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Efficacy and Safety of Ledispavir/Sofosbuvir with or without Ribavirin in patients with Decompensated Liver Cirrhosis and Hepatitis C Infection: a Cohort Study.
- Source :
-
Journal of gastrointestinal and liver diseases : JGLD [J Gastrointestin Liver Dis] 2020 Sep 09; Vol. 29 (3), pp. 385-390. Date of Electronic Publication: 2020 Sep 09. - Publication Year :
- 2020
-
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).<br />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.<br />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).<br />Conclusions: LDV/SOF±RBV proved to be highly efficient in our difficult to treat population with 85.1% SVR.
- 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
Subjects
Details
- Language :
- English
- ISSN :
- 1842-1121
- Volume :
- 29
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- Journal of gastrointestinal and liver diseases : JGLD
- Publication Type :
- Academic Journal
- Accession number :
- 32919421
- Full Text :
- https://doi.org/10.15403/jgld-2448