Taieb Vanessa, Pacou Maud, Ho Sophia, Pettré Ségolène, Van Sanden Suzy, Pisini Marta, Ustianowski Andrew, Mehnert Angelika
a a Amaris , London , UK.
b b Amaris , Paris , France.
J Med Econ. 2015;18(10):787-96. doi: 10.3111/13696998.2015.1046880. Epub 2015 May 26.
To conduct a network meta-analysis (NMA) to assess the relative efficacy and safety of simeprevir, a second generation oral protease inhibitor (PI), compared to telaprevir and boceprevir in combination with pegylated interferon-α and ribavirin (PR) in patients with chronic hepatitis C.
A systematic literature review and NMA of randomized controlled trials involving anti-virals added to PR were conducted. Electronic database searches and hand searches were conducted to identify relevant publications. Outcomes of interest included sustained virologic response (SVR), incidence of adverse events (AEs), and discontinuation due to AEs. Networks were based on treatment-, dose-, and duration-specific nodes. Sub-group analyses were conducted to investigate heterogeneity, based on Metavir scores, sub-genotypes 1a/1b, and prior response.
A total of 15 publications were considered for the base case of the meta-analysis. Simeprevir was associated with higher SVR rates than PR alone. Compared to telaprevir and boceprevir, SVR rates tended to be higher for simeprevir, with odds ratios ranging from 1.27 [0.81-2.00] to 2.61 [1.44-4.74] in treatment-naïve and from 1.04 [0.78-1.38] to 1.74 [0.84-3.61] in treatment-experienced patients, respectively. In terms of safety, the risks of anemia and discontinuations due to AEs were lower for simeprevir compared to PR alone, telaprevir, and boceprevir. The risk of rash was lower for simeprevir compared to telaprevir, and similar compared to PR alone and boceprevir.
This NMA in genotype 1 HCV patients suggests a similar or better efficacy and tolerability profile for simeprevir compared to telaprevir and boceprevir.
进行一项网状荟萃分析(NMA),以评估第二代口服蛋白酶抑制剂(PI)西米普韦与特拉匹韦和博赛匹韦联合聚乙二醇化干扰素-α和利巴韦林(PR)相比,在慢性丙型肝炎患者中的相对疗效和安全性。
对涉及添加到PR中的抗病毒药物的随机对照试验进行系统的文献综述和NMA。进行电子数据库检索和手工检索以识别相关出版物。感兴趣的结果包括持续病毒学应答(SVR)、不良事件(AE)的发生率以及因AE导致的停药情况。网络基于治疗、剂量和持续时间特异性节点。基于梅塔维(Metavir)评分、亚型1a/1b和既往应答进行亚组分析以研究异质性。
荟萃分析的基础病例共考虑了15篇出版物。西米普韦与单独使用PR相比,SVR率更高。与特拉匹韦和博赛匹韦相比(分别),初治患者中西米普韦的SVR率往往更高,优势比范围为1.27 [0.81 - 2.00]至2.61 [1.44 - 4.74],经治患者中为1.04 [0.78 - 1.38]至1.74 [0.84 - 3.61]。在安全性方面,与单独使用PR、特拉匹韦和博赛匹韦相比,西米普韦导致贫血和因AE停药的风险更低。与特拉匹韦相比,西米普韦的皮疹风险更低,与单独使用PR和博赛匹韦相似。
这项针对1型丙型肝炎病毒患者的NMA表明,与特拉匹韦和博赛匹韦相比,西米普韦具有相似或更好的疗效和耐受性。