Blog | Wednesday, April 4, 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:
--hepatocellular carcinoma, or liver cancer,
--end-stage liver disease with all the trimmings,
--liver transplantation, and/or

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 HCV 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 HCV.

Some of them were picked up by the blood bank when their gift of life was declined after HCV 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 HCV 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.

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 judgment. 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 prescribe 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.

This post by Michael Kirsch, MD, FACP, appeared at MD Whistleblower. Dr. Kirsch is a full time practicing physician and writer who addresses the joys and challenges of medical practice, including controversies in the doctor-patient relationship, medical ethics and measuring medical quality. When he's not writing, he's performing colonoscopies.