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The effectiveness and safety of direct-acting antivirals for hepatitis C virus treatment: A single-center experience in Saudi Arabia

BACKGROUND: The introduction of direct-acting antivirals (DAA) to treat the hepatitis C virus (HCV) overcame many drawbacks of interferon-based therapy. DAA achieved sustained viral response (SVR) rates above 90% and overcame many drawbacks of pegylated interferon regimens.The HCV genotype (GT) dist...

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Autores principales: Alarfaj, Sumaiah J., Alzahrani, Abdullah, Alotaibi, Anfal, Almutairi, Malak, Hakami, Mashael, Alhomaid, Njood, Alharthi, Noori, Korayem, Ghazwa B., Alghamdi, Abdullah
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9649346/
https://www.ncbi.nlm.nih.gov/pubmed/36387341
http://dx.doi.org/10.1016/j.jsps.2022.07.005
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author Alarfaj, Sumaiah J.
Alzahrani, Abdullah
Alotaibi, Anfal
Almutairi, Malak
Hakami, Mashael
Alhomaid, Njood
Alharthi, Noori
Korayem, Ghazwa B.
Alghamdi, Abdullah
author_facet Alarfaj, Sumaiah J.
Alzahrani, Abdullah
Alotaibi, Anfal
Almutairi, Malak
Hakami, Mashael
Alhomaid, Njood
Alharthi, Noori
Korayem, Ghazwa B.
Alghamdi, Abdullah
author_sort Alarfaj, Sumaiah J.
collection PubMed
description BACKGROUND: The introduction of direct-acting antivirals (DAA) to treat the hepatitis C virus (HCV) overcame many drawbacks of interferon-based therapy. DAA achieved sustained viral response (SVR) rates above 90% and overcame many drawbacks of pegylated interferon regimens.The HCV genotype (GT) distribution varies by geographical area, with GT-4 being most prevalent in the Middle East region, including Saudi Arabia. Yet, the real-world evidence about using DAAs in the Saudi population is limited.Thus, the aim of this study to investigate the effectiveness and safety of DAAs in Saudi patients with HCV infection. METHODS: A retrospective cohort study included patients treated with DAAs from 2015 to 2017 at a tertiary care hospital in Riyadh, Saudi Arabia. All patients with HCV treated with either ledipasvir plus sofosbuvir (LDS/SOF) ± ribavarin (RBV) or ombitasvir-paritaprevir-ritonavir (OBV/PTV/r) ± dasabuvir (DSV) ± RBV were included. Using a per-protocol analysis, the effectiveness outcome was the end-of-treatment response (EOTr) and Sustained virologic reponce12 weeks after competing the regimen (SVR12). The secondary safety outcome was the adverse event related to the therapy reported by the patients. RESULTS: A total of 97 patients were included; with the majority infected with GT-4 (64 %), followed by GT-1 (18 %), in addition to 8 % having a mixed GT (1 + 4). The EOTr and SVR12 rates were 98 % and 96 %, respectively. SVR12 was 94.4 % within the LDS/SOF ± RBV group and 97.7 % within the OBV/PTV/r ± DSV ± RBV group. Only 4 % had a response failure due to relapse or breakthrough, and all were infected with mixed GT1 + 4. Medications were well tolerated with minimal side effects, including vomiting, nausea, and weakness. CONCLUSION: DAAs regimens are associated with high rates of SVR12 and are well tolerated with a good safety profile in Saudi HCV-infected patients.
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spelling pubmed-96493462022-11-15 The effectiveness and safety of direct-acting antivirals for hepatitis C virus treatment: A single-center experience in Saudi Arabia Alarfaj, Sumaiah J. Alzahrani, Abdullah Alotaibi, Anfal Almutairi, Malak Hakami, Mashael Alhomaid, Njood Alharthi, Noori Korayem, Ghazwa B. Alghamdi, Abdullah Saudi Pharm J Original Article BACKGROUND: The introduction of direct-acting antivirals (DAA) to treat the hepatitis C virus (HCV) overcame many drawbacks of interferon-based therapy. DAA achieved sustained viral response (SVR) rates above 90% and overcame many drawbacks of pegylated interferon regimens.The HCV genotype (GT) distribution varies by geographical area, with GT-4 being most prevalent in the Middle East region, including Saudi Arabia. Yet, the real-world evidence about using DAAs in the Saudi population is limited.Thus, the aim of this study to investigate the effectiveness and safety of DAAs in Saudi patients with HCV infection. METHODS: A retrospective cohort study included patients treated with DAAs from 2015 to 2017 at a tertiary care hospital in Riyadh, Saudi Arabia. All patients with HCV treated with either ledipasvir plus sofosbuvir (LDS/SOF) ± ribavarin (RBV) or ombitasvir-paritaprevir-ritonavir (OBV/PTV/r) ± dasabuvir (DSV) ± RBV were included. Using a per-protocol analysis, the effectiveness outcome was the end-of-treatment response (EOTr) and Sustained virologic reponce12 weeks after competing the regimen (SVR12). The secondary safety outcome was the adverse event related to the therapy reported by the patients. RESULTS: A total of 97 patients were included; with the majority infected with GT-4 (64 %), followed by GT-1 (18 %), in addition to 8 % having a mixed GT (1 + 4). The EOTr and SVR12 rates were 98 % and 96 %, respectively. SVR12 was 94.4 % within the LDS/SOF ± RBV group and 97.7 % within the OBV/PTV/r ± DSV ± RBV group. Only 4 % had a response failure due to relapse or breakthrough, and all were infected with mixed GT1 + 4. Medications were well tolerated with minimal side effects, including vomiting, nausea, and weakness. CONCLUSION: DAAs regimens are associated with high rates of SVR12 and are well tolerated with a good safety profile in Saudi HCV-infected patients. Elsevier 2022-10 2022-07-25 /pmc/articles/PMC9649346/ /pubmed/36387341 http://dx.doi.org/10.1016/j.jsps.2022.07.005 Text en © 2022 The Authors https://creativecommons.org/licenses/by/4.0/This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Original Article
Alarfaj, Sumaiah J.
Alzahrani, Abdullah
Alotaibi, Anfal
Almutairi, Malak
Hakami, Mashael
Alhomaid, Njood
Alharthi, Noori
Korayem, Ghazwa B.
Alghamdi, Abdullah
The effectiveness and safety of direct-acting antivirals for hepatitis C virus treatment: A single-center experience in Saudi Arabia
title The effectiveness and safety of direct-acting antivirals for hepatitis C virus treatment: A single-center experience in Saudi Arabia
title_full The effectiveness and safety of direct-acting antivirals for hepatitis C virus treatment: A single-center experience in Saudi Arabia
title_fullStr The effectiveness and safety of direct-acting antivirals for hepatitis C virus treatment: A single-center experience in Saudi Arabia
title_full_unstemmed The effectiveness and safety of direct-acting antivirals for hepatitis C virus treatment: A single-center experience in Saudi Arabia
title_short The effectiveness and safety of direct-acting antivirals for hepatitis C virus treatment: A single-center experience in Saudi Arabia
title_sort effectiveness and safety of direct-acting antivirals for hepatitis c virus treatment: a single-center experience in saudi arabia
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9649346/
https://www.ncbi.nlm.nih.gov/pubmed/36387341
http://dx.doi.org/10.1016/j.jsps.2022.07.005
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