TY  - JOUR
AU  - Foster, GR
AU  - Chayama, K
AU  - Chuang, W-L
AU  - Fainboim, H
AU  - Farkkila, M
AU  - Gadano, A
AU  - Gaeta, GB
AU  - Hezode, C
AU  - Inada, Y
AU  - Heo, J
AU  - Kumada, H
AU  - Lu, S-N
AU  - Marcellin, P
AU  - Moreno, C
AU  - Roberts, SK
AU  - Strasser, SI
AU  - Thompson, AJ
AU  - Toyota, J
AU  - Paik, SW
AU  - Vierling, JM
AU  - Zignego, AL
AU  - Cohen, D
AU  - McPhee, F
AU  - Wind-Rotolo, M
AU  - Srinivasan, S
AU  - Hruska, M
AU  - Myler, H
AU  - Portsmouth, SD
Y2  - 2020/12/21
Y1  - 2016/08/19
SN  - 2193-1801
UR  - http://hdl.handle.net/11343/256429
AB  - BACKGROUND AND PURPOSE: Peginterferon Lambda was being developed as an alternative to alfa interferon for the treatment of chronic hepatitis C virus (HCV) infection. We compared peginterferon Lambda-1a plus ribavirin (Lambda/RBV) and Lambda/RBV plus daclatasvir (DCV; pangenotypic NS5A inhibitor) with peginterferon alfa-2a plus RBV (alfa/RBV) in treatment-naive patients with HCV genotype 2 or 3 infection. METHODS: In this multicenter, double-blind, phase 3 randomized controlled trial, patients were assigned 2:2:1 to receive 24 weeks of Lambda/RBV, 12 weeks of Lambda/RBV + DCV, or 24 weeks of alfa/RBV. The primary outcome measure was sustained virologic response at post-treatment Week 12 (SVR12). RESULTS: Overall, 874 patients were treated: Lambda/RBV, n = 353; Lambda/RBV + DCV, n = 349; alfa/RBV, n = 172. Patients were 65 % white and 33 % Asian, 57 % male, with a mean age of 47 years; 52 % were infected with genotype 2 (6 % cirrhotic) and 48 % with genotype 3 (9 % cirrhotic). In the Lambda/RBV + DCV group, 83 % (95 % confidence interval [CI] 78.5, 86.5) achieved SVR12 (90 % genotype 2, 75 % genotype 3) whereas SVR12 was achieved by 68 % (95 % CI 63.1, 72.9) with Lambda/RBV (72 % genotype 2, 64 % genotype 3) and 73 % (95 % CI 66.6, 79.9) with peginterferon alfa/RBV (74 % genotype 2, 73 % genotype 3). Lambda/RBV + DCV was associated with lower incidences of flu-like symptoms, hematological abnormalities, and discontinuations due to adverse events compared with alfa/RBV. CONCLUSION: The 12-week regimen of Lambda/RBV + DCV was superior to peginterferon alfa/RBV in the combined population of treatment-naive patients with genotype 2 or 3 infection, with an improved tolerability and safety profile compared with alfa/RBV.
LA  - English
PB  - SPRINGER INTERNATIONAL PUBLISHING AG
T1  - A randomized, controlled study of peginterferon lambda-1a/ribavirin +/- daclatasvir for hepatitis C virus genotype 2 or 3
DO  - 10.1186/s40064-016-2920-z
IS  - SpringerPlus
VL  - 5
IS  - 1
L1  - /bitstream/handle/11343/256429/PMC4990525.pdf?sequence=1&isAllowed=y
ER  -