Mangia Alessandra, Piazzolla Valeria
Liver Unit, IRCCS "Casa Sollievo della Sofferenza", San Giovanni Rotondo, Italy.
Liver Unit, IRCCS "Casa Sollievo della Sofferenza", San Giovanni Rotondo, Italy.
Dig Liver Dis. 2014 Dec 15;46 Suppl 5:S179-85. doi: 10.1016/j.dld.2014.09.026. Epub 2014 Oct 31.
The uridine nucleotide analogue sofosbuvir is a selective hepatitis C virus NS5B polymerase inhibitor, active regardless of genotype. We analyzed data on efficacy and safety of sofosbuvir, either in combination with pegylated interferon alfa-2a and ribavirin, or in combination with ribavirin alone as part of an interferon free regimen in more than 1300 patients. Treatment with sofosbuvir for 12 weeks in combination with P/R, in naïve genotype 1 patients was mainly studied in Neutrino. The efficacy of sofosbuvir as part of an all-oral combination including ribavirin alone, was explored in 555 naïve, ineligible and previous treatment failure genotype 2/3 patients. Rates of Sustained Viral Response in genotype 1 and 2 were higher than 85%. For genotype 3 and 4, a European study, Valence, and a US study on patients of Egyptian origin showed that naïve patients are cured at high rates by the all-oral combination given for 24 weeks. The efficacy of sofosbuvir plus P/R for 12 weeks in previous treatment failure genotype 3 has also been demonstrated. Sofosbuvir-based combinations are safe and well tolerated without side effects directly related to the drug. A large body of evidence suggests that sofosbuvir marks a revolution in HCV treatment.
尿苷核苷酸类似物索磷布韦是一种选择性丙型肝炎病毒NS5B聚合酶抑制剂，对所有基因型均有活性。我们分析了1300多名患者使用索磷布韦的疗效和安全性数据，这些患者接受的治疗方案为索磷布韦联合聚乙二醇化干扰素α-2a和利巴韦林，或单独联合利巴韦林作为无干扰素治疗方案的一部分。初治1型基因型患者接受索磷布韦联合聚乙二醇化干扰素α-2a和利巴韦林治疗12周的疗效主要在Neutrino研究中进行了评估。在555例初治、不符合治疗条件及既往治疗失败的2/3型基因型患者中探索了索磷布韦作为仅包含利巴韦林的全口服联合治疗方案一部分的疗效。1型和2型基因型患者的持续病毒学应答率高于85%。对于3型和4型基因型患者，一项欧洲研究（Valence研究）以及一项针对埃及裔患者的美国研究表明，初治患者接受24周全口服联合治疗方案后治愈率很高。索磷布韦联合聚乙二醇化干扰素α-2a和利巴韦林治疗12周对既往治疗失败的3型基因型患者的疗效也已得到证实。基于索磷布韦的联合治疗方案安全且耐受性良好，无直接与药物相关的副作用。大量证据表明，索磷布韦标志着丙型肝炎病毒治疗的一场革命。
