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Affiliations
Liliana Simona Gheorghe
Carol Davila University of Medicine and Pharmacy, Gastroenterol and Hepatol Depart, Clinic Fundeni Institute, Bucharest, Romania
Carmen Preda
Carol Davila University of Medicine and Pharmacy, Gastroenterol and Hepatol Depart, Clinic Fundeni Institute, Bucharest, Romania
Laura Iliescu
Carol Davila University of Medicine and Pharmacy, Internal Medicine Depart, Clinic Fundeni Institute, Bucharest, Romania
Doina Istratescu
Gastroenterol and Hepatol Depart, Clinic Fundeni Institute, Bucharest; 4) Carol Davila University of Medicine and Pharmacy, Internal Medicine Depart, Emergency Universitary Hospital, Bucharest, Romania
Andreea Elena Chifulescu
Gastroenterol and Hepatol Depart, Clinic Fundeni Institute, Bucharest; 4) Carol Davila University of Medicine and Pharmacy, Internal Medicine Depart, Emergency Universitary Hospital, Bucharest, Romania
Corina Silvia Pop
UMF „Carol Davila” Internal Medicine Department, Emergency Universitary Hospital, Bucharest, Romania
Anca Trifan
Gr. T. Popa University of Medicine and Pharmacy, Gastroenterol and Hepatol Depart, Gastroenterol and Hepatol Institute, Iasi, Romania
Carol Stanciu
Gr. T. Popa University of Medicine and Pharmacy, Gastroenterol and Hepatol Depart, Gastroenterol and Hepatol Institute, Iasi, Romania
Mircea Diculescu
Carol Davila University of Medicine and Pharmacy, Gastroenterol and Hepatol Depart, Clinic Fundeni Institute, Bucharest, Romania
Theodor Voiosu
Carol Davila University of Medicine and Pharmacy, Internal Medicine Depart, Colentina Hospital, Bucharest, Romania
Cristian Baicus
Carol Davila University of Medicine and Pharmacy, Internal Medicine Depart, Colentina Hospital, Bucharest, Romania
Letitia Tugui
Gastroenterology and Hepatology Department, Clinic Fundeni Institute, Bucharest, Romania
Speranta Iacob
Carol Davila University of Medicine and Pharmacy, Gastroenterol and Hepatol Depart, Clinic Fundeni Institute, Bucharest, Romania
Cristian Tieranu
Carol Davila University of Medicine and Pharmacy, Gastroenterol and Hepatol Depart, Elias Emergency Hospital, Bucharest, Romania
Corina Meianu
Carol Davila University of Medicine and Pharmacy, Gastroenterol and Hepatol Depart, Clinic Fundeni Institute, Bucharest, Romania
Mircea Manuc
Carol Davila University of Medicine and Pharmacy, Gastroenterol and Hepatol Depart, Clinic Fundeni Institute, Bucharest, Romania
How to Cite
Efficacy and Safety of Ledispavir/Sofosbuvir with or without Ribavirin in patients with Decompensated Liver Cirrhosis and Hepatitis C Infection: a Cohort Study
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.