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

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

doi:10.1111/hae.12791

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.

Authors

C A M Stedman¹, R H Hyland², X Ding², P S Pang², J G McHutchison², E J Gane³

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^-1 ) 12 weeks after the end of treatment (SVR12).

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.

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