Premium
Comparison of two PEG‐interferon alpha‐2b doses (1.0 or 1.5 μ g/kg) combined with ribavirin in interferon‐naïve patients with chronic hepatitis C and up to moderate fibrosis
Author(s) -
MeyerWyss B.,
Rich P.,
Egger Hp,
Helbling B.,
Müllhaupt B.,
Rammert C.,
Gonvers J.J.,
Oneta C.,
Criblez D.,
Rossi L.,
Borovicka J.,
Meyenberger C.,
Arn M.,
Renner E. L.
Publication year - 2006
Publication title -
journal of viral hepatitis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.329
H-Index - 100
eISSN - 1365-2893
pISSN - 1352-0504
DOI - 10.1111/j.1365-2893.2005.00709.x
Subject(s) - ribavirin , medicine , gastroenterology , alpha interferon , pegylated interferon , adverse effect , hepatitis c , hepatitis c virus , pharmacology , peg ratio , interferon , immunology , virus , finance , economics
Summary. Health regulatory approval of the 1.5 μ g/kg body weight dose of pegylated interferon (PEG‐I) alpha‐2b in combination with ribavirin for the treatment of chronic hepatitis C was based on a study using PEG‐I alpha‐2b at doses of only 0.5 and 1.5 μ g/kg body weight (BW), in spite of the previously shown flat dose–response curve at doses of ≥1.0 μ g/kg. Our aim was to compare PEG‐I alpha‐2b 1.0 μ g/kg with 1.5 μ g/kg, both in combination with ribavirin. Open‐label, randomized study in 227 patients with biopsy‐proven chronic hepatitis C (Metavir ≤F2), receiving oral ribavirin (400 mg, twice daily) in combination with subcutaneous PEG‐I alpha‐2b (1.0 or 1.5 μ g/kg, once weekly) for 24 weeks (genotype 2 or 3), or 48 weeks (other genotypes), followed by a 24‐week drug‐free period. Virologic response rates did not differ between the two doses of PEG‐I alpha‐2b: in patients infected with hepatitis C virus (HCV) genotype 1 or 4 treated with PEG‐I 1.0 μ g/kg BW, 38% (22/58) had a sustained virologic response compared with 39% (27/70) in the PEG‐I 1.5 μ g/kg BW dose group ( P = ns). The corresponding values in patients infected with HCV genotype 2 or 3 were 71% (39/55) and 81% (29/36) respectively ( P = ns). Adverse events led to transient or permanent dose reductions in fewer patients in the 1.0 μ g/kg BW dose group (48/113 patients; 42%) than in the 1.5 μ g/kg BW dose group (63/106 patients; 59%, P = 0.015). Furthermore, 89% of patients treated for 24 weeks but only 58% of patients treated for 48 weeks ( P < 0.001) tolerated the treatment without relevant dose reduction or premature termination. In combination with ribavirin, PEG‐I alpha‐2b 1.0 μ g/kg was as effective as 1.5 μ g/kg but was better tolerated in patients with chronic hepatitis C and up to moderate fibrosis.