BACKGROUND Georgia has one of the highest HCV prevalence in the world and launched the world's first national HCV elimination programs in 2015. Georgia set the ambitious target of diagnosing 90% of people living with HCV, treating 95% of those diagnosed and curing 95% of treated patients by 2020. We report outcomes of Sofosbuvir (SOF) based treatment regimens in patients with chronic HCV infection in Georgia. METHODS Patients with cirrhosis, advanced liver fibrosis and severe extrahepatic manifestations were enrolled in the treatment program. Initial treatment consisted of SOF plus ribavirin (RBV) with or without pegylated interferon (INF). Sustained virologic response (SVR) was defined as undetectable HCV RNA at least 12 weeks after the end of treatment. SVR were calculated using both per-protocol and modified intent-to-treat (mITT) analysis. Results for patients who completed treatment through 31 October 2018 were analyzed. RESULTS Of the 7342 patients who initiated treatment with SOF-based regimens, 5079 patients were tested for SVR. Total SVR rate was 82.1% in per-protocol analysis and 74.5% in mITT analysis. The lowest response rate was observed among genotype 1 patients (69.5%), intermediate response rate was achieved in genotype 2 patients (81.4%), while the highest response rate was among genotype 3 patients (91.8%). Overall, SOF/RBV regimens achieved lower response rates than IFN/SOF/RBV regimen (72.1% vs 91.3%, P < 0.0001). In multivariate analysis being infected with HCV genotype 2 (RR =1.10, CI [1.05-1.15]) and genotype 3 (RR = 1.14, CI [1.11-1.18]) were associated with higher SVR. Patients with cirrhosis (RR = 0.95, CI [0.93-0.98]), receiving treatment regimens of SOF/RBV 12 weeks, SOF/RBV 20 weeks, SOF/RBV 24 weeks and SOF/RBV 48 weeks (RR = 0.85, CI [0.81-0.91]; RR = 0.86, CI [0.82-0.92]; RR = 0.88, CI [0.85-0.91] and RR = 0.92, CI [0.87-0.98], respectively) were less likely to achieve SVR. CONCLUSIONS Georgia's real world experience resulted in high overall response rates given that most patients had severe liver damage. Our results provide clear evidence that SOF plus IFN and RBV for 12 weeks can be considered a treatment option for eligible patients with all three HCV genotypes. With introduction of next generation DAAs, significantly improved response rates are expected, paving the way for Georgia to achieve HCV elimination goals.

中文翻译：

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在佐治亚州的国家丙型肝炎消除计划中，接受基于sofosbuvir联合治疗的慢性丙型肝炎患者的治疗结果。

背景技术佐治亚州是全球HCV感染率最高的国家之一，并于2015年启动了世界上第一个国家HCV消除计划。佐治亚州制定了一个宏伟的目标，即诊断90％的HCV患者，治疗95％的被诊断者和治愈95％的HCV到2020年接受治疗的患者人数。我们报告了佐治亚州基于Sofosbuvir（SOF）的慢性HCV感染患者的治疗方案的结果。方法将肝硬化，晚期肝纤维化和严重肝外表现的患者纳入治疗方案。初始治疗包括SOF加利巴韦林（RBV）或不加聚乙二醇干扰素（INF）。持续的病毒学应答（SVR）定义为治疗结束后至少12周未检测到HCV RNA。使用每个协议和修改后的意向治疗（mITT）分析来计算SVR。分析了截至2018年10月31日完成治疗的患者的结果。结果在7342例开始采用SOF方案治疗的患者中，有5079例接受了SVR测试。按方案分析，总SVR率为82.1％，在mITT分析中为74.5％。在基因型1的患者中观察到最低的应答率（69.5％），在基因型2的患者中达到中等应答率（81.4％），而在基因型3的患者中应答率最高（91.8％）。总体而言，SOF / RBV方案的应答率低于IFN / SOF / RBV方案（72.1％对91.3％，P <0.0001）。在多变量分析中，感染了HCV的基因型2（RR = 1.10，CI [1.05-1.15]）和基因型3（RR = 1.14，CI [1.11-1.18]）与较高的SVR相关。肝硬化患者（RR = 0.95，CI [0.93-0.98]），接受SOF / RBV 12周，SOF / RBV 20周，SOF / RBV 24周和SOF / RBV 48周的治疗方案（RR = 0.85，CI [0.81-0.91]； RR = 0.86，CI [0.82-0.92]； RR = 0.88，CI [0.85-0.91]和RR = 0.92，CI [0.87-0.98]）不太可能实现SVR。结论佐治亚州的现实世界经验表明，鉴于大多数患者患有严重的肝损伤，因此其总体缓解率很高。我们的结果提供了明确的证据，对于所有三种HCV基因型的合格患者，SOF加IFN和RBV治疗12周可被视为一种治疗选择。随着下一代DAA的推出，预计响应率将大大提高，这为佐治亚州实现消除HCV的目标铺平了道路。CI [0.85-0.91]和RR = 0.92，CI [0.87-0.98]分别不太可能实现SVR。结论佐治亚州的现实世界经验表明，鉴于大多数患者患有严重的肝损伤，因此其总体缓解率很高。我们的结果提供了明确的证据，对于所有三种HCV基因型的合格患者，SOF加IFN和RBV治疗12周可被视为一种治疗选择。随着下一代DAA的推出，预计响应率将大大提高，这为佐治亚州实现消除HCV的目标铺平了道路。CI [0.85-0.91]和RR = 0.92，CI [0.87-0.98]分别不太可能实现SVR。结论佐治亚州的现实世界经验表明，由于大多数患者患有严重的肝损伤，因此总体反应率较高。我们的结果提供了明确的证据，对于所有三种HCV基因型的合格患者，SOF加IFN和RBV治疗12周可被视为一种治疗选择。随着下一代DAA的推出，预计响应率将大大提高，这为佐治亚州实现消除HCV的目标铺平了道路。我们的结果提供了明确的证据，对于所有三种HCV基因型的合格患者，SOF加上IFN和RBV治疗12周可被视为一种治疗选择。随着下一代DAA的推出，预计响应率将大大提高，这为佐治亚州实现消除HCV的目标铺平了道路。我们的结果提供了明确的证据，对于所有三种HCV基因型的合格患者，SOF加IFN和RBV治疗12周可被视为一种治疗选择。随着下一代DAA的推出，预计响应率将大大提高，这为佐治亚州实现消除HCV的目标铺平了道路。