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Daclatasvir plasma level and resistance selection in HIV patients with hepatitis C virus cirrhosis treated with daclatasvir, sofosbuvir, and ribavirin

Saverio G. Parisi, Arianna Loregian, Samantha Andreis, Giulio Nannetti Orcid Logo, Silvia Cavinato, Monica Basso, Renzo Scaggiante, Federico Dal Bello, Lorenzo Messa, Anna Maria Cattelan, Giorgio Palù

International Journal of Infectious Diseases, Volume: 49, Pages: 151 - 153

Swansea University Author: Giulio Nannetti Orcid Logo

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DOI (Published version): 10.1016/j.ijid.2016.06.020

Abstract

ObjectivesEffective treatment with direct-acting antiviral drugs against hepatitis C virus (HCV) is a medical need in cirrhotic HIV–HCV co-infected patients.MethodsThis study investigated the plasma levels of daclatasvir (DCV) and ribavirin (RBV) in HIV–HCV co-infected subjects treated with DCV, sof...

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Published in: International Journal of Infectious Diseases
ISSN: 1201-9712
Published: Elsevier BV 2016
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URI: https://cronfa.swan.ac.uk/Record/cronfa57646
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spelling 2021-09-16T15:00:33.1445470 v2 57646 2021-08-18 Daclatasvir plasma level and resistance selection in HIV patients with hepatitis C virus cirrhosis treated with daclatasvir, sofosbuvir, and ribavirin 8d6b68ac6d8a7ab60eb04cae67116565 0000-0003-3227-1537 Giulio Nannetti Giulio Nannetti true false 2021-08-18 PHAR ObjectivesEffective treatment with direct-acting antiviral drugs against hepatitis C virus (HCV) is a medical need in cirrhotic HIV–HCV co-infected patients.MethodsThis study investigated the plasma levels of daclatasvir (DCV) and ribavirin (RBV) in HIV–HCV co-infected subjects treated with DCV, sofosbuvir, and RBV. Drug concentrations were quantified using validated high-performance liquid chromatography methods with ultraviolet detection. The HCV non-structural protein 5A and non-structural protein 5B coding regions were analyzed by population-based sequencing.ResultsDCV was dosed at week 4 and at week 8 of treatment, and RBV at week 8. One patient had the lowest DCV level, corresponding to 32.7% of the overall median value of the other patients at week 4 and about 40% at week 8. The Y93H variant was detected in this subject at weeks 8, 16, and 20 of treatment, but not before treatment or at day 2, and the patient experienced virological failure. Another subject with the Y93H variant at baseline and appropriate DCV levels had HCV RNA <12 IU/ml at week 12 and undetectable at week 16.ConclusionsSub-optimal DCV drug levels allow the selection of resistance-associated variants and fail to contribute to antiviral activity. No definite reason for the low DCV level was found. Quantifying the drug is suggested in difficult-to-treat patients. Journal Article International Journal of Infectious Diseases 49 151 153 Elsevier BV 1201-9712 Daclatasvir; HIV–HCV patients; Therapeutic drug monitoring; Virological failure; Population-based sequencing; Mutation 1 8 2016 2016-08-01 10.1016/j.ijid.2016.06.020 COLLEGE NANME Pharmacy COLLEGE CODE PHAR Swansea University 2021-09-16T15:00:33.1445470 2021-08-18T13:39:21.9062378 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Medicine Saverio G. Parisi 1 Arianna Loregian 2 Samantha Andreis 3 Giulio Nannetti 0000-0003-3227-1537 4 Silvia Cavinato 5 Monica Basso 6 Renzo Scaggiante 7 Federico Dal Bello 8 Lorenzo Messa 9 Anna Maria Cattelan 10 Giorgio Palù 11 57646__20889__1ea85a66097148f2a1b5cd34c0283b8a.pdf 57646.pdf 2021-09-16T14:58:46.0549930 Output 274633 application/pdf Version of Record true 2016 The Author(s). This is an open access article under the CC BY-NC-ND true eng http://creativecommons.org/licenses/by-nc-nd/4.0/
title Daclatasvir plasma level and resistance selection in HIV patients with hepatitis C virus cirrhosis treated with daclatasvir, sofosbuvir, and ribavirin
spellingShingle Daclatasvir plasma level and resistance selection in HIV patients with hepatitis C virus cirrhosis treated with daclatasvir, sofosbuvir, and ribavirin
Giulio Nannetti
title_short Daclatasvir plasma level and resistance selection in HIV patients with hepatitis C virus cirrhosis treated with daclatasvir, sofosbuvir, and ribavirin
title_full Daclatasvir plasma level and resistance selection in HIV patients with hepatitis C virus cirrhosis treated with daclatasvir, sofosbuvir, and ribavirin
title_fullStr Daclatasvir plasma level and resistance selection in HIV patients with hepatitis C virus cirrhosis treated with daclatasvir, sofosbuvir, and ribavirin
title_full_unstemmed Daclatasvir plasma level and resistance selection in HIV patients with hepatitis C virus cirrhosis treated with daclatasvir, sofosbuvir, and ribavirin
title_sort Daclatasvir plasma level and resistance selection in HIV patients with hepatitis C virus cirrhosis treated with daclatasvir, sofosbuvir, and ribavirin
author_id_str_mv 8d6b68ac6d8a7ab60eb04cae67116565
author_id_fullname_str_mv 8d6b68ac6d8a7ab60eb04cae67116565_***_Giulio Nannetti
author Giulio Nannetti
author2 Saverio G. Parisi
Arianna Loregian
Samantha Andreis
Giulio Nannetti
Silvia Cavinato
Monica Basso
Renzo Scaggiante
Federico Dal Bello
Lorenzo Messa
Anna Maria Cattelan
Giorgio Palù
format Journal article
container_title International Journal of Infectious Diseases
container_volume 49
container_start_page 151
publishDate 2016
institution Swansea University
issn 1201-9712
doi_str_mv 10.1016/j.ijid.2016.06.020
publisher Elsevier BV
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Medicine{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Medicine
document_store_str 1
active_str 0
description ObjectivesEffective treatment with direct-acting antiviral drugs against hepatitis C virus (HCV) is a medical need in cirrhotic HIV–HCV co-infected patients.MethodsThis study investigated the plasma levels of daclatasvir (DCV) and ribavirin (RBV) in HIV–HCV co-infected subjects treated with DCV, sofosbuvir, and RBV. Drug concentrations were quantified using validated high-performance liquid chromatography methods with ultraviolet detection. The HCV non-structural protein 5A and non-structural protein 5B coding regions were analyzed by population-based sequencing.ResultsDCV was dosed at week 4 and at week 8 of treatment, and RBV at week 8. One patient had the lowest DCV level, corresponding to 32.7% of the overall median value of the other patients at week 4 and about 40% at week 8. The Y93H variant was detected in this subject at weeks 8, 16, and 20 of treatment, but not before treatment or at day 2, and the patient experienced virological failure. Another subject with the Y93H variant at baseline and appropriate DCV levels had HCV RNA <12 IU/ml at week 12 and undetectable at week 16.ConclusionsSub-optimal DCV drug levels allow the selection of resistance-associated variants and fail to contribute to antiviral activity. No definite reason for the low DCV level was found. Quantifying the drug is suggested in difficult-to-treat patients.
published_date 2016-08-01T04:13:33Z
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score 10.999524

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