Faldaprevir combined with pegylated interferon alfa-2a and ribavirin in treatment-naïve patients with chronic genotype 1 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
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
Format:	Artikel
Sprache:	eng
Schlagworte:	Adult Antiviral Agents - therapeutic use Carrier Proteins - antagonists & inhibitors Double-Blind Method Drug Therapy, Combination Female Genotype Hepacivirus - genetics Hepatitis C, Chronic - drug therapy Hepatitis C, Chronic - virology Humans Interferon-alpha - therapeutic use Intracellular Signaling Peptides and Proteins Male Middle Aged Oligopeptides - pharmacology Oligopeptides - therapeutic use Polyethylene Glycols - therapeutic use Recombinant Proteins - therapeutic use Ribavirin - therapeutic use Thiazoles - pharmacology Thiazoles - therapeutic use Viral Nonstructural Proteins - antagonists & inhibitors
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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:	1527-3350
DOI:	10.1002/hep.26276