New Treatment for Hepatitis C Shows Promise

Patients received testing at a temporary clinic set up in New Hampshire in 2012 after a widespread outbreak of hepatitis C.

Washington — A majority of U.S. volunteers in a drug trial were cured of hepatitis C virus (HCV) with a treatment that is less harmful and shorter than treatments with drugs currently in use. The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) announced the effective trial August 27.

Hepatitis C is caused by a liver-damaging virus and can be a mild illness or a serious lifelong disease that scars the liver severely enough to require a transplant. The World Health Organization (WHO) reports that about 150 million people around the world suffer chronic illness and risk developing cirrhosis of the liver or liver cancer. More than 350,000 people die each from liver diseases stemming from hepatitis C, the Geneva-based organization estimates.

Some 3 million to 4 million people are newly infected each year, a transmission rate boosted by the fact that some people have no symptoms and are unaware they carry the virus. HCV can be passed through poor medical practices — such as contaminated blood transfusions or syringes — or through intravenous drug use. Like HIV, the hepatitis C virus can be passed from mother to newborn and through sexual contact with an infected person.

In places where treatment is available, a course of weekly injections accompanied by other oral medications may go on for an entire year with potentially severe side effects, including depression, anemia and flu-like symptoms.

"There is a pressing need for hepatitis C virus treatments that are less burdensome to the patient, have fewer side effects and take less time to complete," said NIAID Director Anthony Fauci. This trial provides "compelling evidence" that alternate therapies may have promise, according to an NIH news release.

Sixty people were involved in the new study, including ones with liver damage ranging from mild to moderate or severe. The subjects were divided into two groups. Those with mild liver damage, 10 people, received the experimental drug sofosbuvir daily in pill form along with ribavirin, an oral medication used in the treatment regimen widely followed today.

Among the nine subjects who completed the six-month course of medicine, the hepatitis C virus was undetectable after 12 weeks of therapy, NIAID reports. Tested again 24 weeks after therapy ended, the volunteers were still clear of the virus. After that passage of time without a reappearance of HCV, subjects are considered cured, the press release said.

The other group of 50 volunteers was subdivided into two different therapy plans. Half received ribavirin in a dosage based on their body weight. The other half received a low dose. Both of these groups were simultaneously treated with the experimental drug, sofosbuvir.

Ribavirin is one of the drugs used in current treatment with potentially severe side effects, so the study was designed to test the effectiveness of a minimal dose.

At the end of the therapy period, HCV levels were undetectable in 24 volunteers who received the greater dose medications, based on their weight. On the longer term, 17 had undetectable virus when retested 24 weeks after ending the therapy. In the low-dose group, only 12 were considered free of HCV 24 weeks after treatment's end, but all had some positive response to the medication.

"This is an encouraging result," said NIAID researcher Shyam Kottilil. The outcome is of special value because a large proportion of the study subjects were considered difficult to treat. Prior experience with HCV has revealed that African-American males with advanced liver damage are not as responsive to treatment as other groups.

"While African Americans make up about 13 percent of the U.S. population, they represent more than 22 percent of people with chronic HCV infection and, compared to whites, have lower cure rates with traditional HCV therapy," said Kottilil.

Further drug trials are underway to test the effectiveness of various drug combinations, said Kottilil, particularly those that might be effective for patients infected with both HCV and HIV.

The findings of the NIAID study, jointly conducted with the NIH Clinical Center, were published in the August 28 issue of the Journal of the American Medical Association.

The NIAID work is in keeping with a 2010 resolution from the World Health Assembly in recognition of the growing burden of the five viruses that cause hepatitis and a call for greater efforts toward treatment, prevention and control.