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Volume 339:1485-1492 November 19, 1998 Number 21 Next

	Full Text PDF Editorial by Liang, T. J. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited PubMed Citation

ABSTRACT

Background Only 15 to 20 percent of patients with chronic hepatitis C have a sustained virologic response to interferon therapy. We compared the efficacy and safety of recombinant interferon alfa-2b alone with those of a combination of interferon alfa-2b and ribavirin for the initial treatment of patients with chronic hepatitis C.

Methods We randomly assigned 912 patients with chronic hepatitis C to receive standard-dose interferon alfa-2b alone or in combination with ribavirin (1000 or 1200 mg orally per day, depending on body weight) for 24 or 48 weeks. Efficacy was assessed by measurements of serum hepatitis C virus (HCV) RNA and serum aminotransferases and by liver biopsy.

Results The rate of sustained virologic response (defined as an undetectable serum HCV RNA level 24 weeks after treatment was completed) was higher among patients who received combination therapy for either 24 weeks (70 of 228 patients, 31 percent) or 48 weeks (87 of 228 patients, 38 percent) than among patients who received interferon alone for either 24 weeks (13 of 231 patients, 6 percent) or 48 weeks (29 of 225 patients, 13 percent) (P<0.001 for the comparison of interferon alone with both 24 weeks and 48 weeks of combination treatment). Among patients with HCV genotype 1 infection, the best response occurred in those who were treated for 48 weeks with interferon and ribavirin. Histologic improvement was more common in patients who were treated with combination therapy for either 24 weeks (57 percent) or 48 weeks (61 percent) than in those who were treated with interferon alone for either 24 weeks (44 percent) or 48 weeks (41 percent). The drug doses had to be reduced and treatment discontinued more often in patients who were treated with combination therapy.

Conclusions In patients with chronic hepatitis C, initial therapy with interferon and ribavirin was more effective than treatment with interferon alone.

Source Information

From the Division of Gastroenterology–Hepatology, Scripps Clinic and Research Foundation, La Jolla, Calif. (J.G.M.); William Beaumont Hospital, Royal Oak, Mich. (S.C.G.); University of Miami, Miami (E.R.S.); Medical College of Virginia, Richmond (M.L.S.); University of Texas Southwestern Medical Center, Dallas (W.M.L.); Georgetown University, Washington, D.C. (V.K.R.); Armed Forces Institute of Pathology, Washington, D.C. (Z.D.G.); and Schering-Plough Research Institute, Kenilworth, N.J. (M.-H.L., S.C., J.K.A.).

Address reprint requests to Dr. McHutchison at Scripps Clinic and Research Foundation, Division of Gastroenterology–Hepatology (203N), 10666 N. Torrey Pines Rd., La Jolla, CA 92037.

Full Text of this Article

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Combination Therapy for Hepatitis C Infection
Newman T. B., Clay C. M., Davis G. L., McHutchison J. G., Liang T. J.
Extract | Full Text  
N Engl J Med 1999; 340:1207-1209, Apr 15, 1999. Correspondence

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