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Effectiveness of Direct-Acting Antiviral Therapy in Patients With Human Immunodeficiency Virus–Hepatitis C Virus Coinfection in Routine Clinical Care: A Multicenter Study
BACKGROUND: Direct-acting antiviral (DAA) therapy have been shown to be highly successful in clinical trials and observational studies, but less is known about treatment success in patients with a high burden of comorbid conditions, including mental health and substance use disorders. We evaluated D...
Autores principales: | , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6441587/ https://www.ncbi.nlm.nih.gov/pubmed/30949539 http://dx.doi.org/10.1093/ofid/ofz100 |
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author | Kim, H Nina Nance, Robin M Williams-Nguyen, Jessica S Chris Delaney, J A Crane, Heidi M Cachay, Edward R Martin, Jeffrey Mathews, W Christopher Chander, Geetanjali Franco, Ricardo Hurt, Christopher B Geng, Elvin H Rodriguez, Benigno Moore, Richard D Saag, Michael S Kitahata, Mari M |
author_facet | Kim, H Nina Nance, Robin M Williams-Nguyen, Jessica S Chris Delaney, J A Crane, Heidi M Cachay, Edward R Martin, Jeffrey Mathews, W Christopher Chander, Geetanjali Franco, Ricardo Hurt, Christopher B Geng, Elvin H Rodriguez, Benigno Moore, Richard D Saag, Michael S Kitahata, Mari M |
author_sort | Kim, H Nina |
collection | PubMed |
description | BACKGROUND: Direct-acting antiviral (DAA) therapy have been shown to be highly successful in clinical trials and observational studies, but less is known about treatment success in patients with a high burden of comorbid conditions, including mental health and substance use disorders. We evaluated DAA effectiveness across a broad spectrum of patients with human immunodeficiency virus (HIV)–hepatitis C virus (HCV) coinfection in routine clinical care, including those with psychosocial comorbid conditions. METHODS: The primary end point was sustained virologic response (SVR), defined as HCV RNA not detected or <25 IU/mL ≥10 weeks after treatment. We calculated SVR rates and 95% confidence intervals (CIs) in a modified intent-to-treat analysis. We repeated this analysis after multiply imputing missing SVR values. RESULTS: Among 642 DAA-treated patients, 536 had SVR assessments. The median age was 55 years; 79% were men, 59% black, and 32% white. Cirrhosis (fibrosis-4 index>3.25) was present in 24%, and 17% were interferon treatment experienced; 96% had genotype 1 infection and 432 (81%) had received ledipasvir-sofosbuvir. SVR occurred in 96.5% (95% CI, 94.5%–97.9%). Patients who were black, treatment experienced, or cirrhotic all had SVR rates >95%. Patients with depression and/or anxiety, psychotic disorder, illicit drug use, or alcohol use disorder also had high SVR rates, ranging from 95.4% to 96.8%. The only factor associated with lower SVR rate was early discontinuation (77.8%; 95% CI, 52.4%–93.6%). Similar results were seen in multiply imputed data sets. CONCLUSIONS: Our study represents a large multicenter examination of DAA therapy in HIV/HCV-coinfected patients. The broad treatment success we observed across this diverse group of patients with significant comorbid conditions is highly affirming and argues for widespread implementation of DAA therapy. |
format | Online Article Text |
id | pubmed-6441587 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-64415872019-04-04 Effectiveness of Direct-Acting Antiviral Therapy in Patients With Human Immunodeficiency Virus–Hepatitis C Virus Coinfection in Routine Clinical Care: A Multicenter Study Kim, H Nina Nance, Robin M Williams-Nguyen, Jessica S Chris Delaney, J A Crane, Heidi M Cachay, Edward R Martin, Jeffrey Mathews, W Christopher Chander, Geetanjali Franco, Ricardo Hurt, Christopher B Geng, Elvin H Rodriguez, Benigno Moore, Richard D Saag, Michael S Kitahata, Mari M Open Forum Infect Dis Major Articles BACKGROUND: Direct-acting antiviral (DAA) therapy