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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Vitamin D: 1mcg once daily 48 weeks Pegylated interferon 160ug once weekly 48 weeks Ribavirin(\> 75kg:1200 mg, \<75kg:1000mg daily)48 weeks
pegylated interferon 160ug once weekly Ribavirin (\> 75kg:1200 mg, \<75kg:1000mg daily)48 weeks
National Railway Hospital Center
Cairo, Egypt
Sustained virologic response
Undetectable HCV-RNA 24 weeks after end of treatment.
Time frame: 72 weeks
rapid virologic response
undetectable HCV-RNA 4 weeks after commencement of treatment
Time frame: 4 weeks
End-of-treatment response
undetectable HCV-RNA 48 weeks after commencement of treatment
Time frame: 48 weeks
Adverse events
Adverse events that could be reasonably and temporally associated with administration of drugs
Time frame: 72 weeks
early virologic response
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.
Time frame: 12 weeks
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