vitamin d as an add-on therapy with pegylated interferon and ribavirin for chronic hepatitis c

Conditions: Chronic Hepatitis c

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.


Eligibility criteria:
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 \ 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.

Keywords: chronic hepatitis c hcv vitamin d