Vitamin D in Standard HCV Regimen (PEG-Interferon Plus Ribavirin), Its Effect on the Early Virologic Response Rate: A Clinical Trial


1 Department of Gastroenterology and Hepatology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, IR Iran

2 1Department of Gastroenterology and Hepatology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, IR Iran

3 Department of Microbiology and Virology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, IR Iran

4 Department of Community Medicine, School of Medicine, Mashhad University of Medical Sciences, Mashhad, IR Iran

5 Rheumatic Diseases Research Center, School of Medicine, Mashhad University of Medical Sciences, Mashhad, IR Iran

6 Department of Radiology, School of Medicine, Mashhad Branch, Islamic Azad University, Mashhad, IR Iran

7 Department of Pathology, Research and Education Department, Razavi Hospital, Mashhad, IR Iran


Background: Patients chronically infected with the hepatitis C virus (HCV) are more likely to have vitamin D deficiency Recent studies revealed that vitamin D has immunomodulator and antiviral properties and can enhance the effect of interferon on the HCV virus.
Objectives: We aimed to assess the influence of vitamin D supplementation on viral response to PegINF/RBV therapy.
Patients and Methods: In a randomized-controlled trial 66 patients with HCV (30 with genotype 1or 4 and 36 with genotype 2 or 3) were randomly divided into two groups in gastroenterology clinic: the study group (n = 34) received oral vitamin D supplementation (1600 IU/day) to maintain serum levels > 30 ng/mL besides the routine treatment of 180 g PegINF- 2a plus oral ribavirin. The control group (n = 32) received the same treatment without vitamin D supplementation. The primary outcome was undetectable HCV-RNA at week 12 of treatment, referred to as complete early viral response (cEVR). Real-time polymerase chain reaction (sensitivity: 10 IU/mL) was used to assess HCV RNA. Serum Vitamin D levels were measured at baseline and weeks 4, 8, 12 and 24 of treatment.
Spearman’s correlation showed that baseline vitamin D correlated with the stage of liver fibrosis in both study and control group (P = 0.04, r = 0.57).
Results: There were no significant differences in baseline characteristics between two groups except serum AST level. Complete EVR rate at week 12 in the vitamin D group was significantly higher than the controls (100% vs 84.4%; P = 0.023) whereas this figure was not significant when genotypes 1 and 4 or 2 and 3 in the test group were compared to those of the control (100% vs 86.7%; P = 0.19 and 100% vs 82.4%; P = 0.22). Serum vitamin D levels were lowest at baseline (2215 ng/mL), but increased after 12 weeks of vitamin D therapy to a mean level of 5238 ng/mL (P = 0.02) in study group.
Conclusions: The addition of vitamin D to conventional PegIFN/RBV therapy in HCV patients may significantly improve the viral response.


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