Gut and Liver https://doi.org/10.5009/gnl18269 High Efficacy and Safety of Flat-Dose Ribavirin Plus Sofosbuvir/Daclatasvir in Genotype 3 Cirrhotic Patients
Author Information
Adriano Pellicelli1 , Vincenzo Messina2 , Valerio Giannelli1 , Marco Distefano3, Valeria Pace Palitti4, Pascal Vignally5 , Pierluigi Tarquini6, Antonio Izzi7, Alessandra Moretti8, Sergio Babudieri9 , Serena Dell’Isola10, Massimo Marignani11 , Gaetano Scifo3, Vincenzo Iovinella12, Giuseppe Cariti13, Maurizio Pompili14 , Francesco Di Candilo15, Luca Fontanella16 , Giuseppe M Ettorre17 , Giovanni Vennarecci17 , Antonio Massimo Ippolito18 , Giorgio Barbarini19 , for the Working Group CLEO
1Liver and Transplant Unit, San Camillo Forlanini Hospital, Rome, 2Department of Infectious Disease, Sant'Anna and San Sebastiano Hospital, Caserta, 3Liver Unit, Azienda Umberto I Hospital, Siracusa, 4Liver Unit, Department of Medicine, ASL Pescara, Pescara, 5Department of Emergency, Galliera Hospital, Genoa, 6Department of Infectious Disease, Giuseppe Mazzini Hospital, Teramo, 7Department of Infectious Disease and Emergency Infectious Disease, Cotugno Hospital, Napoli, 8Department of Gastroenterology, San Filippo Neri Hospital, Rome, 9Department of Infectious Disease, University of Sassari, Sassari, 10Department of Infectious Disease, Belcolle Hospital, Viterbo, 11Digestive and Liver Disease Unit, Sant’Andrea Hospital, Rome, 12Department of Internal Medicine, San Paolo Hospital, Naples, 13Infectious Disease, Department of Medical Science, University of Turin, Turin, 14Department of Internal Medicine, Catholic University, Rome, 15Department of Infectious Disease, Perugia Hospital, Perugia, 16Center for Liver Disease, Fatebenefratelli Hospital, Napoli, 17Division of General Surgery and Liver Transplantation, San Camillo Forlanini Hospital, Rome, 18Division of Gastroenterology, Casa Sollievo Sofferenza Hospital IRCCS, San Giovanni Rotondo, and 19Department of Infectious Disease, IRCCS San Matteo, Pavia, Italy

Adriano Pellicelli (https://orcid.org/0000-0001-5845-6703)
Liver Unit, Department of Liver Transplantation, San Camillo Forlanini Hospital, Rome 00152, Italy
Tel: +39-0658703472, Fax: +39-0658704667, E-mail: adriano.pellicelli@uniroma1.it
© The Korean Society of Gastroenterology, the Korean Society of Gastrointestinal Endoscopy, the Korean Society of Neurogastroenterology and Motility, Korean College of Helicobacter and Upper Gastrointestinal Research, Korean Association the Study of Intestinal Diseases, the Korean Association for the Study of the Liver, Korean Pancreatobiliary Association, and Korean Society of Gastrointestinal Cancer. All rights reserved.

Abstract
Background/Aims: Patients with genotype 3 hepatitis C virus (G3-HCV) cirrhosis are very difficult to treat compared to patients with other HCV genotypes. The optimal treatment duration and drug regimen associated with ribavirin (RBV) remain unclear. To evaluate the efficacy and safety of daclatasvir (DCV)/sofosbuvir (SOF) plus a flat dose of 800 mg RBV (flat dose) compared to DCV/SOF without RBV or DCV/SOF plus an RBV dose based on body weight (weight-based) in G3-HCV patients with compensated or decompensated cirrhosis. Methods: We analyzed data for 233 G3 cirrhotic patients. Of these, 70 (30%), 87(37%) and 76 (33%) received SOF/DCV, SOF/DCV/RBV flat dose, and SOF/DCV/RBV weight-based dose, respectively. Treatment duration was 24 weeks. Sustained virological response (SVR) was evaluated at week 12 posttreatment (SVR12). Results: Overall, SVR12 was achieved in 220 out of 233 patients (94.4%). The SVR12 rate was lower in the DCV/SOF group than in the DCV/SOF/RBV flat-dose group and the DCV/SOF/RBV weight-based group (87.1% vs 97.7% and 97.4%, respectively, p=0.007). A higher incidence of anemia occurred in the DCV/SOF/RBV weight-based group compared to those in the other two groups (p<0.007). Conclusions: We found that the DCV/SOF/RBV flat-dose regimen is an effective treatment in terms of efficacy and safety in patients with G3-HCV compensated or decompensated cirrhosis. Therefore, antiviral regimens without RBV should be restricted only to naïve patients with G3-HCV compensated cirrhosis who have a clear contraindication for RBV.
Keywords: Daclatasvir; Cirrhosis, liver; Genotypes 3; Hepatitis C; Drug therapy; Ribavirin
Abstract
Background/Aims: Patients with genotype 3 hepatitis C virus (G3-HCV) cirrhosis are very difficult to treat compared to patients with other HCV genotypes. The optimal treatment duration and drug regimen associated with ribavirin (RBV) remain unclear. To evaluate the efficacy and safety of daclatasvir (DCV)/sofosbuvir (SOF) plus a flat dose of 800 mg RBV (flat dose) compared to DCV/SOF without RBV or DCV/SOF plus an RBV dose based on body weight (weight-based) in G3-HCV patients with compensated or decompensated cirrhosis. Methods: We analyzed data for 233 G3 cirrhotic patients. Of these, 70 (30%), 87(37%) and 76 (33%) received SOF/DCV, SOF/DCV/RBV flat dose, and SOF/DCV/RBV weight-based dose, respectively. Treatment duration was 24 weeks. Sustained virological response (SVR) was evaluated at week 12 posttreatment (SVR12). Results: Overall, SVR12 was achieved in 220 out of 233 patients (94.4%). The SVR12 rate was lower in the DCV/SOF group than in the DCV/SOF/RBV flat-dose group and the DCV/SOF/RBV weight-based group (87.1% vs 97.7% and 97.4%, respectively, p=0.007). A higher incidence of anemia occurred in the DCV/SOF/RBV weight-based group compared to those in the other two groups (p<0.007). Conclusions: We found that the DCV/SOF/RBV flat-dose regimen is an effective treatment in terms of efficacy and safety in patients with G3-HCV compensated or decompensated cirrhosis. Therefore, antiviral regimens without RBV should be restricted only to naïve patients with G3-HCV compensated cirrhosis who have a clear contraindication for RBV.
Keywords: Daclatasvir; Cirrhosis, liver; Genotypes 3; Hepatitis C; Drug therapy; Ribavirin
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