Faldaprevir combined with pegylated interferon alfa‐2a and ribavirin in treatment‐naïve patients with chronic genotype1 HCV: SILEN‐C1 trial

Faldaprevir combined with pegylated interferon alfa‐2a and ribavirin in treatment‐naïve patients with chronic genotype1 HCV: SILEN‐C1 trial

Faldaprevir (BI 201335) is a potent, hepatitis C virus (HCV) NS3/4A protease inhibitor with pharmacokinetic properties supportive of once‐daily (QD) dosing. Four hundred and twenty‐nine HCV genotype (GT)‐1 treatment‐naïve patients without cirrhosis were randomized 1:1:2:2 to receive 24 weeks of pegy...

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Veröffentlicht in:Hepatology (Baltimore, Md.) Md.), 2013-06, Vol.57 (6), p.2143-2154
Hauptverfasser: Sulkowski, Mark S., Asselah, Tarik, Lalezari, Jacob, Ferenci, Peter, Fainboim, Hugo, Leggett, Barbara, Bessone, Fernando, Mauss, Stefan, Heo, Jeong, Datsenko, Yakov, Stern, Jerry O., Kukolj, George, Scherer, Joseph, Nehmiz, Gerhard, Steinmann, Gerhard G., Böcher, Wulf O.
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Sprache:eng
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Zusammenfassung:Faldaprevir (BI 201335) is a potent, hepatitis C virus (HCV) NS3/4A protease inhibitor with pharmacokinetic properties supportive of once‐daily (QD) dosing. Four hundred and twenty‐nine HCV genotype (GT)‐1 treatment‐naïve patients without cirrhosis were randomized 1:1:2:2 to receive 24 weeks of pegylated interferon alfa‐2a and ribavirin (PegIFN/RBV) in combination with placebo, faldaprevir 120 mg QD with 3 days of PegIFN/RBV lead‐in (LI), 240 mg QD with LI, or 240 mg QD without LI, followed by an additional 24 weeks of PegIFN/RBV. Patients in the 240 mg QD groups achieving maintained rapid virologic response (mRVR; viral load [VL]
ISSN:0270-9139
1527-3350
DOI:10.1002/hep.26276