H. Pyroli virus which is being treated with antibiotics.

Ultrasound showed normal spleen size <good news> and all the blood flow to the liver seem normal.  My doctor is reluctant to do liver biopsy; so he is going around it. May be because I am 77 yrs of age.  My advice to you all; don't grow old!!

Now to my question: My platelet count was within range in 1998 <180K/uL> but slowly coming down to the present 101K.  Did any of you have similar experience it because of HepC?  Did it come back to normal after HepC was kicked out?  I have to go for blood work to rule out more ominous sounding possibilities.

I am in good health, I go for brisk 2 mile walk every other day on a slopy neighborhood or treadmill at 5% slope <it takes me 30 minutes>. every other day I go to Gym to lift weights not to bulk up but keep me toned.  I have more questions but that can wait.   Thanks. Anand

[Mike]

Hi Anand,

Sounds like the appointment went well and you're in great shape for being 77 years young! Liver results sound great as well.

I don't know a lot about  pallet counts and can't answer your question.

Lucinda has a lot of knowledge (especially with health issues and lab results) and she might be able to answer your question.

I'm glad everything went well.

Best wishes, Mike

[lporterrn]

Hi Anand,
Sounds like a lot of good news. Did you ask your doc about your platelets? There are lots of explanations. One common occurrence among hep C patients is this indicates cirrhosis. However, since your spleen is a normal size, there is no obvious evidence of cirrhosis. Your obvious good health supports this. This is best discussed with your doctor.
Can it be reversed? Yes, sometimes, if caught early, In short, you are on the right track. Even if this does turn out to be cirrhosis, hold fast to the fact that you are healthy. The outward signs are more important than what labs tell you.

[Anand]

Hi Lucinda,

thanks again for your answer. continuing to discuss about the Pandora's box, Ultrasound located kidney stone which is not impeding urine flow for the time being.  My Hepatologist suggested Cranberry juice and talk to my primary doctor about this.  I am also to see another doctor for blood work to find reason for the low blood platelet count. 

He also suggested  that I do a Fibroscan which is non-invasive.  Please Google about fibroscan.  Apparently it is a better alternative to liver biopsy. Have you heard about this?  It is not covered by insurance and it costs $250 which I am going to pay . Anand

[lporterrn]

Personally, I'd opt for the liver biopsy if I had access to it. Weird that insurance won't pay for a less expensive procedure. You can always appeal it. Not a bad price - does that include the professional fees?

[Anand]

HI Lucinda,

Fibroscan is popular in the UK and European countries. It is a recent import in this country and $250 includes everything.  I will post my experience here as I soon I get my scan done hopefully within a month.

My Hepatologist does liver transplant also and am happy with him.  Since I will most likely wait till Oct-Nov when SOV/LDV will be available we have time in our hands. I am not sure whether we are meandering towards my tryst with SOV/LDV.  I am impressed by him and the way he juggles with so many balls up in the air with regards to analyzing the various results keeping in mind the restrictions that my age brings to the table.

 My wife is complaining that he is changing his mind but she brings with her very
good memory and the intangible asset she brings to the discussion.  Her face and body language betrays her feelings as she is the biggest stakeholder in the whole exercise.  I have told him that if she is satisfied I am satisfied.

In my next post I have a question for Mike.  Thanks.  Anand

[lporterrn]

Sounds like an excellent approach!

[Anand]

Hi Mike,

Your D-day will be soon upon us. We are keeping our fingers crossed.

Do you mind recalling the homework and preparation that you did prior to the FDA approval of Sovaldi <last December 7th> so that you may avail of this wonder drug at the earliest possible date <on January 4th>?  You seemed to have been the first one to start the treatment at least in this blog site.  My primary insurance is Medicare and the secondary is Cigna.  They have an arrangement to share the expenses.  Thanks.   Anand

[Mike]

Hi Anand,

Regarding the research I did regarding Solvaldi, it was pretty simple: Since I was a partial responder to INTFR+RIBV in 2001 (I did a 48 week course), I waited for new developments, which my GI said were 3-5 years away.

I would see my GI once per year and we would discuss the new treatments. This went on for about 10 years; but all the new advancements involved INTRF+RIBV x 48 weeks, and given my clinical picture, I still only gave me a 50% chance of clearance.

 I was not going to subject myself to another 48 weeks of INTFR+RIBV, as I had a horrible experience, plus another 6+ months for the side effects to wear off. 

This changed in 2011-2012, with the development of new antivirals, which I was actively watching the clinical trails and research.

When I saw my GI in 2013 (August), I new that Solvaldi was going to be approved, and I discussed this with my GI, who ordered the all the appropriate blood work (viral load, ferritin levels and so on).

