BOSTON - A large multi-center clinical trial has found that a combination of antiviral medications can eradicate hepatitis C infection in more than 90 percent of patients with advanced liver disease. Known as the ASTRAL-4 trial, the study was co-led by investigators at Beth Israel Deaconess Medical Center (BIDMC) and Intermountain Medical Center and published online Nov. 17 in The New England Journal of Medicine (NEJM).
"More than half of the patients in the study had failed a prior course of treatment for hepatitis C infection," said co-principal investigator Michael Curry, MD, Director of Hepatology and Medical Director of Liver Transplantation at BIDMC and Associate Professor of Medicine at Harvard Medical School. "Our trial showed that using a daily combination of the antiviral medications Sofosbuvir and Velpatasvir, with or without the addition of Ribavirin for 12 weeks or 24 weeks, successfully treated Hepatitis C in 83 percent to 94 percent of patients."
The hepatitis C virus (HCV) infects between 130 and 150 million individuals worldwide and is a common cause of liver failure and cirrhosis, which develops when healthy liver tissue is replaced with scar tissue, eventually preventing the liver from carrying out its functions. A total of 267 patients with liver failure caused by hepatitis C participated in the randomized Phase 3 clinical study at 47 sites across the United States.
"There have been few treatment options available for treating hepatitis C infection in patients with existing cirrhosis and liver failure," said Curry. "Our study found that early improvements in liver function were seen in a substantial portion of the study participants, as indicated by improvement in the Childs Pugh score, which assesses severity of liver cirrhosis, and the MELD score, which is used to determine patient priority for liver transplantation."
The liver is largest solid organ in the body and plays a number of key roles, including the manufacture of blood proteins to aid in clotting and immune system function, the manufacture of bile for the digestion of food, and the storage of energy-producing glucose. The liver also rids the body of harmful substances, such as alcohol.
"The number of patients with liver failure due to hepatitis C is expected to substantially increase over the next 10 years," said Curry. "These new findings indicate that patients with more advanced liver disease can still benefit from treatment of hepatitis C -- and that elimination of this infection is associated with early improvement in liver function."
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Study coauthors include co-principal investigator Michael Charlton, MD, Intermountain Medical Center, Salt Lake City, Utah; Jacqueline O'Leary, MD, MPH, Baylor University Medical Center; Eric Lawitz, MD, University of Texas Health Science Center; Natalie Bzowej, MD, Ochsner Medical Center; Andrew Muir, MD, Duke University School of Medicine; Michael Fried, MD, University of North Carolina at Chapel Hill; Kevin Korenblat, MD, Washington University School of Medicine; Jonathan M. Fenkel, MD, Thomas Jefferson University; K. Rajender Reddy, MD, University of Pennsylvania School of Medicine; Steven Flamm, MD, Northwestern University; Thomas Schiano, MD, Mount Saini Hospital; Lewis Teperman, MD, New York University School of Medicine; Robert Brown Jr., MD, MPH, Weill Cornell Medical College; Robert Fontana, MD, University of Michigan; Eugene Schiff, MD, University of Miami; as well as Brian Doehle, PhD; Di An, PhD; John McNally, PhD; Anu Osinusi, MD; Diana Brainard, MD; and John McHutchison, MD, all of Gilead Sciences.
This study was supported by Gilead Sciences.
About Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center is a patient care, teaching and research affiliate of Harvard Medical School and consistently ranks as a national leader among independent hospitals in National Institutes of Health funding.
BIDMC is in the community with Beth Israel Deaconess Hospital-Milton, Beth Israel Deaconess Hospital-Needham, Beth Israel Deaconess Hospital-Plymouth, Anna Jaques Hospital, Cambridge Health Alliance, Lawrence General Hospital, Signature Healthcare, Beth Israel Deaconess HealthCare, Community Care Alliance and Atrius Health. BIDMC is also clinically affiliated with the Joslin Diabetes Center and Hebrew Rehabilitation Center and is a research partner of Dana-Farber/Harvard Cancer Center and the Jackson Laboratory. BIDMC is the official hospital of the Boston Red Sox. For more information, visit http://www.bidmc.org.
Journal
New England Journal of Medicine