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The use of sofosbuvir and velpatasvir successfully treated hepatitis C virus infection in 90% of advanced liver disease patients, a new study notes.
A combination of antiviral medications can eradicate hepatitis C virus (HCV) infection in more than 90% of patients with advanced liver disease, according to a large multi-center clinical trial.
“The results demonstrate that even in patients with liver cirrhosis and liver failure, HCV can be eradicated with a combination of sofosbuvir and velpatasvir, with or without the addition of ribavirin for 12 weeks or 24 weeks,” the co-principal investigator Michael Curry, MD, associate professor of medicine at Harvard Medical School, told Medical Economics.
The number of patients with liver failure due to HCV infections is expected to increase substantially over the next 10 years. The current treatment for patients with liver failure is to add these patients to the liver transplant waiting list for liver transplantation.
Presently, there is no approved therapy for patients with decompensated liver cirrhosis, Curry noted.
The phase 3, randomized, open-label study enrolled 267 patients with liver failure caused by HCV infections.
The study results were published online in the November 17, 2015, issue of the New England Journal of Medicine.
Using a daily combination of the antiviral medications successfully treated HCV in 83-94% of patients. More than half of the patients had failed a prior course of treatment.
Additionally, with eradication of HCV, the researchers found visible improvement in liver function in a significant number of patients, in particular among those with more advanced liver disease.
Serious adverse events occurred in 19% of patients who received 12 weeks of sofosbuvir–velpatasvir, 16% of those who received 12 weeks of that combination plus ribavirin, and 18% of those who received 24 weeks of sofosbuvir–velpatasvir.
The most common adverse events were fatigue (29%), nausea (23%) and headache (22%) in all patients and anemia (31%) in the patients receiving ribavirin.
“These new findings indicate that patients with more advanced liver disease can still benefit from treatment of HCV and that elimination of this infection is associated with early improvement in liver function,” Curry said.
Eradication of HCV in patients with advanced liver disease may translate into fewer liver transplants. “While we did not look at liver transplant candidacy in this study, one could think that improvement in liver function might lead to a decrease in the need for liver transplantation in select patient groups,” said Curry, which is now the focus of other studies.
The important message for clinicians is to continue to test patients for HCV, said Curry. “Ideally, it is best to eradicate HCV prior to the development of liver failure,” he said.
A large fraction of the HCV population still remains undiagnosed. “Three-quarters of patients with HCV come from the baby boomer era. This is the group that needs to be targeted with widespread testing,” Curry said.