Premium
High‐dose prolonged combination therapy in non‐responders to interferon monotherapy for chronic hepatitis C
Author(s) -
Di Marco V.,
Vaccaro A.,
Ferraro D.,
Alaimo G.,
Rodolico V.,
Parisi P.,
Peralta S.,
Di Stefano R.,
Almasio P. L.,
Craxì A.
Publication year - 2001
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1046/j.1365-2036.2001.01005.x
Subject(s) - medicine , ribavirin , tolerability , combination therapy , regimen , gastroenterology , adverse effect , interferon , alpha interferon , interferon alfa , hepatitis c , chronic hepatitis , immunology , virus
Background: Therapy of chronic hepatitis C non‐ responders to interferon monotherapy with standard doses of interferon plus ribavirin is usually ineffective. Aim: To evaluate the efficacy and tolerability of high‐dose prolonged combination retreatment in non‐ responder patients. Methods: Patients were retreated for 6 months with 6 MU αIFN on alternate days and 1000 or 1200 mg/day ribavirin. HCV‐RNA negative patients continued therapy for an additional 6 months. Results: Forty patients (29 males, mean age 49.7 years, 34 genotype 1b, 11 with F3 fibrosis) were treated. At 6 months, 20 (50%) patients were HCV‐RNA negative but six of them discontinued therapy because of adverse events. A sustained response was achieved in 28% of patients (11/40). A sustained response was more frequent among patients with genotype non‐1b than in those with genotype 1b (67 vs. 21%, P =0.005) and clearance of HCV‐RNA in the first 3 months had a high predictive value for sustained response (100% of sustained responders vs. 24% of non‐responders, P =0.0001). Conclusions: High‐dose prolonged combination therapy in non‐responders to IFN monotherapy leads to a higher rate of sustained response than the standard combination regimen. Tolerability may be a rate‐limiting factor. Maximal effectiveness can be predicted in patients with non‐1b genotype and in those who clear HCV‐RNA soon after starting retreatment.