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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
372
Peginterferon alfa-2a was administered at a dose of 180 mcg SC weekly for 48 weeks to participants with genotype 1, 4, 5, 6 and to participants with HIV co-infection, or for 24 weeks to participants with genotype 2 and 3.
Ribavirin was administered at a dose of 1000-1200 mg PO daily for 48 weeks to participants with genotype 1, 4, 5, 6 or 800 mg PO daily for 24 weeks to participants with genotype 2 and 3.
Unnamed facility
Beroun, Czechia
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Brno, Czechia
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Chomutov, Czechia
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Česká Lípa, Czechia
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České Budějovice, Czechia
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Děčín, Czechia
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Havířov, Czechia
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Havlíčkův Brod, Czechia
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Hradec Králové, Czechia
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Hradec Králové, Czechia
...and 25 more locations
Percentage of Participants With Sustained Virological Response
Sustained virological response is defined as having no hepatitis C (HCV) virus detectable in the blood 24 weeks after end of treatment.
Time frame: Up to 72 weeks
Percentage of Participants With End-of-Treatment Virological Response
End-of-treatment virological response is defined as having no HCV virus detectable in the blood immediately after end of treatment.
Time frame: Up to 48 weeks
Percentage of Participants With Early-Treatment Virological Response
Early-treatment virological response is defined as having no HCV virus detectable in the blood or a 2-log (100-fold) decrease in HCV virus concentration in the blood after 12 weeks of study treatment.
Time frame: Up to 12 weeks
Percentage of Participants With Adverse Events
An adverse event is considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsen during the study are reported as adverse events.
Time frame: Up to 72 weeks
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