Safety and effectiveness comparing generic and original sofosbuvir-based treatment regimens in patients with hepatitis C: A prospective multicenter study from Argentina

RIDRUEJO E

Paris

Congreso; International Liver Congress; 2018

EASL

Background and Aims: A major limitation to the wide use of HCV direct acting antivirals (DAAs) in developing countries is its high cost. Generic versions of sofosbuvir are available in Argentina since 2016. Our aim was to evaluate effectiveness, safety, and post-treatment decompensation episodes in patients treated in real-life setting with generic sofosbuvir (G-SOF) or original SOF (O-SOF).Method: A prospective multicenter cohort from the Latin American Liver Research Educational and Awareness Network (LALREAN) was analyzed. We included patients from Argentina who received either O-SOF or G-SOF in combination with daclatasvir for 12 or 24 weeks with or without ribavirin (RBV) according to international guidelines. SOF type was assigned by payers and not by physicians.Results: From a total of 378 patients treated with DAAs, 191 patients received SOF-DCV regimen. Baseline characteristics and outcomes are in table 1. Only 3 (1.6%) patients presented treatment failure, all of them received G-SOF. Median follow-up since the end of treatment was 10.6 weeks and 13.1 weeks in the G-SOF and in the O-SOF, respectively (P=0.01). During post-SVR12 follow-up 1 patient developed ascites, 2 patients encephalopathy and 1 patient variceal bleeding in the G-SOF group, while in the O-SOF group only 1 patient presented ascites (P=NS). One out of 11 and 2 out of 5 patients were delisted in the G-SOF and the O-SOF groups, respectively (P=NS). One patient in the G-SOF group and 2 patients in the O-SOF group developed de-novo HCC. No major adverse events occurred requiring treatment discontinuation.Conclusion: Although generic and original SOF presented similar safety and effectiveness, SVR12 was slightly superior in the O-SOF group. Post-treatment decompensation events were more frequent among those treated with G-SOF despite the fact they were followed for a shorter period of time. To confirm our results, larger cohorts and longer pharmacovigilance studies are need.