Effect of native vitamin D3 supplementation on refractory chronic hepatitis C patients in simeprevir with pegylated interferon/ribavirin. Issue 5 (17th September 2015)

• Record Type: Journal Article
• Authors: Atsukawa, Masanori; Tsubota, Akihito; Shimada, Noritomo; Yoshizawa, Kai; Abe, Hiroshi; Asano, Toru; Ohkubo, Yusuke; Araki, Masahiro; Ikegami, Tadashi; Okubo, Tomomi; Kondo, Chisa; Osada, Yuji; Nakatsuka, Katsuhisa; Chuganji, Yoshimichi; Matsuzaki, Yasushi; Iwakiri, Katsuhiko; Aizawa, Yoshio
• Is Part Of: Hepatology research. Volume 46:Issue 5(2016)
• Page Start: 450
• Page End: 458
• Publication Date: 2015-09-17
• Subjects: native vitamin D -- pegylated interferon -- ribavirin -- simeprevir -- sustained virological response; Liver -- Diseases -- Periodicals; Liver Diseases -- Periodicals; Foie -- Maladies -- Périodiques; 616.362
• DOI: 10.1111/hepr.12575
• Languages: English
• ISSNs: 1386-6346

Abstract

Abstract : Aim: Protease inhibitors with pegylated interferon (PEG IFN)/ribavirin improve a sustained virological response (SVR) rate to approximately 90% in chronic hepatitis C genotype 1b patients with IL28B rs8099917 genotype TT, but yield only approximately 50% in those with the unfavorable non‐TT. Among such treatment‐refractory patients, serum vitamin D levels could influence the SVR rate. This randomized controlled trial was conducted to assess the effect of native vitamin D supplementation in simeprevir with PEG IFN/ribavirin for 1b patients with non‐TT. Methods: Patients were randomly assigned to receive simeprevir (100 mg/day) for 12 weeks plus PEG IFN/ribavirin for 24 weeks (control group, n = 58), or vitamin D (2000 IU/day) for 16 weeks including a lead‐in phase plus PEG IFN/ribavirin for 24 weeks (vitamin D group, n = 57). The primary end‐point was sustainably undetectable viremia 24 weeks after the end of treatment (SVR). Results: SVR rates were 37.9% in the control group and 70.2% in the vitamin D group. In subgroup analysis, SVR rates of prior null responders were 11.8% and 54.5%, respectively. SVR rates for advanced fibrosis were 28.6% and 65.4%. SVR rates for patients with vitamin D3 deficiency at the baseline were 25.0% in the control group and 66.7% in the vitamin D group. Overall, the SVR rate was significantly higher in patients with high serum 25(OH)D3 levels at the beginning of combination therapy than in those with low serum 25(OH)D3 levels. Conclusion: Native vitamin D3 supplementation improved SVR rates in simeprevir with PEG IFN/ribavirin for chronic hepatitis C genotype 1b patients with refractory factors.