Cargando…
Sustained Virological Response on Second-Line Antiretroviral Therapy following Virological Failure in HIV-Infected Patients in Rural South Africa
OBJECTIVE: This study aims to describe the virological, immunological and clinical efficacy of protease inhibitor (PI)-based second-line antiretroviral therapy (ART) in rural South Africa. METHODS: An observational cohort study was performed on 210 patients (including 39 children) who initiated PI-b...
Autores principales: | , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Public Library of Science
2013
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3594302/ https://www.ncbi.nlm.nih.gov/pubmed/23505529 http://dx.doi.org/10.1371/journal.pone.0058526 |
_version_ | 1782262320441851904 |
---|---|
author | Schoffelen, Annelot F. Wensing, Annemarie M. J. Tempelman, Hugo A. Geelen, Sibyl P. M. Hoepelman, Andy I. M. Barth, Roos E. |
author_facet | Schoffelen, Annelot F. Wensing, Annemarie M. J. Tempelman, Hugo A. Geelen, Sibyl P. M. Hoepelman, Andy I. M. Barth, Roos E. |
author_sort | Schoffelen, Annelot F. |
collection | PubMed |
description | OBJECTIVE: This study aims to describe the virological, immunological and clinical efficacy of protease inhibitor (PI)-based second-line antiretroviral therapy (ART) in rural South Africa. METHODS: An observational cohort study was performed on 210 patients (including 39 children) who initiated PI-based second-line therapy at least 12 months prior to data collection. Biannual clinical, immunological and virological monitoring was performed. Primary endpoints were adequate virological response (plasma HIV-1 RNA<400 copies/ml), full virological suppression (plasma HIV-1 RNA<50 copies/ml) and treatment failure (virological failure (plasma HIV-1 RNA>1000 after initial virological response) or on-going viremia (plasma HIV-1 RNA never<400 copies/ml for more than six months)). Data were analyzed by an on-treatment (OT) and intention-to-treat (ITT) approach. Analyses were primarily performed on the group of patients who switched following first-line virological failure. RESULTS: Median duration of follow-up after switch to second-line treatment was 20 months [IQR 11–35]. 191 patients had switched to second-line ART due to first-line virological failure. 139/191 of them (72.8%, ITT) were in care and on treatment at the end of follow-up and 11/191 (5.8%, ITT) had died. After twelve months, an adequate virological response was seen in 92/128 patients (71.9%, OT), of which 78/128 (60.9%, OT) experienced full virological suppression. Virological response remained stable after 24 months. Virological efficacy was similar amongst adult and pediatric patients. As in first-line ART, we observed a lack of correlation between virological failure and WHO-defined immunological failure. CONCLUSIONS: Good virological outcomes following first-line failure can be achieved with PI-based, second-line antiretroviral therapy in both adult and pediatric patients in rural South Africa. Retention rates were high and virological outcomes were sustainable during the two-year follow-up period, although persisting low-level viremia occurred in a subset of patients. The observed viro-immunological dissociation emphasizes the need for virological monitoring. |
format | Online Article Text |
id | pubmed-3594302 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2013 |
publisher | Public Library of Science |
record_format | MEDLINE/PubMed |
spelling | pubmed-35943022013-03-15 Sustained Virological Response on Second-Line Antiretroviral Therapy following Virological Failure in HIV-Infected Patients in Rural South Africa Schoffelen, Annelot F. Wensing, Annemarie M. J. Tempelman, Hugo A. Geelen, Sibyl P. M. Hoepelman, Andy I. M. Barth, Roos E. PLoS One Research Article OBJECTIVE: This study aims to describe the virological, immunological and clinical efficacy of protease inhibitor (PI)-based second-line antiretroviral therapy (ART) in rural South Africa. METHODS: An observational cohort study was performed on 210 patients (including 39 children) who initiated PI-based second-line therapy at least 12 months prior to data collection. Biannual clinical, immunological and virological monitoring was performed. Primary endpoints were adequate virological response (plasma HIV-1 RNA<400 copies/ml), full virological suppression (plasma HIV-1 RNA<50 copies/ml) and treatment failure (virological failure (plasma HIV-1 RNA>1000 after initial virological response) or on-going viremia (plasma HIV-1 RNA never<400 copies/ml for more than six months)). Data were analyzed by an on-treatment (OT) and intention-to-treat (ITT) approach. Analyses were primarily performed on the group of patients who switched following first-line virological failure. RESULTS: Median duration of follow-up after switch to second-line treatment was 20 months [IQR 11–35]. 