1. A different perspective on sofosbuvir-ledipasvir treatment of patients with HCV genotype 1b cirrhosis: The ital-c network study.
- Author
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Barone, M., Iannone, A., Shahini, E., Ippolito, A. M., Brancaccio, G., Morisco, F., Milella, M., Messina, V., Smedile, A., Conti, F., Gatti, P., Santantonio, T., Tundo, P., Lauletta, G., Napoli, N., Masetti, C., Termite, A. P., Francavilla, R., Di Leo, A., and Pesce, F.
- Subjects
HEPATITIS C treatment ,HEPATITIS C ,TREATMENT of cirrhosis of the liver ,SOFOSBUVIR ,COMBINATION drug therapy ,GENOTYPES ,GENETICS - Abstract
The effectiveness of a 12-week course of sofosbuvir-ledipasvir in treatment-experienced HCV genotype 1b-infected patients with cirrhosis is still under debate. Our primary endpoint was to compare the sustained virological response at post-treatment week 12 ( SVR12) of sofosbuvir-ledipasvir in combination with ribavirin for 12 weeks, and sofosbuvir-ledipasvir alone for 24 weeks. This was a prospective observational study that enrolled 424 (195 naive, 229 experienced; 164 treated for 12 weeks with Ribavirin and 260 with sofosbuvir-ledipasvir alone for 24 weeks) consecutive HCV genotype 1b-infected patients with cirrhosis. The SVR12 rates were 93.9% and 99.2% in patients treated for 12 and 24 weeks, respectively ( P = .002). The baseline characteristics of patients treated for 12 weeks were significantly different from those treated for 24 weeks as regards their younger age ( P = .002), prevalence of Child-Pugh class A ( P = .002), lower MELD scores ( P = .001) and smaller number of nonresponders ( P = .04). The shorter treatment was significantly associated with a lower SVR12 in univariate and multivariate analyses ( P = .007 and P = .008, respectively). The SVR rate was unaffected by age, gender, BMI, Child-Pugh class, MELD score or previous antiviral treatment. Patients receiving ribavirin experienced more episodes of ascites and headache but less recurrence of hepatocellular carcinoma ( HCC), and were prescribed more diuretics and cardiopulmonary drugs. No patient discontinued treatment. The therapeutic regimen of sofosbuvir-ledipasvir plus ribavirin administered for 12 weeks was less effective than sofosbuvir-ledipasvir alone given for 24 weeks. At odds with European guidelines, the recommended 12-week treatment with sofosbuvir-ledipasvir alone might be suboptimal for this setting of patients. [ABSTRACT FROM AUTHOR]
- Published
- 2018
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