Hirosawa Takuya, Morimoto Naoki, Miura Kouichi, Tahara Toshiyuki, Murohisa Toshimitsu, Okamura Yukishige, Sato Takashi, Numao Norikatsu, Imai Masato, Tano Shigeo, Murayama Kozue, Kurata Hidekazu, Ozawa Iwao, Fukaya Yukimura, Yoshizumi Hiroaki, Watanabe Shunji, Tsukui Mamiko, Takaoka Yoshinari, Nomoto Hiroaki, Isoda Norio, Yamamoto Hironori
Division of Gastroenterology, Department of Medicine, Jichi Medical University, Japan.
Department of Gastroenterology, Saiseikai Utsunomiya Hospital, Japan.
Intern Med. 2019 Feb 15;58(4):477-485. doi: 10.2169/internalmedicine.1194-18. Epub 2018 Oct 17.
Objective Regional disparities were observed in the outcomes of interferon (IFN)-based therapy for chronic hepatitis C virus (HCV) infection in a Japanese nationwide study. However, whether or not these regional disparities are observed in the outcomes of direct-acting antiviral drugs, including sofosbuvir (SOF) plus ribavirin (RBV) therapy, remains unclear. Methods We conducted a multicenter study to assess the efficacy of SOF plus RBV therapy for HCV genotype 2 infection in Tochigi Prefecture and its vicinity, in which IFN-based therapy yielded a low sustained virologic response (SVR) rate. In addition, we divided Tochigi Prefecture into six regions to examine regional disparities in the SVR. Patients We enrolled patients with chronic HCV genotype 2 infection. Results Of the 583 patients enrolled, 569 (97.6%) completed the treatment, and 566 (97.1%) also complied with post-treatment follow-up for 12 weeks. The overall SVR12 rate was 96.1% by per protocol and 93.7% by intention-to-treat analyses. No marked differences were observed in the SVR12 between subjects ≥65 and <65 years of age. Although large gaps were observed in the characteristics of patients and accessibility to medical resources, there was no significant difference in the SVR12 rate among the six regions in Tochigi Prefecture. Conclusion SOF plus RBV therapy was effective for HCV genotype 2 infection in an area where IFN-based therapy had previously shown unsatisfactory results. In addition, no regional disparities in the SVR12 were observed in Tochigi Prefecture.
目的 在一项日本全国性研究中，基于干扰素（IFN）的慢性丙型肝炎病毒（HCV）感染治疗结果存在地区差异。然而，在包括索磷布韦（SOF）联合利巴韦林（RBV）治疗在内的直接抗病毒药物治疗结果中是否存在这些地区差异仍不清楚。方法 我们开展了一项多中心研究，以评估SOF联合RBV治疗在枥木县及其周边地区HCV 2型感染中的疗效，在该地区基于IFN的治疗产生的持续病毒学应答（SVR）率较低。此外，我们将枥木县分为六个地区，以研究SVR中的地区差异。患者 我们纳入了慢性HCV 2型感染患者。结果 在纳入的583例患者中，569例（97.6%）完成了治疗，566例（97.1%）也完成了治疗后12周的随访。按符合方案分析，总体SVR12率为96.1%，按意向性分析为93.7%。≥65岁和<65岁的受试者之间在SVR12方面未观察到明显差异。尽管在患者特征和医疗资源可及性方面存在较大差距，但枥木县六个地区的SVR12率没有显著差异。结论 SOF联合RBV治疗在一个此前基于IFN的治疗结果不理想的地区对HCV 2型感染有效。此外，枥木县未观察到SVR12的地区差异。
