Gschwantler Michael, Laferl Hermann, Vogel Wolfgang, Korak Wolfgang, Moser Stephan, Hofer Harald, Bauer Bernhard, Schleicher Michael, Bognar Barbara, Bischof Martin, Stauber Rudolf, Maieron Andreas, Ferenci Peter
Department of Internal Medicine IV, Wilhelminenspital, Montleartstrasse 37, 1160, Vienna, Austria.
Department of Internal Medicine IV, Kaiser-Franz-Josef-Spital, Vienna, Austria.
Wien Klin Wochenschr. 2018 Jan;130(1-2):54-61. doi: 10.1007/s00508-017-1263-2. Epub 2017 Sep 12.
Patients with a history of intravenous drug abuse included in an official opioid substitution program represent an important subgroup of patients with chronic hepatitis C. The objective of this study was to assess the efficacy of and adherence to treatment with peginterferon and ribavirin in Austrian patients on stable opioid substitution therapy (OST).
This prospective, multicenter, observational, non-interventional trial (clinicaltrials.gov identifier, NCT01416610) included treatment-naïve patients with chronic hepatitis C on OST. Treatment consisted of peginterferon alpha-2a (PEGASYS®, 180 µg/week) plus ribavirin (COPEGUS®, 1000/1200 mg/day in genotypes (GT) 1/4 and 800 mg/day in GT 2/3) for 24-72 weeks, according to GT and viral response.
The intention-to-treat (ITT) population comprised 88 patients. Mean duration of therapy was 6.0 ± 2.8 months. Treatment was discontinued earlier than planned in 34 out of 88 patients (39%), mainly because of poor adherence or side effects of treatment. At the end of treatment 65/88 patients (74%) were PCR negative. During follow-up, 5 patients relapsed. Only 44/88 patients (50%) could be evaluated 24 weeks after the end of treatment. Sustained virologic response 24 weeks after end of therapy (SVR24) was documented in 39/88 patients (44%). If only patients were considered who finished treatment as planned and for whom results at follow-up week 24 were available, the SVR24 rate was 89% (32/36).
Despite favorable prognostic factors, such as young age and a high proportion of GT3, SVR rates were low in this cohort of patients receiving OST, the main reason being poor adherence; however, in those patients completing treatment, the SVR rate was high.
纳入官方阿片类药物替代治疗项目的有静脉注射药物滥用史的患者是慢性丙型肝炎患者中的一个重要亚组。本研究的目的是评估聚乙二醇干扰素和利巴韦林治疗对奥地利接受稳定阿片类药物替代治疗（OST）患者的疗效及治疗依从性。
这项前瞻性、多中心、观察性、非干预性试验（clinicaltrials.gov标识符，NCT01416610）纳入了初治的接受OST的慢性丙型肝炎患者。治疗方案为根据基因型（GT）和病毒反应，给予聚乙二醇干扰素α-2a（派罗欣®，180μg/周）加利巴韦林（科佩加斯®，GT1/4型患者为1000/1200mg/天，GT2/3型患者为800mg/天），疗程为24 - 72周。
意向性治疗（ITT）人群包括88例患者。平均治疗时长为6.0±2.8个月。88例患者中有34例（39%）治疗提前终止，主要原因是依从性差或治疗副作用。治疗结束时，65/88例患者（74%）PCR检测呈阴性。随访期间，5例患者复发。治疗结束24周后，仅44/88例患者（50%）可进行评估。治疗结束24周时的持续病毒学应答（SVR24）在39/88例患者（44%）中得到记录。如果仅考虑按计划完成治疗且有随访第24周结果的患者，SVR24率为89%（32/36）。
尽管存在年轻和GT3型比例高等有利的预后因素，但在这组接受OST的患者中，SVR率较低，主要原因是依从性差；然而，在完成治疗的患者中，SVR率较高。
