Effectiveness And Safety Of Original And Generic Sofosbuvir For The Treatment Of Chronic Hepatitis C: A Real World Study

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((R)), Gilead Sciences, n=135) or generic sofosbuvir (Probirase((R)), 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((R)), and 89% (95% CI 84-93%) in patients who received Probirase((R)). 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((R)) or Probirase((R)). Serious adverse events were infrequent, in line with prior studies that included patients with cirrhosis treated with protease-inhibitor-free regimes.