a study of combination treatment with peginterferon alfa-2a (pegasys) plus ribavirin (copegus) in participants with chronic hepatitis c

Conditions: Hepatitis C, Chronic

Summary: this 3-arm study assessed the safety and efficacy of combination treatment with peginterferon alfa-2a + ribavirin in participants with chronic hepatitis c. three groups of participants were studied; 1) those with elevated alanine transaminase (alt) levels, 2) those with normal alt levels, and 3) those with human immunodeficiency virus (hiv) co-infection. participants with genotype 1, 4, 5 or 6 received peginterferon alfa-2a 180 micrograms (mcg) subcutaneous (sc) once weekly (qw) + ribavirin 1000-1200 milligrams (mg) orally (po) daily (dependent on body weight) for 48 weeks. those with genotype 2 or 3 received peginterferon alfa-2a 180 mcg sc qw + ribavirin 800 mg po daily for 24 weeks, and all participants with hiv co-infection received peginterferon alfa-2a 180 mcg sc qw + ribavirin 800 mg po daily for 48 weeks.


Eligibility criteria:
inclusion criteria: * adult participants at least 18 years of age * chronic hepatitis c, with detectable serum hepatitis c virus (hcv) ribonucleic acid (rna) * scheduled for treatment with peginterferon alfa-2a * compensated liver disease * women in fertile age must be informed about obligation of using adequate contraception during and 6 months post treatment with ribavirin (copegus®) * men with a sexual partner in fertile age must be informed about obligatory contraception preventing pregnancy during the course of treatment with ribavirin (copegus®) as well as 6 months after treatment cessation * female participants in the study must have a negative pregnancy test performed not sooner than within 2 weeks preceding the planned inclusion to the study * men with a sexual partner in fertile age must produce a negative result of the partner's pregnancy test performed not sooner than within 2 weeks preceding the planned partner's inclusion to the study exclusion criteria: * chronic liver disease other than chronic hepatitis c * active hepatitis a virus or hepatitis b virus infection * therapy with any systemic antiviral, antineoplastic or immunomodulatory treatment less than or equal to (\<=) 6 months prior to first dose of study drug * hemoglobin \<120 grams per liter (g/l) in female participants or \<130 g/l in male participants (the result must not be older than 2 weeks prior to inclusion to the study) * platelet count \<90 x 10\^9/liter (the result must not be older than 2 weeks prior to inclusion to the study * neutrofil count \<1.5 x 10\^9/liter (the result must not be older than 2 weeks prior to inclusion to the study) * participants with increased risk of anaemia, or participants at risk of serious health problems resulting from anaemia or decrease of hemoglobin (e.g., participants with serious cardiovascular or cerebrovascular disease) * history or presence of a serious mental disease, especially depression, which, in the investigator's opinion, does not allow administration of peginterferon alfa-2a (pegasys®) * history or presence of a disease consequent to immunodeficiency (e.g., inflammatory diseases of intestine, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, rheumatoid arthritis)