H Wedemeyer1, A Craxí2, E Zuckerman3, D Dieterich4, R Flisiak5, S K Roberts6, A Pangerl7, Z Zhang7, M Martinez7, Y Bao7, J-L Calleja8. 1. Medizinische Hochschule Hannover, Hannover, Germany. 2. AOU Policlinico "P Giaccone" Dip Di Gastroenterologia ed Epatologia DBMIS, Palermo, Italy. 3. Carmel Medical Center Liver Institute, Haifa, Israel. 4. Mount Sinai Hospital, New York, NY, USA. 5. Klinika Chorób Zakaznych i Hepatologii UM w Bialymstoku, Bialystok, Poland. 6. Alfred Hospital and Monash University, Melbourne, Australia. 7. AbbVie Inc., North Chicago, IL, USA. 8. Hospital Universitario Puerta de Hierro, Universidad Autonoma de Madrid, Spain.
Abstract
The direct-acting antiviral regimen of ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r)±dasabuvir (DSV)±ribavirin (RBV) demonstrated high rates of sustained viral response at post-treatment week 12 (SVR12) in clinical trials for treatment of hepatitis C virus (HCV) genotypes (GT) 1 and 4. To confirm the effectiveness of this regimen in the real world, we conducted meta-analyses of published literature on 30 April 2016. Freeman-Tukey transformation determined the SVR rate within GTs 1a, 1b and 4, as well as specific SVR rates by cirrhosis or prior treatment experience status. Rates of virologic relapse, hepatic decompensation, drug discontinuation and serious adverse events were also analysed. In total, 20 cohorts across 12 countries were identified, totalling 5158 patients. The overall SVR12 rates were 96.8% (95% CI 95.8-97.7) for GT1 and 98.9% (95% CI 94.2-100) for GT4. For GT1a patients, the SVR rates were 94% and 97% for those with or without cirrhosis, and 94% overall. For GT1b patients, the SVR rates were 98% and 99% for those with or without cirrhosis, and 98% overall. The virologic relapse rate of GT1 patients was 1.3%, across 3524 patients in nine studies that reported this parameter. The rate of hepatic decompensation was less than 1% across five studies, including 3440 patients, 70% of which had cirrhosis. CONCLUSIONS: Real-world SVR12 rates for OBV/PTV/r±DSV±RBV were consistently high across HCV GT1 and four irrespective of cirrhosis status or prior HCV treatment experience, confirming effectiveness within a diverse patient population across multiple cohorts and countries.
The direct-acting antiviral regimen of ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r)±dasabuvir (DSV)±ribavirin (RBV) demonstrated high rates of sustained viral response at post-treatment week 12 (SVR12) in clinical trials for treatment of hepatitis C virus (HCV) genotypes (GT) 1 and 4. To confirm the effectiveness of this regimen in the real world, we conducted meta-analyses of published literature on 30 April 2016. Freeman-Tukey transformation determined the SVR rate within GTs 1a, 1b and 4, as well as specific SVR rates by cirrhosis or prior treatment experience status. Rates of virologic relapse, hepatic decompensation, drug discontinuation and serious adverse events were also analysed. In total, 20 cohorts across 12 countries were identified, totalling 5158 patients. The overall SVR12 rates were 96.8% (95% CI 95.8-97.7) for GT1 and 98.9% (95% CI 94.2-100) for GT4. For GT1a patients, the SVR rates were 94% and 97% for those with or without cirrhosis, and 94% overall. For GT1b patients, the SVR rates were 98% and 99% for those with or without cirrhosis, and 98% overall. The virologic relapse rate of GT1patients was 1.3%, across 3524 patients in nine studies that reported this parameter. The rate of hepatic decompensation was less than 1% across five studies, including 3440 patients, 70% of which had cirrhosis. CONCLUSIONS: Real-world SVR12 rates for OBV/PTV/r±DSV±RBV were consistently high across HCVGT1 and four irrespective of cirrhosis status or prior HCV treatment experience, confirming effectiveness within a diverse patient population across multiple cohorts and countries.
Authors: Iman Ibrahim Salama; Hala M Raslan; Ghada A Abdel-Latif; Somaia I Salama; Samia M Sami; Fatma A Shaaban; Aida M Abdelmohsen; Walaa A Fouad Journal: World J Hepatol Date: 2022-06-27
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