Sunday, March 11, 2012

Is Treatment for Hepatitis C Hype or Hope? Big Win for Big Pharm

I see many patients with hepatitis C (HCV).  None of them are under treatment and they all feel quite well. Why don't I treat them?  After all, potential consequences of HCV include:

  • Cirrhosis
  • Hepatocellular carcinoma. or liver cancer
  • End stage liver disease with all the trimmings
  • Liver transplantation
  • Death
One would think that a portentous list like this would justify any treatment, even hazardous therapies.  But, I've never seen it this way, and my hepatitis C patients are all doing well under periodic observation.

Yes, I know that the disease can be serious.  I recall one patient
with advanced disease whom I referred for consideration of a liver transplant many
years ago.  There may have been a few others along the way who received treatment for the disease also.

The vast majority of hepatitis C patients I see in my community practice feel entirely well and the diagnosis is discovered by accident.  In other words, these patients did not exhibit symptoms or abnormal findings on the physical examination that led a physician to suspect a liver condition, which then led to testing for hepatitis C. Some of them were picked up by the blood bank when their gift of life was declined after hepatitis C infection was discovered. Sometimes, a life insurance company makes the diagnosis during their health assessment as they try to cull out from their enrollees those destined to ascend skyward prematurely.  In most cases, patients are diagnosed with hepatitis C when physicians like me order diagnostic HCV blood test to evaluate abnormal liver blood tests.  Nearly all of these patients have no symptoms of liver disease and the abnormal liver blood tests may not even  be a HCV manifestation.

What should we advise patients with HCV who feel perfectly well?  Of course, patients should make the call after they have been informed of the risks and benefits of treatment.  In my experience, after this discussion, none of these patients wants to proceed.  Hopefully, I try to meet my obligation to present the issues to them fairly.  I am certainly aware of my bias, and do my best to compartmentalize it.

I think that there has been a rush to treatment with these patients.  Academic centers tend to be more enthusiastic about racing for the HCV cure with toxic medicines, although in fairness, their HCV population is very different from mine.  Their patients are much more ill, so the risk/benefit analysis of treatment may calculate out differently.  Nevertheless, academicians in writing and on the speaking circuit tend to extol the virtue of treatment, which they regard as the default response.  Watchful waiting just doesn't have the red meat appeal for liver gurus.  They argue that eradicating the virus will prevent the dire consequences I listed at the top of this post.  However, when there was only treatment available 20 years ago - injectable interferon -  academics were gaga over this it, which had a full page of side effects and was effective in less than 20% of patients treated.  I'm amazed that interferon slid by the FDA.  Now, HCV can be cured in a majority of patients, according to data from two drugs approved in 2011 to treat the disease, although there remains substantial toxicity from the medications. .

Even experts acknowledge that only a minority  of HCV patients will develop serious complications.  I'm not persuaded that we have a reliable method to determine who will progress and who won't. And if we did, how firm is the evidence that treating a patient who is destined for cirrhosis will avert this outcome?  Those who believe in HCV treatment will find data to support their view and practice.  And those of who are skeptics will do the same.  That's the beauty of medicine.  There's always conflicting studies to choose from to support any view.

What would Newton say?

Many of my HCV patients can date with some precision when they contracted the virus.  The event may have been a blood transfusion decades ago or from intravenous drug use during a youthful period of hard times and bad judgement. Many of these patients, therefore, have had the virus for decades and are not suffering any ill effects.  While I cannot guarantee a sanguine outcome, I view this in Newtonian terms.

An HCV virus that is asleep tends to remain asleep.

Other physicians don't share my approach and may be dismissive of my nihilism. I wonder how many of them would accept a treatment with enormous toxicity and cost for themselves as readily as they prescribe it to others?  This question applies to all physicians, including me, who prescibe medicine and advise patients.  Remember, we physicians discuss the risks of all treatments with patients in advance. But, we don't suffer the complications.

HCV patients, get informed.  Make sure the treatment won't be worse than the disease.

9 comments:

Elaine Schattner, MD said...

Great question, Michael. As a hematologist/oncologist, I examined patients with serious blood complications of hep C. Lately, in reading on how common is the virus, and so many new drugs on the market, I've wondered the same.

Michael Kirsch, M.D. said...

Thanks, Elaine. The voice of conservatism with hepatitis C - and much else - can be lonely. Glad you're part of the small choir.

bigfish said...

Generalizing one of the concepts from this post, any honest portrayal of the benefit vs. risk profile of a given medical intervention should include a review of the likelihood of experiencing an adverse outcome WITHOUT treatment vs. the likelihood of experiencing an adverse outcome WITH treatment.

Too many patients – consciously or subconsciously – confuse treatment with cure (i.e., going from an X% chance of adverse outcome to 0% chance of adverse outcome).

