1. Efficacy and Safety of Ledispavir/Sofosbuvir with or without Ribavirin in patients with Decompensated Liver Cirrhosis and Hepatitis C Infection: a Cohort Study.
- Author
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Gheorghe LS, Preda C, Iliescu L, Istratescu D, Chifulescu AE, Pop CS, Trifan A, Stanciu C, Diculescu M, Voiosu T, Baicus C, Tugui L, Iacob S, Tieranu C, Meianu C, and Manuc M
- Subjects
- Adult, Aged, Aged, 80 and over, Antiviral Agents adverse effects, Benzimidazoles adverse effects, Female, Fluorenes adverse effects, Genotype, Hepacivirus genetics, Hepatitis C diagnosis, Hepatitis C virology, Humans, Liver Cirrhosis diagnosis, Liver Cirrhosis virology, Male, Middle Aged, Retrospective Studies, Ribavirin adverse effects, Romania, Sofosbuvir adverse effects, Sustained Virologic Response, Time Factors, Treatment Outcome, Viral Load, Antiviral Agents therapeutic use, Benzimidazoles therapeutic use, Fluorenes therapeutic use, Hepatitis C drug therapy, Liver Cirrhosis drug therapy, Ribavirin therapeutic use, Sofosbuvir therapeutic use
- Abstract
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<0.001), lower bilirubin levels (p=0.002) and lower CTP score (p=0.02). In patients with CTP score B or C low bilirubin levels (p=0.003), low INR (p<0.001), increased platelet count (p=0.04), low CTP score (p<0.001), lack of encephalopathy (p=0.02), serum albumin >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.
- Published
- 2020
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