Evaluation of Unipeg® for Response and Ongoing Safety in Pakistani Population

Study Overview
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Brief Summary
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Hepatitis C is a global problem, prevalent in developed as well as in the developing countries. New treatment regimens using PegInterferon in combination with ribavirin has led to improved sustained viral response rates for some genotypes. A single arm, open labeled, multicentre trial was conducted to evaluate the response rate and safety of PegInterferon alfa-2a (Unipeg®) plus ribavirin (Ribazole®) for the treatment of patients with chronic hepatitis C infection. RVR at 4 weeks, ETR at 24 weeks for genotype 3 and at 48 weeks for genotype 1 patients and SVR was determined at 24 weeks after completion of treatment. Quality of life at baseline and at follow-up visits were determined using SF-36.

Detailed Description
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A multicenter, phase IV, open labeled, single arm study was conducted. Total 110 patients were screened for recruitment. Out of which 67 subjects met the inclusion criteria, 3 failed to give the informed consent and were excluded. The final sample size of the study was 64 patients. The duration of study was August 2010 to September 2013. Peginterferon alfa-2a 180µg 20kDa (Unipeg®) solution for injection was administered as single dose sub-cutaneous once weekly for 24 weeks to patients with genotype 3 and 48 weeks in patients with genotype 1 at the site of recruitment. Ribavirin (Ribazole) orally were given in divided daily dose according to body weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg). Quality of life related Physical Component Score (PCS) & Mental Component Score (MCS) were measured through Health-Related Quality of Life (HRQOL) Questionnaire (SF-36). The SF-36 questionnaire was completed for all patients during their evaluations before treatment, at 4 weeks, at the end of treatment and at 24 weeks after completion of treatment.

Official Title
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Response Evaluation of Peginterferon Alfa-2a 180µg 20kDa (Unipeg®) Plus Ribavirin (Ribazole®) in Treatment naïve Pakistani Population With Chronic Hepatitis C Infection

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: Peginterferon alfa-2a
* Drug: Ribavirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written Informed consent Treatment naïve patients Serological evidence of hepatitis C infection by an anti-HCV antibody test HCV positive by PCR Genotype 1,2 and 3 BMI 20-28 Participants were the resident of city where he /she enrolled at their respective centre No evidence of liver cirrhosis No other significant hepatic or systemic disease No evidence of hepatic encephalopathy Normal thyroid functions (By testing TSH) Adequate bone marrow, liver and renal functions test Hematology: ANC≥1,000/mm3, Platelet count ≥100,000 mm3, Hemoglobin≥11.0g/dl in female and ≥ 12.0 g/dl in male Blood Chemistry: Total Bilirubin≤2.0mg/dl, AST and ALT <3 times normal Creatinine Clearance >50 ml/min Proteinuria: ≤ 0.5 g per 24h. Prothrombin Time or partial-thromboplastin time if ≤1.5 times the upper limit of the normal range. Exclusion Criteria: Unable to give consent Prior treatment for Hepatitis C Co-infection with HBV and HCV Obesity Iron overload Other Genotypes e.g. 4, 5, 6 with their sub-types Pregnant and lactating women History of medical condition associated with chronic liver disease other than CHC (e.g. hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposure) Uncontrolled Hypertension Uncontrolled Diabetes Severe Depression Clinically significant cardio-vascular disease Symptomatic peripheral vascular disease Oral or parenteral anticoagulants or anti platelet agents History of systemic anti-viral therapy at least three months prior to first dose of study medication

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PegInterferon alfa-2a and Ribavirin<br>PegInterferon alfa-2a subcutaneously once weekly Ribavirin administered orally according to the body weight | Drug: Peginterferon alfa-2a<br>* PegInterferon alfa-2a 180mcg 20kDa administered subcutaneously once weekly for 24 weeks in genotype 3 and for 48 weeks in genotype 1 patients.<br>* Other names: Unipeg;Drug: Ribavirin<br>* Ribavirin administered orally in a divided daily dose according to body weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)<br>* Other names: Ribazole;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Sustained Virological Response (SVR) | To determine the SVR at 24 weeks after completion of treatment, among those who achieved ETR | Post treatment Week 24 | 
| Number of Participants With End Treatment Response | To determine the End Treatment Response (ETR) rate of all patients treated with PegInterferon alfa-2a plus Ribavirin | Upto 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Reported Adverse Events | To determine the number of patients treated with PegInterferon Alfa-2a plus Ribavirin who experience any adverse drug reaction. All ADR are reported as per patient information leaflet | Upto 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PegInterferon alpha-2a, Ribavirin, Hepatitis C Virus, Sustained Virological Response, End of Treatment Response, Unipeg, Ribazole