Real world efficacy of 12 weeks sofosbuvir, daclastivir with ribavirin among cirrhotic pre and post-transplant genotype 3 (2017)

Type of publication:
Conference abstract

Schmidt-Martin D.; Bufton S.; Haydon G.H.; Mutimer D.; Elsharkawy A.M.; Roberts M.; *Rye K.; Singhal S.; Eldred S.; Perry I.; Corbett C.; Unitt E.; Wood V.; Dillon H.

Journal of Hepatology; 2017; vol. 66 (no. 1)

Background and Aims: Current EASL guidelines recommend combined Sofosbuvir and Daclatasvir with Ribavirin (SOF + DCV + RBV) for 24 weeks in compensated/decompensated cirrhosis for genotype 3 patients. We investigated response to 12weeks treatment in a large cohort of pre and post-transplant predominantly compensated cirrhotic genotype 3 patients. Methods: All patients who received a single dose and treated in 8 treatment centres within our hospital network included. SVR12 rates for all patients who started treatment are reported on an intention to treat (ITT) basis and we include a modified intention to treat (mITT) analysis excluding non virological failures. Results: 156 patients ((M:F) 109:47) mean age 51.5 were commenced on treatment. The overall SVR12 rate was 88.5% (138/156) (ITT) and 95.8% (138/144) (mITT). 2 patients stopped treatment without side effects. Five patients did not attend for confirmation of SVR12, three patients died on treatment (2 due to cardiac arrest, 1 due to sepsis) and a further patient died following completion of treatment prior to SVR12 (hepatocellular carcinoma). mITT SVR12 for patients with compensated and decompensated cirrhosis (Child Pugh B/C) were 96.7% (116/120) and 82% (23/28)respectively. 96.4% (80/83) of patients with previous exposure to interferon and ribavirin achieved SVR12. All patients with HIV co infection achieved SVR (n = 8). 89% of liver transplant patients achieved SVR. 18%(5/28) of the decompensated cohort (Child Pugh B/C) had died within 2 years of commencing treatment. Conclusions: SOF + DCV + RBV for 12 weeks achieved real world SVR12 rates comparable with 24 weeks treatment in cirrhotic genotype 3 patients or 12 weeks sofosbuvir/velpastasvir. This is the largest reported cohort of posttransplant genotype 3 patients with advanced fibrosis. Our data suggests 12 weeks treatment for all cirrhotic patients may be considered regardless of previous interferon and ribavirin exposure (Table presented).