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Efficacy of Pegylated Interferon Alone in Egyptian Patients With Acute Hepatitis C (ANRS 1213)

2014-08-27 03:51:20 | BioPortfolio

Summary

Acute hepatitis C is a liver disease related to a virus: hepatitis C virus (HCV). The type of Hepatitis C Virus present in Egypt (genotype 4), has the reputation to respond poorly to treatment at the chronic hepatitis stage. Without treatment, 85% of patients with acute hepatitis C become chronically HCV infected which means that the virus stays present in the body. Pegylated Interferon is a new form of Interferon that stays in the body for longer time and allows the patient to take less injection per week. It has also proved to be more effective than standard Interferon in treatment of chronic hepatitis C.

Description

Egypt is the country with the highest HCV prevalence worldwide, and the number of infected Egyptians is estimated around 8 million. HCV incidence is high as well, and a typical hepatology department in Cairo diagnoses between 5 and 10 acute hepatitis C per month. The HCV genotype circulating in Egypt is genotype 4. This genotype has the reputation to respond poorly to treatment at the chronic hepatitis stage. It would therefore be interesting to assess the treatment efficacy at the acute stage. This study will evaluate the efficacy of pegylated interferon (peg-IFNα-2a) alone in Egyptian patients with acute hepatitis C.

The study primary objective is to evaluate the efficacy and tolerance of pegylated interferon (peg-IFNα-2a) alone in Egyptian patients with acute hepatitis C.

Methods: One arm clinical trial. Follow-up duration: 36 to 48 weeks depending on response to treatment.

Main inclusion criteria: ALT> 3*N; HCV RNA positive by PCR and negative HCV serology at first presentation or positive HCV serology with a clear and unique exposure within 2 months prior the acute hepatitis episode; no prior treatment with IFNα, peg-IFNα and ribavirin; signed informed consent.

Main exclusion criteria : Liver disease other than hepatitis C. Treatment strategy: Peg-IFNα-2a 180microg/week (subcutaneous injection) for 12 weeks. Patients with positive HCV RNA by qualitative PCR at the end of the 12 weeks treatment period will be offered to continue on the same regimen up to 24 weeks.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Hepatitis C

Intervention

pegylated interferon alpha2a

Location

National Hepatology and Tropical Medicine Research Institute
Cairo
Egypt

Status

Completed

Source

French National Agency for Research on AIDS and Viral Hepatitis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:51:20-0400

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Medical and Biotech [MESH] Definitions

INFLAMMATION of the LIVER in humans due to infection by VIRUSES. There are several significant types of human viral hepatitis with infection caused by enteric-transmission (HEPATITIS A; HEPATITIS E) or blood transfusion (HEPATITIS B; HEPATITIS C; and HEPATITIS D).

A family of hepatotropic DNA viruses which contains double-stranded DNA genomes and causes hepatitis in humans and animals. There are two genera: AVIHEPADNAVIRUS and ORTHOHEPADNAVIRUS. Hepadnaviruses include HEPATITIS B VIRUS, duck hepatitis B virus (HEPATITIS B VIRUS, DUCK), heron hepatitis B virus, ground squirrel hepatitis virus, and woodchuck hepatitis B virus (HEPATITIS B VIRUS, WOODCHUCK).

Interferon secreted by leukocytes, fibroblasts, or lymphoblasts in response to viruses or interferon inducers other than mitogens, antigens, or allo-antigens. They include alpha- and beta-interferons (INTERFERON-ALPHA and INTERFERON-BETA).

A species in the genus HEPATOVIRUS containing one serotype and two strains: HUMAN HEPATITIS A VIRUS and Simian hepatitis A virus causing hepatitis in humans (HEPATITIS A) and primates, respectively.

INFLAMMATION of the LIVER in humans caused by HEPATITIS DELTA VIRUS, a defective RNA virus that can only infect HEPATITIS B patients. For its viral coating, hepatitis delta virus requires the HEPATITIS B SURFACE ANTIGENS produced by these patients. Hepatitis D can occur either concomitantly with (coinfection) or subsequent to (superinfection) hepatitis B infection. Similar to hepatitis B, it is primarily transmitted by parenteral exposure, such as transfusion of contaminated blood or blood products, but can also be transmitted via sexual or intimate personal contact.

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