Telaprevir-Based Triple Therapy Safe for Elderly With Chronic Hepatitis C
SAN FRANCISCO, CA—Telaprevir-based triple therapy can be used successfully and safely in elderly patients with genotype 1 chronic hepatitis C virus (HCV), according to a study presented at IDWeek 2013.
Norihiro Furusyo, MD, PhD, from Kyushu University Hospital in Fukuoka, Japan, and colleagues conducted a prospective, multicenter study to investigate the efficacy and safety of telaprevir-based triple therapy for elderly patients with chronic hepatitis C. Telaprevir, an HCV NS3/4A protease inhibitor, is indicated to treat chronic hepatitis C genotype 1 infection in combination with peginterferon alfa and ribavirin.
Telaprevir-based triple therapy has demonstrated improvement in rate of sustained virological response (SVR) when compared with peginterferon alfa monotherapy and peginterferon alfa-2b + ribavirin dual therapy. However, previous studies of telaprevir-based regimens for chronic HCV have not shown any age correlation to virological outcome.
The study enrolled 403 patients with genotype 1 chronic hepatitis C, of which 33.4% were treatment-naïve, 43.4% were prior relapsers, 18.9% were prior non-responders, and 4.2% had unknown response. Patients received 12-week triple therapy of telaprevir 2250mg/day, peginterferon alfa-2b 60–150mcg/week, and ribavirin 600–1000mg/day followed by a 12-week peginterferon alfa-2b +ribavirin dual therapy. Patients were categorized into either Group A (age >60 years; n=64) or Group B (age <60 years; n=56).
SVR was defined as undetectable serum HCV RNA at 24 weeks after the end of treatment. A rapid virological response (RVR) was defined as undetectable HCV RNA at Week 4.
Study results showed that the rate of undetectable HCV RNA at Week 4 was 75% for Group A and 77.5% for Group B. No significant differences in SVR rate was found between Groups A and B (72.5% vs. 83.7%; P=0.14). The SVR rate of interleukin 28B (IL28B) (rs8099917) TT (88.9% and 91.1% for Groups A and B, respectively) was significantly higher than IL28B TG/GG (46.2% and 45.8%; P<0.001). Further, a multivariate analysis showed IL28B TT (OR 8.8, P<0.01) and undetectable HCV RNA at Week 4 (OR 13.2, P<0.01) as independent factors associated with achieving an SVR.
A total of 12.5% of patients in Group A and 10% in Group B discontinued treatment due to adverse effects. No episodes of death or hepatic decompensation were observed.
“IL28B genotyping and early virological response indicate effectiveness in these difficult-to-treat elderly patients,” Dr. Furusyo concluded.