Combination therapy for chronic hepatitis C

Findings by SBU Alert

Version: 1

Method and target group

Approximately 2500 new cases of hepatitis C are detected annually in Sweden. Most of the cases are detected during health check-ups or examinations for other diseases. Approximately 30 percent of the patients with chronic hepatitis C develop cirrhosis of the liver within 20 years. Ribavirin is a new drug, which, in combination with interferon alfa-2b, has been approved for treating adult patients (>18 years of age) with chronic hepatitis C. It is estimated that approximately 60 percent of the cases are appropriate for treatment according to established criteria. Treatment is given over a long period, at least 24 weeks, and in certain cases 48 weeks is required.

Patient benefits, complications, and side effects

Most randomized studies have reported that combination therapy yields treatment results that are superior to monotherapy with interferon, which was previously the only available treatment method. However, ribavirin in combination with interferon may be associated with serious risks in some patient groups, eg, in patients with heart disease or previous or ongoing severe psychiatric problems. Side effects are common, and most patients experience a reduction in their quality of life during treatment.

Economic aspects

The drug costs for 24-week and 48-week regimens of ribavirin and interferon are approximately 55 000 SEK and 110 000 SEK respectively. The total annual drug costs for treating cases that would be appropriate for therapy would be 65 to 100 million SEK. Compared to interferon monotherapy, this represents an additional cost of 35 to 50 million SEK per year. During a transition period, the demand for treatment would be substantially greater since a large number of patients in whom the disease has been diagnosed already meet the criteria for treatment. Assumptions made in model analyses regarding the long-term effects and costs suggest a moderate extra cost per life-year gained for combination treatment compared to the current strategy.

Scientific evidence

There is good* scientific documentation on the short-term effects of combination treatment. Limited followup data up to 8 years suggests permanent elimination of the virus. There is no documentation on the long-term effects of combination therapy, ie, the extent to which the incidence of cirrhosis and liver cancer decline. There is limited documentation on the cost effectiveness of the method.

Combination therapy with ribavirin and interferon should be limited to treatment on approved indications and should be subject to scientific followup of long-term effects and analysis of its cost effectiveness based on factual data, enabling the verification of estimates presented in model analyses.

*This assessment by SBU Alert uses a 4-point scale to grade the quality and evidence of the scientific documentation. The grades indicate: (1) good, (2) moderate, (3) poor, or (4) no scientific evidence on the subject.

This summary is based on a report prepared at SBU in collaboration with Assoc. Prof. Ingrid Uhnoo, Medical Products Agency and has been reviewed by Prof. Ola Weiland, Huddinge University Hospital.

The complete report is available in Swedish only.

Alert is a joint effort by the Swedish Council on Technology Assessment in Health Care (SBU), the Medical Products Agency, the National Board of Health and Welfare, and the Federation of Swedish County Councils.

References

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