The World Health Organization (WHO) reports that there are about 130 to 150 million people worldwide who have chronic Hepatitis C, an infectious disease that primarily affects the liver. Of these, a significant number develop liver cancer and cirrhosis, the scarring of the liver due to long-term damage resulting in poor liver function. Of those who develop hepatitis C-related liver diseases, as many as 500,000 die each year.
A new experimental drug developed by pharmaceutical company AbbVie, however, may soon improve the outlook of millions of people who have contracted hepatitis C virus (HCV). Researchers conducting the phase 3 trial of the drug called ABT-450 reported that the experimental drug has cured more than 90 percent of the subjects who have hepatitis C and liver cirrhosis, showing a significant improvement in cure as treatment rate for patients with HCV and cirrhosis is historically lower than 50 percent.
The trial, which was described in a report published in the New England Journal of Medicine April 10, involved almost 400 patients who have already been treated before but did not respond well to the treatment or had a relapse. They were given either a placebo or a pill that contains ABT-450 plus ombitasvir and ritonavir as well as dasabuvir and ribavirin.
The researchers said that 96.3 percent of the patients who received ABT-450 combination responded well to the treatment. "Rates of response to a 12-week interferon-free combination regimen were more than 95% among previously treated patients with HCV genotype 1 infection, including patients with a prior null response," the researchers reported.
Interferon is traditionally used as the standard treatment for hepatitis C. Unfortunately, the therapy is associated with a number of side effects and many patients see a relapse of their disease.
"The reason this study is so profound is because interferon is not tolerated nor is it safe in many people with cirrhosis," said study lead author Fred Poordad from The University of Texas Health Science Center at San Antonio. "Many of the patients with cirrhosis in this study were not even eligible to be treated with interferon."
The phase 3 trial is often the last trial needed for a drug to get approval from the Food and Drug Administration (FDA). Once ABT-450 wins FDA's approval, it is anticipated to compete with another innovative albeit excessively expensive hepatitis C treatment, Gilead's Sovaldi, which costs $1,000 per day.