Interferon Alfa-2b Alone or in Combination with Ribavirin as Initial Treatment for Chronic Hepatitis C
John G. McHutchison, M.D., Stuart C. Gordon, M.D., Eugene R. Schiff, M.D., Mitchell L. Shiffman, M.D., William M. Lee, M.D., Vinod K. Rustgi, M.D., Zachary D. Goodman, M.D., Ph.D., Mei-Hsiu Ling, Ph.D., Susannah Cort, M.D., Janice K. Albrecht, Ph.D., for The Hepatitis Interventional Therapy Group
Background Only 15 to 20 percent of patients with chronic hepatitisC have a sustained virologic response to interferon therapy.We compared the efficacy and safety of recombinant interferonalfa-2b alone with those of a combination of interferon alfa-2band ribavirin for the initial treatment of patients with chronichepatitis C.
Methods We randomly assigned 912 patients with chronic hepatitisC to receive standard-dose interferon alfa-2b alone or in combinationwith ribavirin (1000 or 1200 mg orally per day, depending onbody weight) for 24 or 48 weeks. Efficacy was assessed by measurementsof serum hepatitis C virus (HCV) RNA and serum aminotransferasesand by liver biopsy.
Results The rate of sustained virologic response (defined asan undetectable serum HCV RNA level 24 weeks after treatmentwas completed) was higher among patients who received combinationtherapy for either 24 weeks (70 of 228 patients, 31 percent)or 48 weeks (87 of 228 patients, 38 percent) than among patientswho received interferon alone for either 24 weeks (13 of 231patients, 6 percent) or 48 weeks (29 of 225 patients, 13 percent)(P<0.001 for the comparison of interferon alone with both24 weeks and 48 weeks of combination treatment). Among patientswith HCV genotype 1 infection, the best response occurred inthose who were treated for 48 weeks with interferon and ribavirin.Histologic improvement was more common in patients who weretreated with combination therapy for either 24 weeks (57 percent)or 48 weeks (61 percent) than in those who were treated withinterferon alone for either 24 weeks (44 percent) or 48 weeks(41 percent). The drug doses had to be reduced and treatmentdiscontinued more often in patients who were treated with combinationtherapy.
Conclusions In patients with chronic hepatitis C, initial therapywith interferon and ribavirin was more effective than treatmentwith interferon alone.
Source Information
From the Division of GastroenterologyHepatology, 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 GastroenterologyHepatology (203N), 10666 N. Torrey Pines Rd., La Jolla, CA 92037.
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