Adverse events and adherence to HIV post-exposure prophylaxis: a cohort study at the Korle-Bu Teaching Hospital in Accra, Ghana
Identifieur interne : 000119 ( Pmc/Curation ); précédent : 000118; suivant : 000120Adverse events and adherence to HIV post-exposure prophylaxis: a cohort study at the Korle-Bu Teaching Hospital in Accra, Ghana
Auteurs : Raymond A. Tetteh [Pays-Bas] ; Edmund T. Nartey [Ghana] ; Margaret Lartey [Ghana] ; Aukje K. Mantel-Teeuwisse [Pays-Bas] ; Hubert G. M. Leufkens [Pays-Bas] ; Priscilla A. Nortey [Ghana] ; Alexander N. O. Dodoo [Ghana]Source :
- BMC Public Health [ 1471-2458 ] ; 2015.
Abstract
There is strong evidence that post-exposure prophylaxis (PEP) with antiretroviral drugs in the timely management of occupational exposures sustained by healthcare workers decreases the risk of HIV infection and PEP is now widely used. Antiretroviral drugs have well documented toxicities and produce adverse events in patients living with HIV/AIDS. In the era of “highly active antiretroviral therapy”, non-adherence to treatment has been closely linked to the occurrence of adverse events in HIV patients and this ultimately influences treatment success but the influence of adverse events on adherence during PEP is less well studied.
Following the introduction of a HIV post-exposure prophylaxis program in the Korle-Bu Teaching Hospital in January 2005, the incidence of adverse events and adherence were documented in occupationally-exposed healthcare workers (HCWs) and healthcare students (HCSs). Cohort event monitoring was used in following-up on exposed HCWs/HCSs for the two study outcomes; adverse events and adherence. All adverse events reported were grouped by MedDRA system organ classification and then by preferred term according to prophylaxis regimen. Adherence was determined by the completion of prophylaxis schedule. Cox proportional regression analysis was applied to determine the factors associated with the cohort study outcomes. Differences in frequencies were tested using the Chi square test and
A total of 228 exposed HCWs/HCSs were followed up during the study, made up of 101 exposed HCWs/HCSs administered lamivudine/zidovudine (3TC/AZT) for 3 days; 75 exposed HCWs/HCSs administered lamivudine/zidovudine (3TC/AZT) for 28 days; and 52 exposed HCWs/HCSs administered lamivudine/zidovudine/lopinavir-ritonavir (3TC/AZT/LPV-RTV) for 28 days. The frequency of adverse events was 28 % (
The intolerance to adverse events was cited as the sole reason for truncating PEP, thereby indicating the need for adequate, appropriate and effective counselling, education, active follow-up (possibly through mobile /phone contact) and management of adverse events. Education on the need to complete PEP schedule (especially for exposed HCWs/HCSs on 28-day schedule) can lead to increased adherence, which is very critical in minimizing the risk of HIV sero-conversion. The present results also indicate that cohort event monitoring could be an effective pharmacovigilance tool in monitoring adverse events in exposed HCWs/HCSs on HIV post-exposure prophylaxis.
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DOI: 10.1186/s12889-015-1928-6
PubMed: 26092496
PubMed Central: 4474444
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Raymond A. Tetteh<affiliation><nlm:aff id="Aff2">Pharmacy Department, Korle-Bu Teaching Hospital, P.O. Box KB 77, Korle-Bu, Accra Ghana</nlm:aff><wicri:noCountry code="subfield">Accra Ghana</wicri:noCountry></affiliation>Le document en format XML
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Box KB 77, Korle-Bu, Accra Ghana</nlm:aff><wicri:noCountry code="subfield">Accra Ghana</wicri:noCountry></affiliation></author><author><name sortKey="Nartey, Edmund T" sort="Nartey, Edmund T" uniqKey="Nartey E" first="Edmund T." last="Nartey">Edmund T. Nartey</name><affiliation wicri:level="1"><nlm:aff id="Aff3">World Health Organisation Collaborating Centre for Advocacy and Training in Pharmacovigilance, Centre for Tropical Clinical Pharmacology & Therapeutics, School of Medicine and Dentistry, University of Ghana, P. O. Box GP 4236, Accra, Ghana</nlm:aff><country xml:lang="fr">Ghana</country><wicri:regionArea>World Health Organisation Collaborating Centre for Advocacy and Training in Pharmacovigilance, Centre for Tropical Clinical Pharmacology & Therapeutics, School of Medicine and Dentistry, University of Ghana, P. O. Box GP 4236, Accra</wicri:regionArea></affiliation></author><author><name sortKey="Lartey, Margaret" sort="Lartey, Margaret" uniqKey="Lartey M" first="Margaret" last="Lartey">Margaret Lartey</name><affiliation wicri:level="1"><nlm:aff id="Aff4">Department of Medicine, School of Medicine and Dentistry, University of Ghana, P. O. Box GP 4236, Accra, Ghana</nlm:aff><country xml:lang="fr">Ghana</country><wicri:regionArea>Department of Medicine, School of Medicine and Dentistry, University of Ghana, P. O. Box GP 4236, Accra</wicri:regionArea></affiliation></author><author><name sortKey="Mantel Teeuwisse, Aukje K" sort="Mantel Teeuwisse, Aukje K" uniqKey="Mantel Teeuwisse A" first="Aukje K." last="Mantel-Teeuwisse">Aukje K. 