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

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.

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