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Changing from single-drug to fixed-dose combinations: experience from Fiji

Identifieur interne : 001717 ( Pmc/Checkpoint ); précédent : 001716; suivant : 001718

Changing from single-drug to fixed-dose combinations: experience from Fiji

Auteurs : R. Mahadeo [Fidji] ; S. Gounder [Fidji] ; S. M. Graham [Australie, France]

Source :

RBID : PMC:4533822

Abstract

Background: Fixed-dose combinations (FDCs) of first-line anti-tuberculosis drugs were introduced in Fiji in 2011, and there have been concerns about treatment response.

Objective: To evaluate the treatment response to FDCs among tuberculosis (TB) patients.

Methods: A retrospective cohort study was undertaken of treatment outcomes of new TB cases registered from January 2010 to April 2013 and weighing ⩾30 kg. Sputum smear conversion of new sputum smear-positive cases and end-of-treatment outcomes of all cases were evaluated for those receiving FDCs and compared to outcomes with previous use of single-drug preparations.

Results: Among new TB patients, 240 received single-drug preparations and 259 received FDCs for the full duration of treatment. The groups were similar in terms of demographic and clinical characteristics. Treatment outcomes were available for 95% of cases. Unknown outcomes were more common in those receiving FDCs. When known, end-of-treatment outcome was the same in the two treatment groups and did not differ between TB types. Sputum smear conversion after the 2-month intensive phase of treatment was similar in the two treatment groups: 95% and 97%, respectively.

Conclusion: The introduction of FDCs in Fiji for the treatment of TB cases has not been associated with changes in treatment response.


Url:
DOI: 10.5588/pha.14.0024
PubMed: 26400805
PubMed Central: 4533822


Affiliations:


