Evaluation of Unipeg® for Response and Ongoing Safety in Pakistani Population
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: Peginterferon alfa-2a; Ribavirin
Intervention description: PegInterferon alfa-2a 180mcg 20kDa administered subcutaneously once weekly for 24 weeks in genotype 3 and for 48 weeks in genotype 1 patients.; Ribavirin administered orally in a divided daily dose according to body weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: PegInterferon alpha-2a; Ribavirin; Hepatitis C Virus; Sustained Virological Response; End of Treatment Response; Unipeg; Ribazole

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written Informed consent

          2. Treatment naïve patients

          3. Serological evidence of hepatitis C infection by an anti-HCV antibody test

          4. HCV positive by PCR

          5. Genotype 1,2 and 3

          6. BMI 20-28

          7. Participants were the resident of city where he /she enrolled at their respective
             centre

          8. No evidence of liver cirrhosis

          9. No other significant hepatic or systemic disease

         10. No evidence of hepatic encephalopathy

         11. Normal thyroid functions (By testing TSH)

         12. 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:

          1. Unable to give consent

          2. Prior treatment for Hepatitis C

          3. Co-infection with HBV and HCV

          4. Obesity

          5. Iron overload

          6. Other Genotypes e.g. 4, 5, 6 with their sub-types

          7. Pregnant and lactating women

          8. 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)

          9. Uncontrolled Hypertension

         10. Uncontrolled Diabetes

         11. Severe Depression

         12. Clinically significant cardio-vascular disease

         13. Symptomatic peripheral vascular disease

         14. Oral or parenteral anticoagulants or anti platelet agents

         15. History of systemic anti-viral therapy at least three months prior to first dose of
             study medication