A Study of Induction Dosing With Peginterferon Alfa-2a and Ribavirin in Participants With Chronic Hepatitis C (CHC) Genotype 1 Infection

Phase 4CompletedNCT00192647

Hoffmann-La Roche896 enrolled

Overview

This study will evaluate the addition of a higher-dose induction treatment period with peginterferon (PEG-IFN) alfa-2a (Pegasys) and ribavirin prior to standard-dose treatment with PEG-IFN alfa-2a and ribavirin, compared to standard-dose treatment, in treatment-naive participants with CHC, genotype 1 infection.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

896

Conditions

Hepatitis C, Chronic

Interventions

PEG-IFN alfa-2aDRUG

PEG-IFN alfa-2a will be administered once weekly for 48 weeks, at doses specified in respective arms.

RibavirinDRUG

Ribavirin 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight, for 48 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of chronic CHC, genotype 1 * Chronic liver disease consistent with CHC on a biopsy sample obtained within the previous 36 months as judged by a local pathologist (all countries except Australia) * Infection with Hepatitis C virus (Australian sites only had to meet Section 100 criteria for treatment with PEG-IFN alfa-2a plus ribavirin) * Compensated liver disease * Naive to interferon-based therapy for CHC infection Exclusion Criteria: * Systemic antiviral, antineoplastic, or immunomodulatory treatment within 6 months of study drug * Coinfection with active hepatitis A or B virus, or with human immunodeficiency virus (HIV) * Chronic liver disease other than CHC infection

Locations (51)

Outcomes

Primary Outcomes

Percentage of Participants With Sustained Virological Response According to Scheduled Treatment Period

Sustained virological response was calculated as the percentage of participants with undetectable (less than \[\<\] 15 international units per milliliter \[IU/mL\]) hepatitis C virus (HCV) ribonucleic acid (RNA) as measured by the Roche TaqMan HCV Test 24 weeks after completion of the scheduled 48-week treatment period.

Time frame: Week 72

Secondary Outcomes

Percentage of Participants With End-of-Treatment Virological Response According to Scheduled Treatment Period

Virological response at the end of the scheduled treatment period was defined as the percentage of participants with undetectable (\<15 IU/mL) HCV RNA as measured by the Roche TaqMan HCV Test at Week 48.

Time frame: Weeks 48

Percentage of Participants With Virological Responses Over Time

Virological response was defined as undetectable HCV RNA (\<15 IU/mL) as measured by the Roche TaqMan HCV Test. Participants without HCV RNA measurements at a study week are considered non responders at that study week.

Time frame: Weeks 4, 8, 12, and 24

Percentage of Participants With Relapse of End-of-treatment Virological Response

Relapse was determined based on virological response at the actual end of treatment and was calculated by dividing the number of participants who achieved a virological response at end of treatment but later had detectable HCV RNA at the last assessment post-treatment by the number of participants with a virological response at end of treatment, defined as undetectable HCV RNA (\<15 IU/mL). Participants who achieved a virological response at end of treatment but did not have any HCV RNA assessment during follow-up were excluded and were not considered as having relapsed. However, if no assessment was available within the end of-treatment time window but the participant had a sustained virological response according to the actual treatment period, backward imputation was used and the participant was considered to have achieved an end-of-treatment virological response in the analysis.

Data from ClinicalTrials.gov

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Unnamed facility

Buenos Aires, Argentina

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Buenos Aires, Argentina

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La Plata, Argentina

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Rosario, Argentina

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Adelaide, Australia

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Adelaide, Australia

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Bankstown, Australia

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Box Hill, Australia

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Brisbane, Australia

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Cottontree, Australia

...and 41 more locations

Percentage of Participants With Predictive Values of Virological Response for Sustained Virological Response

The ability of virological responses to predict sustained virological response according to the scheduled treatment periods was assessed in terms of positive predictive value (PPV) and negative predictive value (NPV). The PPV indicates probability of achievement of viral suppression (undetectable HCV RNA) for achieving a sustained virological response and the NPV indicates probability of not achieving viral suppression for not achieving a sustained virological response. The PPV at Week 4 or 12 was calculated as the number of participants who achieved viral suppression both at Week 4 or 12 and at Week 72 divided by the number of participants who achieved viral suppression at Week 4 or 12, multiplied by 100. The NPV at Week 4 or 12 was calculated as the number of participants who failed to achieve viral suppression at Week 4 or 12 and at Week 72 divided by the number of participants who failed to achieve viral suppression at Week 4 or 12, multiplied by 100.

Time frame: Weeks 4, 12, and 72