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PMC:4533822

Le document en format XML

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<title xml:lang="en">Changing from single-drug to fixed-dose combinations: experience from Fiji</title>
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<name sortKey="Mahadeo, R" sort="Mahadeo, R" uniqKey="Mahadeo R" first="R." last="Mahadeo">R. Mahadeo</name>
<affiliation wicri:level="1">
<nlm:aff id="aff1"> National Tuberculosis Programme, Ministry of Health, Suva, Fiji</nlm:aff>
<country xml:lang="fr">Fidji</country>
<wicri:regionArea> National Tuberculosis Programme, Ministry of Health, Suva</wicri:regionArea>
<wicri:noRegion>Suva</wicri:noRegion>
</affiliation>
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<name sortKey="Gounder, S" sort="Gounder, S" uniqKey="Gounder S" first="S." last="Gounder">S. Gounder</name>
<affiliation wicri:level="1">
<nlm:aff id="aff1"> National Tuberculosis Programme, Ministry of Health, Suva, Fiji</nlm:aff>
<country xml:lang="fr">Fidji</country>
<wicri:regionArea> National Tuberculosis Programme, Ministry of Health, Suva</wicri:regionArea>
<wicri:noRegion>Suva</wicri:noRegion>
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<name sortKey="Graham, S M" sort="Graham, S M" uniqKey="Graham S" first="S. M." last="Graham">S. M. Graham</name>
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<nlm:aff id="aff2"> Centre for International Child Health, University of Melbourne and Murdoch Children's Research Institute, Royal Children's Hospital, Melbourne, Victoria, Australia</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea> Centre for International Child Health, University of Melbourne and Murdoch Children's Research Institute, Royal Children's Hospital, Melbourne, Victoria</wicri:regionArea>
<wicri:noRegion>Victoria</wicri:noRegion>
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<affiliation wicri:level="3">
<nlm:aff id="aff3"> International Union Against Tuberculosis and Lung Disease, Paris, France</nlm:aff>
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<wicri:regionArea> International Union Against Tuberculosis and Lung Disease, Paris</wicri:regionArea>
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<nlm:aff id="aff1"> National Tuberculosis Programme, Ministry of Health, Suva, Fiji</nlm:aff>
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<wicri:regionArea> National Tuberculosis Programme, Ministry of Health, Suva</wicri:regionArea>
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<country xml:lang="fr">Fidji</country>
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<nlm:aff id="aff2"> Centre for International Child Health, University of Melbourne and Murdoch Children's Research Institute, Royal Children's Hospital, Melbourne, Victoria, Australia</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea> Centre for International Child Health, University of Melbourne and Murdoch Children's Research Institute, Royal Children's Hospital, Melbourne, Victoria</wicri:regionArea>
<wicri:noRegion>Victoria</wicri:noRegion>
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<nlm:aff id="aff3"> International Union Against Tuberculosis and Lung Disease, Paris, France</nlm:aff>
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<wicri:regionArea> International Union Against Tuberculosis and Lung Disease, Paris</wicri:regionArea>
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<title level="j">Public Health Action</title>
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<date when="2014">2014</date>
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<div type="abstract" xml:lang="en">
<p>
<bold>Background:</bold>
Fixed-dose combinations (FDCs) of first-line anti-tuberculosis drugs were introduced in Fiji in 2011, and there have been concerns about treatment response.</p>
<p>
<bold>Objective:</bold>
To evaluate the treatment response to FDCs among tuberculosis (TB) patients.</p>
<p>
<bold>Methods:</bold>
A retrospective cohort study was undertaken of treatment outcomes of new TB cases registered from January 2010 to April 2013 and weighing ⩾30 kg. Sputum smear conversion of new sputum smear-positive cases and end-of-treatment outcomes of all cases were evaluated for those receiving FDCs and compared to outcomes with previous use of single-drug preparations.</p>
<p>
<bold>Results:</bold>
Among new TB patients, 240 received single-drug preparations and 259 received FDCs for the full duration of treatment. The groups were similar in terms of demographic and clinical characteristics. Treatment outcomes were available for 95% of cases. Unknown outcomes were more common in those receiving FDCs. When known, end-of-treatment outcome was the same in the two treatment groups and did not differ between TB types. Sputum smear conversion after the 2-month intensive phase of treatment was similar in the two treatment groups: 95% and 97%, respectively.</p>
<p>
<bold>Conclusion:</bold>
The introduction of FDCs in Fiji for the treatment of TB cases has not been associated with changes in treatment response.</p>
</div>
</front>
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<journal-id journal-id-type="nlm-ta">Public Health Action</journal-id>
<journal-id journal-id-type="iso-abbrev">Public Health Action</journal-id>
<journal-id journal-id-type="publisher-id">puha</journal-id>
<journal-id journal-id-type="pmc">The Union</journal-id>
<journal-title-group>
<journal-title>Public Health Action</journal-title>
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<issn pub-type="epub">2220-8372</issn>
<publisher>
<publisher-name>International Union Against Tuberculosis and Lung Disease</publisher-name>
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<article-meta>
<article-id pub-id-type="pmid">26400805</article-id>
<article-id pub-id-type="pmc">4533822</article-id>
<article-id pub-id-type="doi">10.5588/pha.14.0024</article-id>
<article-id pub-id-type="sici">i2220-8372-4-3-169</article-id>
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<subj-group subj-group-type="heading">
<subject>Original Articles</subject>
</subj-group>
</article-categories>
<title-group>
<article-title>Changing from single-drug to fixed-dose combinations: experience from Fiji</article-title>
<alt-title alt-title-type="running-head">FDCs vs. single-drug preparations for TB</alt-title>
</title-group>
<contrib-group>
<contrib contrib-type="author" corresp="yes">
<name>
<surname>Mahadeo</surname>
<given-names>R.</given-names>
</name>
<xref ref-type="aff" rid="aff1">1</xref>
<xref ref-type="corresp" rid="cor1"></xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Gounder</surname>
<given-names>S.</given-names>
