Departments of Infectious Diseases, Infection Control and Employee Health.
Gastroenterology, Hepatology, and Nutrition, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Eur J Gastroenterol Hepatol. 2022 Oct 1;34(10):1098-1101. doi: 10.1097/MEG.0000000000002437. Epub 2022 Aug 24.
There is no prospective data on 8 weeks of direct-acting antivirals (DAA) therapy with glecaprevir/pibrentasvir (GLE/PIB) or ledipasvir/sofosbuvir (LDV/SOF) in hepatitis C virus (HCV)-infected patients with different types of malignancies. This study evaluated the efficacy and safety with 8 weeks of DAA therapy in cancer patients with chronic HCV infection.
Patients treated with DAAs at our center during 2014-2021 were included in a prospective observational study. Efficacy (sustained virologic response at 12 weeks; SVR12) and safety [adverse events and clinically significant drug-drug interactions (DDIs)] were assessed.
We included 47 patients. Most were men (29; 62%), white (33; 70%), non-cirrhotic (45; 96%), and with HCV genotype 1 (38; 85%). None of the patients had HCC. The SVR12 rate was 96% (45/47; 95% CI: 86-99%) for the entire study cohort, 100% [17/17; 95% CI: 82-100%] for the patients treated with GLE/PIB and 93% [28/30; 95% CI: 79-98%] for the patients treated with LDV/SOF. Fisher's exact test showed no significant difference in SVR12 rates between the regimens (P = 0.53). No patients had serious adverse events (grade 3-4) or treatment discontinuation. Among the 17 patients who received concomitant cancer therapy, no DDIs occurred.
Eight weeks of DAA therapy is highly effective and safe in HCV-infected patients with different types of malignancies and may grant access to investigational cancer therapy, broadening treatment options.
目前尚无直接作用抗病毒药物（DAA）治疗 8 周，glecaprevir/pibrentasvir（GLE/PIB）或 ledipasvir/sofosbuvir（LDV/SOF）治疗丙型肝炎病毒（HCV）感染伴不同类型恶性肿瘤患者的前瞻性数据。本研究评估了 DAA 治疗 8 周在丙型肝炎病毒感染合并恶性肿瘤患者中的疗效和安全性。
纳入 2014 年至 2021 年在本中心接受 DAA 治疗的患者进行前瞻性观察研究。评估疗效（12 周持续病毒学应答；SVR12）和安全性[不良事件和临床显著药物相互作用（DDI）]。
共纳入 47 例患者。大多数为男性（29 例；62%）、白人（33 例；70%）、非肝硬化（45 例；96%）和 HCV 基因型 1 感染（38 例；85%）。所有患者均无 HCC。整个研究队列的 SVR12 率为 96%（45/47；95%可信区间：86-99%），GLE/PIB 治疗组的 SVR12 率为 100%（17/17；95%可信区间：82-100%），LDV/SOF 治疗组的 SVR12 率为 93%（28/30；95%可信区间：79-98%）。Fisher 确切概率法显示两种方案的 SVR12 率无显著差异（P=0.53）。无患者发生严重不良事件（3-4 级）或停药。在接受联合癌症治疗的 17 例患者中，未发生药物相互作用。
DAA 治疗 8 周对伴有不同类型恶性肿瘤的 HCV 感染患者非常有效且安全，可能使患者获得新的癌症治疗方案，拓宽了治疗选择。
