Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand.
Drugs. 2016 Aug;76(12):1203-11. doi: 10.1007/s40265-016-0612-1.
A fixed-dose tablet comprising the NS5A inhibitor ombitasvir, the NS3/4A inhibitor paritaprevir and ritonavir (ombitasvir/paritaprevir/ritonavir) (Technivie(®), Viekirax(®)) is available for use, in combination with ribavirin, for the treatment of chronic hepatitis C virus (HCV) genotype 4 infection. High sustained virological response rates at 12 weeks post-treatment (SVR12) were achieved in treatment-naive or -experienced patients with chronic HCV genotype 4 infection, including patients without cirrhosis who received ombitasvir plus paritaprevir and ritonavir in combination with ribavirin for 12 weeks (SVR12 100 %) (PEARL-I trial), patients with compensated cirrhosis who received ombitasvir/paritaprevir/ritonavir plus ribavirin for 12 or 16 weeks (SVR12 97 and 98 %) (AGATE-I trial), or Egyptian patients without cirrhosis who received ombitasvir/paritaprevir/ritonavir plus ribavirin for 12 weeks (SVR12 94 %) or with compensated cirrhosis who received ombitasvir/paritaprevir/ritonavir plus ribavirin for 12 or 24 weeks (SVR12 97 and 93 %) (AGATE-II trial). Ombitasvir/paritaprevir/ritonavir was generally well tolerated in patients with chronic HCV genotype 4 infection without cirrhosis or with compensated cirrhosis in clinical trials. There have been postmarketing reports of hepatic decompensation and hepatic failure, which mainly occurred in patients with advanced cirrhosis who received regimens containing ombitasvir/paritaprevir/ritonavir. In conclusion, ombitasvir/paritaprevir/ritonavir is a valuable option for use in patients with chronic HCV genotype 4 infection without cirrhosis or with compensated cirrhosis.
一种包含 NS5A 抑制剂奥比他韦、NS3/4A 抑制剂帕利瑞韦和利托那韦（奥比他韦/帕利瑞韦/利托那韦）（Technivie®，Viekirax®）的固定剂量片剂可与利巴韦林联合用于治疗慢性丙型肝炎病毒（HCV）基因型 4 感染。在未经治疗或经治的慢性 HCV 基因型 4 感染患者中，包括未发生肝硬化的患者，接受奥比他韦联合帕利瑞韦和利托那韦联合利巴韦林治疗 12 周后（SVR12）达到了高持续病毒学应答率（SVR12 为 100%）（PEARL-I 试验），代偿性肝硬化患者接受奥比他韦/帕利瑞韦/利托那韦联合利巴韦林治疗 12 或 16 周（SVR12 为 97%和 98%）（AGATE-I 试验），或未发生肝硬化的埃及患者接受奥比他韦/帕利瑞韦/利托那韦联合利巴韦林治疗 12 周（SVR12 为 94%）或发生代偿性肝硬化的患者接受奥比他韦/帕利瑞韦/利托那韦联合利巴韦林治疗 12 或 24 周（SVR12 为 97%和 93%）（AGATE-II 试验）。在临床试验中，奥比他韦/帕利瑞韦/利托那韦在未发生肝硬化或代偿性肝硬化的慢性 HCV 基因型 4 感染患者中通常具有良好的耐受性。在上市后报告中有肝失代偿和肝衰竭的病例，主要发生在接受含有奥比他韦/帕利瑞韦/利托那韦的治疗方案的晚期肝硬化患者中。总之，奥比他韦/帕利瑞韦/利托那韦是治疗无肝硬化或代偿性肝硬化的慢性 HCV 基因型 4 感染患者的一个有价值的选择。
