Authors: Ridruejo, Ezequiel; Solano, Angela Rosario; Marciano, Sebastián; Galdame, Omar; Adrover, Raúl; Cocozzella, Daniel; Delettieres, Dreanina; Martínez, Alfredo; Gadano, Adrián; Mandó, Oscar G.; Silva, Marcelo O.
Publication Date: 2011.
Language: English.
Abstract:
BACKGROUND AND AIMS: Genetic variations in the interleukin 28B (IL28B) gene have been associated with viral response to PEG-interferon-α/ribavirin (PR) therapy in hepatitis C virus (HCV) genotype 1 infected patients from North America, Europe and Asia. The importance of these IL28B variants for Argentine patients remains unknown. MATERIAL AND METHODS: IL28B host genotypes (rs8099917 and rs12979860) were determined in a population of Argentine patients with European ancestry. Results were analyzed looking for their association with sustained virologic response (SVR) to PR therapy and compared with other baseline hosts' biochemical, histological and virological predictors of response. RESULTS: We studied 102 patients, 60% were men, and 40% of them were rs8099917 TT and 18% rs12979860 CC. Mean baseline serum HCV RNA was 1.673.092 IU/mL and mean F score was: 2.10 ± 1.18 (21% cirrhotic). SVR rate was higher in rs8099917 TT genotypes (55%) when compared to GT/GG (25%) (p = 0.002) and in rs1512979860 CC (64%) than in CT/TT (30%) (p = 0.004). The univariate analysis showed that rs8099917 TT (OR 3.7; 95 %CI 1.5-8.7; p = 0.002), rs12979860 CC (OR 4.6; 95%CI 1.5-13.7; p = 0.006), low viral load (OR 4.6; 95% CI 1.7-12.6; p = 0.002) and F0-2 (OR 8.5; 95% CI 2.3-30.6; p = 0.001) were significantly associated with SVR. In the multivariate analysis, rs12979860 CC, rs8099917 TT, viral load < 400.000 IU/mL and F0-2 were associated with SVR rates (p = 0.029, p = 0.012, p = 0.013 and p = 0.004, respectively). CONCLUSION: IL28B host genotypes should be added to baseline predictors of response to PR therapy in Latin American patients with European ancestry.
Author affiliation: Ridruejo, Ezequiel. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. CEMIC-CONICET. Centro de Educaciones Médicas e Investigaciones Clínicas "Norberto Quirno". CEMIC-CONICET.; Argentina. Pontificia Universidad Católica Argentina "Santa María de los Buenos Aires". Instituto de Investigaciones Biomédicas. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto de Investigaciones Biomédicas; Argentina. Hospital Universitario Austral; Argentina
Author affiliation: Solano, Angela Rosario. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. CEMIC-CONICET. Centro de Educaciones Médicas e Investigaciones Clínicas "Norberto Quirno". CEMIC-CONICET.; Argentina. Pontificia Universidad Católica Argentina "Santa María de los Buenos Aires". Instituto de Investigaciones Biomédicas. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto de Investigaciones Biomédicas; Argentina
Author affiliation: Marciano, Sebastián. Centro de Educación Médica e Investigaciones Clínicas “Norberto Quirno”; Argentina. Hospital Italiano; Argentina
Author affiliation: Galdame, Omar. Hospital Italiano; Argentina
Author affiliation: Adrover, Raúl. Centro de Hepatologia; Argentina
Author affiliation: Cocozzella, Daniel. Centro de Hepatologia; Argentina
Author affiliation: Delettieres, Dreanina. Centro de Educación Médica e Investigaciones Clínicas “Norberto Quirno”; Argentina
Author affiliation: Martínez, Alfredo. Centro de Educación Médica e Investigaciones Clínicas “Norberto Quirno”; Argentina
Author affiliation: Gadano, Adrián. Hospital Italiano; Argentina
Author affiliation: Mandó, Oscar G.. Centro de Educación Médica e Investigaciones Clínicas “Norberto Quirno”; Argentina
Author affiliation: Silva, Marcelo O.. Hospital Universitario Austral; Argentina
Repository: CONICET Digital (CONICET). Consejo Nacional de Investigaciones Científicas y Técnicas
Authors: Mendizabal, Manuel; Haddad, Leila; Gallardo, Patricia E.; Ferrada, Alejandro; Soza, Alejandro A.; Adrover, Raul; Aravena, Edmundo; Roblero, Juan P.; Prieto, Jhon; Vujacich, Claudia; Romero, Gustavo; Muñoz, Alberto; Anders, Margarita; Hernández, Nelia; Coccozella, Daniel; Gruz, Fernando; Reggiardo, Maria V.; Ruf, Andres E.; Varón, Adriana; Cartier, Mariano; Pérez Ravier, Roberto; Ridruejo, Ezequiel; Peralta, Mirta; Poncino, Daniel; Vorobioff, Julio; Aballay Soteras, Gabriel; Silva, Marcelo O.
