Clinical Trial of the Efficacy of the Combination of Pegylated Interferon (PEG-IFNα-2a) Plus Ribavirin in Egyptian Patients With Untreated Chronic Hepatitis C
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Chronic Hepatitis C
- Sponsor
- French National Agency for Research on AIDS and Viral Hepatitis
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- - Disappearance of HCV RNA by qualitative PCR 24 weeks after the end of treatment
- Status
- Completed
- Last Updated
- 19 years ago
Overview
Brief Summary
Chronic hepatitis C is a liver disease related to a virus: hepatitis C virus (HCV). The type of HCV present in Egypt (genotype 4), has the reputation to respond poorly to Interferon treatment at the chronic stage. 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 proved to be more effective than standard Interferon. The combination of two drugs, Interferon and Ribavirin, is considered to be the best treatment available for chronic hepatitis C.
Detailed Description
Egypt is the country with the highest HCV prevalence worldwide, and the number of infected Egyptians is estimated around 8 million. The HCV genotype circulating in Egypt is genotype 4. This genotype has the reputation, based on the few available data, to respond poorly to treatment. This study will estimate the safety and efficacy of the combination of peg-IFNα-2a plus Ribavirin, in Egyptian patients with chronic hepatitis C. This treatment has been chosen based on its better expected efficacy compared to pegylated interferon alone. The primary objective of the study is to assess the efficacy and tolerance of the combination of pegylated interferon (peg-IFNα-2a) plus ribavirin in Egyptian patients with chronic hepatitis C and with no prior treatment for HCV. Methods: Open trial. Follow-up duration: 72 weeks. Enrolment duration: 18 months. Total trial duration: 3 years and a half, including trial analysis (carried out in the 6 months following the follow-up completion of the last patient). Total number of patients: 100. Precision around the expected efficacy rate (40% in intention-to-treat analysis): 9.6%. Treatment strategy: Peg-IFNα-2a 180microg/week for 48 weeks, Ribavirin at least 11 mg/kg/day for 48 weeks Main inclusion criteria: HCV RNA positive by PCR; METAVIR score : \>A2 and \>= F1 or \>= A1 and \> F2; ALAT over 1.5\*N; no prior treatment with IFNalpha, PEG-IFNalpha and ribavirin Main exclusion criteria : Liver disease other than hepatitis C; advanced liver disease; negative HCV RNA. Patient from a cohort follow-up conducted in a village in rural Egypt with High HCV prevalence (Menoufia governorate) will be proposed to participate in the trial. Pre-enrolment investigations, liver biopsy, and patients follow-up will be carried out at a local hospital. Blood test analyses will be carried out under the responsibility of Hepatitis Virology Reference Laboratory at the National Hepatology and Tropical Medicine Institute, Cairo; trial monitoring will be carried out by the Department of Community Medicine of Ain Shams; methodological assistance from the "Unite des Maladies Emergentes" at Pasteur Institute and INSERM U444, Paris. Treatment for patients with HCV RNA by qualitative PCR still positive after 24 weeks of the combination Peg-IFNα-2a with ribavirin, will be stopped.
Investigators
Eligibility Criteria
Inclusion Criteria
- •HCV antibodies using a third generation test
- •HCV RNA positive by PCR
- •Liver biopsy in the past 18 months with METAVIR score over A2 and over or equal to F1, or over or equal A1 and over F2
- •ALT over 1.5 time the normal range in the 24 weeks prior to inclusion (Week-28; W-2);
- •Patients never treated with ribavirin, IFNalpha or PEG-IFNalpha
- •Normal albumin
- •Prothrombin time over or equal to 60 percent
- •Normal bilirubin
- •Alpha-foeto-protein under or equal to 3 times the normal range for the laboratory
- •HBs antigen negative
Exclusion Criteria
- •Co-infection with hepatitis B (positive HBs antigen)
- •Hemochromatosis
- •Alpha-1 anti-trypsin deficiency
- •Wilson disease
- •Alcoholism-related liver disease
- •Gilbert disease
- •Alcohol intake over 50g/day for males and 40 g/day for females
- •Ongoing intravenous drug use
- •Aggravated liver cirrhosis (history or presence of ascitis, oesophageal varicosis, liver encephalopathy)
- •Hepatocellular carcinoma
Outcomes
Primary Outcomes
- Disappearance of HCV RNA by qualitative PCR 24 weeks after the end of treatment
Secondary Outcomes
- Evaluation of HCV RNA at 12 and 24 weeks
- changes in HCV RNA load during treatment
- Normalization of ALT during treatment and 24 weeks after the end of treatment
- Study of side effects
- Histological changes 24 weeks after the end of treatment (decrease by at least 1 point of the Metavir score)