Reuters Health Information (2013-11-29): Telaprevir effective for treating advanced hepatitis C
Telaprevir effective for treating advanced hepatitis C
Last Updated: 2013-11-29 9:00:18 -0400 (Reuters Health)
NEW YORK (Reuters Health) - Telaprevir appears effective and relatively safe for treating advanced hepatitis caused by HCV genotype 1, according to an open-label study from Janssen Pharmaceutics.
Although the addition of telaprevir to pegylated interferon (PEG-IFN) plus ribavirin has significantly improved treatment outcomes of hepatitis C, advanced hepatic fibrosis could limit the access to the drug and response rates.
At least one observational study reported high rates of anemia and severe adverse events in patients with cirrhosis who received telaprevir-based triple therapy, researchers write in Gut, online November 7.
Dr. Massimo Colombo from Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico in Milan, Italy, and researchers from 16 countries worldwide investigated the safety and efficacy of telaprevir plus PEG-IFNalpha/ribavirin (PR) in 1,782 patients with HCV genotype 1 and bridging fibrosis or compensated cirrhosis.
This study includes the first 1,587 patients who reached week 16 of therapy. During the first 12 weeks, all patients received oral telaprevir 750 mg every eight hours in combination with PR, and after week 12, PR was administered for another 12 or 36 weeks depending on the virological response to treatment and/or previous response type.
Overall, 82% of patients at week 4 and 86% of patients at week 12 had a serum HCV RNA level below 25 IU/mL. At week 12, 85% of treatment na�ve patients, 88% of treatment relapsers, 80% of partial responders, 72% of null responders, and 84% of breakthrough patients had undetectable HCV RNA levels.
Factors significantly associated with a higher chance of early rapid virological response (eRVR) included baseline viral load below 800,000 IU/mL, genotype 1b, alpha-fetoprotein below 10 pg/mL, and na�ve, relapser, or partial response versus prior null response.
Nearly two-thirds of patients (64%) experienced grade 2-4 adverse events considered related to telaprevir treatment, including, most commonly, anemia (44%), rash (13%), thrombocytopenia (8%), pruritus (6%), and asthenia (6%).
More patients with cirrhosis (67%) than with bridging fibrosis (60%) developed adverse events.
One in eight patients experienced adverse events that ultimately led to discontinuation of telaprevir, and seven patients died from hepatitis complications during the PR tail.
The strongest predictors of anemia at any time on treatment were female sex, age >65 years, low baseline hemoglobin, and higher weight-based dosing of ribavirin.
"The 16-week interim analysis of the telaprevir early access program in 1587 patients provided encouraging insights on the safety, tolerability, and preliminary efficacy of telaprevir triple therapy in difficult to cure categories of hepatitis C patients with advanced fibrosis," the researchers conclude.
Janssen Pharmaceuticals funded the study, employed six of the authors, and had various relationships with all but one of the other nine authors.
Dr. Colombo did not respond to a request for comments.