Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria.
Aliment Pharmacol Ther. 2013 Jul;38(2):118-23. doi: 10.1111/apt.12350. Epub 2013 May 26.
The introduction of direct-acting anti-virals has increased sustained virological response (SVR) rates in chronic hepatitis C genotype 1 infection. At present, data on long-term durability of viral eradication after successful triple therapy are lacking.
To evaluate the long-term durability of viral eradication in patients treated with triple therapy, including direct-acting anti-virals.
Patients who participated in randomised, controlled trials or an extended access programme of treatment with peginterferon-α2a/ribavirin in combination with a direct-acting anti-viral (telaprevir, danoprevir, faldaprevir, simeprevir, mericitabine, balapiravir) were followed after achieving SVR. The median follow-up after the patients was 21 (range: 7-64) months.
One hundred and three patients with chronic hepatitis C genotype 1 infection [f/m: 34/69; GT-1b: 67 GT-1a: 34, GT-4: 2; mean age: 47.6 years (45.5-49.7; 95% CI)] achieving a SVR triple therapy were followed. Two cases of late relapses (2/103, 1.9%; 95% CI: 0.24-6.8) were observed. One patient was cirrhotic, both carried the genotype 1b and completed the prescribed treatment. The relapses occurred 8 and 12 months after cessation of anti-viral treatment. Cloning sequencing revealed identical sequence in both patients. Resistance analysis revealed no presence of viral resistance.
Like the SVR after peginterferon-α2/ribavirin combination treatment, HCV eradication after triple therapy remains durable after long-term follow-up.
直接作用抗病毒药物的引入提高了慢性丙型肝炎基因型 1 感染的持续病毒学应答（SVR）率。目前，缺乏成功三联疗法后病毒清除的长期耐久性数据。
评估包括直接作用抗病毒药物在内的三联疗法治疗患者的病毒清除长期耐久性。
对接受聚乙二醇干扰素-α2a/利巴韦林联合直接作用抗病毒药物（特拉泼维、达诺普韦、法地昔韦、西美瑞韦、美替拉韦、巴洛沙韦）治疗的随机对照试验或扩展准入方案的患者进行随访，以评估其 SVR 后情况。中位随访时间为 21 个月（范围：7-64）。
103 例慢性丙型肝炎基因型 1 感染患者（男/女：34/69；GT-1b：67；GT-1a：34；GT-4：2；平均年龄：47.6 岁（45.5-49.7）；95%CI）在 SVR 三联疗法后接受了随访。观察到 2 例晚期复发（2/103，1.9%；95%CI：0.24-6.8）。1 例患者为肝硬化，均携带基因型 1b 且完成了规定的治疗。复发发生在抗病毒治疗停止后 8 个月和 12 个月。克隆测序显示两位患者的序列完全相同。耐药性分析显示无病毒耐药性。
与聚乙二醇干扰素-α2/利巴韦林联合治疗后的 SVR 一样，三联疗法后的 HCV 清除在长期随访后仍然持久。
