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Comparing direct acting antivirals for hepatitis C using observational data – Why and how?
The World Health Organisation's goal of hepatitis C virus (HCV) elimination by 2030 will require lower drug prices. Estimates of comparative efficacy promote competition between pharmaceutical companies but direct acting antivirals have been approved for the treatment of HCV without comparative...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7507378/ https://www.ncbi.nlm.nih.gov/pubmed/32894643 http://dx.doi.org/10.1002/prp2.650 |
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author | Young, Jim Wong, Stanley Janjua, Naveed Z. Klein, Marina B. |
author_facet | Young, Jim Wong, Stanley Janjua, Naveed Z. Klein, Marina B. |
author_sort | Young, Jim |
collection | PubMed |
description | The World Health Organisation's goal of hepatitis C virus (HCV) elimination by 2030 will require lower drug prices. Estimates of comparative efficacy promote competition between pharmaceutical companies but direct acting antivirals have been approved for the treatment of HCV without comparative trials. We emulated a randomized trial to answer the question of whether easy to treat patients with genotype 1 HCV could be treated with sofosbuvir/ledipasvir (SOF/LDV) rather than sofosbuvir/velpatasvir (SOF/VEL). Patients without comorbidities or end stage liver disease were selected from the British Colombia Hepatitis Testers Cohort. To create a conceptual trial, we matched each patient starting SOF/VEL (a ‘case’) to the patient starting SOF/LDV with the closest propensity score (a ‘control’). We estimated the probability of treatment failure under a Bayesian logistic model with a random effect for each case‐control set and used that model to give an estimate of a risk difference for the conceptual trial. Treatment failure was recorded for 27 of 825 (3%) cases and for 29 of 602 (5%) matched controls. Estimates from our model were treatment success rates of 97% (95% credible interval, CrI, 95%‐98%) for treatment with SOF/VEL, 95% (95% CrI 93%‐97%) for treatment with SOF/LDV and a risk difference between treatments of 2% (95% CrI 0%‐4%). This risk difference is evidence that SOF/LDV is not inferior to SOF/VEL for easy to treat patients with genotype 1 HCV. The approach is a template for comparing drugs when there are no data from comparative trials. |
format | Online Article Text |
id | pubmed-7507378 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-75073782020-09-28 Comparing direct acting antivirals for hepatitis C using observational data – Why and how? Young, Jim Wong, Stanley Janjua, Naveed Z. Klein, Marina B. Pharmacol Res Perspect Original Articles The World Health Organisation's goal of hepatitis C virus (HCV) elimination by 2030 will require lower drug prices. Estimates of comparative efficacy promote competition between pharmaceutical companies but direct acting antivirals have been approved for the treatment of HCV without comparative trials. We emulated a randomized trial to answer the question of whether easy to treat patients with genotype 1 HCV could be treated with sofosbuvir/ledipasvir (SOF/LDV) rather than sofosbuvir/velpatasvir (SOF/VEL). Patients without comorbidities or end stage liver disease were selected from the British Colombia Hepatitis Testers Cohort. To create a conceptual trial, we matched each patient starting SOF/VEL (a ‘case’) to the patient starting SOF/LDV with the closest propensity score (a ‘control’). We estimated the probability of treatment failure under a Bayesian logistic model with a random effect for each case‐control set and used that model to give an estimate of a risk difference for the conceptual trial. Treatment failure was recorded for 27 of 825 (3%) cases and for 29 of 602 (5%) matched controls. Estimates from our model were treatment success rates of 97% (95% credible interval, CrI, 95%‐98%) for treatment with SOF/VEL, 95% (95% CrI 93%‐97%) for treatment with SOF/LDV and a risk difference between treatments of 2% (95% CrI 0%‐4%). This risk difference is evidence that SOF/LDV is not inferior to SOF/VEL for easy to treat patients with genotype 1 HCV. The approach is a template for comparing drugs when there are no data from comparative trials. John Wiley and Sons Inc. 2020-09-07 /pmc/articles/PMC7507378/ /pubmed/32894643 http://dx.doi.org/10.1002/prp2.650 Text en © 2020 The Authors. Pharmacology Research & Perspectives published by British Pharmacological Society and American Society for Pharmacology and Experimental Therapeutics and John Wiley & Sons Ltd This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
spellingShingle | Original Articles Young, Jim Wong, Stanley Janjua, Naveed Z. Klein, Marina B. Comparing direct acting antivirals for hepatitis C using observational data – Why and how? |
title | Comparing direct acting antivirals for hepatitis C using observational data – Why and how? |
title_full | Comparing direct acting antivirals for hepatitis C using observational data – Why and how? |
title_fullStr | Comparing direct acting antivirals for hepatitis C using observational data – Why and how? |
title_full_unstemmed | Comparing direct acting antivirals for hepatitis C using observational data – Why and how? |
title_short | Comparing direct acting antivirals for hepatitis C using observational data – Why and how? |
title_sort | comparing direct acting antivirals for hepatitis c using observational data – why and how? |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7507378/ https://www.ncbi.nlm.nih.gov/pubmed/32894643 http://dx.doi.org/10.1002/prp2.650 |
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