Anonymous said...

nice opinion.. thanks for sharing....

Michael Kirsch, M.D. said...

Thanks, bigfish. I think well meaning physicians tend to exaggerate benefits and gloss over hazards & limitations of treatments they are advocating. Appreciate your comment.

gwizard43 said...

Thanks for the post, Doc. I was dx'd with HCV over 10 years ago, in all probability contracted 30 years ago. I am one of those you describe who are symptom-free and who discovered the disease by accident, during a routine blood panel. The GE I initially consulted pushed for treatment (this was back in the peg interferon + ribaviran days when odds were good it would not take) - I declined.

I'm curious to know if there is any ongoing research that seeks to devise "a reliable method to determine who will progress and who won't." That is, is any progress being made in terms of knowing why the current treatment regimen tends to work for some, not for others?

Even were a test available, and were it to inform me that I would be likely to achieve remission, and were I in a position where insurance would cover the cost, I am not at all sure I'd move in that direction.

I quit drinking immediately upon learning I was infected, and as time progressed, I quit smoking, changed my diet to one that's vastly more healthful - rarely eat meat, lots of fresh veggies and fruits, very few processed foods, and now cutting out sugar. I also do a couple hours of yoga daily, ride my bicycle everywhere, etc.

In short, the dx of a chronic and potentially terminal disease was, for me, a gateway to a far more healthful - and enjoyable - life.

I can't help but wonder, if I was cured, would that motivation - at least to some degree - recede?

I prefer not to take that chance.

Hannah said...

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Kelly said...

Interesting article Dr. Kirsch and so true about your comment concerning for every yes, there is a no. I personally have hep C genotype 1b, and before 2011, my doctor had taken your same approach, we’ll just wait and see. I’ve had 2 biopsies now, 5 years apart, both showing stage1 and my viral load fluctuates from 19,500 to about 23,000. I am probably your typical “wait and see” patient that you speak about. However, in the past 5 years, I have been plagued with joint problems, one right after the other it seemed, which were put down as tendonitis in my elbow, and or bursitus in my shoulder, SI joint popped out problem, and knee wear and tear. All of those were dealt with by cortisone shots and physical therapy, lots of PT without much relief. Finally an allergic reaction at a dentist office got me on the road to the real culprit. The allergist sent me to a hemotologist when a blood test of my immune system showed a problem. Turns out, I have a very high concentration of Cryogobulins which is an antibody, circulating in my blood and is directly related to the Hep C. This is and has been causing me all the problems with my joints. I also have a non working, or should I say gravely overworked immune system. My compliment system (CH50 is non existant) it’s being drained from constantly fighting the Hep C virus the hemotologist informed me.I catch the flu and other viral infections at the drop af a hat as well. With these 2 extra Hep C related issues, I have to say that they have made me fairly miserable. My doctors, (the Hep C specialist, the Hemo Doctor, My Cancer doctor (had breast cancer surgery and RAD 9 months ago) and my PCP all agree that it’s time to treat the Hep C. I know my chances of getting rid of the Cryogobulins, entirely, is slim, but it does happen, and maybe it will stop the advancing vascular problems that I’m experiencing. Also, it should put my immune system back in normal working order since it will no longer have to fight a virus that it can’t beat, on a daily basis. In light of these things I have mentioned here, think of your patients that you treat. Do any of them complain about joint pain (average age of Hep C patients is 50+, and the majority of patients along with their doctors put the joint pain down to just getting older), or maybe they seem to get sick with viruses like colds and flu more frequently? I will be starting the 3 drug treatment in 1 month, but wish that I would have started before my overall health went south. Remember, I would probably be one of your wait and see patients, stage1, viral load less than 25,000, non drinker. My tests show that my liver is doing actually pretty good considering I have Hep C. My point is there’s more to this virus than the damage to your liver, and can be easily missed. Perhaps this will encourage you to ask your “wait and see” patients about other symptoms they might be having. Some that they might think have nothing to do with Hep C. Maybe you can help some of them before they get into my situation.
Thank you for the article and for listening.

Also a comment for Elaine.

I bet you are seeing more patients such as myself in your practice. Would you as a hemotologist recommend the Hep C treatment to try and relieve the immune system such as myself?
Take care,
Kelly

Anonymous said...

As you know, without a liver biopsy it's hard to know what's really going on. (at least order an ultrasound people!) Many folks have totally normal LFT's with Hep C, and are found to have serious liver fibrosis or worse. I don't like family medicine docs/internists that do a quite physical and tell the patient they are fine without explaining ALL complications. Every patients with Hep C should see a grastro/hepatoligist at least once. All is well until someone ends up in the ICU with liver decompensation and it's a fast ride to the grave. Yes, it's rare, but I'm sick and tired of MDs that are so comfortable ignoring serious conditions because they think "treatment is toxic".

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