Effects of Harvoni in Patients With Decompensated Cirrhosis Due to Hepatitis C Genotype 1 Infection
Status:
Completed
Trial end date:
2018-06-01
Target enrollment:
Participant gender:
Summary
There are now several licensed drug treatments for patients with HCV infection. These
medications have been shown to be very effective in getting rid of the virus in patients with
HCV infection including those with early stages of cirrhosis without complications known as
compensated cirrhosis, with a greater than 90% cure rate. At present, there are very little
data to show that treating patients with HCV infection and decompensated cirrhosis will give
the same effects. However, patients with decompensated cirrhosis as a result of hepatitis B
infection who received treatment to control their virus show improvement of their overall
liver condition, and the liver complications of many of these patients disappeared. Also,
patients with cirrhosis due to excess alcohol and who stopped drinking also showed
improvement in liver function and their complications of cirrhosis coming under control.
Therefore, treatment of patients with HCV infection and decompensated cirrhosis is expected
to show the same positive effects, because the underlying cause of cirrhosis is coming under
control. Harvoni is a combination of two direct-acting antivirals (ledipasvir and sofosbuvir)
that prevents the hepatitis C virus from copying and multiplying themselves, allowing the
body to clear the virus from their systems and be cured of HCV infection. This study is being
conducted to find out if treatment with Harvoni will lead to clearance of HCV infection in
patients with decompensated cirrhosis giving rise to improvement in liver function, together
with improvement of quality of life and survival.
Phase:
Phase 3
Details
Lead Sponsor:
University Health Network, Toronto
Collaborator:
Gilead Sciences
Treatments:
Ledipasvir Ledipasvir, sofosbuvir drug combination Sofosbuvir