Publication Date: 2017.
Language: English.
Abstract:
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.
Author affiliation: Mendizabal, Manuel. Hospital Universitario Austral; Argentina
Author affiliation: Haddad, Leila. Hospital Italiano; Argentina
Author affiliation: Gallardo, Patricia E.. Fundación Sayani; Argentina
Author affiliation: Ferrada, Alejandro. Hospital Clinico San Borja Arriaran; Chile
Author affiliation: Soza, Alejandro A.. Universidad Católica de Chile; Chile. Pontificia Universidad Católica de Chile; Chile
Author affiliation: Adrover, Raul. Centro de Hepatología; Argentina
Author affiliation: Aravena, Edmundo. Hospital Clinico San Borja Arriaran; Chile
Author affiliation: Roblero, Juan P.. Hospital Clinico San Borja Arriaran; Chile
Author affiliation: Prieto, Jhon. Clínica Universitaria Colombia y Centro de Enfermedades Hepáticas y Digestivas; Colombia
Author affiliation: Vujacich, Claudia. Fundacion Centro de Estudios Infectologicos; Argentina
Author affiliation: Romero, Gustavo. Gobierno de la Ciudad de Buenos Aires. Hospital de Gastroenterología ; Argentina
Author affiliation: Muñoz, Alberto. Gobierno de la Ciudad de Buenos Aires. Hospital de Gastroenterología ; Argentina
Author affiliation: Anders, Margarita. Hospital Alemán; Argentina
Author affiliation: Hernández, Nelia. Hospital de Clinicas Dr. Manuel Quintela; Uruguay
Author affiliation: Coccozella, Daniel. Centro de Hepatología; Argentina
Author affiliation: Gruz, Fernando. Fundación Favaloro; Argentina
Author affiliation: Reggiardo, Maria V.. Provincia de Santa Fe. Ministerio de Salud y Medio Ambiente - Rosario. Hospital Provincial del Centenario; Argentina
Author affiliation: Ruf, Andres E.. FUNDIEH; Argentina
Author affiliation: Varón, Adriana. Instituto de Cardiologia; Colombia
Author affiliation: Cartier, Mariano. Gobierno de la Ciudad de Buenos Aires. Hospital de Gastroenterología ; Argentina
Author affiliation: Pérez Ravier, Roberto. Instituto Universidad Escuela de Medicina del Hospital Italiano; Argentina
Author affiliation: Ridruejo, Ezequiel. Hospital Universitario Austral; Argentina. Centro de Educación Medica E Invest.clinicas; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Author affiliation: Peralta, Mirta. Gobierno de la Ciudad de Buenos Aires. Hospital de Infecciosas ; Argentina
Author affiliation: Poncino, Daniel. Sanatorio Municipal Dr. Julio Méndez; Argentina
Author affiliation: Vorobioff, Julio. Universidad Nacional de Rosario; Argentina
Author affiliation: Aballay Soteras, Gabriel. Sanatorio Mitre; Argentina
Author affiliation: Silva, Marcelo O.. Hospital Universitario Austral; Argentina
Repository: CONICET Digital (CONICET). Consejo Nacional de Investigaciones Científicas y Técnicas