New Combination Therapy Works Well With Liver Transplants In Hepatitis C

New Combination Therapy Works Well With Liver Transplants In Hepatitis C

Liver Transplants In Hepatitis CDuring the American Association for the Study of Liver Diseases (The Liver Meeting® 2014) to be held in Boston, MA, between November 7 and 11, a new report will be presented on the use of two new drugs, simeprevir and sofosbuvir, in liver transplant patients by the research group of the study’s lead researcher Surakit Pungpapong, M.D., a transplant hepatologist and an associate professor of medicine at Mayo Clinic in Florida.

Chronic hepatitis C infection is a disease of the liver caused by the blood-borne hepatitis C virus (HCV). It is the most common chronic blood-borne infection in the United States, affecting more than 3 million people. Around 130–150 million people worldwide have chronic hepatitis C infection, often referred to as a “silent killer,” since the infection can remain asymptomatic for many years, which happens to 5-30 percent of infected individuals. This infection can induce liver damage, and patients that are chronically infected will probably develop liver pathologies, such as cirrhosis (destruction of normal liver tissue) and cancer. Presently, there is no vaccine for hepatitis C, but antiviral therapies are successful in 50–90% of patients. However, access to diagnosis and treatment is low, as only 3% of people with hepatitis C receive treatment each year. Importantly, the hepatitis C infection is responsible for two-thirds of newly diagnosed cases of chronic liver disease, and 40% of liver transplants. All patients with hepatitis C infection that receive a liver transplant will ultimately have their new livers infected. These patients will require anti-viral treatment before their transplanted livers become severely injured by the virus. Although the common therapy for post-transplanted patients with hepatitis C can take up to a year, it may be very toxic and can lead to organ rejection. Thus, the findings of the present study may have a substantial impact on these transplanted patients.

“This is the first study to examine the use of these two new drugs — simeprevir and sofosbuvir — in liver transplant recipients, and, based on this large study, we find it to be a better option than current treatment,” said Dr. Surakit Pungpapon, in a press release.

In this clinical trial, researchers from the Mayo Clinic recruited more than 100 post-transplant patients in three of their locations, including Rochester, Minnesota, Scottsdale, Arizona and the Mayo Clinic Transplant Center in Jacksonville, Florida, which is one of the five most dynamic liver transplant programs in the United States. In this study, the researchers tested these drugs together without interferon in post-transplantation patients, extending the results of a previous large clinical trial, where researchers tested simeprevir and sofosbuvir without interferon as non-approved drugs in patients before receiving a transplant, establishing that the combination was suited as needing only a short duration to be effective. The researchers observed that the elimination of the virus was excellent — more efficient than interferon and ribavirin and with much fewer side effects. The study is still running, and researchers will report the outcomes when the study is completed.

Dr. Pungpapong said that the patients were too ill to be treated for hepatitis C before their transplant. “By the time liver cirrhosis occurs, it could be too late to use anti-viral drugs,” he added. “We believe use of these drugs, both pre- and post-transplant represents a substantial clinical advance.”

In 2013, the Food and Drug Administration (FDA) approved simeprevir and sofosbuvir for use on pre-transplanted patients — not as a combined therapy, but required that they should be used in combination with interferon and ribavirin.

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