Vitamin D as an add-on Therapy With Pegylated Interferon and Ribavirin for Chronic Hepatitis c
Vitamin D as an add-on Therapy With Pegylated Interferon and Ribavirin for Chronic Hepatitis c
Chronic hepatitis C is endemic in Egypt with a high prevalence of the resistant genotype 4.
 Conventional standard of care treatment has modest response with only 50% sustained virologic
 response. Recent reports have suggested an augmented response with the addition of vitamin D.
 This is a prospective randomized trial to assess the effectiveness of adding vitamin D to
 standard of care for chronic hepatitis C genotype 4.
Inclusion Criteria:

 -  Adult (male or female), 18 to 65 years of age, with chronic HCV infection

 -  Liver biopsy showing chronic hepatitis with significant fibrosis using Ishak scoring
 system

 -  Compensated liver disease; serum bilirubin < 1.5 mg/dl, INR no more than 1.5, serum
 albumin > 3.4, platelet count > 75,000 mm, and no evidence of hepatic decompensation
 (hepatic encephalopathy or ascites)

 -  Acceptable hematological and biochemical indices (hemoglobin 12.5g/dl for men and 12
 g/dl for women; neutrophil count 1500/mm3 or more and serum creatinine < 1.5 mg/dl

 -  Patients must be serum hepatitis B surface antigen (HBsAg) negative

 -  Negative Antinuclear Antibodies (ANA) or titer of < 1:160

 -  Serum positive for anti-HCV antibodies and HCV-RNA

 -  Abdominal Ultrasound obtained within 3 months prior to entry in the study

 -  Electrocardiogram for men aged > 40 years and for women aged > 50 years

 -  Normal fundus examination

 -  Proper contraception measure throughout the course of treatment and six months later

 -  Female patients must not breast feed during therapy

 Exclusion Criteria:

 -  Patients who previously received interferon

 -  HgbA1c > 7.5 or history of diabetes mellitus

 -  BMI > 34

 -  Women who are pregnant or breast-feeding

 -  Males whose female partners are either pregnant or of child-bearing potential or not
 using birth control and are sexually active

 -  Other causes of liver disease including autoimmune hepatitis

 -  Transplant recipients receiving immune suppression therapy

 -  Screening tests positive for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab or anti-HIV Ab

 -  Decompensated cirrhosis, history of variceal bleeding, ascites, hepatic
 encephalopathy, CTP score > 6 or MELD score > 8

 -  Absolute neutrophil count < 1500 cells/mm3; platelet count < 135,000 cells/mm3;
 hemoglobin < 12 g/dL for women and < 12.5 g/dL for men; or serum creatinine
 concentration ≥ 1.5 times ULN

 -  Hypothyroidism or hyperthyroidism not effectively treated with medication

 -  Alcohol consumption of > 40 grams per day or an alcohol use pattern that will
 interfere with the study

 -  History or other clinical evidence of significant or unstable cardiac disease

 -  History or other clinical evidence of chronic pulmonary disease associated with
 functional impairment

 -  Serious or severe bacterial infection(s)

 -  History of severe or uncontrolled psychiatric disease, including severe depression,
 history of suicidal ideation, suicidal attempts or psychosis requiring medication
 and/or hospitalization

 -  History of uncontrolled severe seizure disorder

 -  History of immunologically mediated disease requiring more than intermittent
 anti-inflammatory medications for management or that requires frequent or prolonged
 use of corticosteroids

 -  Patients with clinically significant retinal abnormalities

 -  Subjects receiving vitamin D for any other medical condition.

 -  Subjects with significant active rheumatologic or orthopaedic conditions.