Efficacy and Safety of Short Course Therapy With Peginterferon Alpha-2b (PEG-IFN Alfa-2b) and Ribavirin (RBV) for Chronic Hepatitis C (Genotype 4) Participants Achieving a Rapid Virological Response at Week 4 of Treatment (MK-8908B-059) (START 4)

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 4

Conditions: Hepatitis C, Chronic

Treatments: Drug: PEG-IFN alfa-2b; Drug: ribavirin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01606800

8908B-059

MK-8908B-059 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to assess the efficacy of a short course of therapy (24 weeks) versus standard 48 week treatment in previously untreated adult participants with chronic hepatitis C (CHC) genotype 4 infection who achieve rapid virologic response (RVR), defined as HCV ribonucleic acid (RNA) negativity after 4 weeks of treatment.

Full description

Participants who achieved RVR after 4 weeks of PEG-INF alfa-2b plus RBV treatment were randomized to receive either 20 or 44 weeks of continued therapy, for a total of 24 or 48 weeks total of PEG-INF plus RBV therapy.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant is ≥40 kg and ≤120 kg weight
• Participant and participant's partner(s) must each agree to use acceptable methods of contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study medication, or longer if dictated by local regulations.
• Previously documented CHC genotype 4 infection
• Liver biopsy or fibrotest and fibroscan with histology consistent with CHC and no other etiology and with hepatic fibrosis scores (F0, F1, F2, F3).

Exclusion criteria

• Co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus
• Treatment for hepatitis C with any investigational medication
• Treatment with any investigational drug within 30 days of the screening visit
• Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy
• Autoimmune hepatitis or a history of autoimmune disease
• Hepatic fibrosis score F4
• Severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months
• Autoimmune hepatitis or a history of autoimmune disease
• Thyroid disease uncontrolled with conventional treatment
• Epilepsy and/or compromised central nervous system (CNS) function

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

44 Weeks of PEG-IFN alfa-2b + RBV

Experimental group

Description:

Participants achieving RVR at 4 weeks of treatment will receive 44 additional weeks of Peg-IFN Alfa-2b + RBV.

Treatment:

Drug: PEG-IFN alfa-2b

Drug: ribavirin

20 Weeks of PEG-IFN alfa-2b + RBV

Experimental group

Description:

Participants achieving RVR at 4 weeks of treatment will receive 20 additional weeks of Peg-IFN Alfa-2b + RBV.

Treatment:

Drug: PEG-IFN alfa-2b

Drug: ribavirin