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Response-Guided Telaprevir Combination Treatment for Hepatitis C Virus Infection

September 20, 2011

A 24-week course of treatment for chronic hepatitis C virus (HCV) infection that added telaprevir to peginterferon and ribavirin was just as effective as a 48-week regimen for many patients in the current study.

This multicenter research enrolled 540 treatment-naïve patients with chronic infection with HCV genotype 1. All received telaprevir (Incivek), peginterferon alfa-2a and ribavirin for 12 weeks, after which telaprevir was suspended.

Patients who had an extended rapid virologic response (ERVR) (undetectable HCV RNA levels at weeks 4 and 12) were randomly assigned, after week 20, to receive dual therapy for four more weeks (24-week group) or for 28 more weeks (48-week group). Patients without ERVR were assigned to the 48-week group.

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Of the 540 patients, 352 (65 percent) had ERVR. Overall the rate of sustained virologic response was 72 percent. Among the 322 patients with ERVR who were randomized to a study group, 149 (92 percent) in the 24-week group and 140 (88 percent) in the 48-week group had a sustained virologic response (absolute difference, 4 percentage points, 95 percent confidence interval, -2 to 11), establishing noninferiority. Adverse events noted included rash (37 percent of patients; severe in 5 percent) and anemia (39 percent of patients; severe in 6 percent). Discontinuation of all study drugs was based on adverse events in 18 percent of patients overall, as well as in 1 percent of patients (all of whom were randomly assigned) in the 24-week group and 12 percent of patients randomly assigned to the 48-week group.

"In this study, among patients with chronic HCV infection who had not received treatment previously, a regimen of peginterferon-ribavirin for 24 weeks, with telaprevir for the first 12 weeks, was noninferior to the same regimen for 48 weeks in patients with undetectable HCV RNA at weeks 4 and 12, with [ERVR] achieved in nearly two-thirds of patients," the authors concluded.

Back to other news for September 2011

Adapted from:
New England Journal of Medicine
09.15.2011; Vol. 365: P. 1014-1024; Kenneth E. Sherman, M.D., Ph.D., and others




This article was provided by CDC National Prevention Information Network. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update.

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