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AIM: To investigate if correction of hypovitaminosis D before initiation of Peg-interferon-alpha/ribavirin(Peg IFN/RBV) therapy could improve the efficacy of Peg IFN/RBV in previously null-responder patients with chronic genotype 1 or 4 hepatitis C virus(HCV) infection.METHODS:Genotype 1 or 4 HCV-infected patients with null response to previous Peg IFN/RBV treatment and with hypovitaminosis D(<30 ng/m L)prospectively received cholecalciferol 100000 IU per week for 4 wk[from week-4(W-4)to W0],followed by 100000 IUper month in combination with Peg IFN/RBV for 12 mo(from W0 to W48).The primary outcome was the rate of early virological response defined by an HCV RNA<12 IU/m L after 12 wk Peg IFN/RBV treatment.RESULTS:A total of 32 patients were included,19(59%)and 13(41%)patients were HCV genotype1 and 4,respectively.The median baseline vitamin D level was 15 ng/m L(range:7-28).In modified intention-to-treat analysis,29 patients who received at least one dose of Peg IFN/RBV were included in the analysis.All patients except one normalized their vitamin D serum levels.The rate of early virologic response was 0/29(0%).The rate of HCV RNA<12IU/m L after 24 wk of Peg IFN/RBV was 1/27(4%).The safety profile was favorable.CONCLUSION:Addition of vitamin D to Peg IFN/RBV does not improve the rate of early virologic response in previously null-responders with chronic genotype 1or 4 HCV infection.
AIM: To investigate if correction of hypovitaminosis D before initiation of Peg-interferon-alpha / ribavirin (Peg IFN / RBV) therapy could improve the efficacy of Peg IFN / RBV in previously null-responder patients with chronic genotype 1 or 4 hepatitis C virus (HCV) infection. METHODS: Genotype 1 or 4 HCV-infected patients with null response to previous Peg IFN / RBV treatment and with hypovitaminosis D (<30 ng / mL) prospectively received cholecalciferol 100000 IU per week for 4 weeks [from week -4 (W-4) to W0] followed by 100000 IUper month in combination with Peg IFN / RBV for 12 mo (from W0 to W48). The primary outcome was the rate of early virological response defined by an HCV RNA <12 IU / m L after 12 wk Peg IFN / RBV treatment. RESULTS: A total of 32 patients were included, 19 (59%) and 13 (41%) patients were HCV genotype 1 and 4, respectively. The median baseline vitamin D level was 15 ng / m L (range: 7-28). In modified intention-to-treat analysis, 29 patients who received at least one dose of Peg IFN / RBV were included i n the analysis. All except one normalized their vitamin D serum levels. The rate of early virologic response was 0/29 (0%). The rate of HCV RNA <12 IU / m L after 24 wk of Peg IFN / RBV was 1 /27(4%).The safety profile was favorable. CONCLUSION: Addition of vitamin D to Peg IFN / RBV does not improve the rate of early virologic response in ago null-responders with chronic genotype 1or 4 HCV infection.