Department of Gastroenterology, Hepatology, Infectious Diseases and Endocrinology, Hannover Medical School, Carl-Neuberg-Straße 1, 30625, Hannover, Germany.
Centre for Individualised Infection Medicine (CiiM), Hannover, Germany.
Adv Ther. 2024 Dec;41(12):4669-4682. doi: 10.1007/s12325-024-02996-6. Epub 2024 Oct 29.
This brief report presents updated findings from the previously published CREST study evaluating the safety and effectiveness of 8-week glecaprevir/pibrentasvir (GLE/PIB) in treatment-naïve patients with chronic hepatitis C virus (HCV) infection and compensated cirrhosis. The current study includes an additional 51 patients, presents effectiveness data stratified by additional comorbidities and comedications, and offers insights into healthcare resource utilization.
Analysis of treatment-naïve patients with HCV infection and compensated cirrhosis enrolled in the CREST study, a real-world, observational multicenter study. All enrolled patients were included in the full analysis set (FAS); the modified analysis set (MAS) excluded patients with missing SVR12 data, or who discontinued GLE/PIB for nonvirologic failure. The primary endpoint was sustained virologic response at posttreatment week 12 (SVR12) in the MAS. Safety and healthcare resource utilization were also assessed.
The FAS included 437 patients, and the MAS 375. Overall, the results were consistent with the previously published study, with 98.9% of patients in the MAS achieving SVR12. Patients with comorbidities such as alcoholism, diabetes, and hyperlipidemia achieved SVR12 rates > 94%. High SVR12 rates were also achieved by patients receiving comedications such as anxiolytics, antidepressants, and opioid agonists. Of the 26.8% of patients with an adverse event, 1.1% had a serious adverse event, none of which were deemed related to GLE/PIB. Healthcare resource utilization varied by employment status and history of drug use. Active drug users had more physician and nurse visits than specialist visits compared with former drug users.
This study provides further evidence on the safety and effectiveness of 8-week GLE/PIB, supporting the use of shorter treatment in treatment-naïve patients with Child-Pugh A cirrhosis including subgroups of interest, regardless of comorbidities and comedications observed in this population. The variable healthcare resource utilization in different patient types can help plan and resource linkage to care better, thus supporting HCV elimination efforts.
本简要报告介绍了先前发表的 CREST 研究的最新结果，该研究评估了 8 周 glecaprevir/pibrentasvir（GLE/PIB）在初治慢性丙型肝炎病毒（HCV）感染合并代偿性肝硬化患者中的安全性和有效性。本研究纳入了额外的 51 名患者，按其他合并症和合并用药进行了有效性数据分层，并提供了对医疗资源利用的见解。
对 CREST 研究中纳入的初治 HCV 感染合并代偿性肝硬化患者进行分析，该研究为一项真实世界、观察性多中心研究。所有入组患者均纳入全分析集（FAS）；修改后的分析集（MAS）排除了 SVR12 数据缺失的患者，或因非病毒学失败而停用 GLE/PIB 的患者。主要终点为 MAS 中治疗后第 12 周的持续病毒学应答（SVR12）。还评估了安全性和医疗资源利用情况。
FAS 纳入 437 例患者，MAS 纳入 375 例患者。总体而言，结果与先前发表的研究一致，MAS 中 98.9%的患者达到 SVR12。有合并症如酒精中毒、糖尿病和高血脂症的患者 SVR12 率>94%。接受抗焦虑药、抗抑郁药和阿片类激动剂等合并用药的患者也获得了较高的 SVR12 率。在 26.8%发生不良事件的患者中，有 1.1%发生严重不良事件，但均与 GLE/PIB 无关。医疗资源利用情况因就业状况和药物使用史而异。与前药物使用者相比，现药物使用者的医生和护士就诊次数多于专科医生就诊次数。
本研究进一步证明了 8 周 GLE/PIB 的安全性和有效性，支持在包括该人群中观察到的合并症和合并用药的 Child-Pugh A 肝硬化初治患者中使用更短的治疗方案。不同患者类型的可变医疗资源利用情况有助于更好地计划和资源链接到护理，从而支持 HCV 消除工作。
