TY - JOUR
T1 - Exploratory trial of ombitasvir and ABT-450/r with or without ribavirin for HCV genotype 1, 2, and 3 infection
AU - Lawitz, Eric
AU - Sullivan, Greg
AU - Rodriguez-Torres, Maribel
AU - Bennett, Michael
AU - Poordad, Fred
AU - Kapoor, Mudra
AU - Badri, Prajakta
AU - Campbell, Andrew
AU - Rodrigues, Lino
AU - Hu, Yiran
AU - Pilot-Matias, Tami
AU - Vilchez, Regis A.
N1 - Funding Information:
This study was funded by AbbVie Inc . The authors would like to express their gratitude to the study participants and coordinators who made this study possible. The study investigators were Humberto Aguilar, Bruce R. Bacon, Michael Bennett, Pedram Enayati, Gregory T. Everson, Bradley Freilich, Eliot Godofsky, Daniel Jackson, Kris Kowdley, Eric Lawitz, Maribel Rodriguez-Torres, Vinod Rustgi, Aasim Sheikh, Greg Sullivan, and Fredrick Weber. The authors also thank Travis Yanke, Christian Naylor, Jim Watson, Jan Hairrell, Lois Larsen, Martin King, Lindsey Haas, Christine Collins, Gretja Schnell, Jill Beyer, Tom Reisch, Preethi Krishnan, and Rakesh Tripathi of AbbVie and Michele Heckaman for their contributions.
Publisher Copyright:
© 2014 The Authors.
PY - 2015/2/1
Y1 - 2015/2/1
N2 - Objectives: To examine the safety and efficacy of ombitasvir and ABT-450 with ritonavir (ABT-450/r)±ribavirin (RBV) in treatment-naïve, non-cirrhotic adults with chronic HCV genotype 1-3 infection. Methods: Patients in this open-label, exploratory, phase 2, multicenter study received ombitasvir (25mg QD) and ABT-450/r (200/100mg QD)±RBV for 12 weeks. Primary efficacy endpoint was HCV RNA12) was a secondary endpoint. Results: Sixty-one patients were enrolled. Among genotype 1-, 2-, and 3-infected patients, respectively, HCV RNA was<LLOQ from week 4 through 12 in 10 (100%; 95% CI 69-100), 9 (90%; 56-100), and 7 (70%; 35-93) receiving the RBV-containing regimen and 9 (90%; 56-100), 8 (80%; 44-97), and 2 (18%; 2-52) receiving the RBV-free regimen. Among genotype 1-, 2-, and 3-infected patients, respectively, SVR12 was achieved by 10 (100%), 8 (80%), and 5 (50%) receiving the RBV-containing regimen, and 6 (60%), 6 (60%), and 1 (9%) receiving the RBV-free regimen. The most common adverse events were fatigue, nausea, and headache. One patient discontinued due to an adverse event. Conclusions: In this study, ombitasvir and ABT-450/r±RBV regimens were generally well-tolerated. Sustained virologic response was achieved in most patients with HCV genotype 1 or 2 infection, but low SVR rates were observed in HCV genotype 3-infected patients.
AB - Objectives: To examine the safety and efficacy of ombitasvir and ABT-450 with ritonavir (ABT-450/r)±ribavirin (RBV) in treatment-naïve, non-cirrhotic adults with chronic HCV genotype 1-3 infection. Methods: Patients in this open-label, exploratory, phase 2, multicenter study received ombitasvir (25mg QD) and ABT-450/r (200/100mg QD)±RBV for 12 weeks. Primary efficacy endpoint was HCV RNA12) was a secondary endpoint. Results: Sixty-one patients were enrolled. Among genotype 1-, 2-, and 3-infected patients, respectively, HCV RNA was<LLOQ from week 4 through 12 in 10 (100%; 95% CI 69-100), 9 (90%; 56-100), and 7 (70%; 35-93) receiving the RBV-containing regimen and 9 (90%; 56-100), 8 (80%; 44-97), and 2 (18%; 2-52) receiving the RBV-free regimen. Among genotype 1-, 2-, and 3-infected patients, respectively, SVR12 was achieved by 10 (100%), 8 (80%), and 5 (50%) receiving the RBV-containing regimen, and 6 (60%), 6 (60%), and 1 (9%) receiving the RBV-free regimen. The most common adverse events were fatigue, nausea, and headache. One patient discontinued due to an adverse event. Conclusions: In this study, ombitasvir and ABT-450/r±RBV regimens were generally well-tolerated. Sustained virologic response was achieved in most patients with HCV genotype 1 or 2 infection, but low SVR rates were observed in HCV genotype 3-infected patients.
KW - HCV genotype 2
KW - HCV genotype 3
KW - Hepatitis C virus
KW - Interferon-free therapy
KW - SVR
KW - Sustained virologic response
UR - http://www.scopus.com/inward/record.url?scp=84921059015&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84921059015&partnerID=8YFLogxK
U2 - 10.1016/j.jinf.2014.09.008
DO - 10.1016/j.jinf.2014.09.008
M3 - Article
C2 - 25246359
AN - SCOPUS:84921059015
SN - 0163-4453
VL - 70
SP - 197
EP - 205
JO - Journal of Infection
JF - Journal of Infection
IS - 2
ER -