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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.

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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