Chronic Hepatitis c
Conditions
Keywords
chronic hepatitis c, hcv, vitamin d
Brief summary
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.
Interventions
DRUGvitamin D +pegylated interferon + ribavirin
Vitamin D: 1mcg once daily 48 weeks Pegylated interferon 160ug once weekly 48 weeks Ribavirin(\> 75kg:1200 mg, \<75kg:1000mg daily)48 weeks
DRUGpegylated interferon + ribavirin
pegylated interferon 160ug once weekly Ribavirin (\> 75kg:1200 mg, \<75kg:1000mg daily)48 weeks
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained virologic response | 72 weeks | Undetectable HCV-RNA 24 weeks after end of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| rapid virologic response | 4 weeks | undetectable HCV-RNA 4 weeks after commencement of treatment |
| End-of-treatment response | 48 weeks | undetectable HCV-RNA 48 weeks after commencement of treatment |
| Adverse events | 72 weeks | Adverse events that could be reasonably and temporally associated with administration of drugs |
| early virologic response | 12 weeks | Early virologic response: undetectable HCV-RNA 12 weeks after commencement of treatment. Partial early virologic response: decrease of more than 2login HCV-RNA. No early virologic response: increase, stationary or decreased less than 2log HCV-RNA. |
Countries
Egypt
Outcome results
None listed