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

Background: Patients chronically infected with the hepatitis C virus (HCV) are more likely to have vitamin D deficiency Recentstudies revealed that vitamin D has immunomodulator and antiviral properties and can enhance the effect of interferon on theHCV 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. Thecontrol group (n = 32) received the same treatment without vitamin D supplementation. The primary outcome was undetectableHCV-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 EVRrate at week 12 in the vitamin D group was significantly higher than the controls (100% vs 84.4%; P = 0.023) whereas this figure wasnot 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 = 0.19and 100% vs 82.4%; P = 0.22). Serum vitamin D levels were lowest at baseline (22 15 ng/mL), but increased after 12 weeks of vitaminD therapy to a mean level of 52 38 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 viralresponse.

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

Hepatitis C , Vitamin D , Early Virologic Response