Filomena Morisco1, Rocco Granata1, Silvia Camera1, Antonio Ippolito2, Michele Milella3, Fabio Conti4, Chiara Masetti5, Antonella Smedile6, Paolo Tundo7, Teresa Santantonio8, Maria Rosa Valvano2, Antonio Termite9, Pietro Gatti10, Vincenzo Messina11, Angelo Iacobellis2, Marta Librandi12, Nicola Caporaso1, Angelo Andriulli2. 1. Gastroenterology Unit, Department of Clinical Medicine and Surgery, "Federico II" University, Napoli, Italy. 2. Division of Gastroenterology, "Casa Sollievo della Sofferenza" Hospital, IRCCS, San Giovanni Rotondo, Italy. 3. Clinics of Infectious Diseases, University of Bari, Italy. 4. Centre for the Study of Hepatitis, Department of Medical and Surgical Sciences (DIMEC), University of Bologna, Italy. 5. Hepatology and Liver Transplantation Unit, University of Tor Vergata, Roma, Italy. 6. Department of Medical Sciences, University of Torino, Italy. 7. Division of Infectious Diseases, Hospital of Galatina, Italy. 8. Clinics of Infectious Diseases, University of Foggia, Italy. 9. Liver Unit, Hospital of Castellaneta, Italy. 10. Internal Medicine, Hospital of Ostuni, Italy. 11. Infectious and Tropical Diseases Unit, S. Anna and S. Sebastiano Hospital, Caserta, Italy. 12. Department of Physiology, Faculty of Pharmacy, "La Sapienza" University, Roma, Italy.
Abstract
BACKGROUND AND AIM: Direct antiviral agents (DAAs) have led to high sustained virological responses (SVR) in hepatitis C virus (HCV) patients. However, genotype 3 patients respond to treatment in a suboptimal way. This study aims to identify which of the several treatment schedules recommended for genotype 3 would constitute the best option. METHODS: Twenty-four Italian centers were involved in this real-life study of HCV genotype 3 patients treated with DAAs. To expand the number of cases, we conducted a systematic review of the literature on the outcome of genotype 3 patients treated with DAAs. RESULTS: A total of 233 patients with HCV genotype 3 were enrolled. Cirrhotic patients accounted for 83.7%. Overall, the SVR12 rate was achieved by 205 patients (88.0%); the SVR rates were 78.8% after sofosbuvir/ribavirin, 92.5% after sofosbuvir/daclatasvir ± ribavirin, and 100% after sofosbuvir/ledipasvir (seven patients). No difference in rate of SVR was observed in cirrhotic and non-cirrhotic patients (92.2 vs 94.4) using a combination regimen of NS5A and NS5B inhibitors.The systematic review of the literature provided data of 3311 patients: The mean weighted SVR12 rate was 84.4% (CI: 80.4-87.8); the rates varied from 79.0% (CI: 70.9-85.3) with sofosbuvir/ribavirin, to 83.7% (CI: 66.2-93.1) with sofosbuvir/ledispavir, and to 88.2% (CI: 83.3-91.7) with sofosbuvir/daclatasvir. CONCLUSIONS: Our results reinforce the concept that patients with HCV genotype 3 should no longer be considered difficult-to-treat individuals. The optimal therapeutic regimen for these patients appears to be the combination sofosbuvir/daclatasvir, administered for 12 weeks without the use of RBV in non-cirrhotic patients. In cirrhotics the meta-analytic approach suggests extending therapy to 24 weeks.
BACKGROUND AND AIM: Direct antiviral agents (DAAs) have led to high sustained virological responses (SVR) in hepatitis C virus (HCV) patients. However, genotype 3 patients respond to treatment in a suboptimal way. This study aims to identify which of the several treatment schedules recommended for genotype 3 would constitute the best option. METHODS: Twenty-four Italian centers were involved in this real-life study of HCV genotype 3 patients treated with DAAs. To expand the number of cases, we conducted a systematic review of the literature on the outcome of genotype 3 patients treated with DAAs. RESULTS: A total of 233 patients with HCV genotype 3 were enrolled. Cirrhotic patients accounted for 83.7%. Overall, the SVR12 rate was achieved by 205 patients (88.0%); the SVR rates were 78.8% after sofosbuvir/ribavirin, 92.5% after sofosbuvir/daclatasvir ± ribavirin, and 100% after sofosbuvir/ledipasvir (seven patients). No difference in rate of SVR was observed in cirrhotic and non-cirrhotic patients (92.2 vs 94.4) using a combination regimen of NS5A and NS5B inhibitors.The systematic review of the literature provided data of 3311 patients: The mean weighted SVR12 rate was 84.4% (CI: 80.4-87.8); the rates varied from 79.0% (CI: 70.9-85.3) with sofosbuvir/ribavirin, to 83.7% (CI: 66.2-93.1) with sofosbuvir/ledispavir, and to 88.2% (CI: 83.3-91.7) with sofosbuvir/daclatasvir. CONCLUSIONS: Our results reinforce the concept that patients with HCV genotype 3 should no longer be considered difficult-to-treat individuals. The optimal therapeutic regimen for these patients appears to be the combination sofosbuvir/daclatasvir, administered for 12 weeks without the use of RBV in non-cirrhotic patients. In cirrhotics the meta-analytic approach suggests extending therapy to 24 weeks.
Entities:
Keywords:
HCV; cirrhosis; direct antiviral agent; genotype 3; meta-analysis
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