Open AccessEfficacy and Safety of Ledispavir/Sofosbuvir with or without Ribavirin in patients with Decompensated Liver Cirrhosis and Hepatitis C Infection: a Cohort Study
Author(s) -
L. Gheorghe,
Preda Carmen,
Laura Iliescu,
Doina Istrătescu,
Andreea Elena Chifulescu,
Corina Silvia Pop,
Anca Trifan,
C Stanciu,
Mircea Diculescu,
Theodor Voiosu,
Cristian Băicuș,
Letiţia Tugui,
Speranţa Iacob,
Cristian Tieranu,
Corina Meianu,
Mircea Mănuc
Publication year - 2020
Publication title -
journal of gastrointestinal and liver diseases
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.641
H-Index - 48
eISSN - 1842-1121
pISSN - 1841-8724
DOI - 10.15403/jgld-2448
Subject(s) - medicine , sofosbuvir , cirrhosis , gastroenterology , ribavirin , cohort , hepatitis c virus , hepatitis c , population , hepatocellular carcinoma , immunology , virus , environmental health
Background and Aims: Ledipasvir/Sofosbuvir (LDV/SOF) with or without Ribavirin (RBV) has shown good results in terms of efficacy and safety in clinical trials in advanced liver cirrhosis, but real-life data are still needed in order to confirm this profile. We investigated the efficacy and safety of LDV/SOF in a large Romanian population with liver cirrhosis and genotype 1b hepatitis C virus (HCV).
Methods: We analyzed a multicentric retrospective cohort enrolling 349 patients with decompensated liver cirrhosis due to HCV who received LDV/SOF±RBV 12/24 weeks (301/48). Patients were included between 2017-2018, all with genotype 1b. Main inclusion criteria were liver cirrhosis and detectable HCV RNA. The cases were followed-up monthly during therapy and 12 weeks after the end of therapy.
Results: The cohort included 60% females with a median age of 61, 16% interferon (IFN) pre-treated, 53% with comorbidities, 40/53/7 % with Child Pugh A/B/C, 4% with virus B co-infection and 8% with previously treated hepatocellular carcinoma. Mean initial MELD score was 11.92 (6.82÷ 24.5). Six patients were lost during follow-up. Sustained virologic response (SVR) in intention-to-treat was reported in 85.1%. Predictive factors of SVR in decompensated cirrhosis were female gender (p=0.01), advanced age (p 3.5g/dl (p=0.002) predicted improvement of liver function. Serious adverse events were reported in 16/349 (4.6%), most of them due to severe liver decompensation (9/16).
Conclusions: LDV/SOF±RBV proved to be highly efficient in our difficult to treat population with 85.1% SVR.