Jensen D.M.Asselah T.Dieterich D.Foster G.R.Sulkowski M.S.Zeuzem S.Mantry P.Yoshida E.M.Moreno C.Ouzan D.Wright M.Morano L.E.Buynak R.Bourlière M.Hassanein T.Nishiguchi S.JIA-HORNG KAOOmata M.Paik S.W.Wong D.K.Tam E.Kaita K.Victor Feinman S.Stern J.O.Scherer J.Quinson A.-M.Voss F.Gallivan J.-P.Böcher W.O.Ferenci P.2021-09-042021-09-0420161665-2681https://www.scopus.com/inward/record.uri?eid=2-s2.0-84963705855&doi=10.5604%2f16652681.1198803&partnerID=40&md5=ef6b684783924331ef8b11c7ee8d7e54https://scholars.lib.ntu.edu.tw/handle/123456789/581916Introduction & aim. Faldaprevir is a potent once-daily (q.d.) hepatitis C virus (HCV) NS3/4A protease inhibitor. The STARTVerso1 and STARTVerso2 phase 3 studies evaluated faldaprevir plus peginterferon alfa-2a/ribavirin (PegIFN/RBV) in treatment-na?ve patients with chronic HCV genotype-1 infection. Material and methods. Patients were randomized 1:2:2 to receive placebo, faldaprevir 120 mg q.d. (12 or 24 weeks) or faldaprevir 240 mg q.d. (12 weeks) all with PegIFN/RBV (24–48 weeks). Faldaprevir 120 mg for 12 weeks only (STARTVerso1 only) required early treatment success (ETS, HCV RNA < 25 IU/mL at week 4 and undetected at week 8). All faldaprevir-treated patients with ETS stopped PegIFN/RBV at week 24. Primary endpoint: sustained virologic response 12 weeks post-treatment (SVR12). Results. SVR12 rates were significantly higher for patients treated with faldaprevir 120 or 240 mg (72% and 73%, respectively) compared with placebo (50%); estimated differences (adjusted for trial, race, and genotype-1 subtype) faldaprevir 120 mg 24% (95% CI: 17–31%, P < 0.0001), faldaprevir 240 mg 23% (95% CI: 16–30%, P < 0.0001). Subgroup analyses consistently showed higher SVR12 rates for patients receiving faldaprevir compared with placebo. The incidence of adverse events (AEs) was similar in faldaprevir 120-mg and placebo groups and slightly higher in the faldaprevir 240-mg group. Serious AEs were reported in 6%, 7%, and 8% of patients in placebo, faldaprevir 120-mg, and faldaprevir 240-mg groups, respectively. Conclusion. Addition of faldaprevir to PegIFN/RBV increased SVR12 in patients with HCV genotype-1, and was well tolerated. Faldaprevir 120 mg is effective in the treatment of HCV genotype-1. ClinicalTrials.gov: NCT01343888 and NCT01297270. ? 2016, Fundacion Clinica Medica Sur. All rights reserved.Direct-acting antiviral; Hepatitis C; SVR12; Viral hepatitis[SDGs]SDG3alanine aminotransferase; bilirubin; faldaprevir; peginterferon alpha2a plus ribavirin; alpha interferon; antivirus agent; biological marker; carrier protein; macrogol derivative; N-((cyclopentyloxy)carbonyl)-3-methylvalyl-4-((8-bromo-7-methoxy-2-(2-((2-methylpropanoyl)amino)-1,3-thiazol-4-yl)quinolin-4-yl)oxy)-N-(1-carboxy-2-ethenylcyclopropyl)prolinamide; NS3 protein, hepatitis C virus; NS4A cofactor peptide, Hepatitis C virus; oligopeptide; peginterferon alpha2a; proteinase inhibitor; recombinant protein; ribavirin; thiazole derivative; viral protein; virus RNA; adult; aged; alanine aminotransferase blood level; alopecia; anemia; Article; bilirubin blood level; clinical effectiveness; controlled study; coughing; decreased appetite; diarrhea; double blind procedure; drug dose comparison; drug safety; drug tolerability; drug withdrawal; dry skin; elastography; fatigue; female; fever; headache; hemoglobin blood level; hepatitis C; Hepatitis C virus genotype 1; human; insomnia; jaundice; leukocyte count; loading drug dose; lymphocyte count; major clinical study; male; morning dosage; multicenter study; myalgia; nausea; neutrophil count; outcome assessment; parallel design; phase 3 clinical trial; pruritus; randomized controlled trial; rash; side effect; thrombocyte count; treatment duration; treatment response; vomiting; antagonists and inhibitors; blood; combination drug therapy; drug effects; enzymology; genetics; genotype; Hepacivirus; hepatitis C; meta analysis; metabolism; middle aged; odds ratio; phase 3 clinical trial (topic); randomized controlled trial (topic); statistical model; time factor; treatment outcome; virus load; Adult; Antiviral Agents; Biomarkers; Carrier Proteins; Clinical Trials, Phase III as Topic; Drug Therapy, Combination; Female; Genotype; Hepacivirus; Hepatitis C; Humans; Interferon-alpha; Logistic Models; Male; Middle Aged; Odds Ratio; Oligopeptides; Polyethylene Glycols; Protease Inhibitors; Randomized Controlled Trials as Topic; Recombinant Proteins; Ribavirin; RNA, Viral; Thiazoles; Time Factors; Treatment Outcome; Viral Load; Viral Nonstructural Proteinsjournal article10.5604/16652681.1198803270494872-s2.0-84963705855