Efficacy and Safety of Ledispavir/Sofosbuvir with or without Ribavirin in patients with Decompensated Liver Cirrhosis and Hepatitis C Infection: a Cohort Study

Authors

  • 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

DOI:

https://doi.org/10.15403/jgld-2448

Keywords:

ledipasvir/sofosbuvir, ribavirin, liver cirrhosis, hepatitis C virus, direct acting antiviral agents

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.

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Published

2020-09-09

How to Cite

1.
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, Manuc M. Efficacy and Safety of Ledispavir/Sofosbuvir with or without Ribavirin in patients with Decompensated Liver Cirrhosis and Hepatitis C Infection: a Cohort Study. JGLD [Internet]. 2020 Sep. 9 [cited 2025 Jul. 14];29(3):385-90. Available from: https://jgld.ro/jgld/index.php/jgld/article/view/2448

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Original Article