Bwa Aung H, Nangia Gayatri, Win Si T S, Maung Soe T, Han Khin A W, Htar Su S, Wine Lei Y, Ko Wint W, Oo Moe P, Hlaing Naomi K T, Palecki Julia, Loza Bao L, Win Khin M, Reddy Rajender
Yangon Gastroenterology and Liver Centre, Yangon, Myanmar.
University of Pennsylvania, Philadelphia, PA, USA.
J Clin Exp Hepatol. 2019 May-Jun;9(3):283-293. doi: 10.1016/j.jceh.2018.12.001. Epub 2018 Dec 19.
In resource-constrained areas, generic direct-acting antivirals (DAAs) have considerably reduced the cost of hepatitis C virus (HCV) therapy while there remain significant costs related to the baseline and follow-up virologic assays.
The aim was to assess the efficacy and safety of HCV therapy in Myanmar with pan-genotypic generic DAA sofosbuvir/velpatasvir (SOF/VEL) and with and without the baseline genotype testing, while the duration of treatment and use of ribavirin (RBV) was dictated by cirrhosis and prior treatment failure.
Between September 2016 and June 2017, data from the 359 participants who completed treatment with SOF/VEL (± RBV) for 12-24 weeks were analyzed. Two hundred one patients did not have the baseline HCV genotype tested.
Regimens included SOF/VEL for 12 weeks (n = 43), SOF/VEL/RBV for 12 weeks (n = 275), or SOF/VEL/RBV for 24 weeks (n = 41). The mean age was 52 years, 44% were men (n = 159), 41 (11.4%) had a history of previous DAA therapy, 7 (1.9%) had a history of hepatocellular carcinoma, and 55 (15.3%) had cirrhosis. Overall, the sustained viral response (SVR)12 rate was 98.6% (354/359) and with a good adverse event profile. SVR rates were similar to those with and without baseline genotype testing and also across all genotypes in those who had genotype tested.
In Myanmar, generic and pan-genotypic SOF/VEL ± RBV is a highly effective and safe treatment for HCV, regardless of the HCV genotype, and therefore, the requirement for the baseline genotype can be eliminated. Future strategies should include elimination of treatment and end of treatment HCV RNA testing to enhance treatment uptake and further reduce cost.
在资源有限的地区，通用型直接抗病毒药物（DAA）已大幅降低了丙型肝炎病毒（HCV）治疗的成本，不过基线和随访病毒学检测仍存在显著成本。
本研究旨在评估泛基因型通用型DAA索磷布韦/维帕他韦（SOF/VEL）在缅甸用于HCV治疗时，无论有无基线基因型检测的疗效和安全性，同时治疗持续时间和利巴韦林（RBV）的使用由肝硬化情况和既往治疗失败情况决定。
对2016年9月至2017年6月期间359例完成12 - 24周SOF/VEL（±RBV）治疗的参与者的数据进行分析。201例患者未进行基线HCV基因型检测。
治疗方案包括12周的SOF/VEL（n = 43）、12周的SOF/VEL/RBV（n = 275）或24周的SOF/VEL/RBV（n = 41）。平均年龄为52岁，44%为男性（n = 159），41例（11.4%）有既往DAA治疗史，7例（1.9%）有肝细胞癌病史，55例（15.3%）有肝硬化。总体而言，12周持续病毒学应答（SVR）率为98.6%（354/359），且不良事件情况良好。有或无基线基因型检测者的SVR率相似，在进行基因型检测的患者中，所有基因型的SVR率也相似。
在缅甸，通用型泛基因型SOF/VEL ± RBV无论HCV基因型如何，都是一种高效且安全的HCV治疗方法，因此，可以不再需要进行基线基因型检测。未来策略应包括取消治疗中和治疗结束时的HCV RNA检测以提高治疗接受度并进一步降低成本。
