基因型(GT)3的HCV感染患者的标准治疗是口服sofosbuvir (SOF)+
在这一研究队列中（该研究的1组），我们评估了相同的方案在治疗经治的GT-3的HCV感染患者（包括肝硬化的患者）是否一样有效。我们也评估了LDV/SOF（不联合利巴韦林）方案治疗初治的和经治的GT-6的HCV感染患者是否一样有效（2组）。研究结果在AASLD2014上公布。
研究方法
50位经治的GT-3的HCV感染患者应用LDV/SOF+利巴韦林治疗12周后评估疗效。25位初治的和经治的GT-6的HCV感染患者被分配到应用LDV/SOF治疗12周。
研究结果
经治的GT-3的HCV感染患者中，大多数患者为男性(39, 78%),白种人 (40, 80%), IL28B 非-CC基因型 (31, 62%)。22位患者(44%)有肝硬化。GT-6的HCV感染患者（2组）中，大多数为男性(16, 64%), 亚洲人 (21, 84%), IL28B CC 基因型(20, 80%)。2位患者(8%)有肝硬化，2位患者(8%)以前治疗过。2位GT-6的HCV感染患者未完成治疗：1位怀孕，在10周后停止治疗，另一位移民，仅仅治疗8周后就停止治疗，随后复发了。4周的持续病毒学应答的数据见表格。12周的持续病毒学应答的数据将随后公布。
治疗的耐受性很好。不良反应与固定剂量的LDV/SOF±利巴韦林的III期试验中的相似。
结论
经治的GT-3的HCV感染患者（无论是否存在代偿性肝硬化）应用LDV/SOF+利巴韦林治疗12周后，持续性病毒学应答的发生率较高，高于以前报道的SOF+利巴韦林治疗24周的结果，与SOF+PEG+利巴韦林治疗12周的结果相似。在GT-6的HCV感染患者中，LDV/SOF（不联合利巴韦林）治疗12周是首个报道的安全有效的全口服方案。这些方案可能会为GT-3或GT-6的HCV感染患者提供一种吸引人的全口服的治疗方案。
英文原文
High Efficacy of LDV/SOF Regimens for 12 Weeks for Patients with HCV Genotype 3 or 6 Infection.（摘要号：LB-11）
Abstract Body: Background: The standard of care for patients with HCV genotype (GT) 3 infection is all oral therapy with sofosbuvir (SOF) +ribavirin (RBV) for 24 weeks; there is no approved all oral regimen for patients with HCV GT-6 infection. As previously reported in ELECTRON2, 26/26 (100%) of treatment-naïve patients with HCV GT-3 achieved SVR12 after receiving treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination with RBV for 12 weeks.
In a this subsequent cohort, (group 1 of this study) we evaluated whether this same regimen would be effective in treatment-experienced GT-3 patients, including those with cirrhosis. We also evaluated whether LDV/SOF without RBV would be effective in treatment-naïve (TN) and treatment experienced (TE) patients with HCV genotype 6 (group 2).
Methods: 50 treatment-experienced GT-3 patients were assigned to receive LDV/SOF+RBV for 12 weeks. 25 GT-6 TN and TE patients were assigned to receive LDV/SOF for 12 weeks.
Results: Among treatment experienced GT-3 patients, the majority of patients were male (39, 78%), Caucasian (40, 80%), and IL28B non-CC genotype (31, 62%). Twenty-two (44%) had cirrhosis. Among the GT-6 patients (group 2), the majority were male (16, 64%), Asian (21, 84%), and had IL28B CC genotype (20, 80%). Two (8%) had cirrhosis and 2 (8%) were treatment experienced. Two GT-6 patients did not complete therapy: one became pregnant and stopped treatment after 10 weeks, and another emigrated and stopped treatment after only 8 weeks and subsequently relapsed. SVR4 data are reported in the table. SVR12 data will be presented.
Treatment was well tolerated. The adverse event profile was consistent with that seen in the Phase 3 program of fixed dose combination LDV/SOF ± RBV.
Conclusions: LDV/SOF+RBV for 12 weeks resulted in high rates of SVR in treatment experienced patients with HCV genotype 3 regardless of the presence of compensated cirrhosis, higher than those previously reported following SOF+RBV for 24 weeks and similar to SOF+PEG+RBV for 12 weeks. In patients with HCV genotype 6 infection, LDV/SOF for 12 weeks without RBV provides the first reported safe and effective all oral regimen . These regimens may offer an attractive all oral treatment regimen for patients with HCV genotype 3 or genotype 6 infection.
查看会议专题》》》第65届美国肝病学会年会（AASLD2014）
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