| Title: |
Annals of Hepatology / Faldaprevir, pegylated interferon, and ribavirin for treatment-naïve HCV genotype-1: pooled analysis of two phase 3 trials |
| Authors: |
Ferenci, Peter; Jensen, Donald M.; Asselah, Tarik; Dieterich, Douglas; Foster, Graham R.; Sulkowski, Mark S.; Zeuzem, Stefan; Mantry, Parvez; Yoshida, Eric M.; Moreno, Christophe; Ouzan, Denis; Wright, Mark; Morano, Luis E.; Buynak, Robert; Bourlière, Marc; Hassanein, Tarek; Nishiguchi, Shuhei; Kao, Jia-Horng; Omata, Masao; Paik, Seung W.; Wong, David K.; Tam, Edward; Kaita, Kelly; Feinman, S. Victor; Stern, Jerry O. |
| Publisher Information: |
Elsevier |
| Publication Year: |
2016 |
| Collection: |
MedUni Vienna ePub (Medzinische Universität Wien) |
| Subject Terms: |
Hepatitis C; Viral hepatitis; Direct-acting antiviral; SVR12 |
| Subject Geographic: |
UMW:14572 |
| 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. |
| Document Type: |
article in journal/newspaper |
| File Description: |
text/html |
| Language: |
English |
| ISSN: |
1665-2681 |
| Relation: |
vignette : https://repositorium.meduniwien.ac.at/titlepage/urn/urn:nbn:at:at-ubmuw:3-24846/128; local:99145536894803331; system:AC15690784 |
| DOI: |
10.5604/16652681.1198803 |
| Availability: |
https://resolver.obvsg.at/urn:nbn:at:at-ubmuw:3-24846; https://doi.org/10.5604/16652681.1198803; https://repositorium.meduniwien.ac.at/doi/10.5604/16652681.1198803 |
| Rights: |
CC BY-NC-ND 4.0 |
| Accession Number: |
edsbas.6AD69A2F |
| Database: |
BASE |