Sofosbuvir-based therapy successfully treats HCV patients with decompensated liver disease, according to a new study.
Patients infected with hepatitis C virus (HCV) who have decompensated liver disease should be treated with a sofosbuvir-based regimen, according to a new study.
Direct-acting antiviral agents (DAAs) have transformed the treatment of chronic HCV infection. However, the impact of treating with DAAs versus no treatment on key outcomes in patients with decompensated cirrhosis has not been well defined.
“This is the first study to demonstrate the impact of DAAs in this sick population in the context of multiple clinical trials and comparing to a group of control patients who were not treated,” senior author Michael Charlton, MD, associate director of Intermountain Medical Center Transplant Program in Salt Lake City, Utah, told Medical Economics.
The researchers presented the results at the 2017 International Joint Congress of ILTS, ELITA & LICAGE in Prague, Czech Republic.
Next: Study details
They compared the outcomes of 1,857 patients waitlisted for liver transplant in the United Network for Organ Sharing Database in the five years before FDA approval of sofosbuvir with 623 similar patients who were treated with sofosbuvir in four prospective, multicenter, multinational randomized controlled clinical trials.
At 48 weeks, 95% of patients in the sofosbuvir group were alive and had not undergone transplant compared with 30% of controls. The liver transplant rate was only 3% in sofosbuvir patients compared with 43% among controls. Models have been developed that can determine the likely benefit or futility for individual patients, noted Charlton.
“Benefits can be measured in terms of laboratory values (bilirubin, albumin, prothrombin time), avoiding the need for liver transplantation, survival and resolution/near resolution of all laboratory and clinical abnormalities. Each of these was several fold more likely in treated patients,” he said.
He recommends sofosbuvir-based therapy specifically in patients with decompensated cirrhosis. “There are other choices for patients with milder forms of disease. Sofosbuvir can be used with other agents, but is the cornerstone of DAA therapy in this population,” said Charlton.
“It is the safety and efficacy profile that makes sofosbuvir an essential component,” he added. “Patients can be too sick to be treated. There are not enough data to know the safety and efficacy in patients with a MELD score of greater than 30, for example.”
Patients with decompensated liver disease are commonly denied access to antiviral therapy by payers or providers. This study shows the dramatic potential benefit of extending therapy to these patients. The next step is to extend the period of follow-up to look at the longer term impact, he said.
Charlton noted that the benefits do not only accrue to patients with HCV. “A liver that is not needed for a patient with HCV infection can be used to save the life of a patient with an incurable liver disease,” said Charlton, who added that about 1 in 5 patients die waiting for a liver transplant.
He recommends that primary care physicians refer patients with cirrhosis due to HCV infection to a transplant center for evaluation and consideration of antiviral therapy. “You might save two lives,” said Charlton.