I called my GI on December 9th, 2013 and told him I would commit to the new treatment, even though it involved 12 weeks of INTFR+RIBV. We sent a script in for SOL+INTFR+SOL, to see if my insurance (Medical Mutual) would approve.

It was approved, without question on December 26th, 2013, and I moved forward a few weeks later.

For me, I think it was timing. I wanted to slay this dragon, was prepared to put my life on hold for 12 weeks, and a new treatment was just approved, offering me great hope for a cure. The other factor, is that I don't think the insurance company knew what they had approved ($120,000 other of drugs), and I was lucky to slide in before the influx of treatment requests that occurred in January and February, as the insurance company's are not approving the medication for all due to the high cost.

I ended treatment on April 17th, 2014, and it took about 4-5 weeks for the medication to wear off and the side effects to disappear.

I feel the best I have in a decade and half. It seems like the Hep-C fog is gone, and I have my 'step' back.

I have my 12 week post-treatment blood work is 7/4/14, and I'll find out if the dragon is slayed for good.

If not, I'll wait for the next generation of antivirals, which are just around the corner. I wont be devastated.

If I'm undetectable, I know I'll cry, and fall to my knees, head bowed, and give thanks for an answered prayer!

My prayer now is that everyone can get treated, and the suffering from Hep-C is eradicated forever!

Best wishes, Mike

[Anand]

Hi Mike,
I am a late comer to your SRV12 party.  I was away.  I do understand that you carried an extra burden for a positive outcome.  Anyway any other outcome would have been a travesty of justice.  Congratulations.  May the good Lord bless you with a happy, healthy and a long life.

I had my final piece of the Jigsaw puzzle before my treatment: Fibroscan.   I was surprised it took only about 5 or 6 minutes. I still do not know how it compares with the gold standard, liver biopsy.  Though it was FDA approved about 15 months ago, it is not supported by many insurance companies, mine included. I had to pay $249.  The result was sent to my Hepatologist.

I got a phone call from the PA who said that she has good news; that my liver is at stage 3.  An audible gasp from my wife who was on the extension phone betrayed her feelings.  Here I had, from upper endoscopy, no esophageal varises <good news> and from lower abdominal ultrasound with Doppler, a patent hepatic vasculature<good news> which means blood flow to the liver via portal vein and blood flow from the liver via hepatic veins are normal.  Only negative results are some infusion of fats<triglycerides>into the liver which is reversible easily. Liver is not inflamed, spleen and pancreas are normal.

The PA thought it was good news because it will take about 5 years for the onset of next stage and therefore we have plenty of time for treatment. I had told her earlier that waiting for the treatment for 3 months or so is hard on us.
 
Mike, thanks for your detailed blog about paper work and leg work that you did prior to your own Sovaldi treatment.  Now to my questions. 1) I hear Gilead may combine the active ingredients from Sofobusvir and Ledipasvir <who comes up with these names?> into a single tablet.  Do they have to get a separate FDA approval?
 
2) The Japanese have opted for the medicine from Bristol Meyers and not Gilead. The target Japanese patients are older<70s and 80s> as there is a preponderance of older people with Hepatitis C in their population.  As I fall in their age group, do they know something that I should know. Can you throw some light?   Thanks.  Anand

[Mike]

Hi Anand,

Gilead is developing a Sovaldi-based drug combination (Sofobusvir and Ledipasvir) that is very effective against GT 1 viral infections. This combination doesn't involve the use of RIBV or INTF - both of which cause the majority of side effects associated  with Hep-C treatments.

Current research suggests that this combination is as effective as the current tx protocol and has reduced the side effects.

This is great news and a big step forward in the tx of chronically infected Hep-C patients.

The FDA has fast track this drug combination (Sovaldi and Ledipasvir) and it should be available in Oct or Nov 2014.

Regarding tx in Japan, the most common GT in the population is genotype 1, subgroup 1b (GT 1b). The average age of Japanese infected with Hep-C is 65.

This means that the majority of this population are elderly and infect with GT 1b HCV virus.

 Bristol Meyers has developed a drug combination that appears to be very effective with this population and with less side effects.

The Japanese Medical Association has endorsed this treatment protocol (c.f  Sovaldi-based treatment).

Treatment for a Hep-C infection is becoming more effective, more targeted to the individual patient/population profile, more tolerable and with very effective tx outcomes!

This is a golden age for Hep-C tx! New things are coming around ever corner everyday!

Best wishes, Mike

[Shirleyb]

That is the first reference, I think, to genotype 1b except for myself. I am a 56 year old white lady and my dr said that 1 b was not normal for me. I don't know what that means just like I can't figure out where this came from. My first thought was the tacky tattoo I got over 30 years ago, but I tracked down my old friend that got hers(identical lol) first, got her to test, she was neg. thank God! My husband doesn't have it so I am at a loss.