THURSDAY, April 10, 2014 (HealthDay News) -- Researchers report
that an experimental drug has cured more than 95 percent of
patients infected with hepatitis C, including some who failed other
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
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
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 Newsreport, 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.
Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.
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