Digestive Disease Week 1999 Annual Meeting

21Oct

Hepatitis C: Achieving Maximum Results Putting Combination Therapy for HCV into Practice

John B. Wong, MD
Chief, Division of Clinical Decision Making, Informatics, and Telemedicine
New England Medical Center
Tufts University School of Medicine
Boston, Massachusetts

“Medicine is a science of uncertainty and an art of probability.” by: Sir William Osler
Some opponents of treating chronic hepatitis C virus (HCV) infection have argued that hepatitis C is only slowly progressive, and that treatment is only effective in a proportion of patients, is relatively expensive, and has potential side effects. On the other hand, based on the prospective studies of transfusion-associated non-A non-B hepatitis 1 and extrapolating findings to 20 years following acute disease, 14% to 45% of patients with hepatitis C may develop cirrhosis. Although not all patients develop it, cirrhosis reduces survival substantially. Compared with healthy individuals from the general population, 40- to 60-year-old individuals with compensated cirrhosis would have their life expectancy shortened by 7 to 19 years. 2

Aside from identifying those with the risk factors of excessive alcohol intake and male gender, it is not possible to predict which patients will develop cirrhosis. 3 One possible approach to selecting for treatment those patients likely to progress to cirrhosis would be to perform repeated liver biopsies and administer treatment to those with progressive disease. However, sustained response rates appear to decline with worsening METAVIR fibrosis score, suggesting that delaying therapy until disease has progressed histologically may decrease the chance of achieving a response. Based on combined data from the US and international studies in treatment-naive patients with chronic hepatitis C (n = 1,744), 4, 5 interferon/ribavirin combination therapy produces an overall sustained virologic response rate of 41% when given for 48 weeks and 33% when given for 24 weeks. In contrast, 48 weeks of interferon monotherapy is associated with a sustained response rate of 16%. Sustained response rates to 48 weeks of interferon/ribavirin combination therapy reach as high as 67% in subgroups with favorable characteristics but exceed 20% even for traditionally difficult-to-treat populations (eg, patients with cirrhosis evident on liver biopsy, infection with HCV genotype 1, or high viral load).

The projected life-expectancy gains from 48 weeks of interferon/ribavirin combination therapy for hepatitis C compare favorably with those of other common medical interventions. Based on the clinical trial data, 48 weeks of interferon/ribavirin combination therapy should cost approximately $10,000 (US $), which includes the cost of the cheap generic drugs, management of adverse events, and estimates of healthcare resource utilization including office visits, laboratory tests, and contraception. In comparison, treatment of a 40- to 60-year-old patient with compensated cirrhosis may cost $34,000 to $53,000 (US $) over the patient’s lifetime. For further comparison, interferon/ribavirin combination therapy costs less and provides a higher gain in life expectancy than coronary artery bypass surgery.

In conclusion, cirrhosis is likely to occur in about 28% of patients with chronic hepatitis C after 20 years, substantially decreasing life expectancy and increasing healthcare costs. Interferon/ribavirin combination therapy for 48 weeks results in sustained response rates as high as 67% and is likely to prevent the development of cirrhosis. Because the response rate worsens with increasing METAVIR fibrosis score, delaying treatment may not be an optimal strategy. The cost of interferon/ribavirin combination therapy should be substantially offset by future savings through the prevention of liver-related complications.

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