Timing and Duration of Acute Hepatitis C Treatment

Ain Shams University

Status and phase

Completed

Phase 4

Conditions

Hepatitis C

Treatments

Drug: Ribavirin

Drug: Pegylated interferon alpha 2

Study type

Interventional

Funder types

Other

Industry

NIH

Identifiers

NCT00241618

AI41563

994058402

Fulbright

ISID

TEMPUS

AI054887

Details and patient eligibility

About

Spontaneous resolution of acute hepatitis C infection cannot be predicted and the majority of cases persist and become chronic. This randomized trial assesses the efficacy and safety of peginterferon alfa-2b. The investigators hypothesize that therapy strategies could prevent the development of chronic hepatitis.

Full description

With nearly 4 million people in the United States, and an estimated 170-200 million people worldwide, the hepatitis C virus (HCV) represents a clear and significant public health issue. Unfortunately, for most people infected with HCV (70%-85%) spontaneous resolution is uncommon and 60% to 80% of patients with acute hepatitis C infection develop chronic hepatitis. This randomized trial focuses on defining the effect of treatment of acute HCV on prevention of chronic hepatitis in addition to optimization of the treatment regimen, onset and the length of peginterferon alpha therapy in acute hepatitis C infections. This randomized, multi-center prospective study assesses the efficacy of peginterferon in acute hepatitis. We will also compare differences in sustained viral response rates in patients with acute hepatitis C starting treatment at 8, 12, or 24 weeks. We will also compare the efficacy of 8, 12 or 24 weeks therapy with PEG-IFN-alpha. All eligible patients are enrolled and screened for an initial observation period starting from the time of their first positive HCV-RNA-PCR, during which bi-weekly serum ALT and HCV-RNA subjects were performed. Patients who did not resolve spontaneously (loss of HCV-RNA without treatment) by the end of the observation period were randomly assigned to receive PEG-IFN-alpha at the assigned onset and/or duration. Patients who do not consent to therapy at enrollment are included as a non-randomized comparison group. All subjects with SVR were followed for 48 weeks after the follow-up at 24 weeks when SVR was determined.

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age: 18-50 years, with or without symptoms
Diagnosis of acute hepatitis C: elevated serum alanine aminotransferase (ALT) > 10 times the upper limit of normal (ULN)
Seroconversion from negative to positive anti-HCV antibody status (third-generation enzyme-linked immunosorbent assay)
Conversion from negative to positive polymerase chain reaction (PCR) for HCV-RNA, ruling out other causes of hepatitis by history and appropriate serologic and virologic studies.

Exclusion criteria

Decompensated liver disease
Coinfection with human immunodeficiency virus (HIV) or Schistosoma mansoni
Marked anemia (hemoglobin level ≤ 120 g/L in women and ≤ 130 g/L in men)
Neutropenia (< 1,500/mm3)
Thrombocytopenia (< 90,000/mm3)
A creatinine concentration > 1.5 times ULN
Serum alpha-fetoprotein > 25 ng/ml
An organ transplant
Neoplastic disease
Severe cardiac or pulmonary disease
Unstable thyroid dysfunction
A psychiatric disorder
Seizure disorder
Severe retinopathy
A current pregnancy or were breast feeding or unwillingness to practice contraception
Therapy with immunomodulatory agents within the last 6 months
Alcohol or drug dependence within 1 year of study entry.