191 patients had switched to second-line ART due to first-line virological failure. 139/191 of them (72.8%, ITT) were in care and on treatment at the end of follow-up and 11/191 (5.8%, ITT) had died. After twelve months, an adequate virological response was seen in 92/128 patients (71.9%, OT), of which 78/128 (60.9%, OT) experienced full virological suppression. Virological response remained stable after 24 months. Virological efficacy was similar amongst adult and pediatric patients. As in first-line ART, we observed a lack of correlation between virological failure and WHO-defined immunological failure. CONCLUSIONS: Good virological outcomes following first-line failure can be achieved with PI-based, second-line antiretroviral therapy in both adult and pediatric patients in rural South Africa. Retention rates were high and virological outcomes were sustainable during the two-year follow-up period, although persisting low-level viremia occurred in a subset of patients. The observed viro-immunological dissociation emphasizes the need for virological monitoring. Public Library of Science 2013-03-11 /pmc/articles/PMC3594302/ /pubmed/23505529 http://dx.doi.org/10.1371/journal.pone.0058526 Text en © 2013 Schoffelen et al http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited. |
spellingShingle | Research Article Schoffelen, Annelot F. Wensing, Annemarie M. J. Tempelman, Hugo A. Geelen, Sibyl P. M. Hoepelman, Andy I. M. Barth, Roos E. Sustained Virological Response on Second-Line Antiretroviral Therapy following Virological Failure in HIV-Infected Patients in Rural South Africa |
title | Sustained Virological Response on Second-Line Antiretroviral Therapy following Virological Failure in HIV-Infected Patients in Rural South Africa |
title_full | Sustained Virological Response on Second-Line Antiretroviral Therapy following Virological Failure in HIV-Infected Patients in Rural South Africa |
title_fullStr | Sustained Virological Response on Second-Line Antiretroviral Therapy following Virological Failure in HIV-Infected Patients in Rural South Africa |
title_full_unstemmed | Sustained Virological Response on Second-Line Antiretroviral Therapy following Virological Failure in HIV-Infected Patients in Rural South Africa |
title_short | Sustained Virological Response on Second-Line Antiretroviral Therapy following Virological Failure in HIV-Infected Patients in Rural South Africa |
title_sort | sustained virological response on second-line antiretroviral therapy following virological failure in hiv-infected patients in rural south africa |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3594302/ https://www.ncbi.nlm.nih.gov/pubmed/23505529 http://dx.doi.org/10.1371/journal.pone.0058526 |
work_keys_str_mv | AT schoffelenannelotf sustainedvirologicalresponseonsecondlineantiretroviraltherapyfollowingvirologicalfailureinhivinfectedpatientsinruralsouthafrica AT wensingannemariemj sustainedvirologicalresponseonsecondlineantiretroviraltherapyfollowingvirologicalfailureinhivinfectedpatientsinruralsouthafrica AT tempelmanhugoa sustainedvirologicalresponseonsecondlineantiretroviraltherapyfollowingvirologicalfailureinhivinfectedpatientsinruralsouthafrica AT geelensibylpm sustainedvirologicalresponseonsecondlineantiretroviraltherapyfollowingvirologicalfailureinhivinfectedpatientsinruralsouthafrica AT hoepelmanandyim sustainedvirologicalresponseonsecondlineantiretroviraltherapyfollowingvirologicalfailureinhivinfectedpatientsinruralsouthafrica AT barthroose sustainedvirologicalresponseonsecondlineantiretroviraltherapyfollowingvirologicalfailureinhivinfectedpatientsinruralsouthafrica |