have been shown to be highly successful in clinical trials and observational studies, but less is known about treatment success in patients with a high burden of comorbid conditions, including mental health and substance use disorders. We evaluated DAA effectiveness across a broad spectrum of patients with human immunodeficiency virus (HIV)–hepatitis C virus (HCV) coinfection in routine clinical care, including those with psychosocial comorbid conditions. METHODS: The primary end point was sustained virologic response (SVR), defined as HCV RNA not detected or <25 IU/mL ≥10 weeks after treatment. We calculated SVR rates and 95% confidence intervals (CIs) in a modified intent-to-treat analysis. We repeated this analysis after multiply imputing missing SVR values. RESULTS: Among 642 DAA-treated patients, 536 had SVR assessments. The median age was 55 years; 79% were men, 59% black, and 32% white. Cirrhosis (fibrosis-4 index>3.25) was present in 24%, and 17% were interferon treatment experienced; 96% had genotype 1 infection and 432 (81%) had received ledipasvir-sofosbuvir. SVR occurred in 96.5% (95% CI, 94.5%–97.9%). Patients who were black, treatment experienced, or cirrhotic all had SVR rates >95%. Patients with depression and/or anxiety, psychotic disorder, illicit drug use, or alcohol use disorder also had high SVR rates, ranging from 95.4% to 96.8%. The only factor associated with lower SVR rate was early discontinuation (77.8%; 95% CI, 52.4%–93.6%). Similar results were seen in multiply imputed data sets. CONCLUSIONS: Our study represents a large multicenter examination of DAA therapy in HIV/HCV-coinfected patients. The broad treatment success we observed across this diverse group of patients with significant comorbid conditions is highly affirming and argues for widespread implementation of DAA therapy. Oxford University Press 2019-03-23 /pmc/articles/PMC6441587/ /pubmed/30949539 http://dx.doi.org/10.1093/ofid/ofz100 Text en © The Author(s) 2019. Published by Oxford University Press on behalf of Infectious Diseases Society of America. http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com |
spellingShingle | Major Articles Kim, H Nina Nance, Robin M Williams-Nguyen, Jessica S Chris Delaney, J A Crane, Heidi M Cachay, Edward R Martin, Jeffrey Mathews, W Christopher Chander, Geetanjali Franco, Ricardo Hurt, Christopher B Geng, Elvin H Rodriguez, Benigno Moore, Richard D Saag, Michael S Kitahata, Mari M Effectiveness of Direct-Acting Antiviral Therapy in Patients With Human Immunodeficiency Virus–Hepatitis C Virus Coinfection in Routine Clinical Care: A Multicenter Study |
title | Effectiveness of Direct-Acting Antiviral Therapy in Patients With Human Immunodeficiency Virus–Hepatitis C Virus Coinfection in Routine Clinical Care: A Multicenter Study |
title_full | Effectiveness of Direct-Acting Antiviral Therapy in Patients With Human Immunodeficiency Virus–Hepatitis C Virus Coinfection in Routine Clinical Care: A Multicenter Study |
title_fullStr | Effectiveness of Direct-Acting Antiviral Therapy in Patients With Human Immunodeficiency Virus–Hepatitis C Virus Coinfection in Routine Clinical Care: A Multicenter Study |
title_full_unstemmed | Effectiveness of Direct-Acting Antiviral Therapy in Patients With Human Immunodeficiency Virus–Hepatitis C Virus Coinfection in Routine Clinical Care: A Multicenter Study |
title_short | Effectiveness of Direct-Acting Antiviral Therapy in Patients With Human Immunodeficiency Virus–Hepatitis C Virus Coinfection in Routine Clinical Care: A Multicenter Study |
title_sort | effectiveness of direct-acting antiviral therapy in patients with human immunodeficiency virus–hepatitis c virus coinfection in routine clinical care: a multicenter study |
topic | Major Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6441587/ https://www.ncbi.nlm.nih.gov/pubmed/30949539 http://dx.doi.org/10.1093/ofid/ofz100 |
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