Smith Michael A, Johnson Heather J, Chopra Kapil B, Dunn Michael A, Ulrich Ashley M, Mohammad Rima A
University of the Sciences, Philadelphia, PA, USA
University of Pittsburgh, Pittsburgh, PA, USA.
Ann Pharmacother. 2014 Sep;48(9):1166-1171. doi: 10.1177/1060028014539274. Epub 2014 Jun 17.
Telaprevir-induced rash is a common, therapy-limiting adverse drug event (ADE) for patients with hepatitis c virus (HCV) infection. Given the similarity between telaprevir and simeprevir, real-world management of rash during treatment with an NS3/4A protease inhibitor and its implications are important.
The objectives of this study were to determine the incidence of rash in telaprevir-treated patients, its management, and the impact on sustained virological response and to identify any risk factors for rash development.
This was a retrospective study of adult patients who were treated with telaprevir in a hepatology clinic from July 1, 2011, to August 31, 2012. Pertinent information on demographics, past medical history, medications, laboratory data, outcomes of rash, other ADEs related to treatment, and physician grading of rash were collected.
Of 159 patients included, 44% (70/159) developed rash, and 4% (7/159) discontinued therapy because of rash. Median number of days until rash did not differ between patients who continued and discontinued therapy (25 vs 45, respectively; P = 0.88). Patients who developed rash were more likely to have lower actual body weight (ABW) or body mass index (BMI; P ≤ 0.01). No significant difference in rash development when drug-allergy history was considered was found. Most patients who continued telaprevir were prescribed topical corticosteroids (93.7%) and cetirizine (41.3%). Patients who discontinued therapy were more likely to be evaluated by dermatology (P = 0.002), prescribed oral corticosteroids (P = 0.02), hydroxyzine (P = 0.001), and topical triamcinolone (P = 0.01).
ABW and BMI appear to be related to rash development. This finding may have implications in the treatment of HCV with simeprevir, given its similarity to telaprevir.
对于丙型肝炎病毒(HCV)感染患者,特拉匹韦引起的皮疹是一种常见的、限制治疗的药物不良事件(ADE)。鉴于特拉匹韦与simeprevir之间的相似性,在使用NS3/4A蛋白酶抑制剂治疗期间皮疹的实际处理及其影响很重要。
本研究的目的是确定接受特拉匹韦治疗的患者中皮疹的发生率、其处理方式以及对持续病毒学应答的影响,并确定皮疹发生的任何风险因素。
这是一项对2011年7月1日至2012年8月31日在肝病诊所接受特拉匹韦治疗的成年患者的回顾性研究。收集了有关人口统计学、既往病史、用药情况、实验室数据、皮疹结局、与治疗相关的其他药物不良事件以及医生对皮疹分级的相关信息。
在纳入的159例患者中,44%(70/159)出现皮疹,4%(7/159)因皮疹停药。继续治疗和停药的患者出现皮疹的中位天数无差异(分别为25天和45天;P = 0.88)。出现皮疹的患者实际体重(ABW)或体重指数(BMI)更可能较低(P≤0.01)。考虑药物过敏史时,皮疹发生无显著差异。大多数继续使用特拉匹韦的患者被开具局部用皮质类固醇(93.7%)和西替利嗪(41.3%)。停药的患者更可能由皮肤科进行评估(P = 0.002),被开具口服皮质类固醇(P = 0.02)、羟嗪(P = 0.001)和局部用曲安奈德(P = 0.01)。
ABW和BMI似乎与皮疹发生有关。鉴于simeprevir与特拉匹韦的相似性,这一发现可能对HCV的治疗有影响。