| Title: |
Faldaprevir, pegylated interferon, and ribavirin for treatment-naïve HCV genotype-1: Pooled analysis of two phase 3 trials |
| Authors: |
Jensen, Donald M.; Ouzan, Denis; Wright, Mark; Morano, Luis Enrique; Buynak, Robert; Bourlière, Marc; Hassanein, Tarek; Nishiguchi, Shuhei; Kao, Jia Horng; Omata, Masao; Paik, Seungwoon; Asselah, Tarik; Wong, David; Tam, Edward; Kaita, Kelly; Victor Feinman, S.; Stern, Jerry J.O.; Scherer, Joseph; Quinson, Anne Marie; Voss, Florian; Gallivan, John Paul; Böcher, Wulf Otto; Dieterich, Douglas; Ferenci, Peter; Foster, Graham Russell; Sulkowski, Mark; Zeuzem, Stefan; Mantry, Parvez; Yoshida, Ericmasao E.M.; Moreno, Christophe |
| Source: |
Annals of Hepatology, 15 (3 |
| Publication Year: |
2016 |
| Collection: |
DI-fusion : dépôt institutionnel de l'Université libre de Bruxelles (ULB) |
| Subject Terms: |
Gastro-entérologie; Direct-acting antiviral; Hepatitis C; SVR12; Viral hepatitis |
| Description: |
Introduction & 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-naïve 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. ; SCOPUS: ar.j ; info:eu-repo/semantics/published |
| Document Type: |
article in journal/newspaper |
| File Description: |
No full-text files |
| Language: |
English |
| ISBN: |
978-84-96370-58-6; 84-96370-58-5 |
| Relation: |
uri/info:doi/10.5604/16652681.1198803; uri/info:scp/84963705855 |
| Availability: |
https://hdl.handle.net/2013/ULB-DIPOT:oai:dipot.ulb.ac.be:2013/231464 |
| Accession Number: |
edsbas.7F437DC7 |
| Database: |
BASE |