G1 HCV patients who achieve an early viral response can be successfully treated within 6 months

Posted By News On April 16, 2010 - 2:40pm

Vienna, Austria, Friday 16 April: 24 weeks of treatment could be sufficient to cure between 93 and 100% of treatment-naïve chronic hepatitis C virus (HCV) genotype 1 (G1) infected patients if they have a fast antiviral response to Telaprevir (TVR) with Peginterferon (PEG-IFN) and Ribavirin (RBV), according to new research presented today at the International Liver CongressTM 2010, the Annual Meeting of the European Association for the Study of the Liver in Vienna, Austria.

Worldwide, approximately 170 million people are chronically infected with the hepatitis C virus . Since no vaccination is available, effective drug treatment is required to slow down or stop the virus from replicating to help prevent progressive liver damage, cirrhosis, liver failure and liver cancer – one of the top three causes of cancer death in men, and a major cause of cancer death in women .

Professor Mark Thursz, EASL Vice-Secretary said: "This trial is really helpful as it shows that patients with a good early virological response only need 24 weeks of treatment and that a twice daily dose of Telaprevir is just as effective as three times a day. Although the number of patients in this study was relatively small and should therefore be treated with caution, I expect such findings will make an important contribution in terms of patients' adherence to their therapy and overall treatment outcomes. This will ultimately impact on their overall quality of life."

161 patients from centres throughout Europe and the United States were enrolled in this phase II trial and randomised to receive 12 weeks of TVR at different doses and intervals, in addition to either PEG-IFN-alfa-2a or alpha-2b plus 800-1200mg/day RBV. After 12 weeks, patients received additional PEG-IFN and RBV based on treatment responses – an additional 12 weeks if HCV RNA was undetectable from week four to week 20, or an additional 36 weeks otherwise.

Interestingly, of the 68% (range across all study arms 56-75%) of patients that qualified to receive only 24 weeks of treatment, between 93 and 100% of the group achieved a Sustained Virologic Response (SVR, when the virus is no longer detected in the blood even after stopping the treatment and considered as a cure for hepatitis C) - an effect that was observed regardless of the type of PEG-IFN or TVR dosing schedule. Researchers also found that a high SVR was observed in the 18% of patients (range across all study arms 10-24%) that received TVR, PEG-IFN and RBV treatment for 48 weeks.

Overall, within the study period, 14% of patients discontinued treatment before week 24 for reasons including virological failure and adverse events (AE). Between study groups, AE incidence was reported as being comparable and discontinuations of all therapy due to AEs (most frequently reported included rash and anaemia) were recorded at 8% with the majority occurring before week 24.

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