FDA Approves Combo Treatment for Hepatitis C

Olysio approved for treatment of chronic hepatitis C infection in combination with sofosbuvir

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) The US Food and Drug Administration (FDA) approved a new combination treatment for hepatitis C infection Wednesday.

The FDA approved simeprevir (brand name Olysio) to be used with sofosbuvir (brand name Sovaldi) to treat patients with chronic hepatitis C infection.

The new combination treatment proved safe and effective in clinical trials.

Hepatitis C is an infectious disease that can cause chronic hepatitis C infection. People with hepatitis C often do not show symptoms. However, the disease can severely damage the liver, posing the risk of liver failure.

A study involving 167 hepatitis C patients found the combination of simeprevir and sofosbuvir effective and safe. According to the study results, which were published July 28 in The Lancet, the blood of 92 percent of patients who received both medications contained no hepatitis C virus for at least 12 weeks after the patients stopped the treatment.

Some of the patients experienced side effects. The most common of these included fatigue, headache and nausea.

Also this week, Mayo Clinic researchers reported findings from an ongoing study testing the combination of simeprevir and sofosbuvir in hepatitis C patients who received a liver transplant. After a liver transplant in people with hepatitis C, the new liver is still likely to get infected with the virus. For this reason, the transplanted livers often need anti-viral treatment before they become too damaged. Unfortunately, the traditional therapy used after transplants lasts for about a year, can be toxic and and can lead to organ rejection.

At the meeting of the American Association for the Study of Liver Diseases, the researchers at Mayo Clinic reported that simeprevir and sofosbuvir appeared to be safe and beneficial for these transplant patients. Furthermore, the combination required only 12 weeks of treatment.

"This is the first study to examine the use of these two new drugs ... in liver transplant recipients, and, based on this large study, we find it to be a better option than current treatment," said lead researcher Surakit Pungpapong, MD, a transplant hepatologist and associate professor of medicine at Mayo Clinic in Florida.

Last year, the FDA approved these two oral medications for use before liver transplant, but not as a combined therapy. They have yet to be approved for post-transplant therapy.

Janssen markets Olysio. Gilead Sciences markets Sovaldi.

Review Date: 
November 7, 2014
Last Updated:
November 12, 2014