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Antiviral activity of telaprevir (VX‐950) and peginterferon alfa‐2a in patients with hepatitis C
Author(s) -
Forestier Nicole,
Reesink Hendrik W.,
Weegink Christine J.,
McNair Lindsay,
Kieffer Tara L.,
Chu HuiMay,
Purdy Susan,
Jansen Peter L.M.,
Zeuzem Stefan
Publication year - 2007
Publication title -
hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.488
H-Index - 361
eISSN - 1527-3350
pISSN - 0270-9139
DOI - 10.1002/hep.21774
Subject(s) - telaprevir , peginterferon alfa 2a , medicine , gastroenterology , placebo , dosing , adverse effect , hepatitis c virus , virology , ribavirin , pharmacology , virus , pathology , alternative medicine
Telaprevir (VX‐950), an inhibitor of the hepatitis C virus (HCV) NS3/4A protease, substantially decreased plasma HCV RNA levels in a prior clinical study. The present study evaluated viral kinetics and safety during dosing with telaprevir alone and in combination with peginterferon alfa‐2a for 14 days. Previously untreated patients with genotype 1 hepatitis C were randomized to receive placebo and peginterferon alfa‐2a (n = 4); telaprevir (n = 8); or telaprevir and peginterferon alfa‐2a (n = 8). Telaprevir was given as 750 mg oral doses every 8 hours; peginterferon alfa‐2a was given as weekly 180 μg subcutaneous injections. The median change in HCV RNA from baseline to day 15 was −1.09 log 10 (range, −2.08 to −0.46) in the placebo and peginterferon alfa‐2a group; −3.99 log 10 (range, −5.28 to −1.26) in the telaprevir group, and −5.49 log 10 (range, −6.54 to −4.30) in the telaprevir and peginterferon alfa‐2a group. Day 15 HCV RNA levels were undetectable in 4 patients who received telaprevir and peginterferon alfa‐2a and in 1 patient who received telaprevir alone. No viral breakthrough occurred in patients who received telaprevir and peginterferon alfa‐2a. The majority of adverse events were mild. There were no serious adverse events or premature discontinuations. Twelve weeks after starting off‐study standard therapy, HCV RNA was undetectable in all 8 patients in the telaprevir and peginterferon alfa‐2a group, 5 patients in the telaprevir group, and 1 patient in the placebo and peginterferon alfa‐2a group. Conclusion: This study confirmed the substantial antiviral effects of telaprevir and showed an increased antiviral effect of telaprevir combined with peginterferon alfa‐2a. (H EPATOLOGY 2007;46:640–648.)