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® , 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.

Ombitasvir/paritaprevir/ritonavir/dasabuvir ± ribavirin is safe and effective in HCV-infected patients in a real-life cohort from Latin America.

Information about the use of ombitasvir/paritaprevir/ritonavir/dasabuvir ± ribavirin (OBV/PTV/r/DSV ± RBV) in real-clinical practice in Latin America is scarce. We aimed to confirm safety and effectiveness of OBV/PTV/r/DSV ± RBV therapy in real-world setting. We analyzed a cohort of patients with genotype 1 infection treated with OBV/PTV/r/DSV ± RBV. Data on demographics, clinical features, safety, and virological response were retrospectively collected from 21 centers in Latin America. A total of 96 patients received OBV/PTV/r/DSV, associated with RBV in 68% of the cases. Most were genotype 1b (80%), 56 (58%) had cirrhosis, and 45 (47%) failed prior HCV treatment. Adverse events occurred in 62% of patients. The most common adverse events were pruritus (21%), hyperbilirubinemia (17%), and asthenia (17%). Five patients discontinued therapy prematurely due to hepatic decompensation, three of them were Child-Pugh B at baseline and one patient died due to multi-organ failure. Follow up HCV-RNA 12 weeks after completion of therapy was evaluated in all the patients and sustained virologic response rate was 97%. No virologic breakthrough was detected. Our study confirms that OBV/PTV/r/DSV treatment is highly effective in patients with chronic HCV without cirrhosis or with Child-Pugh A cirrhosis in non-European populations. Adverse events were often mild and rarely led to treatment discontinuation except for patients with Child-Pugh B cirrhosis or with previous history of hepatic decompensation. These results can support the development of public strategies to expand the access of OBV/PTV/r + DSV and other DAAs combinations in order to reduce the burden of HCV infection in our region.

Etiology of hepatocellular carcinoma in Argentina: results of a multicenter retrospective study.

Incidence and etiology of hepatocellular carcinoma (HCC) are variable around the world, depending mainly on theprevalence ofchronic hepatitis B carriers in each region. No study has been published analyzing epidemiological features of patients with HCC in Argentina. The aim of this retrospective study was to describe demographical and etiological results in a series of 587 consecutive patients with HCC diagnosed in 15 Hepatology and Gastroenterology Units distributed all around our country. Seventy-two per cent of patients were male, the median age was 62 years (interquartile range 55-68 years), and 93% had cirrhosis. Regarding to etiological data (fully available in 551 cases), main etiologies were chronic alcoholism in 229 patients (41.6%) (the sole risk factor in 182, associated to HCVin 35 and to HBV in 12); hepatitis C in 223 patients (40.5%) (the sole risk factor in 181, associated to alcoholism in 35 and to HBV in 7); hepatitis B in 74 patients (13.4%) (the sole risk factor in 55, associated to alcoholism in 12 and to HCV in 7); cryptogenic cirrhosis in 51 patients (9.2%). There were significant differences in percentages of genders between main groups: males were highly predominant in alcoholic cirrhosis (93%), hepatitis B (87%) and HCV plus alcohol (94%), compared to 63% in cryp togenic cirrhosis and 49% in hepatitis C (p<0.01). There were no differences in age at presentation between the main etiologies. In conclusion, the main causes of HCC in Argentina are alcoholic cirrhosis and hepatitis C (76% of cases). A majority of patients with HCC in our country are cirrhotics, males, and in their 6th or -7th decades of life.