Sherigar Jagannath M, Gayam Vijay, Khan Arifa, Mukhtar Osama, Arefiev Yavgeniy, Khalid Mazin, Siddiqui Imran, Rangaraju Ayyappa M, Budhathoki Nibash, Mansour Mohammed, Guss Debra, Mohanty Smruti R
aDepartment of Medicine, Division of Gastroenterology and Hepatology, New York Presbyterian Brooklyn Methodist Hospital bDepartment of Medicine and Gastroenterology, Interfaith Medical Center, New York, USA.
Eur J Gastroenterol Hepatol. 2017 Jul;29(7):767-776. doi: 10.1097/MEG.0000000000000871.
There is a lack of evidence-based data on aged patients with newer direct-acting antivirals (DAAs) and with shorter duration of treatment regimens involving DAAs with or without ribavirin (RBV) and pegylated interferon (Peg IFN).
Medical records of 240 patients treated with DAAs with or without Peg IFN and RBV between January 2013 and July 2015 were retrospectively analyzed. Patients were divided into two groups: patients aged 65 years and older (N=84) and patients aged younger than 65 years (N=156). Pretreatment baseline patient characteristics, treatment efficacy, factors affecting sustained virologic response at 12 weeks after treatment, and adverse reactions were compared between the groups.
No statistically significant difference was observed with end of treatment response (98.8 vs. 98%, P=0.667) and sustained virologic response at 12 weeks after treatment (93.1 vs. 94.1%, P=0.767) between patients aged 65 and older and those younger than 65 years of age. Fatigue was the most common adverse event recorded (32.5%), followed by anemia (19.6%), leukopenia (11.7%), thrombocytopenia (10%), skin rash (8.3%), and headache (7.9%). The RBV dose was reduced in eight (8%) patients and four patients discontinued the RBV treatment because of severe anemia. RBV dose reduction or discontinuation did not reach statistical significance (P=0.913). Increased fibrosis, cirrhosis, aspartate aminotransferase, alanine aminotransferase, hemoglobin, and platelet levels seem to affect the sustained virologic response in the elderly. Twelve (6.28%) patients failed to respond to treatment and the failure rate was not significant (P=0.767) between the groups.
DAAs with or without IFN and RBV in the standard recommended 12 or 24-week treatment regimens are effective, well tolerated, and may be safely extended to elderly patients infected with chronic hepatitis C.
对于使用新型直接抗病毒药物(DAA)治疗的老年患者,以及使用含或不含利巴韦林(RBV)和聚乙二醇干扰素(Peg IFN)的DAA且疗程较短的治疗方案,缺乏循证医学数据。
回顾性分析2013年1月至2015年7月间240例接受含或不含Peg IFN及RBV的DAA治疗的患者的病历。患者分为两组:65岁及以上患者(n = 84)和65岁以下患者(n = 156)。比较两组患者治疗前的基线特征、治疗效果、治疗后12周影响持续病毒学应答的因素及不良反应。
65岁及以上患者与65岁以下患者在治疗结束时的应答率(98.8%对98%,P = 0.667)和治疗后12周的持续病毒学应答率(93.1%对94.1%,P = 0.767)方面,未观察到统计学上的显著差异。疲劳是记录到的最常见不良事件(32.5%),其次是贫血(19.6%)、白细胞减少(11.7%)、血小板减少(10%)、皮疹(8.3%)和头痛(7.9%)。8例(8%)患者减少了RBV剂量,4例患者因严重贫血停止了RBV治疗。RBV剂量减少或停药未达到统计学显著性(P = 0.913)。纤维化程度增加、肝硬化、天冬氨酸转氨酶、丙氨酸转氨酶、血红蛋白和血小板水平似乎影响老年患者的持续病毒学应答。12例(6.28%)患者治疗无应答,两组间的无应答率无显著性差异(P = 0.767)。
在标准推荐的12周或24周治疗方案中使用含或不含IFN及RBV的DAA是有效的,耐受性良好,并且可以安全地应用于慢性丙型肝炎感染的老年患者。