Ledipasvir–sofosbuvir and sofosbuvir plus ribavirin in patients with chronic hepatitis C and bleeding disorders. Issue 2 (25th January 2017)

• Record Type: Journal Article
• Authors: Walsh, C. E.; Workowski, K.; Terrault, N. A.; Sax, P. E.; Cohen, A.; Bowlus, C. L.; Kim, A. Y.; Hyland, R. H.; Han, B.; Wang, J.; Stamm, L. M.; Brainard, D. M.; McHutchison, J. G.; von Drygalski, A.; Rhame, F.; Fried, M. W.; Kouides, P.; Balba, G.; Reddy, K. R.
• Is Part Of: Haemophilia. Volume 23:Issue 2(2017)
• Page Start: 198
• Page End: 206
• Publication Date: 2017-01-25
• Subjects: hepatitis C virus -- ledipasvir–sofosbuvir fixed‐dose combination -- NS5A inhibitor -- NS5B inhibitor -- ribavirin -- sofosbuvir; Hemophilia -- Periodicals; 616.1572005
• DOI: 10.1111/hae.13178
• Languages: English
• ISSNs: 1351-8216

Abstract

Abstract : Introduction: Chronic hepatitis C virus (HCV) infection is prevalent among patients with inherited bleeding disorders and is a leading cause of mortality in those with haemophilia. Aim: We evaluated the efficacy and safety of ledipasvir–sofosbuvir and sofosbuvir plus ribavirin in patients with chronic HCV genotype 1–4 infection and an inherited bleeding disorder. Methods: Ledipasvir–sofosbuvir was administered for 12 weeks to patients with genotype 1 or 4 infection and for 12 or 24 weeks to treatment‐experienced cirrhotic patients with genotype 1 infection. Patients with genotype 2 and 3 infection received sofosbuvir plus ribavirin for 12 and 24 weeks respectively. Results: The majority of the 120 treated patients had a severe bleeding disorder (55%); overall, 65% of patients had haemophilia A and 26% of patients had haemophilia B; 22% were HIV coinfected. Sustained virologic response at 12 weeks posttreatment was 99% (98/99) in patients with genotype 1 or 4 infection; 100% (5/5) in treatment‐experienced cirrhotic patients with genotype 1 infection; 100% (10/10) in patients with genotype 2 infection; and 83% (5/6) in patients with genotype 3 infection. There were no treatment discontinuations due to adverse events (AEs). The most frequent non‐bleeding AEs were fatigue, headache, diarrhoea, nausea and insomnia. Bleeding AEs occurred in 22 patients, of which all but one were considered unrelated to treatment. Conclusion: Treatment with ledipasvir–sofosbuvir for patients with HCV genotype 1 or 4 infection or sofosbuvir plus ribavirin for patients with genotype 2 or 3 infection was highly effective and well tolerated among those with inherited bleeding disorders.