Landmark assessment also finds treating early helps prevent liver failure
WEDNESDAY, July 22 (HealthDay News) -- A landmark hepatitis C virus study shows that the top two treatment options are equally effective and safe.
The long-awaited study, thought to be the largest of its kind, is important for the 180 million people worldwide -- 4 million in the United States -- who are infected with hepatitis C virus and at risk for liver scarring, organ failure and death.
Hepatitis C is America's leading cause of liver failure, liver cancer and liver transplantation. The disease is transmitted by contact with blood through sexual activities, drug use or personal care items.
The study of 3,070 adults at Johns Hopkins and 118 other U.S. medical centers showed that treating patients with either of the two standard antiviral therapies is safe and helps prevent liver damage.
The report appears online July 22 in the New England Journal of Medicine.
The drug therapies -- peginterferon alfa-2b plus ribavirin, or peginterferon alfa-2a plus ribavirin -- worked in 39.8 percent and 40.9 percent of patients, respectively. Commonly observed side effects included anemia, fatigue, headache, nausea, insomnia and depression.
The equality of the only two U.S. Food and Drug Administration-approved drug-treatment regimens for suppressing the virus surprised the researchers, according to a news release from Johns Hopkins.
"When considering treatments for hepatitis C infection, patients and their doctors now have solid evidence that they can weigh both antiviral therapies equally for effectiveness, safety and tolerability," Dr. Mark Sulkowski, medical director of the Johns Hopkins Center for Viral Hepatitis and the study's co-principal investigator, said in the news release.
While 10 percent to 13 percent of the study's participants quit the treatment because of side effects, Sulkowski said that was "within expectations for this type of therapy."
The researchers also found that the sooner patients get into treatment, the better.
"Treatment success is highly dependent on starting before liver cirrhosis has already set in, which can take from a year to decades," Sulkowski noted in the news release.
Evidence from the study also will help doctors learn more quickly whether the patient is responding to the drug therapy. This will allow patients to avoid side effects and the expense of taking unnecessary drugs.
The study was funded by the Schering-Plough Corp., the maker and provider of the study drugs ribavirin and peginterferon alfa-b.
The U.S. Centers for Disease Control and Prevention has more information on hepatitis.
-- Dennis Thompson
SOURCE: Johns Hopkins University, news release, July 22, 2009
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