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New Hepatitis C Treatment Given FDA Breakthrough Status

Hepatitis C virus (

Hepatitis C virus (

A new anti-viral combination treatment for hepatitis C developed by the biopharmaceutical company AbbVie received a breakthrough therapy designation by the U.S. Food and Drug Administration. AbbVie, in North Chicago, Illinois was spun-off from Abbott Laboratories as a separate company on 1 January 2013.

Hepatitis C is an infection that attacks the liver and usually has no symptoms, and thus can lead to extensive liver damage if not diagnosed. The virus is often transmitted through blood transfusions,  intravenous drug use, mother-to-infant transmission, unsafe medical practices, and high-risk sexual behavior. World Health Organization says some 150 million people are infected with the hepatitis C virus, leading to 350,000 deaths a year. There are six major types of hepatitis C , with treatment decisions often based on the stage of the disease and amount of liver damage.

The treatment developed by AbbVie is a direct-acting antiviral that combines three different components, each with a separate mechanism for addressing the disease. The treatment is being tested with and without another antiviral component, ribavirin. One of the components, ABT-450, was developed by AbbVie with the biotechnology company Enanta Pharmaceuticals.

The drug combination offers an alternative to treatments based on interferon, while somewhat effective in treating hepatitis C especially with ribavirin, the combination of interferon and ribavirin has been shown to cause serious side effects, including anemia.

AbbVie is testing the treatments in a phase 3 clinical trial with some 2,000 patients in 29 countries with hepatitis C, type 1. The company completed a phase 2 trial on 571 patients, also with hepatitis C type 1, both those who had not been treated before and patients for whom previous treatments with interferon failed. In results of the phase 2 trial reported last month, more than 90 percent of patients receiving the combination drugs showed sustained viral response rates after 12 and 24 weeks.

More than 10 percent of patients reported side-effects including headache, fatigue, nausea, insomnia, and diarrhea, with four patients reporting serious reactions and discontinuing their participation in the trial.

FDA’s breakthrough designation aims to expedite drug development drugs for serious and life-threatening conditions, with clinical evidence showing substantial improvement in at least one of its objectives compared to current treatments. The designation provides fast-track reviews, as well as a commitment by FDA to more intensive official guidance related to the drugs.

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