Gilead announces Phase II results in hepatitis C trials
Gilead scientists evaluated the treatment regimen of an investigational once-daily nucleotide analogue of sofosbuvir plus ribavirin for the prevention and treatment of chronic hepatitis C virus infection among patients undergoing liver transplantation. HCV recurrence is common following liver transplantation.
In a study conducted among pre-transplant HCV patients, the patients received up to 48 weeks of the investigational therapy. The researchers found that 64 percent of patients with undetectable HCV at the time of transplantation achieved undetectable HCV RNA 12 weeks post transplantation, which is also known as PTVR12. Patients who are PTVR12 are considered cured of HCV infection.
In the second study, patients with HCV infection after liver transplantation received 24 weeks of the investigational treatment. The study found that 77 percent of patients in the study achieved a sustained virologic response four weeks after the conclusion of treatment.
Three percent of patients in the pre-transplant study and five percent of patients in the post-transplant study discontinued treatment due to adverse events. There were no serious adverse events reported that were associated with sofosbuvir.
"Recurrence of HCV following liver transplantation almost always occurs in clinical practice," Michael Curry, an investigator for the pre- and post-liver transplant trials, said. "These patients are at higher risk for disease progression the development of cirrhosis liver graft failure re-transplantation and increased morbidity and mortality. In these studies sofosbuvir clearly demonstrated the potential to improve patient outcomes by either preventing or effectively treating recurrent HCV infection following liver transplantation."
HCV infection is the most common cause of liver transplantation in Europe and the U.S. Recurrence of HCV infection is universal among patients with active hepatitis C at the time of transplantation. Currently available treatment options to suppress HCV RNA before liver transplantation are typically ineffective and poorly tolerated.