Carmen M Preda1, Corneliu P Popescu2, Cristian Baicus3, Theodor A Voiosu3, Mircea Manuc1, Corina Silvia Pop4, Liana Gheorghe1, Ioan Sporea5, Anca Trifan6, Marcel Tantau7, Alina Tantau7, Emanoil Ceausu2, Doina Proca1, Ileana Constantinescu1, Simona M Ruta2, Mircea M Diculescu1, Alexandru Oproiu1. 1. UMF "Carol Davila" Gastroenterology & Hepatology Department, Clinic Fundeni Institute, Bucharest, Romania. 2. UMF "Carol Davila" Virology Department, Victor Babes Hospital, Bucharest, Romania. 3. UMF "Carol Davila" Internal Medicine Department, Colentina Hospital, Bucharest, Romania. 4. UMF "Carol Davila" Gastroenterology Department, Emergency Universitary Hospital, Bucharest, Romania. 5. UMF Timisoara, Gastroenterology & Hepatology Department, Timisoara Emergency Hospital, Timisoara, Romania. 6. UMF Gr T Popa Iasi, Gastroenterology & Hepatology Department, Gastroenterology & Hepatology Institute, Iasi, Romania. 7. UMF I.Hatieganu Cluj, Gastroenterology & Hepatology Department, Medicala III, Cluj County Hospital, Cluj Napoca, Romania.
Abstract
BACKGROUND: Direct antiviral agents (DAA) showed very good results in terms of efficacy and safety in clinical trials, but real-life data are still needed in order to confirm this profile. MATERIAL AND METHODS: In Romania, through a nationwide government-funded programme in 2015-2016, approx.5800 patients with virus C cirrhosis received fully reimbursed DAA therapy with OBV/PTV/r+DSV+RBV for 12 weeks. We analysed a national prospective cohort enrolling the first 2070 patients, all with genotype 1b. The only key inclusion criteria was advanced fibrosis (Metavir stage F4) confirmed by Fibromax testing (or liver biopsy/Fibroscan). Efficacy was assessed by the percentage of patients achieving SVR 12 weeks post-treatment (SVR12). RESULTS: Forty patients stopped the treatment because of hepatic decompensation (1.9%), 21 stopped because of other adverse events and one was lost to follow-up. This cohort was 51% females, mean age 60 years (25÷82), 67% pretreated, 70% associated NASH, 67% with severe necro-inflammation (severity score 3-Fibromax), 37% with comorbidities, 10.4% with Child Pugh A6, 0.5% B7. The median MELD score was 8.09 (6 ÷ 22). SVR by intention-to-treat was reported in 1999/2070(96.6%), 55/2070 failed to respond. Liver decompensation was statistically associated in multivariate analysis with platelets< 105 /mm3 (P = .03), increased total bilirubin (P < .001), prolonged INR (P = .02), and albumin<3.5 g/dL (P = .03). CONCLUSIONS: OBV/PTV/r+DSV+RBV proved to be highly efficient in our population of cirrhotics with a 96.6% SVR. Serious adverse events related to therapy were reported in 61/2070(2.9%), most of them liver decompensation (1.9%), related to hepatic dysfunction, and lower platelet count.
BACKGROUND: Direct antiviral agents (DAA) showed very good results in terms of efficacy and safety in clinical trials, but real-life data are still needed in order to confirm this profile. MATERIAL AND METHODS: In Romania, through a nationwide government-funded programme in 2015-2016, approx.5800 patients with virus C cirrhosis received fully reimbursed DAA therapy with OBV/PTV/r+DSV+RBV for 12 weeks. We analysed a national prospective cohort enrolling the first 2070 patients, all with genotype 1b. The only key inclusion criteria was advanced fibrosis (Metavir stage F4) confirmed by Fibromax testing (or liver biopsy/Fibroscan). Efficacy was assessed by the percentage of patients achieving SVR 12 weeks post-treatment (SVR12). RESULTS: Forty patients stopped the treatment because of hepatic decompensation (1.9%), 21 stopped because of other adverse events and one was lost to follow-up. This cohort was 51% females, mean age 60 years (25÷82), 67% pretreated, 70% associated NASH, 67% with severe necro-inflammation (severity score 3-Fibromax), 37% with comorbidities, 10.4% with Child Pugh A6, 0.5% B7. The median MELD score was 8.09 (6 ÷ 22). SVR by intention-to-treat was reported in 1999/2070(96.6%), 55/2070 failed to respond. Liver decompensation was statistically associated in multivariate analysis with platelets< 105 /mm3 (P = .03), increased total bilirubin (P < .001), prolonged INR (P = .02), and albumin<3.5 g/dL (P = .03). CONCLUSIONS: OBV/PTV/r+DSV+RBV proved to be highly efficient in our population of cirrhotics with a 96.6% SVR. Serious adverse events related to therapy were reported in 61/2070(2.9%), most of them liver decompensation (1.9%), related to hepatic dysfunction, and lower platelet count.
Authors: Carmen M Preda; Cristian Baicus; Irina Sandra; Alexandru Oproiu; Teodora Manuc; Ileana Constantinescu; Daniel Gavrila; Mircea Diculescu; Radu Dumitru; Catalin Vasilescu; Cristian Tieranu; Doina Istratescu; Theodor Voiosu; Mircea Manuc Journal: United European Gastroenterol J Date: 2019-03-29 Impact factor: 4.623
Authors: Bilgehan Aygen; Neşe Demirtürk; Orhan Yıldız; Mustafa Kemal Çelen; İlhami Çelik; Şener Barut; Onur Ural; Ayşe Batırel; Reşit Mıstık; Funda Şimşek; Ali Asan; Gülden Ersöz; Nesrin Türker; Hüseyin Bilgin; Sami Kınıklı; Faruk Karakeçili; Gökmen Zararsız; The Study Group For Viral Hepatitis Of The Turkish Society Of Clinical Microbiology And Infectious Diseases Journal: Turk J Gastroenterol Date: 2020-04 Impact factor: 1.852
Authors: Daniela Manuc; Carmen Monica Preda; Irina Sandra; Cristian Baicus; Razvan Cerban; Ileana Constantinescu; Andrei Ovidiu Olteanu; Cosmin Alexandru Ciora; Teodora Manuc; Daniela Elena Chiriac; Andreea Elena Chifulescu; Mircea Diculescu; Cristian Tieranu; Lucian Negreanu; Gabriela Oprea-Calin; Mircea Manuc Journal: J Med Life Date: 2020 Jan-Mar
Authors: Cristina Maria Muzica; Carol Stanciu; Laura Huiban; Ana-Maria Singeap; Catalin Sfarti; Sebastian Zenovia; Camelia Cojocariu; Anca Trifan Journal: World J Gastroenterol Date: 2020-11-21 Impact factor: 5.742