Macías Juan, Rivero Antonio
Unidad de Enfermedades Infecciosas y Microbiología, Hospital Universitario de Valme, Sevilla, España.
Enferm Infecc Microbiol Clin. 2013 Jul;31 Suppl 3:33-6. doi: 10.1016/S0213-005X(13)70122-8.
Related to the use of telaprevir in patients with HIV and genotype 1 hepatitis C virus, there is available data from a phase IIb clinical trial in patients not previously treated for HCV, study 110; and preliminary data from a real practice study in patients with previous failure to a HCV treatment, study ARNSHC26 (TelapreVIH). Additionally, there are two ongoing phase III studies in coinfected patients, C3008 and 115, both in naive and previously treated patients. In the 110 study, rates of sustained viral response (SVR) in patients receiving the triple combination of pegylated interferon + ribavirin + telaprevir was 74%. This SVR rate is similar to those reported in treatment-naïve patients with genotype 1 HCV monoinfection who received pegylated interferon + ribavirin + telaprevir. Similarly, the adverse effects in this trial did not differ from those found in patients with genotype 1 HCV monoinfection. Telaprevir has been approved for use in patients with HCV genotype 1 monoinfection by the European Commission through a centralized procedure. Telaprevir label includes data on coinfected patients, covering efficacy, security, and practical management with different antirretroviral drugs. The Spanish Agency for Medications and Health Care Products has established recommendations that regulate and allow the use of telaprevir in patients with HIV/HCV genotype 1 coinfection. The most important restrictions on the use of telaprevir established by the Agency are as follows: a) patients with stage F3-F4 liver fibrosis on liver biopsy or liver stiffness ≥ 9.5kPa can be treated; b) in the absence of advanced fibrosis, telaprevir can be used to treat severe extrahepatic manifestations of HCV infection; c) patients with cirrhosis must have Child-Pugh stage A.
关于替拉瑞韦在合并人类免疫缺陷病毒（HIV）和1型丙型肝炎病毒（HCV）患者中的应用，有一项针对既往未接受过HCV治疗患者的IIb期临床试验（研究110）的可用数据，以及一项针对既往HCV治疗失败患者的真实实践研究（研究ARNSHC26，即“替拉瑞韦治疗HIV/HCV合并感染研究”）的初步数据。此外，目前有两项针对合并感染患者的III期研究正在进行，即C3008和115研究，入组患者均为初治及经治患者。在研究110中，接受聚乙二醇干扰素+利巴韦林+替拉瑞韦三联疗法的患者持续病毒学应答（SVR）率为74%。该SVR率与接受聚乙二醇干扰素+利巴韦林+替拉瑞韦治疗的初治1型HCV单一感染患者所报告的SVR率相似。同样，该试验中的不良反应与1型HCV单一感染患者中发现的不良反应并无差异。替拉瑞韦已获欧盟委员会通过集中程序批准用于1型HCV单一感染患者。替拉瑞韦的药品说明书包含了合并感染患者的数据，涵盖了与不同抗逆转录病毒药物联合使用时的疗效、安全性及实际管理。西班牙药品和医疗保健产品管理局已制定了相关建议，规范并允许在HIV/1型HCV合并感染患者中使用替拉瑞韦。该管理局对替拉瑞韦使用所设定的最重要限制如下：a）肝活检显示为F3 - F4期肝纤维化或肝脏硬度≥9.5kPa的患者可以接受治疗；b）在无晚期纤维化的情况下，替拉瑞韦可用于治疗HCV感染的严重肝外表现；c）肝硬化患者必须为Child - Pugh A级。
