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Effectiveness of ravidasvir plus sofosbuvir in interferon-naïve and treated patients with chronic hepatitis c genotype-4
Journal of Hepatology ( IF 26.8 ) Pub Date : 2018-01-01 , DOI: 10.1016/j.jhep.2017.09.006
Gamal Esmat 1 , Tamer Elbaz 1 , Maissa El Raziky 2 , Asmaa Gomaa 3 , Mahmoud Abouelkhair 2 , Hadeel Gamal El Deen 1 , Aliaa Sabry 3 , Mohamed Ashour 2 , Naglaa Allam 3 , Mohamed Abdel-Hamid 4 , Ola Nada 5 , Sherine Helmy 6 , Hanaa Abdel-Maguid 6 , Richard Colonno 7 , Nathaniel Brown 7 , Eric Ruby 7 , Pamela Vig 7 , Imam Waked 3
Affiliation  

BACKGROUND & AIMS Although treatment of hepatitis C virus (HCV) and HCV-genotype-4 (GT4) has become very effective, it remains very expensive, and affordable options are needed, especially in limited resource countries. The aim of this study was to assess the efficacy and safety of the combination of ravidasvir (an NS5A inhibitor) and sofosbuvir to treat patients with chronic HCV-GT4 infection. METHODS A total of 300 patients with HCV-GT4 infection were recruited in three groups: treatment-naïve patients with or without compensated Child-A cirrhosis (Group 1); interferon-experienced patients without cirrhosis (Group 2); and interferon-experienced patients with cirrhosis (Group 3). Groups 1 and 2 received ravidasvir 200 mg QD plus sofosbuvir 400 mg QD for 12 weeks and were randomized 1:1 to treatment with or without weight-based ribavirin. Group 3 patients received ravidasvir plus sofosbuvir with ribavirin and were randomized 1:1 to a treatment duration of 12 weeks or 16 weeks. The primary endpoint was sustained virologic response at 12 weeks post-treatment (SVR12). RESULTS A total of 298 patients were enrolled: 149 in Group 1, 79 in Group 2 and 70 in Group 3. SVR12 was achieved in 95.3% of all patients who started the study, including 98% of patients without cirrhosis and 91% of patients with cirrhosis, whether treatment-naïve or interferon-experienced. Ribavirin intake and history of previous interferon therapy did not affect SVR12 rates. No virologic breakthroughs were observed and the study treatment was well tolerated. CONCLUSIONS Treatment with ravidasvir plus sofosbuvir, with or without ribavirin, was well tolerated and associated with high sustained virologic response rate for HCV-GT4 infected patients with and without cirrhosis, regardless of previous interferon-based treatments. TRIAL REGISTRATION NUMBER ClinicalTrials.gov Identifier: NCT02371408. LAY SUMMARY This study evaluated efficacy and safety of the new oral hepatitis C drug ravidasvir in combination with the approved oral drug sofosbuvir in 298 patients infected with hepatitis C type 4. Our results showed that treatment with ravidasvir plus sofosbuvir, with or without ribavirin, was well tolerated and associated with high response rate in patients with and without cirrhosis.

中文翻译:


拉维达韦加索磷布韦对未接受过干扰素治疗且接受过治疗的基因 4 型慢性丙型肝炎患者的疗效



背景与目标 虽然丙型肝炎病毒 (HCV) 和 HCV 基因型 4 (GT4) 的治疗已变得非常有效,但它仍然非常昂贵,并且需要负担得起的选择,特别是在资源有限的国家。本研究的目的是评估拉维达韦(一种 NS5A 抑制剂)和索磷布韦联合治疗慢性 HCV-GT4 感染患者的有效性和安全性。方法 总共招募了 300 名 HCV-GT4 感染患者,分为三组:患有或不患有代偿性 Child-A 肝硬化的初治患者(第 1 组);接受过干扰素治疗但无肝硬化的患者(第 2 组);以及接受过干扰素治疗的肝硬化患者(第 3 组)。第 1 组和第 2 组接受拉维达韦 200 mg QD 加索非布韦 400 mg QD 治疗 12 周,并按 1:1 随机分配至使用或不使用基于体重的利巴韦林治疗。第 3 组患者接受拉维达韦加索非布韦和利巴韦林治疗,并按 1:1 随机分配至 12 周或 16 周的治疗持续时间。主要终点是治疗后 12 周的持续病毒学应答 (SVR12)。结果 共有 298 名患者入组:第 1 组 149 名,第 2 组 79 名,第 3 组 70 名。开始研究的所有患者中 95.3% 实现了 SVR12,其中包括 98% 的无肝硬化患者和 91% 的患者患有肝硬化,无论是未经治疗还是接受过干扰素治疗。利巴韦林摄入量和既往干扰素治疗史不影响 SVR12 率。没有观察到病毒学突破,研究治疗的耐受性良好。 结论 对于患有或不患有肝硬化的 HCV-GT4 感染患者,拉维达韦联合索磷布韦治疗(联合或不联合利巴韦林)具有良好的耐受性,并且与高持续病毒学应答率相关,无论之前是否进行过基于干扰素的治疗。试验注册号 ClinicalTrials.gov 标识符:NCT02371408。本研究评估了新型口服丙型肝炎药物拉维达韦 (ravidasvir) 与已批准的口服药物索磷布韦 (sofosbuvir) 联合治疗 298 名感染丙型肝炎 4 型的患者的疗效和安全性。我们的结果表明,拉维达韦 (ravidasvir) 加索磷布韦 (sofosbuvir) 联合或不联合利巴韦林治疗的疗效和安全性耐受性良好,并且与肝硬化和非肝硬化患者的高反应率相关。
更新日期:2018-01-01
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