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Summaries for Patients are a service provided by Annals to help patients better understand the complicated and often mystifying language of modern medicine.
SUMMARIES FOR PATIENTS
Watchful Waiting versus Immediate Treatment for Mild Hepatitis C
7 November 2000 | Volume 133 Issue 9 | Page S-5
Summaries for Patients are presented for informational purposes only. These summaries are not a substitute for advice from your own medical provider. If you have questions about this material, or need medical advice about your own health or situation, please contact your physician.
The summary below is from the full report titled "Watchful Waiting with Periodic Liver Biopsy versus Immediate Empirical Therapy for Histologically Mild Chronic Hepatitis C. A Cost-Effectiveness Analysis." It is in the 7 November 2000 issue of Annals of Internal Medicine (volume 133, pages 665-675). The authors are JB Wong and RS Koff, for the International Hepatitis Interventional Therapy Group.
What is the problem and what is known about it so far?
Hepatitis C virus can lead to severe liver disease, but not everyone with this infection develops liver problems. Drugs to treat hepatitis C can cause side effects, are only partly effective, and are expensive. The effects of hepatitis C on the liver begin with inflammation of the liver (hepatitis) and progress to scarring (fibrosis), then cirrhosis (severe fibrosis with loss of liver function), and finally liver failure. If treatment starts too early, patients who would never develop liver failure might be exposed to expensive drugs with possible unpleasant side effects. But if patients wait to start taking the drugs until inflammation, fibrosis, or cirrhosis is present, it may be too late to stop the process that leads to liver failure. Usually, doctors periodically examine a sample of the patient's liver (a liver biopsy). They begin treatment when a moderate amount of inflammation or cirrhosis exists. However, some experts believe that it is better to begin treatment as soon as mild inflammation exists.
Why did the researchers do this particular study?
To determine the best time, in terms of costs and benefits, to start therapy with the hepatitis C drugs interferon and ribavirin.
Who was studied?
The researchers used a computer model to study a "virtual" group of patients with hepatitis C whose liver biopsies show only a small amount of inflammation (mild hepatitis).
How was the study done?
Rather than studying an actual group of patients, the researchers used a computer model to simulate what would happen to hypothetical patients who received drug treatment for hepatitis C at various points in time. Patients could receive drugs as soon as disease was diagnosed and liver biopsy showed mild hepatitis, or they could get liver biopsies every 3 years and begin treatment when either moderate inflammation or cirrhosis was present. The researchers used information from previous studies to estimate the outcomes and costs of each of the three treatment options. The computer simulated what would happen to patients over the next 20 years.
What did the researchers find?
Compared with no treatment, immediate treatment with interferon and ribavirin for mild hepatitis achieved the best outcomes at the most reasonable costs. Biopsy with treatment for moderate hepatitis was the second best option.
What were the limitations of the study?
We do not know for sure that this is what would happen to a group of actual patients treated in this fashion. In addition, the study does not address all potential treatment strategies, such as more frequent biopsy or other drug combinations. Of note, the researchers received support from the company that makes interferon and ribavirin.
What are the implications of the study?
In terms of costs and associated benefits, it seems that treating people with hepatitis C with interferon and ribavirin as soon as mild hepatitis develops is preferable to doing liver biopsies every 3 years and beginning treatment when worse liver abnormalities develop.
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