Cachay Edward R, Ballard Craig, Colwell Bradford, Torriani Francesca, Hicks Charles, Mathews Wm Christopher
Department of Medicine-Owen Clinic, University of California at San Diego, 200 W. Arbor Drive, San Diego, CA, 92103-8681, USA.
Division of Infectious Diseases, University of California at San Diego, 9500 Gilman Drive #0711, La Jolla, CA, 92093-0711, USA.
AIDS Res Ther. 2017 Sep 20;14(1):56. doi: 10.1186/s12981-017-0182-7.
Clinicians are incorporating patient-reported outcomes in the management of HIV-infected persons co-infected with hepatitis C virus (HCV), but there are no validated inventories to monitor symptoms of patients during HCV therapy.
Five-year retrospective cohort analysis of persons living with HIV (PLWH) treated for HCV.
The HCV symptom-inventory (HCV-SI) was administered before, during, and after HCV treatment. Discriminant validity was assessed, separately, in mixed model linear regression of HCV-SI T-scores on treatment regimens (pegylated-interferon and ribavirin; pegylated-interferon, ribavirin, and telaprevir; and interferon-free antivirals); and side effect-related premature treatment discontinuation (SE-DC).
From the 103 patients who completed the HCV-SI, 7% were female, 26% non-white, 32% cirrhotics and 91% had undetectable HIV viral loads. Most had genotype 1 (83%) and were HCV treatment-naïve (78%). We treated 19% of patients with pegylated-interferon and ribavirin, 22% with pegylated-interferon, ribavirin, and telaprevir and 59% received interferon-free antivirals. Overall, 77% achieved a sustained virologic response, and 6% discontinued HCV treatment due to side effects. In the treatment discrimination model, compared to the no treatment period, HCV-SI scores were significantly (p < 0.01) lower for interferon-free antivirals and higher for interferon-containing regimens. In the SE-DC model, the total HCV-SI, somatic and neuropsychiatric scores significantly predicted those patients who prematurely discontinued HCV treatment (P < 0.05).
The HCV-SI effectively differentiated among treatment regimens known to vary by side effect profiles and between patients with and without treatment discontinuation due to side effects. The HCV-SI may have value as a patient-reported outcome instrument predicting the risk of HCV treatment discontinuation.
临床医生在对合并丙型肝炎病毒（HCV）感染的HIV感染者进行管理时纳入了患者报告的结局，但目前尚无经过验证的量表来监测HCV治疗期间患者的症状。
对接受HCV治疗的HIV感染者（PLWH）进行为期五年的回顾性队列分析。
在HCV治疗前、治疗期间和治疗后使用HCV症状量表（HCV-SI）。分别在治疗方案（聚乙二醇干扰素和利巴韦林；聚乙二醇干扰素、利巴韦林和特拉匹韦；以及无干扰素抗病毒药物）的混合模型线性回归中评估HCV-SI T分数的判别效度；以及与副作用相关的提前停药（SE-DC）。
在完成HCV-SI的103例患者中，7%为女性，26%为非白人，32%为肝硬化患者，91%的HIV病毒载量检测不到。大多数患者为基因1型（83%），且未曾接受过HCV治疗（78%）。我们对19%的患者使用聚乙二醇干扰素和利巴韦林治疗，22%的患者使用聚乙二醇干扰素、利巴韦林和特拉匹韦治疗，59%的患者接受无干扰素抗病毒药物治疗。总体而言，77%的患者实现了持续病毒学应答，6%的患者因副作用而停止HCV治疗。在治疗判别模型中，与未治疗期相比，无干扰素抗病毒药物治疗时HCV-SI分数显著更低（p < 0.01），而含干扰素方案的分数更高。在SE-DC模型中，HCV-SI总分、躯体和神经精神分数显著预测了提前停止HCV治疗的患者（P < 0.05）。
HCV-SI能够有效区分已知副作用特征不同的治疗方案，以及因副作用而停药和未停药的患者。HCV-SI作为一种患者报告的结局工具，可能在预测HCV治疗停药风险方面具有价值。
