CHAPEL HILL, N.C. – A new multinational study finds that a 24-week treatment course for hepatitis C that adds telaprevir to peginterferon alfa and ribavirin is just as effective as a 48-week regimen for many patients.
This is good news for up to 4 million people in the U.S. who suffer from this chronic liver disease, many of whom will undergo treatment for hepatitis C, said Michael W. Fried, MD, professor of medicine at the University of North Carolina at Chapel Hill, director of the UNC Liver Center and a co-author of the ILLUMINATE study, which is published in the Sept. 15, 2011 issue of The New England Journal of Medicine.
“The medications that we use to treat hepatitis C do have some side effects, and shortening the duration of treatment shortens a patient’s exposure to these side effects,” Fried said.
Lead author of the study, which was conducted at 74 sites in Belgium, the Netherlands and the U.S., was Kenneth E. Sherman, MD, PhD, of the University of Cincinnati College of Medicine.
The study included 540 patients with chronic genotype 1 hepatitis C who had not previously been treated or who could not be successfully treated with a combination of peginterferon alfa and ribavirin, which is the current standard of care. Nineteen of the patients in the study were enrolled at UNC Hospitals in Chapel Hill or at Medical Specialty Services, in Greensboro, N.C., where UNC runs a hepatitis C practice in collaboration with the Moses Cone Health System.
All of the patients started the study by taking all three drugs for 12 weeks. They stopped taking telaprevir after week 12. Then patients who tested negative for the hepatitis C virus were randomized to receive either 12 weeks or 36 weeks of additional treatment with the other two drugs, peginterferon alfa and ribavirin. One group received a total of 24 weeks of treatment while the other group was treated for 48 weeks.
Michael W. Fried, MD
In the 24-week group, 92 percent of the patients ultimately achieved a sustained virological response, meaning that the hepatitis C virus remained undetectable in their blood after treatment was discontinued. In the 48-week group, 88 percent achieved a sustained virological response. Fried notes that sustained virological response is analogous to cure of hepatitis C.
“These are very nearly identical results, showing that 24 weeks of treatment with triple therapy is just as effective as 48 weeks,” Fried said. About two-thirds of the patients who started with triple therapy were eligible for shorter duration of treatment by clearing virus early in their treatment course.
In addition, the study found uniformly high rates of sustained virologic response regardless of the race or ethnicity of the patients, and no matter whether they had advanced fibrosis or cirrhosis of the liver.
Side effects associated with telaprevir reported in the study include rash and anemia, but in most cases these side effects were mild or moderate and could be managed by the patient’s physician, Fried said.
The study was funded by Vertex Pharmaceuticals and Tibotec. Vertex markets telaprevir in the United States under the brand name Incivek. Tibotec plans to market the drug in Europe.
The U.S. Food and Drug Administration approved Incivek on May 23, 2011 for the treatment of chronic hepatitis C in combination with peginterferon alfa and ribavirin.
Peginterferon alfa is marketed under the brand name Pegasys, while ribavirin is sold as Copegus and Rebetol.
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The study tested the use of telaprevir, shown above, in combination with peginterferon alfa and ribavirin. The FDA approved telaprevir for this indication on May 23, 2011.