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

MARCIANO, SEBASTIÁN; HADDAD, LEILA; REGGIARDO, MARÍA V.; PERALTA, MIRTA; VISTARINI, CECILIA; MARINO, MÓNICA; DESCALZI, VALERIA I.; D'AMICO, CLAUDIA; FIGUEROA ESCUTI, SEBASTIÁN; GAITE, LUIS A.; PEREZ RAVIER, ROBERTO; LONGO, CRISTINA; BORZI, SILVIA M.; GALDAME, OMAR A.; BESSONE, FERNANDO; FAINBOIM, HUGO A.; FRÍAS, SILVIA; CARTIER, MARIANO; GADANO, ADRIÁN C.

JOURNAL OF MEDICAL VIROLOGY

WILEY-LISS, DIV JOHN WILEY & SONS INC

Lugar: New York; Año: 2018 vol. 90 p. 951 - 958

0146-6615

AbstractWe 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.