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- Title
Treatment of Chronic Hepatitis C in Patients Who Failed Interferon Monotherapy: Effects of Higher Doses of Interferon and Ribavirin Combination Therapy.
- Authors
Shiffman, Michelle L.; Hofmann, Charlotte M.; Gabbay, Joubin; Luketic, Velimir A.; Sterling, Richard K.; Sanyal, Arun J.; Contos, Melissa J.; Ryan, Michael J.; Yoshida, Cynthia; Rustgi, Vinod
- Abstract
OBJECTIVE: The present study was designed to evaluate the effectiveness of interferon-ribavirin combination therapy for treatment of chronic hepatitis C virus (HCV) in patients who failed previous treatment with interferon monotherapy. METHODS: A total of 140 patients with well-documented chronic HCV who failed to achieve a virological (if HCV-RNA was assessed) or biochemical response (if HCV-RNA was not assessed) to interferon monotherapy, 3 mU three times weekly (TIW) for 3-18 months, were randomly assigned to one of three treatment groups. Group A patients were treated with 5 mU interferon TIW for 6 months. Ribavitin (1000-1200 mg daily) was added in those patients HCV-RNA positive at month 3. Group B patients were treated with 3 mU interferon TIW plus ribavirin (1000-1200 mg daily) for 6 months. The dose of interferon was increased to 5 mU TIW in those patients HCV-RNA positive at month 3. Group C patients were treated with 5 mU interferon TIW plus rihavirin (1000-1200 mg daily) for 6 months. Serum ALT and HCV-RNA were monitored during and after treatment for a total of 15 months. RESULTS: Seventeen percent of patients in group A became HCV-RNA negative by treatment month 3. Adding ribavirin resulted in one additional patient becoming HCV-RNA negative. However, none of the patients in this group achieved sustained virological response. Twenty-six percent of patients in group B became HCV-RNA negative by treatment month 3. Increasing the dose of interferon from 3 to 5 mU TIW increased virological response to 30%. However, sustained virological response was observed in only 14%. Thirty percent of patients in group C became HCV-RNA negative, but sustained virological response was observed in only 12%. Sustained virological response was found to be significantly greater in patients with a nontype 1 HCV genotype (<em>p</em> < 0.002) and in patients who had a decline in HCV-RNA titer to a value < 100,000 copies/ml during their previous course of interferon monotherapy (<em>p</em> < 0.0001). None of the 12 sustained responders were African Americans <em>p</em> < 0.013). CONCLUSIONS: Retreatment of nonresponders with interferon- ribavirin combination therapy results in limited benefit; only 13% of patients achieved sustained virological response. Response was extremely poor in African Americans and those with HCV genotype 1.
- Subjects
INTERFERONS; RIBAVIRIN; HEPATITIS C virus; HEPATITIS C; THERAPEUTICS; AFRICAN Americans
- Publication
American Journal of Gastroenterology (Springer Nature), 2000, Vol 95, Issue 10, p2928
- ISSN
0002-9270
- Publication type
Article
- DOI
10.1111/j.1572-0241.2000.02321.x