University of Cincinnati research published in the Sept. 14, 2011, advance online edition of the New England Journal of Medicine shows that patients with hepatitis C who took a combination medication -- a telaprevir-based regimen that is commonly used to treat the illness -- for 24 weeks were cured.
Usually, the treatment is administered for 48 weeks, and these results show that extended treatment is unnecessary, possibly changing the standard of care for hepatitis C patients. Researchers say this could mean better medication adherence as well as the decrease in side effects associated with longer medication use.
"Chronic infection with hepatitis C represents a serious health issue for nearly 200 million people worldwide," says Kenneth Sherman, MD, PhD, a UC Health digestive diseases expert, professor and chair of the division of digestive diseases at the UC College of Medicine and principal investigator of the study. "For many years, standard treatment of the type of hepatitis C most common in the United States required 48 weeks of treatment with two drugs: pegylated interferon and ribavirin. Sustained virologic response (cure) occurred in 40 to 50 percent of patients.
"In this clinical trial, we wanted to determine whether there was a group of patients that could be treated for a shorter period without sacrificing the response rate."
Hepatitis C is a viral disease that leads to inflammation of the liver. It can be spread through exchange of bodily fluids with an infected person.
In the study, 540 patients with hepatitis C who had not previously received treatment were enrolled. Seventy-two percent of all patients who entered the study had sustained viral response.
"The high viral cure rates showed that there was no benefit to extending the therapy to 48 weeks for the majority of people in this trial," Sherman says. "Importantly, patients in this trial had a high likelihood of achieving a cure with 24 weeks of total therapy if they had a rapid response to these regimens by week four. Knowing this may provide important motivation for people to continue therapy."
For this study, all patients received telaprevir -- a protease inhibitor for hepatitis C -- every eight hours, peginterferon alfa-2a every week and ribavirin daily for 12 weeks. Then, telaprevir was stopped, and patients received just peginterferon-ribavirin until week 20.
Patients who had an extended rapid virologic response (undetectable hepatitis C virus RNA levels in their blood at four and 12 weeks) were randomly assigned after the 20th week to receive the pegylated interferon and ribavirin for either four or 28 more weeks. Patients without an extended rapid virologic response, who still had detectable hepatitis C, were automatically assigned to an additional 28 weeks
A total of 352 -- 65 percent -- of patients in the study had an extended rapid virologic response.
Among the patients with an extended rapid virologic response who were randomly assigned to receive the combination, 92 percent in the 24-week group and 88 percent in the 48-week group had a sustained virologic response of hepatitis C infection.
"These results are likely to change treatment standards for patients with hepatitis C and reduce adverse effects of the treatment regimen," adds Sherman.
This study was funded by Vertex and Tibotec Pharmaceuticals. Sherman has served as an advisor to these companies for the past year.
- Kenneth E. Sherman, Steven L. Flamm, Nezam H. Afdhal, David R. Nelson, Mark S. Sulkowski, Gregory T. Everson, Michael W. Fried, Michael Adler, Hendrik W. Reesink, Marie Martin, Abdul J. Sankoh, Nathalie Adda, Robert S. Kauffman, Shelley George, Christopher I. Wright, Fred Poordad, for the ILLUMINATE Study Team. Response-Guided Telaprevir Combination Treatment for Hepatitis C Virus Infection. New England Journal of Medicine, 2011; DOI: 10.1056/NEJMoa1014463
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