Results of a long-awaited study of 3,070 American adults at Johns Hopkins and 118 other U.S. medical centers show that treatment with either of the two standard antiviral drug therapies is safe and offers the best way for people infected with hepatitis C to prevent liver scarring, organ failure and death.
A report on the so-called comparative effectiveness study, believed to be the largest of its kind conducted on people with hepatitis C infections, appears in the
New England Journal of Medicine online July 22. The disease, transmitted by contact with blood and other body fluids of an infected person, through sexual activities, injection drug use or sharing of personal care items, kills more than 10,000 Americans annually. An estimated 180 million people worldwide, including 4 million in the United States, are infected with hepatitis C, the nation's leading cause of liver failure, liver cancer and liver transplantation.
"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," says study co-principal investigator Mark Sulkowski, M.D., medical director of Johns Hopkins' Center for Viral Hepatitis.In a surprise finding, the researchers say, the study found no major difference between the only two U.S. Food and Drug Administration-approved drug treatment regimens in suppressing the virus to undetectable levels in the blood.
Either of the two standard, 48-week, dual drug therapies peginterferon alfa-2b, plus ribavirin, or peginterferon alfa-2a, plus ribavirin worked equally well, at 39.8 percent and 40.9 percent, respectively. Side effects, such as anemia, fatigue, headache, nausea, insomnia and depression, were commonly observed in study participants. Between 10 percent and 13 percent of study participants withdrew from treatment due to their drug side effects, a number Sulkowski says is "within expectations for this type of therapy." However, the new study, he says, shows that "we now have evidence that we can safely use less aggressive dosages without compromising a patient's chances for long-term recovery."