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Ombitasvir, paritaprevir, and ritonavir with peginterferon-α2a plus ribavirin in treatment-experienced patients with chronic hepatitis C virus genotype 1 infection
Authors Bernstein D, Tripathi R, Cohen DE
Received 29 September 2018
Accepted for publication 27 December 2018
Published 13 February 2019 Volume 2019:11 Pages 35—40
DOI https://doi.org/10.2147/HMER.S189158
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 3
Editor who approved publication: Dr Gerry Lake-Bakaar
David Bernstein,1 Rakesh Tripathi,2 Daniel E Cohen2
1Zucker School of Medicine, Hofstra University, Hempstead, New York, NY, USA; 2AbbVie Inc., North Chicago, IL, USA
Background: This international, phase 2, open-label, multicenter study (ClinicalTrials.gov Identifier: NCT01609933) was conducted to evaluate the safety and efficacy of an enhanced regimen consisting of the direct-acting antivirals (DAAs) ombitasvir, paritaprevir, and ritonavir administered for 24 weeks, combined with pegylated interferon-α2a plus ribavirin (pegIFN-α2a/RBV) for 48 weeks, in patients with chronic hepatitis C virus (HCV) genotype 1 infection who had experienced virologic failure with a prior DAA regimen. This study was undertaken at a time when options were limited for the retreatment of patients who had failed prior DAA therapy.
Methods and results: Thirty-two patients were enrolled; the majority were male (78%) and White (94%), and the median age was 54.5 years. Twelve weeks after the last dose of study drug, sustained virologic response was achieved in 81.3% of patients. Five patients prematurely discontinued the study drugs and one patient relapsed. Safety and tolerability were similar to prior studies of pegIFN-α2a/RBV alone.
Conclusion: Given the availability of highly efficacious DAA regimens that are both IFN- and RBV-free, this regimen is no longer relevant in today’s HCV treatment landscape.
Keywords: direct-acting antiviral, retreatment, virologic failure
Data sharing statement
AbbVie is committed to responsible data sharing regarding the clinical trials it sponsored. This includes access to anonymized, individual, and trial-level data (analysis data sets), as well as other information (eg, protocols and Clinical Study Reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. This clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. For more information on the process, or to submit a request, visit the following link: https://www.abbvie.com/our-science/clinical-trials/clinicaltrials-data-and-information-sharing/data-and-informationsharing-with-qualified-researchers.html.
Acknowledgments
Paritaprevir was identified by AbbVie and Enanta. The authors would like to express their gratitude to the patients who participated in this study and their families, as well as all of the trial investigators and their research staff. Editorial support was provided by Fiona Powell, PhD, and Paul MacCallum, PhD, of Fishawack Communications Ltd.; funded by AbbVie. AbbVie sponsored the study; contributed to its design; and participated in the collection, analysis, and interpretation of the data and in the writing, reviewing, and approval of the publication.
Disclosure
David Bernstein has acted as a consultant for and received research grants from AbbVie and Gilead. Daniel E Cohen and Rakesh Tripathi are employees of AbbVie and may hold stock or options. The authors report no other conflicts of interest in this work.
References
VIEKIRA PAK (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) [prescribing information]. North Chicago, IL: AbbVie, Inc.; approved December 2014. Available from. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206619s017lbl.pdf. Accessed August 28, 2018. | ||
VIEKIRAX (ombitasvir, paritaprevir, and ritonavir tablets) [summary of product characteristics]. North Chicago, IL: AbbVie, Inc.; approved January 2015. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003839/WC500183997.pdf. Accessed August 28, 2018. | ||
EXVIERA (dasabuvir tablets) [summary of product characteristics]. North Chicago, IL: AbbVie, Inc.; approved January 2015. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003837/WC500182233.pdf. Accessed August 28, 2018. | ||
Ferenci P. Treatment options for anti-HCV treatment-experienced patients. Clin Liv Dis. 2012;1(2):49–50. | ||
American Association for the Study of Liver Diseases and the Infectious Diseases Society of America. HCV guidance: recommendations for testing, managing, and treating hepatitis C; 2018. Available from: https://www.hcvguidelines.org/sites/default/files/full-guidance-pdf/HCVGuidance_May_24_2018b.pdf. Accessed August 28, 2018. |
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