Premium
Therapy of hepatitis C: Meta‐analysis of interferon alfa‐2b trials
Author(s) -
Carithers R L,
Emerson S S
Publication year - 1997
Publication title -
hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.488
H-Index - 361
eISSN - 1527-3350
pISSN - 0270-9139
DOI - 10.1002/hep.510260715
Subject(s) - medicine , interferon alfa , meta analysis , hepatitis c , alpha interferon , interferon , gastroenterology , virology , pharmacology
We performed an independent meta‐analysis of all available randomized clinical trials of interferon alfa‐2b in patients with chronic hepatitis C. Articles published between 1986 and 1996 had to include previously untreated patients who were randomly allocated to therapy with at least 2 million units (MU) of interferon alfa‐2b three times weekly for 24 weeks. A total of 32 trials met the inclusion criteria. Of these, 20 compared interferon‐treated patients to placebo recipients or untreated patients and were used in the primary meta‐analysis that compared rates of end‐of‐treatment and 6‐month post‐treatment sustained biochemical (normal alanine aminotransferase [ALT] levels) responses, end‐of‐treatment and 6‐month sustained virological responses (absence of hepatitis C virus [HCV] RNA), and end‐of‐treatment histological responses in patients with paired biopsies. An additional 12 trials compared different doses, duration, or strategies of treatment. In comparison with no treatment, interferon alfa‐2b therapy was associated with significant improvement in all end points measured. End‐of‐ treatment biochemical responses were seen in 47% of treated patients compared with 4% of controls (odds ratio, 25.1; P < .0001). The biochemical responses were sustained for at least 6 months in 23% of treated patients compared with 2% of controls (odds ratio, 17.8; P < .0001). End‐of‐treatment virologic responses were observed in 29% of treated patients compared with 5% of controls (odds ratio, 9.4; P < .001) and 6‐month sustained virologic responses were documented in 8% of treated patients compared with 1% of controls (odds ratio, 8.6; P < .001). Histological responses were recorded in 73% of treated patients compared with 38% of controls (odds ratio, 4.8; P < .0001). Extended therapy for 12 to 24 months resulted in significant improvement in 6‐ month sustained responses: 27% versus 14% (odds ratio, 2.9; P < .001). Higher dose therapy also resulted in modest increases in end‐of‐ treatment (61% vs. 52%; odds ratio, 1.8; P < .02) and 6‐month sustained responses (28% vs. 19%; odds ratio, 2.2; P < .01).