Trial results for AbbVie’s Hepatitis C candidate heat up race for effective treatment
The race to replace interferon with a far more effective treatment for hepatitis C has become one of the most promising and lucrative battles in drug development, as AbbVie, Gilead Sciences, Merck and Bristol-Myers Squibb vie for the finish line.
Although Gilead is the current leader in the field, AbbVie has announced comparable results with a combination of drugs that cured 92% of 380 patients with liver cirrhosis in 12 weeks, rising to 96% of patients 24 weeks after their last dose, according to a new study published by The New England Journal of Medicine. The cocktail works by disrupting the hepatitis C’s virus replication process.
“It may now be possible to imagine the global eradication of chronic hepatitis C,” Harvard Medical School liver specialists Raymond Chung and Thomas Baumert wrote. In the same way antibiotics made victory over human bacterial infections possible in the 20th century, the new antiviral medications have "revolutionized" the treatment of hepatitis C, wrote Chung and Baumert, who were not involved in the trials, saying the drugs offer "genuine prospects for the first comprehensive cure of a chronic viral infection in humans."
An estimated three million Americans (150 million worldwide)are affected by hepatitis C, which is caused by a virus that spreads through contact with infected blood and is the number one driver of cirrhosis—the scarring of the liver caused by many forms of liver diseases and conditions, such as hepatitis and chronic alcohol abuse. Interferon—a series of proteins, known as cytokines, that “interfere” with viral replication within host cells—works in about 50% of hepatitis C cases, although cirrhosis patients treated with this drug often relapse with increased toxic effects.
AbbVie, according to the study, tested its new therapy, a combination of four anti-viral drugs—ABT-450/ritonavir, ombitasvir, dasabuvir and ribavirin—in 380 patients between ages 18 and 70 screened and recruited at 78 different hospitals and clinics in the U.S., Canada, England, Germany and Spain. Final results revealed no trace of Hepatitis C virus in the bloodstream for the vast majority of patients in the study. Blood sample testing will continue for three years after the end of treatment, the investigators said, and there have been no late relapses according to Fred Poordad, the first study author and chief medical officer at the Texas Liver Institute, and professor of medicine at the University of Texas Health Science Center in San Antonio. The study is part of AbbVie’s expansive late-stage program, in which it tracked more than 2,300 patients.
"These data are encouraging, as cirrhotic patients often are a difficult-to-treat population in the HCV community,” said Poordad in a statement, adding that he and his colleagues expect the new treatment to be available later this year or early in 2015.
AbbVie’s biggest rival is Gilead Sciences, which gained FDA approval in December for Sovaldi, an injection treatment reportedly on its way to becoming the most successful new drug in the pharmaceutical industry’s history, with analysts forecasting sales of up to $10 billion in its debut year.
At last week’s International Liver Congress in London, both Merck and Bristol-Myers Squibb revealed solid trial results for their respective hepatitis C drugs—strategies that will make it a very large and competitive market, according to several analysts.
Already, policy makers and healthcare providers welcomed the competition, as Solvadi’s $84,000 price tag for a 12-week treatment has raised concerns. Express Scripts labeled Solvadi’s price as “unsustainable,” and the World Health Organization has called for a “concerted effort” to drive down the price of new hepatitis treatments.