Treatment of Recently Acquired Hepatitis C Virus Infection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2015-06-30

Brief Summary

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To determine whether response guided treatment with pegylated interferon +/- ribavirin is effective for the treatment of recently acquired hepatitis C infection. Response guided treatment is when the length of treatment is determined by how quickly you respond to the treatment.

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Detailed Description

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A prospective longitudinal study of natural history and treatment outcomes following response guided treatment of recent hepatitis C infection.

Conditions

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Acute Hepatitis C

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A - 8 weeks therapy

8 weeks total of Pegylated interferon and ribavirin if undetectable HCV RNA after 2 weeks of therapy.

Group Type EXPERIMENTAL

Peginterferon alfa-2a

Intervention Type DRUG

PEG-IFN 180 mcg in 0.5 ml (prefilled syringes) administered subcutaneously (SC) once weekly

Ribavirin

Intervention Type DRUG

Genotype 1: 1000mg or 1200mg p.o. daily in split doses (1000mg for patients weighing \<75kg and 1200mg for patients weighing ≥ 75kg) Genotypes 2/3: 800mg daily p.o. daily in split doses for genotype 2 and 3 patients

Group B - 16 weeks therapy

16 weeks total of Pegylated interferon and ribavirin if undetectable HCV RNA after 4 weeks of therapy.

Group Type EXPERIMENTAL

Peginterferon alfa-2a

Intervention Type DRUG

PEG-IFN 180 mcg in 0.5 ml (prefilled syringes) administered subcutaneously (SC) once weekly

Ribavirin

Intervention Type DRUG

Genotype 1: 1000mg or 1200mg p.o. daily in split doses (1000mg for patients weighing \<75kg and 1200mg for patients weighing ≥ 75kg) Genotypes 2/3: 800mg daily p.o. daily in split doses for genotype 2 and 3 patients

Group C - 24 weeks therapy

24 weeks total of Pegylated interferon and ribavirin if undetectable HCV RNA after 6 weeks of therapy.

Group Type EXPERIMENTAL

Peginterferon alfa-2a

Intervention Type DRUG

PEG-IFN 180 mcg in 0.5 ml (prefilled syringes) administered subcutaneously (SC) once weekly

Ribavirin

Intervention Type DRUG

Genotype 1: 1000mg or 1200mg p.o. daily in split doses (1000mg for patients weighing \<75kg and 1200mg for patients weighing ≥ 75kg) Genotypes 2/3: 800mg daily p.o. daily in split doses for genotype 2 and 3 patients

Group D - 32 weeks (gt1) or 24 weeks (gt 2/3)

32 weeks total of Pegylated interferon and ribavirin if undetectable HCV RNA after 8 weeks of therapy (genotype 1) or 24 weeks total of Pegylated interferon and ribavirin if undetectable HCV RNA after 8 weeks of therapy.

Group Type EXPERIMENTAL

Peginterferon alfa-2a

Intervention Type DRUG

PEG-IFN 180 mcg in 0.5 ml (prefilled syringes) administered subcutaneously (SC) once weekly

Ribavirin

Intervention Type DRUG

Genotype 1: 1000mg or 1200mg p.o. daily in split doses (1000mg for patients weighing \<75kg and 1200mg for patients weighing ≥ 75kg) Genotypes 2/3: 800mg daily p.o. daily in split doses for genotype 2 and 3 patients

Group E - 48 weeks (gt 1) or 24 weeks (gt 2/3)

48 weeks total of Pegylated interferon and ribavirin if undetectable HCV RNA after 12 weeks of therapy (genotype 1) or 24 weeks total of Pegylated interferon and ribavirin if undetectable HCV RNA after 12 weeks of therapy (genotype 2/3).

Group Type EXPERIMENTAL

Peginterferon alfa-2a

Intervention Type DRUG

PEG-IFN 180 mcg in 0.5 ml (prefilled syringes) administered subcutaneously (SC) once weekly

Ribavirin

Intervention Type DRUG

Genotype 1: 1000mg or 1200mg p.o. daily in split doses (1000mg for patients weighing \<75kg and 1200mg for patients weighing ≥ 75kg) Genotypes 2/3: 800mg daily p.o. daily in split doses for genotype 2 and 3 patients

Untreated Group

Observation only. No treatment for hepatitis C administered. Subjects who have undetectable HCV RNA at baseline, do not wish to commence treatment or are ineligible for treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Peginterferon alfa-2a

PEG-IFN 180 mcg in 0.5 ml (prefilled syringes) administered subcutaneously (SC) once weekly

Intervention Type DRUG

Ribavirin

Genotype 1: 1000mg or 1200mg p.o. daily in split doses (1000mg for patients weighing \<75kg and 1200mg for patients weighing ≥ 75kg) Genotypes 2/3: 800mg daily p.o. daily in split doses for genotype 2 and 3 patients

Intervention Type DRUG

Other Intervention Names

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Pegasys

Eligibility Criteria

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Inclusion Criteria

* Male and female patients ≥ 16 years of age
* Recent hepatitis C infection with an estimated duration of Infection ≤ 18 months defined as

A)

* i) First anti-HCV antibody or HCV RNA positive within the previous 6 months and
* ii) Documented anti-HCV antibody negative or HCV RNA negative within the 24 months prior to anti-HCV antibody positive result

OR

B)

* i) First anti-HCV antibody or HCV RNA positive within the previous 6 months and
* ii) acute clinical hepatitis (jaundice or ALT\> 10 X ULN) within the 12 months prior to first positive HCV antibody or HCV RNA with no other cause of acute hepatitis identifiable and
* Adequate English to provide written, informed consent and to provide reliable responses to the study interview
* Provision of written, informed consent.

Exclusion Criteria

All patients:

• Individuals considered by the study investigators to be unlikely to participate in intensive follow-up and/or unwilling to provide extra blood samples

Treatment group only:

* Age between 16 and 18 years
* Women with ongoing pregnancy or breast feeding
* Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) \*6 months prior to the first dose of study drug
* Any investigational drug \<6 weeks prior to the first dose of study drug
* Positive test at screening for anti-HAV IgM Ab, anti-HBc IgM Ab
* History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g. hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
* History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
* Neutrophil count \<1500 cells/mm3 or platelet count \<90,000 cells/mm3 at screening
* Serum creatinine level \>1.5 times the upper limit of normal at screening
* Hgb\< 12g/dL in women or \< 13g/dL in men at screening (for patients who receive combination therapy with PEG-IFN and ribavirin only)
* Male partners of women who are pregnant (for patients who receive combination therapy with PEG-IFN and ribavirin only)
* History of a severe seizure disorder or current anticonvulsant use
* History of immunologically mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
* History of thyroid disease poorly controlled on prescribed medications, elevated thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease
* Evidence of severe retinopathy (e.g. CMV retinitis, macular degeneration)

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No