State University of New York, Buffalo, NY 14203, USA.
Aliment Pharmacol Ther. 2013 Feb;37(4):473-81. doi: 10.1111/apt.12200. Epub 2013 Jan 7.
Chronic hepatitis C (HCV) treatment with pegylated-interferon (PEG-IFN)/ribavirin (RBV) is often limited by preexisting medical, psychiatric and psychosocial contraindications. However, limited data exist in general patient populations.
To evaluate the percentage of HCV-infected patients in the general US population who may have contraindications to PEG-IFN/RBV.
The General Electric (GE) Centricity dataset was used to screen the US population between 2004 and 2009 for HCV infection and contraindications to PEG-IFN/RBV. HCV diagnosis and contraindications were identified using ICD-9-CM codes or laboratory values. Only patients with an encounter 180 days prior to HCV diagnosis were included. Demographic differences were calculated using Pearson's chi-squared test. Frequencies and percentages for absolute and relative contraindications to PEG-IFN and/or RBV were determined and proportions and rates/1000 person-months were calculated.
A total of 15 561 021 patients were screened, and 45 690 (0.3%) were HCV-positive and were evaluated. Those with contraindications were significantly younger, female, White, not currently married and receiving Medicare or Medicaid coverage (all P < 0.0001). 17.3% had at least one contraindication to PEG-IFN/RBV (5.5 events/1000 person-months); bipolar disorder (6.5%), anaemia (Hgb < 10 g/dL; 5.9%), pregnancy (1.9%) and neutropenia (neutrophils <750 cells/mm(3) ; 1.2%) were most frequently cited.
Approximately, 17% of HCV-infected patients in the general US population had at least one contraindication to PEG-IFN/RBV. Most contraindications were relative and potentially modifiable. Clinical assessment of contraindications as relative and/or modifiable should be considered and used to determine if patients could benefit from current PEG-IFN-containing triple therapy or future PEG-IFN- or RBV-free regimens.
慢性丙型肝炎(HCV)的治疗采用聚乙二醇干扰素(PEG-IFN)/利巴韦林(RBV),但常受到预先存在的医学、精神和社会心理禁忌的限制。然而,一般患者人群中的相关数据有限。
评估美国一般人群中感染 HCV 的患者中可能对 PEG-IFN/RBV 有禁忌的比例。
使用通用电气(GE)Centricity 数据集,筛选 2004 年至 2009 年美国人群中 HCV 感染和 PEG-IFN/RBV 禁忌证。HCV 诊断和禁忌证采用 ICD-9-CM 编码或实验室值来确定。仅纳入 HCV 诊断前 180 天内有就诊记录的患者。采用 Pearson χ2 检验比较人口统计学差异。确定 PEG-IFN 和/或 RBV 的绝对和相对禁忌证的频率和百分比,并计算比例和每千人月发生率/率。
共筛选出 15 561 021 例患者,其中 45 690(0.3%)例 HCV 阳性并进行了评估。有禁忌证的患者明显更年轻、女性、白人、未婚且接受医疗保险或医疗补助(均 P < 0.0001)。17.3%的患者至少有一种 PEG-IFN/RBV 的禁忌证(5.5 例/千人月);最常见的是双相情感障碍(6.5%)、贫血(Hb < 10 g/dL;5.9%)、妊娠(1.9%)和中性粒细胞减少症(中性粒细胞 <750 个/μL;1.2%)。
美国一般 HCV 感染人群中,约 17%的患者至少有一种 PEG-IFN/RBV 的禁忌证。大多数禁忌证是相对的,且可能是可改变的。应考虑将禁忌证评估为相对和/或可改变,并用于确定患者是否能从当前含 PEG-IFN 的三联疗法或未来的 PEG-IFN 或 RBV 无方案中获益。