Vitamin D in Standard HCV Regimen (PEG-Interferon Plus Ribavirin), Its Effect on the Early Virologic Response Rate: A Clinical Trial
نویسندگان
1 1Department of Gastroenterology and Hepatology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, IR Iran
2 Department of Gastroenterology and Hepatology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, IR Iran
3 Department of Gastroenterology and Hepatology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, IR Iran
4 Department of Gastroenterology and Hepatology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, IR Iran
5 Department of Radiology, School of Medicine, Mashhad Branch, Islamic Azad University, Mashhad, IR Iran
6 Department of Pathology, Research and Education Department, Razavi Hospital, Mashhad, IR Iran
7 Department of Gastroenterology and Hepatology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, IR Iran
8 Department of Gastroenterology and Hepatology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, IR Iran
9 Department of Microbiology and Virology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, IR Iran
10 Department of Community Medicine, School of Medicine, Mashhad University of Medical Sciences, Mashhad, IR Iran
11 Rheumatic Diseases Research Center, School of Medicine, Mashhad University of Medical Sciences, Mashhad, IR Iran
12 Department of Gastroenterology and Hepatology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, IR Iran
doi
10.30483/rijm.2016.116396چکیده
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. 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.
