Oral combination proves safe for patients who could not have interferon therapy
SAN ANTONIO (April 15, 2014) — 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, noted Fred Poordad, M.D., lead author on the study, which was released by The New England Journal of Medicine in conjunction with Dr. Poordad’s presentation of the data Saturday (April 12) 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 Dr. Poordad is a clinical 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,” Dr. Poordad said. “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, M.D. Diagnosed with hepatitis C infection 11 years ago, Dr. 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, M.D., of the Texas Liver Institute told him of the possibility of treatment with the new therapy, Dr. Buentello said 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,” Dr. Buentello said.
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.
UT Medicine San Antonio is the clinical practice of the School of Medicine at the UT Health Science Center San Antonio. With more than 700 doctors – all School of Medicine faculty – UT Medicine is the largest medical practice in Central and South Texas. Expertise is in more than 100 medical specialties and subspecialties. Primary care doctors and specialists see patients in private practice at UT Medicine’s flagship clinical home, the Medical Arts & Research Center (MARC), located at 8300 Floyd Curl Drive, San Antonio 78229. Most major health plans are accepted, and UT Medicine physicians also practice at several local and regional hospitals. Call (210) 450-9000 to schedule an appointment, or visit http://www.UTMedicine.org for a list of clinics and phone numbers.
The Texas Liver Institute’s mission is to set the standard of excellence in care and innovative research in the field of liver disease. The institute is affiliated with The University of Texas Health Science Center at San Antonio. The physicians are professors and teach at University Hospital of the University Health System and are involved with the liver transplantation program of the University Transplant Center, a partnership of the Health Science Center and the University Health System. For more information, visit http://www.txliver.com/.