Asbprimeaumedwriting.com

Shorter Telaprevir Combination Regimen Noninferior in HCV

HCV treatment with telaprevir, peginterferon alfa-2a, and ribavirin for 24 weeks showed noninferiority to a
48-week regimen.
Andrea S. Blevins Primeau, PhD, MBA

September 13, 2011 – In patients with hepatitis C virus (HCV) genotype 1, combination treatment
peginterferon alfa-2a and ribavirin for 24 weeks was noninferior to 48 weeks of treatment, when telaprevir
was added for the first 12 weeks to both treatment arms, according to the findings of a randomized
noninferiority trial.
Kenneth E. Sherman, MD, PhD, of the Division of Digestive Diseases at the University of Cincinnati
College of Medicine, and colleagues of the ILLUMINATE (Illustrating the Effects of Combination Therapy
with Telaprevir) study team reported their findings in the September 15, 2011 issue of the New England
Journal of Medicine.
Telaprevir is a nonstructural 3/4A (NS3/4A) HCV protease inhibitor and combination treatment with
telaprevir, peginterferon, and ribavirin in treatment naïve patients has resulted in sustained virologic
response in phase II and phase III trials.
This randomized, noninferiority, phase III trial included 540 patients with HCV who had not yet received
treatment. All patients received 750 mg per 8 hours of telaprevir, 180 µg of peginterferon alfa-2a per
week, and 1000-1200 mg per day of ribavirin for 12 weeks.
Patients with an extended rapid virologic response, characterized by undetectable HCV RNA levels at
weeks 4 and 12, were randomized at week 20 to receive peginterferon and ribavirin for an additional 4
(n=149) or 28 weeks (n=140).
Rapid virologic response occurred in 72% of the patients and an extended response occurred in 65%.
Inferiority of a 24-week combination treatment of telaprevir, peginterferon alfa-2a, and ribavirin was
noninferior to 48 weeks of treatment. Patients that received the combination treatment for a total of 24
weeks demonstrated a 92% sustained virologic response, as compared with 88% of patients who
received the treatment for 48 weeks.
A total of 100 patients withdrew from the study due to adverse events, consent withdrawal, or other
reasons. Serious adverse events occurred in 9% of study participants, including 2% of patients receiving
treatment for 24 weeks, as compared with 10% of patients receiving treatment for 48 weeks.
The most common serious adverse effect was anemia, which occurred in 2% of patients. The most
common adverse effects included fatigue, pruritus, nausea, anemia, headaches, rash, insomnia, diarrhea,
and influenza-like symptoms. Virologic failure, marked by detectable HCV RNA at the end of treatment,
occurred in 8% of participants.
The authors state that response-guided treatment may “decrease the risk of exposure to patients to not
only potential side effects from telaprevir, but also to the well-characterized adverse events associated
with the 480week use of peginterferon and ribavirin.”
The study was funded by Vertex Pharmaceuticals and Tibotec.
N Engl J Med. September 15, 2011 online.

Source: http://www.asbprimeaumedwriting.com/uploads/News_Sample_HCV.pdf