Gut Liver.
2020 May;14(3):357-367. 10.5009/gnl18269.
High Efficacy and Safety of Flat-Dose Ribavirin Plus Sofosbuvir/Daclatasvir in Genotype 3 Cirrhotic Patients
- Pellicelli A
1 - Messina V2
- Giannelli 1
- Distefano 3
- Palitti VP4
- Vignally P5
- Tarquini P6
- Izzi A7
- Moretti A8
- Babudieri 9
- Dell’Isola S10
- Marignani 11
- Scifo G3
- Iovinella 12
- Cariti G13
- Pompili M14
- Candilo FD15
- Fontanella L16
- Ettorre GM17
- Vennarecci G17
- Ippolito A18
- Barbarini 19
- Affiliations
-
- 1Liver and Transplant Unit, San Camillo Forlanini Hospital, Rome, Italy
- 2Department of Infectious Disease, Sant'Anna and San Sebastiano Hospital, Caserta, Italy
- 33Liver Unit, Azienda Umberto I Hospital, Siracusa, Italy
- 4Liver Unit, Department of Medicine, ASL Pescara, Pescara, Italy
- 5Department of Emergency, Galliera Hospital, Genoa, Italy
- 6Department of Infectious Disease, Giuseppe Mazzini Hospital, Teramo, Italy
- 7Department of Infectious Disease and Emergency Infectious Disease, Cotugno Hospital, Napoli, Italy
- 8Department of Gastroenterology, San Filippo Neri Hospital, Rome, Italy
- 9Department of Infectious Disease, University of Sassari, Sassari, Italy
- 10Department of Infectious Disease, Belcolle Hospital, Viterbo, Italy
- 11Digestive and Liver Disease Unit, Sant’Andrea Hospital, Rome, Italy
- 12Department of Internal Medicine, San Paolo Hospital, Naples, Italy
- 13Infectious Disease, Department of Medical Science, University of Turin, Turin, Italy
- 14Department of Internal Medicine, Catholic University, Rome, Italy
- 15Department of Infectious Disease, Perugia Hospital, Perugia, Italy
- 16Center for Liver Disease, Fatebenefratelli Hospital, Napoli, Italy
- 17Division of General Surgery and Liver Transplantation, San Camillo Forlanini Hospital, Rome, Italy
- 18Division of Gastroenterology, Casa Sollievo Sofferenza Hospital IRCCS, San Giovanni Rotondo, Italy
- 19Department of Infectious Disease, IRCCS San Matteo, Pavia, Italy
- KMID: 2500540
- DOI: http://doi.org/10.5009/gnl18269
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.
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