Tailored Hepatitis C Therapy May Cut Treatment Time in Half
WEDNESDAY Sept. 14, 2011 -- Patients infected with hepatitis C virus who have an early favorable response to a new three-drug regimen can be cured of the disease in half the normal time, a new study says.
In the multinational study, researchers showed that tailoring patients' treatment regimen to their response to the drugs, which is known as response-guided therapy, enabled many patients to cut treatment time in half and still achieve the same cure rates.
The paper was published Sept. 15 in the New England Journal of Medicine.
"Patients treated with this regimen who clear virus from their blood by 4 weeks of therapy and who remain virus negative after 12 weeks of therapy can shorten total treatment time from 48 to 24 weeks and have an excellent chance of hepatitis C virus cure," said the study's lead author, Dr. Kenneth E. Sherman, Gould Professor of Medicine and director of the digestive diseases division at the University of Cincinnati College of Medicine in Ohio.
The regimen combines peginterferon and ribavirin, two drugs that have been the standard of care for hepatitis C for more than a decade, with a recently approved hepatitis C medication called telaprevir, which is in a class of medications known as protease inhibitors. Telaprevir and another protease inhibitor called boceprevir were approved by the U.S. Food and Drug Administration in May. The drugs work by blocking an enzyme that the hepatitis C virus needs in order to replicate itself.
For the study, Sherman and his colleagues studied 540 men and women with hepatitis C who hadn't previously been treated for the disease. All of the patients started therapy by receiving the three-drug regimen for 12 weeks, followed by just the peginterferon-ribavirin combination.
After 20 weeks, 322 patients who had an extended rapid virologic response (meaning they had undetectable levels of the virus by four weeks and remained virus-free after 12 weeks) were then randomly assigned to receive peginterferon-ribavirin for either four more weeks or 28 more weeks. At the end of the treatment period, 92 percent of the patients in the 24-week group had a sustained virologic response, meaning the virus remained cleared from their systems, compared with 88 percent of patients in the 48-week group.
Sherman said the patients who received a shorter course of treatment had lower rates of side effects and were less likely to stop treatment than those treated for 48 weeks. "In practice, this would be associated with lower treatment costs and better tolerability compared to use of 48-week treatment regimens," he said.
Another hepatitis specialist who was not involved in the study praised the findings.
"The standard medications for this disease have quite bothersome side effects, including flu-like symptoms, depression and hair loss, so if we're able to shorten the treatment duration by six months, that's worth quite a bit," said Dr. Nancy S. Reau, associate professor of medicine at the University of Chicago Medical Center.
Nearly 4 million Americans live with this difficult-to-manage disease, which can lead to liver cancer and is the number one cause of liver transplants in the United States. However, only about 25 percent of people are aware of their diagnosis because the virus can lurk in the body for years before patients begin to feel symptoms.
Many people become infected with the hepatitis C virus by sharing needles or other equipment to inject drugs. Sex with an infected person can also spread hepatitis C, and some patients contracted the virus through blood transfusions decades ago, before donor screening began in 1990.
Some patients responded so quickly to the regimen that they may have been able to shorten treatment time to fewer than 24 weeks, Sherman noted. "However, this was not investigated in this study, and would require other similarly designed studies to determine if this is true," he said.
The study was funded by two companies: Vertex Pharmaceuticals Inc., which markets telaprevir in North America under the brand name Incivek; and Tibotec, which markets the drug in Europe, Latin America and other parts of the world under the brand name Incivo.
To learn more about hepatitis C, visit the U.S. Centers for Disease Control and Prevention.
Posted: September 2011