BACKGROUND: Virologic and safety outcomes of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin (OBV/PTV/r ± DSV ± RBV) therapy have shown high sustained virologic response (SVR) rates and good tolerability in most patient populations in pre-registration studies. AIM: To confirm these clinical trial findings in the treatment of genotype 1 and 4 hepatitis C under real-world conditions. METHODS: Patients enrolled for treatment with OBV/PTV/r ± DSV ± RBV based on therapeutic guidelines were included, and the regimen was administered according to product characteristics. Clinical and laboratory data, including virologic response, were collected at baseline, end of treatment (EOT) and 12 weeks after EOT. RESULTS: A total of 209 patients with chronic hepatitis C were enrolled, most were genotype 1b-infected (84.2%) and 119 (56.9%) had liver cirrhosis. Among these, 150 (71.7%) had failed previous anti-viral therapies and 84 (40.2%) were null-responders. At 12 weeks after EOT, SVR was achieved by 207 (99.0%) patients, ranging from 96.4% to 100.0% across subgroups. All Child-Pugh B and post-orthotopic liver transplantation patients achieved SVR. Adverse events occurred in 151 (72.2%) patients and were mostly mild and associated with the use of RBV. Serious adverse events, including hepatic decompensation, renal insufficiency, anaemia, hepatotoxicity and diarrhoea, were reported in eight (3.8%) patients. In five (2.4%) patients, adverse events led to treatment discontinuation. On-treatment decompensation was experienced by seven (3.3%) patients. CONCLUSIONS: The results of our study confirm previous findings. They demonstrate excellent effectiveness and a good safety profile of OBV/PTV/r± DSV±RBV in HCV genotype 1-infected patients treated in the real-world setting.
BACKGROUND: Virologic and safety outcomes of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin (OBV/PTV/r ± DSV ± RBV) therapy have shown high sustained virologic response (SVR) rates and good tolerability in most patient populations in pre-registration studies. AIM: To confirm these clinical trial findings in the treatment of genotype 1 and 4 hepatitis C under real-world conditions. METHODS:Patients enrolled for treatment with OBV/PTV/r ± DSV ± RBV based on therapeutic guidelines were included, and the regimen was administered according to product characteristics. Clinical and laboratory data, including virologic response, were collected at baseline, end of treatment (EOT) and 12 weeks after EOT. RESULTS: A total of 209 patients with chronic hepatitis C were enrolled, most were genotype 1b-infected (84.2%) and 119 (56.9%) had liver cirrhosis. Among these, 150 (71.7%) had failed previous anti-viral therapies and 84 (40.2%) were null-responders. At 12 weeks after EOT, SVR was achieved by 207 (99.0%) patients, ranging from 96.4% to 100.0% across subgroups. All Child-Pugh B and post-orthotopic liver transplantation patients achieved SVR. Adverse events occurred in 151 (72.2%) patients and were mostly mild and associated with the use of RBV. Serious adverse events, including hepatic decompensation, renal insufficiency, anaemia, hepatotoxicity and diarrhoea, were reported in eight (3.8%) patients. In five (2.4%) patients, adverse events led to treatment discontinuation. On-treatment decompensation was experienced by seven (3.3%) patients. CONCLUSIONS: The results of our study confirm previous findings. They demonstrate excellent effectiveness and a good safety profile of OBV/PTV/r± DSV±RBV in HCV genotype 1-infectedpatients treated in the real-world setting.
Authors: Ashley N Tran; Rishabh Sachdev; Zachary P Fricker; Michael Leber; Toni Zahorian; Bhavesh Shah; David P Nunes; Michelle T Long Journal: Dig Dis Sci Date: 2018-08-04 Impact factor: 3.199
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: Tarik Asselah; Christophe Moreno; Christoph Sarrazin; Michael Gschwantler; Graham R Foster; Antonio Craxí; Peter Buggisch; Faisal Sanai; Ceyhun Bicer; Oliver Lenz; Gino Van Dooren; Catherine Nalpas; Isabelle Lonjon-Domanec; Michael Schlag; Maria Buti Journal: PLoS One Date: 2017-01-05 Impact factor: 3.240
Authors: Sammy Saab; Justin Rheem; Melissa A Jimenez; Tiffany M Fong; Michelle H Mai; Caterina A Kachadoorian; Negin L Esmailzadeh; Sherona N Bau; Susan Kang; Samantha D Ramirez; Jonathan Grotts; Gina Choi; Francisco A Durazo; Mohammed M El-Kabany; Steven-Huy B Han; Ronald W Busuttil Journal: J Clin Transl Hepatol Date: 2017-05-14
Authors: Robert Flisiak; Joanna Pogorzelska; Hanna Berak; Andrzej Horban; Iwona Orłowska; Krzysztof Simon; Ewelina Tuchendler; Grzegorz Madej; Anna Piekarska; Maciej Jabłkowski; Zbigniew Deroń; Włodzimierz Mazur; Marcin Kaczmarczyk; Ewa Janczewska; Arkadiusz Pisula; Jacek Smykał; Krzysztof Nowak; Marek Matukiewicz; Waldemar Halota; Joanna Wernik; Katarzyna Sikorska; Iwona Mozer-Lisewska; Błażej Rozpłochowski; Aleksander Garlicki; Krzysztof Tomasiewicz; Joanna Krzowska-Firych; Barbara Baka-Ćwierz; Wiesław Kryczka; Dorota Zarębska-Michaluk; Iwona Olszok; Anna Boroń-Kaczmarska; Barbara Sobala-Szczygieł; Bronisława Szlauer; Bogumiła Korcz-Ondrzejek; Jerzy Sieklucki; Robert Pleśniak; Agata Ruszała; Barbara Postawa-Kłosińska; Jolanta Citko; Anna Lachowicz-Wawrzyniak; Joanna Musialik; Edyta Jezierska; Witold Dobracki; Beata Dobracka; Jan Hałubiec; Rafał Krygier; Anna Strokowska; Wojciech Chomczyk; Krystyna Witczak-Malinowska Journal: Clin Exp Hepatol Date: 2016-11-28
Authors: Waldemar Halota; Robert Flisiak; Jacek Juszczyk; Piotr Małkowski; Małgorzata Pawłowska; Krzysztof Simon; Krzysztof Tomasiewicz Journal: Clin Exp Hepatol Date: 2017-05-18