</name>
<xref ref-type="aff" rid="aff1">1</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Graham</surname>
<given-names>S. M.</given-names>
</name>
<xref ref-type="aff" rid="aff2">2</xref>
<xref ref-type="aff" rid="aff3">3</xref>
</contrib>
<aff id="aff1">
<label>1</label>
National Tuberculosis Programme, Ministry of Health, Suva, Fiji</aff>
<aff id="aff2">
<label>2</label>
Centre for International Child Health, University of Melbourne and Murdoch Children's Research Institute, Royal Children's Hospital, Melbourne, Victoria, Australia</aff>
<aff id="aff3">
<label>3</label>
International Union Against Tuberculosis and Lung Disease, Paris, France</aff>
</contrib-group>
<author-notes>
<corresp id="cor1">
<bold>CORRESPONDENCE</bold>
Rineesha Mahadeo, P J Twomey Hospital, Ministry of Health, Fiji, Tel: (+679) 932 0336, e-mail:
<email>rineesha21@gmail.com</email>
</corresp>
</author-notes>
<pub-date pub-type="ppub">
<day>21</day>
<month>9</month>
<year>2014</year>
</pub-date>
<pub-date pub-type="epub">
<day>21</day>
<month>9</month>
<year>2014</year>
</pub-date>
<volume>4</volume>
<issue>3</issue>
<fpage>169</fpage>
<lpage>173</lpage>
<history>
<date date-type="received">
<day>7</day>
<month>3</month>
<year>2014</year>
</date>
<date date-type="accepted">
<day>7</day>
<month>7</month>
<year>2014</year>
</date>
</history>
<permissions>
<copyright-statement>© 2014 The Union</copyright-statement>
<copyright-year>2014</copyright-year>
</permissions>
<abstract>
<p>
<bold>Background:</bold>
Fixed-dose combinations (FDCs) of first-line anti-tuberculosis drugs were introduced in Fiji in 2011, and there have been concerns about treatment response.</p>
<p>
<bold>Objective:</bold>
To evaluate the treatment response to FDCs among tuberculosis (TB) patients.</p>
<p>
<bold>Methods:</bold>
A retrospective cohort study was undertaken of treatment outcomes of new TB cases registered from January 2010 to April 2013 and weighing ⩾30 kg. Sputum smear conversion of new sputum smear-positive cases and end-of-treatment outcomes of all cases were evaluated for those receiving FDCs and compared to outcomes with previous use of single-drug preparations.</p>
<p>
<bold>Results:</bold>
Among new TB patients, 240 received single-drug preparations and 259 received FDCs for the full duration of treatment. The groups were similar in terms of demographic and clinical characteristics. Treatment outcomes were available for 95% of cases. Unknown outcomes were more common in those receiving FDCs. When known, end-of-treatment outcome was the same in the two treatment groups and did not differ between TB types. Sputum smear conversion after the 2-month intensive phase of treatment was similar in the two treatment groups: 95% and 97%, respectively.</p>
<p>
<bold>Conclusion:</bold>
The introduction of FDCs in Fiji for the treatment of TB cases has not been associated with changes in treatment response.</p>
</abstract>
<trans-abstract xml:lang="FR">
<p>
<bold>Contexte :</bold>
L'association de médicaments anti-tuberculeux de première ligne à dose fixe (FDC) a été introduite en 2011 aux Fidji et a soulevé des préoccupations en matière de réponse thérapeutique.</p>
<p>
<bold>Objectif :</bold>
Evaluer la réponse thérapeutique des patients tuberculeux aux FDC.</p>
<p>
<bold>Méthodes :</bold>
Nous avons entrepris une étude rétrospective de cohorte sur les résultats du traitement de nouveaux cas de la tuberculose (TB) enregistrés entre janvier 2010 et avril 2013 et pesant ⩾30 kg. La conversion du frottis de crachats des nouveaux cas à frottis positif et les résultats en fin de traitement de tous les cas ont été évalués chez les patients recevant des FDC et comparés aux résultats obtenus auparavant avec des préparations à médicament unique.</p>
<p>
<bold>Résultats :</bold>
Parmi les nouveaux patients tuberculeux, 240 ont reçu des préparations de médicaments uniques et 259 ont reçu des FDC pendant toute la durée de leur traitement. Les deux groupes étaient similaires en termes de caractéristiques démographiques et cliniques. Les résultats du traitement étaient disponibles pour 95% des cas ; les résultats étaient plus souvent indisponibles pour les patients recevant des FDC. Lorsqu'ils étaient connus, les résultats en fin de traitement étaient identiques dans les deux groupes thérapeutiques et ne différaient pas en fonction des types de TB. La conversion des frottis de crachats après 2 mois de la phase intensive était également similaire dans les deux groupes : 95% et 97%, respectivement.</p>
<p>
<bold>Conclusion :</bold>
L'introduction des FDC aux Fidji dans le traitement des cas de TB n'a pas été associée à des modifications de la réponse thérapeutique.</p>
</trans-abstract>
<trans-abstract xml:lang="ES">
<p>
<bold>Marco de referencia:</bold>
El uso de las combinaciones de dosis fijas (FDC) de medicamentos antituberculosos de primera línea se introdujo en Fiji en el 2011 y se han planteado inquietudes acerca de la respuesta terapéutica que generan.</p>
<p>
<bold>Objetivo:</bold>
Evaluar la respuesta al tratamiento de la tuberculosis (TB) en los pacientes que recibían FDC.</p>
<p>
<bold>Métodos:</bold>
Fue este un estudio retrospectivo de cohortes sobre los desenlaces terapéuticos de los casos nuevos de TB registrados entre enero del 2010 y abril del 2013, en pacientes con un peso de ⩾30 kg. Se evaluó la conversión de la baciloscopia del esputo de los casos nuevos con baciloscopia positiva y el desenlace terapéutico definitivo de todos los casos que recibieron FDC y se compararon con los desenlaces de pacientes que habían recibido el tratamiento usado anteriormente con base en especialidades farmacéuticas de un solo medicamento.</p>
<p>
<bold>Resultados:</bold>
De los casos nuevos de TB, 240 pacientes recibieron preparaciones con medicamentos únicos y 259 recibieron FDC durante todo el período de tratamiento. Los grupos presentaron características demográficas y clínicas semejantes. Se conoció el desenlace terapéutico de 95% de los casos. El desconocimiento del desenlace fue más frecuente en los casos que recibían FDC. En los casos con desenlace conocido no se observaron diferencias entre ambos grupos de tratamiento ni entre los diferentes tipos de TB. La tasa de conversión del esputo tras 2 meses de tratamiento intensivo fue equivalente en ambos grupos (FDC 95% y medicamentos únicos 97%).</p>
<p>
<bold>Conclusión:</bold>
La introducción de los medicamentos antituberculosos en FDC en Fiji no se ha asociado con modificaciones de la respuesta al tratamiento.</p>
</trans-abstract>
<kwd-group>
<kwd>tuberculosis</kwd>
<kwd>fixed-dose combination</kwd>
<kwd>treatment outcomes</kwd>
<kwd>Fiji</kwd>
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