Aluzaite Kristina, Fraser Margaret, Johnson Steve, Giles Hannah, Schultz Michael
Gastroenterology Research Unit, Department of Medicine, Dunedin School of Medicine, University of Otago, Dunedin.
Gastroenterology Otago Ltd, Mercy Hospital, Dunedin.
N Z Med J. 2020 Nov 20;133(1525):53-61.
Direct acting antiviral (DAA) hepatitis C (HCV) medications are funded in New Zealand since 2016 for some and since 2019 for all genotypes. The purpose of this study was to review New Zealand-wide data of the use of generic HCV DAA medications imported through Tasmanian FixHepC Buyer's Club and the associated side effect profiles.
This is a retrospective data audit on the use of generic DAAs to treat HCV; outcomes from consecutive hepatitis C patients (naïve and pre-treated) treated with generic DAAs (sofosbuvir/ledipasvir, sofosbuvir/daclatasvir, sofosbuvir/ledipasvir, ribavirin) collected from all known sites that used Buyer's club medications in eight New Zealand district health board regions were summarised. Demographic, disease characteristics, FibroScan and blood markers' (platelets, ALT, GGT, AFP) data were collected.
Study sample was 81.8% New Zealand European, 64.8% male of median 56.0 (IQR: 48.0-60.0) years old. Three participants (4.5%) were HIV positive. 74.7% of the participants had signs of fibrosis (F1-F4); 40.5% had cirrhosis/scaring (F4). 61.7% of the patients were naïve to treatment. 42.0%, 40.1% and 12.0% received sofosbuvir/ledipasvir, sofosbuvir/daclatasvir, sofosbuvir/velpatasvir, respectively; 32.1% also received ribavirin. 80.2% of patients received treatment for 12 weeks. 95.1% (154/162) of the sample achieved sustained virological response at 12 weeks post-treatment, 2.5% relapsed, 1.2% were lost to follow-up. The main minor side effects included fatigue, headache, difficulty sleeping, experienced by 21.7%, 7.0%, 7.0%, respectively. An average total cost for medication and monitoring was 2,027 to 2,659 NZD (12 weeks), and 3,054 to 4,260 NZD (24 weeks) per patient.
Generic DAAs to treat hepatitis C are safe, efficient and a cheaper than branded medications option.
自2016年起，直接作用抗病毒（DAA）丙型肝炎（HCV）药物在新西兰开始为部分基因型提供资金支持，自2019年起为所有基因型提供资金支持。本研究的目的是回顾新西兰范围内通过塔斯马尼亚FixHepC买家俱乐部进口的通用型HCV DAA药物的使用数据及相关副作用情况。
这是一项关于使用通用型DAA治疗HCV的回顾性数据审计；总结了从新西兰八个地区卫生委员会区域所有使用买家俱乐部药物的已知地点收集的连续接受通用型DAA（索磷布韦/来迪帕司韦、索磷布韦/达卡他韦、索磷布韦/维帕他韦、利巴韦林）治疗的丙型肝炎患者（初治和经治）的治疗结果。收集了人口统计学、疾病特征、FibroScan和血液标志物（血小板、谷丙转氨酶、谷氨酰转肽酶、甲胎蛋白）的数据。
研究样本中81.8%为新西兰欧洲人，64.8%为男性，年龄中位数为56.0岁（四分位间距：48.0 - 60.0）。三名参与者（4.5%）为HIV阳性。74.7%的参与者有纤维化迹象（F1 - F4）；40.5%有肝硬化/瘢痕形成（F4）。61.7%的患者为初治患者。分别有42.0%、40.1%和12.0%的患者接受了索磷布韦/来迪帕司韦、索磷布韦/达卡他韦、索磷布韦/维帕他韦治疗；32.1%的患者还接受了利巴韦林治疗。80.2%的患者接受了12周的治疗。95.1%（154/162）的样本在治疗后12周达到持续病毒学应答，2.5%复发，1.2%失访。主要的轻微副作用分别为疲劳、头痛、睡眠困难，发生率分别为21.7%、7.0%、7.0%。每位患者药物和监测的平均总费用为2027至2659新西兰元（12周），以及3054至4260新西兰元（24周）。
治疗丙型肝炎的通用型DAA药物安全、有效，且比品牌药物更便宜。
