Successful use of generic direct acting antiviral medications to treat hepatitis C-a New Zealand-wide study.

AIMS: 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.

METHODS: 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.

RESULTS: 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.

CONCLUSIONS: Generic DAAs to treat hepatitis C are safe, efficient and a cheaper than branded medications option.