Department of Medicine, University of California Los Angeles, 200 Medical Plaza, Suite 214, Los Angeles, CA, 90095, USA.
Department of Surgery, University of California Los Angeles, Los Angeles, CA, USA.
Dig Dis Sci. 2018 Dec;63(12):3480-3486. doi: 10.1007/s10620-018-5283-1. Epub 2018 Sep 27.
Results of recent studies have confirmed the efficacy of an 8-week course of ledipasvir/sofosbuvir (LDV/SOF) in patients who are non-cirrhotics, native to treatment, are infected with hepatitis C (HCV) genotype 1, and have HCV viral load < 6 million IU/mL. However, there are limited data on a shortened treatment course in patients who are over the age of 65.
A retrospective study was performed to examine the safety, tolerability, and sustained viral response rates (SVR) of the 8-week LDV/SOF therapy compared to the 12-week LDV/SOF therapy among non-cirrhotic, treatment-naïve, genotype 1 HCV patients with viral load < 6 million IU/mL who are 65 years of age or older.
A total of 454 patients were identified of which 182 non-cirrhotic, genotype 1 HCV-RNA < 6 million IU/mL patients received the 8-week LDV/SOF treatment and 272 received the 12-week LDV/SOF treatment. Mean [± standard deviation (SD)] aspartate aminotransferase to platelet ratio index score for the entire cohort was 0.45 ± 0.03. The mean (± SD) age for the 8-week treatment was 69.7 (± 7) years, 54.7% male and 45.3% female. The mean (± SD) age of the 12-week treatment was 71.7 (± 3) years, 56.4% male and 43.6% female. Overall, SVR-12 for the 8-week regimen was 93% and SVR-12 for the 12-week regimen was 95%. For the 182 treated with the 8-week LDV/SOF treatment, there were no serious adverse events requiring hospitalization or signs of liver failure requiring transplantation. Overall, the 8-week treatment patient cohort experienced less fatigue, headache, dry mouth, and diarrhea. This finding was statistically significant with a P value < 0.001.
Eight-week LDV/SOF therapy in treatment-naive, non-cirrhotic, genotype 1 HCV patients with RNA < 6 million IU/mL was found safe, better tolerated, effective, and required less upfront cost when compared with the 12-week LDV/SOF treatment regimen in properly selected geriatric population.
最近的研究结果证实，对于非肝硬化、初治、感染 HCV 基因型 1 且 HCV 病毒载量<600 万 IU/mL 的患者，8 周疗程的 ledipasvir/sofosbuvir（LDV/SOF）治疗有效。然而，对于年龄超过 65 岁的患者，关于缩短疗程的数据有限。
一项回顾性研究比较了非肝硬化、初治、基因型 1 HCV 患者的 8 周 LDV/SOF 治疗与 12 周 LDV/SOF 治疗的安全性、耐受性和持续病毒学应答率（SVR），这些患者的病毒载量<600 万 IU/mL，年龄为 65 岁或以上。
共确定了 454 名患者，其中 182 名非肝硬化、基因型 1 HCV-RNA<600 万 IU/mL 的患者接受了 8 周 LDV/SOF 治疗，272 名患者接受了 12 周 LDV/SOF 治疗。整个队列的平均（±标准差）天冬氨酸转氨酶血小板比值指数评分（AST/PLT）为 0.45±0.03。8 周治疗的平均（±标准差）年龄为 69.7（±7）岁，54.7%为男性，45.3%为女性。12 周治疗的平均（±标准差）年龄为 71.7（±3）岁，56.4%为男性，43.6%为女性。总的来说，8 周方案的 SVR-12 为 93%，12 周方案的 SVR-12 为 95%。对于接受 8 周 LDV/SOF 治疗的 182 名患者，没有需要住院的严重不良事件或需要肝移植的肝衰竭迹象。总的来说，8 周治疗组的患者疲劳、头痛、口干和腹泻较少。这一发现具有统计学意义（P 值<0.001）。
对于非肝硬化、基因型 1 HCV 患者，8 周 LDV/SOF 治疗初治、RNA<600 万 IU/mL 与 12 周 LDV/SOF 治疗方案相比，在适当选择的老年人群中，更安全、更耐受、更有效，且前期费用更少。
