A new study seeks to enroll patients with chronic hepatitis C viral (HCV) infection and mild or moderate hemophilia to assess the safety and efficacy of an HCV therapy regimen that includes the oral drugs daclatasvir (NS5A inhibitor) and ribavirin, plus intravenous injections of pegylated interferon. Bristol-Myers Squibb is sponsoring “A Phase 3 Evaluation of the Safety and Efficacy of Lambda/RBV/DCV in Treatment Naive Subjects with Chronic HCV Infection, Who Have Underlying Mild or Moderate Hemophilia or Patients Who Are Prior Relapsers to Pegylated Interferon Alfa/RBV.”
The effectiveness of the therapy will be defined through sustained virological response (SVR), which reflects a patient’s ability to “clear” the virus. Though not technically a cure--HCV is difficult to eliminate from the liver--SVR is still the goal for clinicians. Lowering the viral load to undetectable levels in the bloodstream decreases the disease’s most harmful effects. Success is usually signaled when SVR is sustained for at least six months after completion of the therapy. Investigators in this study will measure SVR at various points throughout the study, including 12 weeks after the cessation of treatment and at the bench mark of 24 weeks (six months).
To be eligible for the study, patients must meet the following baseline criteria:
- infection with HCV with underlying mild or moderate hemophilia
- males 18 years of age and above
- have not been previously treated with an interferon
At the time of this release, patient recruitment had not yet begun. The study is slated to begin in February 2013. For updates on this and other clinical studies, go to http://www.clinicaltrials.gov, a service of the U.S. National Institutes of Health.
Source: clinicaltrials.gov, December 2012