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J Viral Hepat. 2019 Feb 11. doi: 10.1111/jvh.13075. [Epub ahead of print]

Low recurrence rate of hepatocellular carcinoma following ledipasvir and sofosbuvir treatment in a real-world chronic hepatitis C patients cohort.

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Department of Gastroenterology, Ankara University School of Medicine, Ankara, Turkey.
Department of Gastroenterology, Mustafa Kemal University School of Medicine, Hatay, Turkey.
Department of Gastroenterology, İnönü University School of Medicine, Malatya, Turkey.
Department of Internal Medicine, Ankara University School of Medicine, Ankara, Turkey.
Department of Gastroenterology, İstanbul University İstanbul School of Medicine, İstanbul, Turkey.
Department of Gastroenterology, Hacettepe University School of Medicine, Ankara, Turkey.
Department of Gastroenterology, Memorial Sisli Hospital, İstanbul, Turkey.
Mersin State Hospital, Mersin, Turkey.
Department of Gastroenterology, Ege University School of Medicine, İzmir, Turkey.
Department of Infectious Disease, Karadeniz Technical University, Faculty of Medicine, Trabzon, Turkey.
Department of Gastroenterology, Osmangazi University School of Medicine, Eskişehir, Turkey.
Department of Gastroenterology, Marmara University School of Medicine, İstanbul, Turkey.
Department of Gastroenterology, Necmettin Erbakan University Meram School of Medicine, Konya, Turkey.
Department of Gastroenterology, Türkiye Yüksek İhtisas Hospital, Ankara, Turkey.
Department of Gastroenterology, Uludag University School of Medicine, Bursa, Turkey.
Department of Gastroenterology, Sakarya University School of Medicine, Sakarya, Turkey.
Department of Gastroenterology, Kocaeli University School of Medicine, Department of Infectious Disease and Clinical Microbiology, Kocaeli, Turkey.
Department of Infectious Disease and Clinical Microbiology, İstanbul University Cerrahpasa School of Medicine, İstanbul, Turkey.


The aims of the present study were to evaluate the efficacy and tolerability of ledipasvir/sofosbuvir (LDV/SOF) with or without ribavirin in the treatment of chronic hepatitis C (CHC) in patients with advanced liver disease and to analyse whether the use of LDV/SOF treatment is associated with a new occurrence of hepatocellular carcinoma (HCC) during and after LDV/SOF treatment. The Turkish Early Access Program provided LDV/SOF treatment to a total of 200 eligible CHC patients with advanced liver disease. The median follow-up period was 22 months. All patients were Caucasian, 84% were infected with genotype 1b, and 24% had a liver transplantation before treatment. The sustained virological response (SVR12) was 86.0% with ITT analysis. SVR12 was similar among patients with Child-Pugh classes A, B and C disease and transplant recipients. From baseline to SVR12, serum ALT level and MELD score were significantly improved (P < 0.001). LDV/SOF treatment was generally well tolerated. Only one patient developed a new diagnosed HCC. Seventeen of the 35 patients, who had a history of previous HCC, developed HCC recurrence during the LDV/SOF treatment or by a median follow-up of 6 months after treatment. HCC recurrence was less commonly observed in patients who received curative treatment for HCC compared with those patients who received noncurative treatment (P = 0.007). In conclusion, LDV/SOF with or without ribavirin is an effective and tolerable treatment in CHC patients with advanced liver disease. Eradication is associated with improvements in liver function and a reduced risk of developing a new occurrence of HCC.


cirrhosis; direct-acting antivirals; hepatitis C virus; hepatocellular carcinoma; liver transplantation


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