Ferenci, PeterPeterFerenciAsselah, TarikTarikAsselahFoster, Graham RGraham RFosterZeuzem, StefanStefanZeuzemSarrazin, ChristophChristophSarrazinMoreno, ChristopheChristopheMorenoOuzan, DenisDenisOuzanMaevskaya, MarinaMarinaMaevskayaCalinas, FilipeFilipeCalinasMorano, Luis ELuis EMoranoCrespo, JavierJavierCrespoDufour, Jean-FrançoisJean-FrançoisDufourBourlière, MarcMarcBourlièreAgarwal, KoshKoshAgarwalForton, DanielDanielFortonSchuchmann, MarcusMarcusSchuchmannZehnter, ElmarElmarZehnterNishiguchi, ShuheiShuheiNishiguchiOmata, MasaoMasaoOmataKukolj, GeorgeGeorgeKukoljDatsenko, YakovYakovDatsenkoGarcia, MiguelMiguelGarciaScherer, JosephJosephSchererQuinson, Anne-MarieAnne-MarieQuinsonStern, Jerry OJerry OStern2024-10-232024-10-232015-01-02https://boris-portal.unibe.ch/handle/20.500.12422/132167BACKGROUND & AIMS The efficacy and tolerability of faldaprevir, a potent hepatitis C virus (HCV) NS3/4A protease inhibitor, plus peginterferon and ribavirin was assessed in a double-blind, placebo-controlled phase 3 study of treatment-naïve patients with HCV genotype-1 infection. METHODS Patients were randomly assigned (1:2:2) to peginterferon/ribavirin plus: placebo (arm 1, n=132) for 24 weeks; faldaprevir (120 mg, once daily) for 12 or 24 weeks (arm 2, n=259); or faldaprevir (240 mg, once daily) for 12 weeks (arm 3, n=261). In arms 2 and 3, patients with early treatment success (HCV RNA <25 IU/mL at week 4 and undetectable at week 8) stopped all treatment at week 24. Other patients received peginterferon/ribavirin until week 48 unless they met futility criteria. The primary endpoint was sustained virologic response 12 weeks post-treatment (SVR12). RESULTS SVR12 was achieved by 52%, 79%, and 80% of patients in arms 1, 2, and 3, respectively (estimated difference for arms 2 and 3 versus arm 1: 27%, 95% confidence interval 17%-36%; and 29%, 95% confidence interval, 19%-38%, respectively; P<.0001 for both). Early treatment success was achieved by 87% (arm 2) and 89% (arm 3) of patients, of whom 86% and 89% achieved SVR12. Adverse event rates were similar among groups; few adverse events led to discontinuation of all regimen components. CONCLUSIONS Faldaprevir plus peginterferon/ribavirin significantly increased SVR12, compared with peginterferon/ribavirin, in treatment-naïve patients with HCV genotype-1 infection. There do not seem to be any differences in responses of patients given once-daily 120 or 240 mg faldaprevir.enClinical trialDAAEarly treatment successNS3/4A protease inhibitorPhase 3SVR12600 - Technology::610 - Medicine & healtharticle10.7892/boris.671592555932410.1016/j.jhep.2014.12.024