Cure Rate for Experimental Hepatitis C Drug Tops 95 Percent
THURSDAY, April 10, 2014 -- Researchers report that an experimental drug has cured more than 95 percent of patients infected with hepatitis C, including some who failed other treatments.
If it wins approval from the U.S. Food and Drug Administration, this new drug, called ABT-450, could potentially compete with another innovative hepatitis C medication that costs $1,000 a day.
Nearly 3 million Americans have hepatitis C, a disease that can cause liver cirrhosis and cancer.
These newer, advanced treatments are better-tolerated and easier to take than interferon, the traditional standard treatment for hepatitis C, researchers say.
"Interferon is no longer required to cure hepatitis C," said Dr. Stefan Zeuzem, a professor of medicine at the J.W. Goethe University Hospital in Frankfurt, Germany, and lead researcher on the ABT-450 study.
His research pairing ABT-450 with other interferon-free medications showed "almost all patients with chronic hepatitis C can be cured even if previous treatments were unsuccessful," Zeuzem said.
The report was published online April 10 in the New England Journal of Medicine, to coincide with presentation of the findings at the annual meeting of the European Association for the Study of the Liver in London. The drug trial was funded by the drug's maker, AbbVie.
"Hepatitis C is a big, bad problem," said Dr. William Carey, a liver specialist at the Cleveland Clinic in Ohio.
This new drug represents "one among many breakthroughs in our ability to deal with hepatitis C," Carey said.
An advantage to this treatment is that it is a pill, while interferon is given in weekly injections. Also, older treatments went on for a year, while this new therapy takes only three months to work, Carey said.
Interferon treatment also has severe side effects, including fatigue and flu-like symptoms.
"This is not the only drug combination that is interferon-free, but it's a very promising one," he said.
One drawback to the therapy is that some pills are taken once a day and some twice, which might make following the treatment tricky. Carey hopes that treatment eventually is simplified. "Wouldn't it be great if we could take one or two pills once a day and be done with it?" he said.
Since many people with hepatitis C remain symptom-free, the medical community has not agreed on whom to treat.
With these new cures, that question becomes easier to answer, Carey said. "When you have a treatment that is this simple, effective and free of side effects, there are fewer and fewer reasons to think about withholding treatment," he noted.
"The major barrier is cost," he added.
Whether the new drug will be priced like Sovaldi, the $1,000-a-day medication, is still unknown.
With Sovaldi, the necessary three-month course costs $90,000, plus any other drug expenses and medical care.
Carey said some insurance companies cover the cost of the drug, while others have denied it.
Cost is even more significant in light of the millions of Baby Boomers who are five times more likely to be infected with hepatitis C than other adults, according to the U.S. Centers for Disease Control and Prevention.
"It's going to get harder as time goes on for insurance companies not to cover the cost of these drugs," Carey said. "This is a curable disease."
According to a CBS News report, lawmakers and insurance companies complain that Gilead Sciences, the maker of Sovaldi, is trying to "milk desperate patients." Gilead says that, despite the high price, Sovaldi is cheaper because it "cures patients quickly and eliminates a long and expensive treatment using other drugs."
For this phase 3 trial of ABT-450 -- typically the last trial needed for FDA approval -- nearly 400 patients were randomly assigned to take a placebo or a combination of ABT-450 and these other pills: ombitasvir, ritonavir, dasabuvir or ribavirin. All patients had been treated before, but saw their diseases return or had a poor response or no response to treatment.
Taking the ABT-450 combination, 96.3 percent of the patients responded, the researchers said.
Previous research showed that patients who had never been treated also responded to this combination.
Dr. Marc Siegel, an associate professor of medicine at NYU Langone Medical Center, New York City, said the results look promising for the millions of people with hepatitis C.
"Hepatitis C is under-diagnosed," said Siegel.
These new treatments, with their high cure rates, make it important to diagnose and treat hepatitis C early to prevent cirrhosis and liver cancer, he said.
Hepatitis C can be spread by injectable drug use or sexual contact with an infected person. The U.S. Centers for Disease Control and Prevention recommends one-time screening for those born between 1945 and 1965 -- that's potentially millions of people who would qualify for treatment.
For more information on hepatitis C, visit the U.S. National Library of Medicine.
Posted: April 2014