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Twelve weeks of an investigational oral therapy cured hepatitis C infection in more than 90 percent of patients with liver cirrhosis and was well tolerated by these patients, according to an international study that included researchers from UT Medicine San Antonio and the Texas Liver Institute. Historically, hepatitis C cure rates in patients with cirrhosis (liver scarring) have been lower than 50 percent and the treatment was not safe for many of these patients.
Hepatitis C virus is the No. 1 driver of cirrhosis, liver transplants and liver cancer in the United States, notes Fred Poordad, MD, lead author on the study, which was released Saturday by The New England Journal of Medicine in conjunction with Poordad's presentation of the data at the International Liver Congress in London. UT Medicine is the clinical practice of the School of Medicine at the University of Texas Health Science Center at San Antonio, where Poordad is a professor of medicine. He is vice president of the Texas Liver Institute in San Antonio.
Interferon previously was the only agent to show effectiveness against hepatitis C, but patients often relapsed and the therapy caused multiple side effects. The new regimen is interferon-free and consists of several agents - ABT-450/ritonavir, ombitasvir, dasabuvir and ribavirin. Twelve weeks after the last dose, no hepatitis C virus was detected in the bloodstream of 91.8 percent of patients who took the pills for 12 weeks. Among patients treated for 24 weeks, 95.9 percent were virus-free 12 weeks after the end of therapy.
"These are out-of-the-ballpark response rates, not on the same planet as interferon," Poordad says. "The reason this study is so profound is because interferon is not tolerated nor is it safe in many people with cirrhosis. Many of the patients with cirrhosis in this study were not even eligible to be treated with interferon."
One of those patients was retired San Antonio anesthesiologist Sergio Buentello, MD. Diagnosed with hepatitis C infection 11 years ago, Buentello had treatment with side effects and no cure eight years ago. "My viral count came down, but never to zero," he said.
When Eric Lawitz, MD, of the Texas Liver Institute told him of the possibility of treatment with the new therapy, Buentello says he was skeptical. But as for so many others, the therapy worked.
"I feel very lucky to be living in this time, because I was almost resigned to the idea that I could never be cured," Buentello says.
The study examined outcomes in 380 patients at 78 sites, including hospitals and centers in Spain, Germany, England, Canada and the U.S. The biopharmaceutical company AbbVie provided support.
Investigators are cataloging patient blood samples for three years after therapy and so far have noticed no long-term, late relapses, Dr. Poordad said.
"Patients with advanced liver disease can now be cured of their hepatitis with a very well-tolerated and short regimen," he said.
The combination medication regimen is expected to be on the market as early as the end of 2014 or very early 2015.
Source: UT Medicine San Antonio, Texas Liver Institute