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Stedman CAM, Hyland RH, Ding X, et al. Once daily ledipasvir/sofosbuvir fixed-dose combination with ribavirin in patients with inherited bleeding disorders and hepatitis C genotype 1 infection. Haemophilia. 2015;22(2):214-217doi: 10.1111/hae.12791.
Stedman, C. A. M., Hyland, R. H., Ding, X., Pang, P. S., McHutchison, J. G., & Gane, E. J. (2016). Once daily ledipasvir/sofosbuvir fixed-dose combination with ribavirin in patients with inherited bleeding disorders and hepatitis C genotype 1 infection. Haemophilia : the official journal of the World Federation of Hemophilia, 22(2), 214-217. https://doi.org/10.1111/hae.12791
Stedman, C A M, et al. "Once daily ledipasvir/sofosbuvir fixed-dose combination with ribavirin in patients with inherited bleeding disorders and hepatitis C genotype 1 infection." Haemophilia : the official journal of the World Federation of Hemophilia vol. 22,2 (2016): 214-217. doi: https://doi.org/10.1111/hae.12791
Stedman CAM, Hyland RH, Ding X, Pang PS, McHutchison JG, Gane EJ. Once daily ledipasvir/sofosbuvir fixed-dose combination with ribavirin in patients with inherited bleeding disorders and hepatitis C genotype 1 infection. Haemophilia. 2016 Mar;22(2):214-217. doi: 10.1111/hae.12791. Epub 2015 Aug 28. PMID: 26315711.
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Haemophilia. 2016 Mar;22(2):214-217. doi: 10.1111/hae.12791. Epub 2015 Aug 28.

Once daily ledipasvir/sofosbuvir fixed-dose combination with ribavirin in patients with inherited bleeding disorders and hepatitis C genotype 1 infection.

Haemophilia : the official journal of the World Federation of Hemophilia

C A M Stedman, R H Hyland, X Ding, P S Pang, J G McHutchison, E J Gane

Affiliations

  1. Gastroenterology Department, Christchurch Hospital and University of Otago, Christchurch, New Zealand.
  2. Gilead Sciences Inc., Foster City, CA, United States.
  3. New Zealand Liver Transplant Unit, Auckland City Hospital, Auckland, New Zealand.

PMID: 26315711 DOI: 10.1111/hae.12791

Abstract

AIM: People with inherited bleeding disorders have been disproportionally affected by HCV. We assessed the fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) with the NS5B polymerase inhibitor sofosbuvir (SOF) with ribavirin (RBV) in patients with genotype 1 HCV and inherited bleeding disorders.

METHODS: To be eligible, patients had to be over 18 years of age and have an inherited bleeding disorder. HCV treatment-naïve and -experienced patients could enrol. All patients received LDV 90 mg per SOF 400 mg once daily and weight-based RBV in a divided dose for 12 weeks. The primary efficacy endpoint was sustained virologic response (SVR), defined as HCV RNA below the limit of detection (15 IU mL

RESULTS: Of the 14 patients enrolled, 8 (57%) had haemophilia A, 3 (21%) had haemophilia B and 2 (14%) had von Willebrand disease, and 1 (7%) had factor XIII deficiency. All 14 patients (100%, 95% CI: 77-100%) achieved SVR12. Treatment was well tolerated: all patients completed therapy, with mostly mild adverse events. No specific safety concerns associated with the patient's underlying bleeding disorders were noted.

CONCLUSION: These results appear to suggest that people with HCV and inherited bleeding disorders can be safely and effectively treated with 12 weeks of LDV/SOF plus RBV.

© 2015 John Wiley & Sons Ltd.

Keywords: antiviral; haemophilia; hepatitis C virus; ledipasvir; sofosbuvir

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