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Resistance characterization of hepatitis C virus genotype 2 from Japanese patients treated with ombitasvir and paritaprevir/ritonavir.
- Source :
-
Journal of medical virology [J Med Virol] 2018 Jan; Vol. 90 (1), pp. 109-119. Date of Electronic Publication: 2017 Sep 22. - Publication Year :
- 2018
-
Abstract
- Treatment of HCV genotype (GT) 2-infected Japanese patients with paritaprevir (NS3/4A inhibitor boosted with ritonavir) and ombitasvir (NS5A inhibitor) without ribavirin for 12 weeks in the phase 2 study M12-536, and with ribavirin for 16 weeks in phase 3 study GIFT II resulted in SVR rates of 72.2% to 91.5%. Overall, 11 out of 125 patients with GT2a and 37 out of 79 patients with GT2b infection experienced virologic failure. The prevalence of baseline polymorphisms in NS3 and NS5A and their the impact on treatment outcome, as well as the development of viral resistance in GT2-infected patients experiencing virologic failure were evaluated by HCV NS3 and NS5A population and clonal sequence analyses. Baseline polymorphisms in NS3 that confer resistance to paritaprevir were rare in both GT2a- and GT2b-infected patients, while baseline polymorphisms in NS5A that confer resistance to ombitasvir were detected in 11.2% and 14.1% of the GT2a- and GT2b-infected patients, respectively. There was no significant impact of baseline polymorphisms on treatment outcome in Japanese patients. The most common treatment-emergent substitutions at the time of virologic failure occurred at amino acid positions 168 in NS3 and 28 in NS5A in both GT2a- and GT2b-infected patients. Although there was a higher rate of virologic failure in patients with GT2b infection, the resistance analyses presented in this report support the conclusion that testing for baseline resistance-associated polymorphisms is not warranted for HCV GT2-infected patients treated with a regimen of ombitasvir/paritaprevir/ritonavir + ribavirin for 16 weeks.<br /> (© 2017 The Authors. Journal of Medical Virology Published by Wiley Periodicals, Inc.)
- Subjects :
- Anilides administration & dosage
Anilides adverse effects
Antiviral Agents administration & dosage
Antiviral Agents adverse effects
Carbamates administration & dosage
Carbamates adverse effects
Cyclopropanes
Drug Therapy, Combination adverse effects
Female
Genotype
Hepacivirus genetics
Hepatitis C, Chronic drug therapy
Hepatitis C, Chronic epidemiology
Hepatitis C, Chronic ethnology
Humans
Japan epidemiology
Lactams, Macrocyclic
Macrocyclic Compounds administration & dosage
Macrocyclic Compounds adverse effects
Male
Middle Aged
Polymorphism, Genetic
Proline analogs & derivatives
Ribavirin administration & dosage
Ribavirin adverse effects
Ribavirin therapeutic use
Ritonavir administration & dosage
Ritonavir adverse effects
Sulfonamides
Treatment Failure
Treatment Outcome
Valine
Anilides therapeutic use
Antiviral Agents therapeutic use
Carbamates therapeutic use
Drug Resistance, Viral genetics
Hepacivirus drug effects
Hepatitis C, Chronic virology
Macrocyclic Compounds therapeutic use
Ritonavir therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1096-9071
- Volume :
- 90
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Journal of medical virology
- Publication Type :
- Academic Journal
- Accession number :
- 28842997
- Full Text :
- https://doi.org/10.1002/jmv.24923