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.
Original Papers 1. “Direct Catalytic Asymmetric Intramolecular Conjugate Addition of Thioamide to α,β-Unsaturated Ester” Yuta Suzuki, Ryo Yazaki, Naoya Kumagai,* and Masakatsu Shibasaki* Chem. Eur. J . 2011 , in press. “Asymmetric Synthesis of Isothiazoles Through Cu Catalysis: Direct Catalytic Asymmetric Conjugate Addition of Allyl Cyanide to α,β-Unsaturated Thioamides”
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