BACKGROUND: The current standard of care for patients with chronic hepatitis C virus (HCV) infection is a combination of direct-acting antiviral agents (DAAs). However, rare clinical trials have been reported on the combination regimen of sofosbuvir (SOF) with ombitasvir, paritaprevir, and ritonavir (OBV/PTV/r) plus ribavirin (RBV) for treated patients with HCV genotype 4 (GT4) infection. AIMS: To clarify the retreatment efficacy and safety of the recent regimen, SOF with OBV/PTV/r + RBV, for chronic HCV GT4-experienced patients who failed treatment with DAA-based regimens. METHODS: A total of 113 treatment-experienced patients were allocated for the completion of their treatment period. The enrolled patients were treated orally with SOF plus a fixed dose combination of OBV/PTV/r + RBV, which was administered orally based on the patients' tolerability. The primary end point was a sustained virological response (HCV RNA < 15 IU/mL), observed 12 weeks after the end of the treatment (SVR12). RESULTS: Among all patients, the treatment-experienced patients with SOF plus OBV/PTV/r + RBV had a higher SVR12 rate (97%; 109/113). Further, SVR12 was achieved by 98% (81/83) of non-cirrhotic patients and 93% (28/30) of cirrhotic patients. Additionally, the most common adverse events reported included fatigue, headache, insomnia, nausea, and dyspnea. CONCLUSIONS: The recent multi-targeted regimen of SOF plus OBV/PTV/r + RBV was well tolerated and achieved excellent SVR rates among retreatment-experienced Egyptian patients with prior DAA treatments failure, thus providing an alternative regimen for the retreatment of difficult-to-cure HCV GT4 patients.
BACKGROUND: The current standard of care for patients with chronic hepatitis C virus (HCV) infection is a combination of direct-acting antiviral agents (DAAs). However, rare clinical trials have been reported on the combination regimen of sofosbuvir (SOF) with ombitasvir, paritaprevir, and ritonavir (OBV/PTV/r) plus ribavirin (RBV) for treated patients with HCV genotype 4 (GT4) infection. AIMS: To clarify the retreatment efficacy and safety of the recent regimen, SOF with OBV/PTV/r + RBV, for chronic HCV GT4-experienced patients who failed treatment with DAA-based regimens. METHODS: A total of 113 treatment-experienced patients were allocated for the completion of their treatment period. The enrolled patients were treated orally with SOF plus a fixed dose combination of OBV/PTV/r + RBV, which was administered orally based on the patients' tolerability. The primary end point was a sustained virological response (HCV RNA < 15 IU/mL), observed 12 weeks after the end of the treatment (SVR12). RESULTS: Among all patients, the treatment-experienced patients with SOF plus OBV/PTV/r + RBV had a higher SVR12 rate (97%; 109/113). Further, SVR12 was achieved by 98% (81/83) of non-cirrhotic patients and 93% (28/30) of cirrhotic patients. Additionally, the most common adverse events reported included fatigue, headache, insomnia, nausea, and dyspnea. CONCLUSIONS: The recent multi-targeted regimen of SOF plus OBV/PTV/r + RBV was well tolerated and achieved excellent SVR rates among retreatment-experienced Egyptian patients with prior DAA treatments failure, thus providing an alternative regimen for the retreatment of difficult-to-cure HCV GT4 patients.
Authors: Richard K Sterling; Eduardo Lissen; Nathan Clumeck; Ricard Sola; Mendes Cassia Correa; Julio Montaner; Mark S Sulkowski; Francesca J Torriani; Doug T Dieterich; David L Thomas; Diethelm Messinger; Mark Nelson Journal: Hepatology Date: 2006-06 Impact factor: 17.425
Authors: H Wedemeyer; A Craxí; E Zuckerman; D Dieterich; R Flisiak; S K Roberts; A Pangerl; Z Zhang; M Martinez; Y Bao; J-L Calleja Journal: J Viral Hepat Date: 2017-07-03 Impact factor: 3.728
Authors: Vincent Soriano; José V Fernandez-Montero; Carmen de Mendoza; Laura Benitez-Gutierrez; José M Peña; Ana Arias; Pablo Barreiro Journal: Expert Opin Pharmacother Date: 2017-07-30 Impact factor: 3.889
Authors: R Flisiak; E Janczewska; M Wawrzynowicz-Syczewska; J Jaroszewicz; D Zarębska-Michaluk; K Nazzal; B Bolewska; J Bialkowska; H Berak; K Fleischer-Stępniewska; K Tomasiewicz; K Karwowska; K Rostkowska; A Piekarska; O Tronina; G Madej; A Garlicki; M Lucejko; A Pisula; E Karpińska; W Kryczka; A Wiercińska-Drapało; I Mozer-Lisewska; M Jabłkowski; A Horban; B Knysz; M Tudrujek; W Halota; K Simon Journal: Aliment Pharmacol Ther Date: 2016-09-09 Impact factor: 8.171
Authors: Eric Lawitz; Alessandra Mangia; David Wyles; Maribel Rodriguez-Torres; Tarek Hassanein; Stuart C Gordon; Michael Schultz; Mitchell N Davis; Zeid Kayali; K Rajender Reddy; Ira M Jacobson; Kris V Kowdley; Lisa Nyberg; G Mani Subramanian; Robert H Hyland; Sarah Arterburn; Deyuan Jiang; John McNally; Diana Brainard; William T Symonds; John G McHutchison; Aasim M Sheikh; Zobair Younossi; Edward J Gane Journal: N Engl J Med Date: 2013-04-23 Impact factor: 91.245
Authors: Marc Bourlière; Stuart C Gordon; Steven L Flamm; Curtis L Cooper; Alnoor Ramji; Myron Tong; Natarajan Ravendhran; John M Vierling; Tram T Tran; Stephen Pianko; Meena B Bansal; Victor de Lédinghen; Robert H Hyland; Luisa M Stamm; Hadas Dvory-Sobol; Evguenia Svarovskaia; Jie Zhang; K C Huang; G Mani Subramanian; Diana M Brainard; John G McHutchison; Elizabeth C Verna; Peter Buggisch; Charles S Landis; Ziad H Younes; Michael P Curry; Simone I Strasser; Eugene R Schiff; K Rajender Reddy; Michael P Manns; Kris V Kowdley; Stefan Zeuzem Journal: N Engl J Med Date: 2017-06-01 Impact factor: 91.245
Authors: David A DeGoey; John T Randolph; Dachun Liu; John Pratt; Charles Hutchins; Pamela Donner; A Chris Krueger; Mark Matulenko; Sachin Patel; Christopher E Motter; Lissa Nelson; Ryan Keddy; Michael Tufano; Daniel D Caspi; Preethi Krishnan; Neeta Mistry; Gennadiy Koev; Thomas J Reisch; Rubina Mondal; Tami Pilot-Matias; Yi Gao; David W A Beno; Clarence J Maring; Akhter Molla; Emily Dumas; Andrew Campbell; Laura Williams; Christine Collins; Rolf Wagner; Warren M Kati Journal: J Med Chem Date: 2014-01-15 Impact factor: 7.446
Authors: Adel Abdel-Moneim; Alaa Aboud; Mohamed Abdel-Gabbar; Mohamed I Zanaty; Amr A Abd Elbary; Mohamed Ramadan Journal: Ann Gastroenterol Date: 2018-11-24