Barone M, et al. – Authors performed this study to determine the effectiveness of a 12–week course of sofosbuvir–ledipasvir in treatment–experienced HCV genotype 1b–infected patients with cirrhosis. In comparison to sofosbuvir–ledipasvir alone given for 24 weeks, the therapeutic regimen of sofosbuvir–ledipasvir plus ribavirin administered for 12 weeks proved less effective. At odds with European guidelines, the recommended 12–week treatment with sofosbuvir–ledipasvir alone could be suboptimal for these patients.

Methods

• Authors primarily performed comparison of 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.
• A prospective observational study was performed of 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.

Results

• The SVR12 rates of 93.9% and 99.2% in patients treated for 12 and 24 weeks, respectively (p=0.002) were observed.
• Patients treated for 12 weeks indicated significantly different baseline characteristics from those treated for 24 weeks as regards their younger age (p=0.002), prevalence of Child–Pugh class A (p=0.002), lower MELD scores (p=0.001) and smaller number of non–responders (p=0.04).
• The significantly shorter treatment seemed associated with a lower SVR12 in univariate and multivariate analysis (p=0.007 and p=0.008, respectively).
• The SVR rate remained unaffected with regard to age, gender, BMI, Child–Pugh class, MELD score or previous antiviral treatment.
• In this study, 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 treatment discontinuation was observed.