Effectiveness and safety of original and generic sofosbuvir for the treatment of chronic hepatitis C: A real world study

Abstract

We report the first real‐world prospective multicenter cohort study that evaluated the effectiveness and safety of original or generic sofosbuvir‐based regimens in patients with chronic hepatitis C in Latin America. The main endpoints were assessment of sustained virological response and serious adverse events rates. A total of 321 patients with chronic hepatitis C treated with the following regimens were included: sofosbuvir plus daclatasvir for 12 ( n = 34) or 24 ( n = 135) weeks, sofosbuvir plus daclatasvir plus ribavirin for 12 ( n = 84) or 24 ( n = 56) weeks, or sofosbuvir plus ribavirin for 12 ( n = 8) or 24 ( n = 2) weeks. Patients received either original sofosbuvir (Sovaldi ® , Gilead Sciences, n = 135) or generic sofosbuvir (Probirase ® , Laboratorios RICHMOND, n = 184) which were randomly assigned by the National Ministry of Health. Overall, 292 (91%) patients had cirrhosis, 136 (42%) were treatment experienced, and 240 (75%) genotype 1. The overall sustained virological response was 90% (95% CI 86‐93%); 91% (95% CI 84‐95%) in patients who received Sovaldi ® , and 89% (95% CI 84‐93%) in patients who received Probirase ® . Anemia was the most common adverse event and was reported in 52 (17%) patients. Bacterial infection, gastrointestinal bleeding, worsening of ascites or encephalopathy occurred in less than 5% of the patients. During the study, seven (2%) patients died, four of whom died of cirrhosis‐related complications. In summary, we observed similar sustained virological response rates than prior studies, both in patients who received Sovaldi ® or Probirase ® . Serious adverse events were infrequent, in line with prior studies that included patients with cirrhosis treated with protease‐inhibitor‐free regimes.