Investigators of a new clinical trial for people with both chronic hepatitis C viral (HCV) infection and bleeding disorders are currently recruiting new patients. HCV trials often exclude patients with conditions such as hemophilia, which makes this new study noteworthy and relevant to the bleeding disorders community.
The Phase 2b, multicenter trial, “Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination and Sofosbuvir + Ribavirin for Subjects with Chronic Hepatitis C Virus and Inherited Bleeding Disorders,” is being sponsored by Gilead Sciences. In February 2014, Gilead filed a New Drug Application with the US Food and Drug Administration for ledipasvir (LDV)/sofosbuvir (SOF), a fixed-dose combination therapy for genotype 1 HCV. Both drugs are direct-acting antivirals. LDV is an NS5A inhibitor, a drug that disrupts nonstructural proteins HCV needs to replicate. SOF is a nucleotide analog polymerase inhibitor, which blocks polymerase, an enzyme that provides instructions for making copies of HCV RNA.
The purpose of the study is to determine the efficacy, safety and tolerability of treatment with LDV/SOF fixed-dose combination for participants with genotypes 1 and 4 HCV infection, and SOF + ribavirin for participants with genotypes 2 and 3 HCV infection.
This trial is recruiting people exclusively with inherited bleeding disorders and chronic HCV infection (either mono-infected or HIV-1/HCV co-infected).
