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Safety and Efficacy of Limited Laboratory Monitoring for Hepatitis C Treatment: A Blinded Clinical Trial in Rwanda
Direct‐acting antivirals for hepatitis C virus (HCV) are highly effective and well‐tolerated. However, only a small percentage of HCV‐infected individuals globally have received therapy. Reducing the complexity of monitoring during HCV therapy, if shown to be safe, could facilitate greater access to...
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/PMC7109339/ https://www.ncbi.nlm.nih.gov/pubmed/32258951 http://dx.doi.org/10.1002/hep4.1482 |
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author | Grant, Philip Shumbusho, Fabienne Van Nuil, Jennifer Ilo Kateera, Fredrick Mukherjee, Joia Kabahizi, Jules Ntaganda, Fabien Nsanzimana, Sabin Mbituyumuremyi, Aimable Damascene, Makuza Jean Muvunyi, Claude Mambo Mukabatsinda, Constance Musabeyezu, Emmanuel Ntirenganya, Cyprien Gupta, Neil |
author_facet | Grant, Philip Shumbusho, Fabienne Van Nuil, Jennifer Ilo Kateera, Fredrick Mukherjee, Joia Kabahizi, Jules Ntaganda, Fabien Nsanzimana, Sabin Mbituyumuremyi, Aimable Damascene, Makuza Jean Muvunyi, Claude Mambo Mukabatsinda, Constance Musabeyezu, Emmanuel Ntirenganya, Cyprien Gupta, Neil |
author_sort | Grant, Philip |
collection | PubMed |
description | Direct‐acting antivirals for hepatitis C virus (HCV) are highly effective and well‐tolerated. However, only a small percentage of HCV‐infected individuals globally have received therapy. Reducing the complexity of monitoring during HCV therapy, if shown to be safe, could facilitate greater access to HCV services, particularly in resource‐limited settings such as sub‐Saharan Africa. We enrolled a total of 300 patients who were chronically infected with genotype 4 HCV in Rwanda and treated them with fixed‐dose ledispasvir/sofosbuvir for 12 weeks. For 60 consecutive participants enrolled, we blinded the study clinician to on‐treatment laboratory results. We compared the efficacy, safety, and tolerability in those with blinded laboratory results to those with standard laboratory monitoring. Baseline characteristics among those with blinded laboratory values were comparable to those with standard monitoring. Among both groups, the median age was 63 years, and the median HCV viral load was 5.9 log (versus 64 years and 6.0 log, respectively). Sustained virologic response rates at 12 weeks after treatment completion were similar in those with blinded laboratories (87%) compared to those with standard laboratory monitoring (87%). There was no increase in adverse events in those with blinded laboratory results, and no participants discontinued the study medication because of an adverse event. Conclusion: On‐treatment laboratory monitoring did not improve patient outcomes in those treated with ledispasvir/sofosbuvir. Eliminating this monitoring in treatment programs in resource‐limited settings may facilitate and accelerate scale‐up of HCV therapy. |
format | Online Article Text |
id | pubmed-7109339 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-71093392020-04-01 Safety and Efficacy of Limited Laboratory Monitoring for Hepatitis C Treatment: A Blinded Clinical Trial in Rwanda Grant, Philip Shumbusho, Fabienne Van Nuil, Jennifer Ilo Kateera, Fredrick Mukherjee, Joia Kabahizi, Jules Ntaganda, Fabien Nsanzimana, Sabin Mbituyumuremyi, Aimable Damascene, Makuza Jean Muvunyi, Claude Mambo Mukabatsinda, Constance Musabeyezu, Emmanuel Ntirenganya, Cyprien Gupta, Neil Hepatol Commun Original Articles Direct‐acting antivirals for hepatitis C virus (HCV) are highly effective and well‐tolerated. However, only a small percentage of HCV‐infected individuals globally have received therapy. Reducing the complexity of monitoring during HCV therapy, if shown to be safe, could facilitate greater access to HCV services, particularly in resource‐limited settings such as sub‐Saharan Africa. We enrolled a total of 300 patients who were chronically infected with genotype 4 HCV in Rwanda and treated them with fixed‐dose ledispasvir/sofosbuvir for 12 weeks. For 60 consecutive participants enrolled, we blinded the study clinician to on‐treatment laboratory results. We compared the efficacy, safety, and tolerability in those with blinded laboratory results to those with standard laboratory monitoring. Baseline characteristics among those with blinded laboratory values were comparable to those with standard monitoring. Among both groups, the median age was 63 years, and the median HCV viral load was 5.9 log (versus 64 years and 6.0 log, respectively). Sustained virologic response rates at 12 weeks after treatment completion were similar in those with blinded laboratories (87%) compared to those with standard laboratory monitoring (87%). There was no increase in adverse events in those with blinded laboratory results, and no participants discontinued the study medication because of an adverse event. Conclusion: On‐treatment laboratory monitoring did not improve patient outcomes in those treated with ledispasvir/sofosbuvir. Eliminating this monitoring in treatment programs in resource‐limited settings may facilitate and accelerate scale‐up of HCV therapy. John Wiley and Sons Inc. 2020-02-04 /pmc/articles/PMC7109339/ /pubmed/32258951 http://dx.doi.org/10.1002/hep4.1482 Text en © 2020 The Authors. Hepatology Communications published by Wiley Periodicals, Inc., on behalf of the American Association for the Study of Liver Diseases. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Original Articles Grant, Philip Shumbusho, Fabienne Van Nuil, Jennifer Ilo Kateera, Fredrick Mukherjee, Joia Kabahizi, Jules Ntaganda, Fabien Nsanzimana, Sabin Mbituyumuremyi, Aimable Damascene, Makuza Jean Muvunyi, Claude Mambo Mukabatsinda, Constance Musabeyezu, Emmanuel Ntirenganya, Cyprien Gupta, Neil Safety and Efficacy of Limited Laboratory Monitoring for Hepatitis C Treatment: A Blinded Clinical Trial in Rwanda |
title | Safety and Efficacy of Limited Laboratory Monitoring for Hepatitis C Treatment: A Blinded Clinical Trial in Rwanda |
title_full | Safety and Efficacy of Limited Laboratory Monitoring for Hepatitis C Treatment: A Blinded Clinical Trial in Rwanda |
title_fullStr | Safety and Efficacy of Limited Laboratory Monitoring for Hepatitis C Treatment: A Blinded Clinical Trial in Rwanda |
title_full_unstemmed | Safety and Efficacy of Limited Laboratory Monitoring for Hepatitis C Treatment: A Blinded Clinical Trial in Rwanda |
title_short | Safety and Efficacy of Limited Laboratory Monitoring for Hepatitis C Treatment: A Blinded Clinical Trial in Rwanda |
title_sort | safety and efficacy of limited laboratory monitoring for hepatitis c treatment: a blinded clinical trial in rwanda |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7109339/ https://www.ncbi.nlm.nih.gov/pubmed/32258951 http://dx.doi.org/10.1002/hep4.1482 |
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