Smirne Carlo, Carbone Roberto, Colletta Cosimo, Scivetti Paolo, Sainaghi Pier Paolo, Elena Grossini, Pirisi Mario
Department of Translational Medicine, Università del Piemonte Orientale UPO, Novara, Italy; Internal Medicine Unit, AOU Maggiore della Carità Hospital, Novara, Italy.
Gastroenterology and Infectious Diseases Units, SS Antonio e Biagio e Cesare Arrigo Hospital, Alessandria, Italy.
Eurasian J Med. 2022 Jun;54(2):113-120. doi: 10.5152/eurasianjmed.2022.20421.
Sofosbuvir and ribavirin represented until recently the standard of care in hepatitis C virus genotype 2 cirrhotic patients. In registration trials, 12-16 week durations were associated with 90% sus- tained virological responses, although not confirmed by real-life studies. In Italy, various durations (12,16, 20, and 24 weeks) represent lawfully reimbursable healthcare practice. The aim is, therefore, to study the behavior of Italian clinicians and the possible impact of therapy durations on sustained virological responses and patient safety.
Data of all consecutive genotype 2 cirrhotic patients who started sofosbuvir plus ribavirin therapy between January 2015 and March 2017 in 7 Italian liver clinics were collected retrospectively.
Overall, 147 patients (138 Child-Pugh A, mean age: 71 years) were treated. The median treatment duration was 16 weeks, but marked differences were found among the clinicians; however, the 12-week duration was not considered by the vast majority of them. Rates of intention-to-treat and per-protocol sus- tained virological responses were 95.9% and 97.1%, respectively, and neither showed differences between the various durations. No independent, sustained virological response predictors could be found, but the median baselines for Child-Pugh and Model For End-Stage Liver Disease scores were higher in non-respond- ers. Anemia was not associated with treatment duration. One case of acute kidney injury attributed to the possible sofosbuvir effect was reported.
In genotype 2 cirrhotic patients, sofosbuvir plus ribavirin was associated with real-life-sustained virological response rates of almost 96%, without a significant impact on treatment duration provided it was longer than 12 weeks.
直到最近，索磷布韦和利巴韦林仍是丙型肝炎病毒2型肝硬化患者的标准治疗方案。在注册试验中，12至16周的疗程与90%的持续病毒学应答相关，尽管现实研究尚未证实这一点。在意大利，各种疗程（12周、16周、20周和24周）均为合法可报销的医疗行为。因此，本研究旨在探讨意大利临床医生的治疗行为，以及疗程对持续病毒学应答和患者安全性的可能影响。
回顾性收集2015年1月至2017年3月期间在7家意大利肝病诊所开始接受索磷布韦加利巴韦林治疗的所有连续丙型肝炎病毒2型肝硬化患者的数据。
总共治疗了147例患者（138例Child-Pugh A级，平均年龄：71岁）。中位治疗疗程为16周，但临床医生之间存在显著差异；然而，绝大多数临床医生未考虑12周的疗程。意向性治疗和符合方案的持续病毒学应答率分别为95.9%和97.1%，不同疗程之间均未显示出差异。未发现独立的持续病毒学应答预测因素，但无应答者的Child-Pugh和终末期肝病模型评分的中位基线较高。贫血与治疗疗程无关。报告了1例可能由索磷布韦引起的急性肾损伤病例。
在丙型肝炎病毒2型肝硬化患者中，索磷布韦加利巴韦林的实际持续病毒学应答率接近96%，只要疗程超过12周，对治疗疗程就没有显著影响。
