-- HealthDay staff
MONDAY, May 23 (HealthDay News) -- The U.S. Food and Drug
Administration on Monday approved Incivek (telaprevir), one of a
new class of drugs, to fight chronic hepatitis C infection.
The approval comes after the agency gave a thumbs-up on May 13
to another drug in the same class, called Victrelis
Both pills appear to help more people clear the virus from their
system in a shorter time than older drugs for hepatitis C.
In three clinical trials sponsored by the drug's maker,
Massachusetts-based Vertex Pharmaceuticals, a much higher
percentage of patients responded favorably when Incivek was added
to their care vs. the use of older drugs alone. The length of time
needed to treat also fell, from 48 weeks to 24 weeks, the FDA
"With the approval of Incivek, there are now two important new treatment options for hepatitis C that offer a greater chance at a cure for some patients with this serious condition," Dr. Edward Cox, director of the Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research, said in a statement. "The availability of new therapies that significantly increase responses while potentially decreasing the overall duration of treatment is a major step forward in the battle against chronic hepatitis C infection."
Experts working in the field agreed.
"Both patients and physicians are really excited about the approval of this drug, which represents a huge advance in the treatment of hepatitis C. It is expected to almost double the cure rate of this disease," said Dr. Douglas Dieterich, a professor of medicine in the division of liver diseases, at Mount Sinai School of Medicine in New York City.
"We are all very excited about the approval of a new treatment option for hepatitis C," added Dr. Joseph Rahimian, an infectious disease specialist at NYU Langone Medical Center. "This disease has been very difficult to treat, with limited therapeutic options. Many patients have either not been able to tolerate treatment, or have not responded to treatment. Telaprevir will be a welcome addition to treating hepatitis C."
More than 3 million Americans have chronic infection with the
hepatitis C virus, which can cause long-term damage to the liver
and lead to liver dysfunction or failure, according to the U.S.
Centers for Disease Control and Prevention. Hepatitis C is a
blood-borne infection; people typically become infected via needle
sharing, sharing toothbrushes or razors with someone who is
infected, or sexual contact. Infants can pick up hepatitis C from
an infected mother.
Hepatitis C infection is a "silent killer" because infected
individuals may go for years without displaying symptoms before
liver damage becomes apparent. This damage can take the form of
cirrhosis, which is also tied to bleeding, jaundice and even liver
cancer. According to the CDC, chronic hepatitis C infection is
responsible for most of the liver transplants now conducted in the
Incivek is taken three times daily with food. According to the
FDA, for the first three months, patients should take Incivek in
combination with older medications, peginterferon alfa and
ribavirin. People who respond well to that regimen can usually then
be treated with Incivek for 24 weeks rather than the usual 48.
Incivek's approval was based on the results of three clinical
trials involving about 2,250 adults with hepatitis C who had either
never been treated before for the infection, or who had received
prior therapy. All patients got Incivek alongside the two older
Among previously untreated patients, 79 percent saw hepatitis C
fall to undetectable levels in blood (suggesting a cure) after
adding Incivek to their care. In fact, the "virologic response"
rate rose between 20 percent to 45 percent higher across all three
studies and all patient groups, compared to standard medications
alone, the FDA said.
Most patients on Incivek also saw a halving of the average time
needed to achieve a good response to treatment from four years to
just two years, according to the FDA. Ninety percent of these
"early responders" achieved a sustained virologic response, the
"When a person achieves a sustained virologic response after completing treatment, this suggests that the hepatitis C infection has been cured," the FDA explained.
Incivek is one of a class of drugs called protease inhibitors.
These drugs work by binding with the virus and blocking its
Similar results have been seen in trials of Victrelis, sponsored
by Merck, the drug's maker. Victrelis is also taken three times a
day with food.
Approval for Victrelis came after the drug's safety and
effectiveness were tested in two phase 3 trials involving 1,500
Side effects with either Incivek or Victrelis include anemia,
nausea and headache, the FDA said. Some patients taking Incivek
also experienced fatigue or diarrhea, and itching and rashes. In
certain cases, the rash can be severe enough to warrant stopping
Incivek or the full three-drug regimen.
Nevertheless, the approval of Incivek and Victrelis "represent
the first real advances in the treatment of hepatitis C in 13
years," Dieterich said. "It arrives just in time to help prevent
new deaths that were anticipated over the next 10 years in the Baby
Boomer generation, the group that has the most Hepatitis C
Find out more about hepatitis C infection at the
U.S. National Library of Medicine.
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