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Leufkens</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Universiteitsweg 99, 3584 CG Utrecht, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Universiteitsweg 99, 3584 CG Utrecht</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff5">Medicines Evaluation Board, Utrecht, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Medicines Evaluation Board, Utrecht</wicri:regionArea></affiliation></author><author><name sortKey="Nortey, Priscilla A" sort="Nortey, Priscilla A" uniqKey="Nortey P" first="Priscilla A." last="Nortey">Priscilla A. Nortey</name><affiliation wicri:level="4"><nlm:aff id="Aff6">Department of Epidemiology and Disease Control, School of Public Health, University of Ghana, P.O. Box LG 25, Legon, Accra Ghana</nlm:aff><orgName type="university">Université du Ghana</orgName><country>Ghana</country><placeName><settlement type="city">Accra</settlement><settlement type="town">Legon (Ghana)</settlement><region type="region">Région du Grand Accra</region></placeName></affiliation></author><author><name sortKey="Dodoo, Alexander N O" sort="Dodoo, Alexander N O" uniqKey="Dodoo A" first="Alexander N. O." last="Dodoo">Alexander N. O. Dodoo</name><affiliation wicri:level="1"><nlm:aff id="Aff3">World Health Organisation Collaborating Centre for Advocacy and Training in Pharmacovigilance, Centre for Tropical Clinical Pharmacology & Therapeutics, School of Medicine and Dentistry, University of Ghana, P. O. Box GP 4236, Accra, Ghana</nlm:aff><country xml:lang="fr">Ghana</country><wicri:regionArea>World Health Organisation Collaborating Centre for Advocacy and Training in Pharmacovigilance, Centre for Tropical Clinical Pharmacology & Therapeutics, School of Medicine and Dentistry, University of Ghana, P. O. Box GP 4236, Accra</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">26092496</idno><idno type="pmc">4474444</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4474444</idno><idno type="RBID">PMC:4474444</idno><idno type="doi">10.1186/s12889-015-1928-6</idno><date when="2015">2015</date><idno type="wicri:Area/Pmc/Corpus">000120</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000120</idno><idno type="wicri:Area/Pmc/Curation">000119</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">000119</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Adverse events and adherence to HIV post-exposure prophylaxis: a cohort study at the Korle-Bu Teaching Hospital in Accra, Ghana</title><author><name sortKey="Tetteh, Raymond A" sort="Tetteh, Raymond A" uniqKey="Tetteh R" first="Raymond A." last="Tetteh">Raymond A. Tetteh</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Universiteitsweg 99, 3584 CG Utrecht, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Universiteitsweg 99, 3584 CG Utrecht</wicri:regionArea></affiliation><affiliation><nlm:aff id="Aff2">Pharmacy Department, Korle-Bu Teaching Hospital, P.O. Box KB 77, Korle-Bu, Accra Ghana</nlm:aff><wicri:noCountry code="subfield">Accra Ghana</wicri:noCountry></affiliation></author><author><name sortKey="Nartey, Edmund T" sort="Nartey, Edmund T" uniqKey="Nartey E" first="Edmund T." last="Nartey">Edmund T. Nartey</name><affiliation wicri:level="1"><nlm:aff id="Aff3">World Health Organisation Collaborating Centre for Advocacy and Training in Pharmacovigilance, Centre for Tropical Clinical Pharmacology & Therapeutics, School of Medicine and Dentistry, University of Ghana, P. O. Box GP 4236, Accra, Ghana</nlm:aff><country xml:lang="fr">Ghana</country><wicri:regionArea>World Health Organisation Collaborating Centre for Advocacy and Training in Pharmacovigilance, Centre for Tropical Clinical Pharmacology & Therapeutics, School of Medicine and Dentistry, University of Ghana, P. O. Box GP 4236, Accra</wicri:regionArea></affiliation></author><author><name sortKey="Lartey, Margaret" sort="Lartey, Margaret" uniqKey="Lartey M" first="Margaret" last="Lartey">Margaret Lartey</name><affiliation wicri:level="1"><nlm:aff id="Aff4">Department of Medicine, School of Medicine and Dentistry, University of Ghana, P. O. Box GP 4236, Accra, Ghana</nlm:aff><country xml:lang="fr">Ghana</country><wicri:regionArea>Department of Medicine, School of Medicine and Dentistry, University of Ghana, P. O. Box GP 4236, Accra</wicri:regionArea></affiliation></author><author><name sortKey="Mantel Teeuwisse, Aukje K" sort="Mantel Teeuwisse, Aukje K" uniqKey="Mantel Teeuwisse A" first="Aukje K." last="Mantel-Teeuwisse">Aukje K. Mantel-Teeuwisse</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Universiteitsweg 99, 3584 CG Utrecht, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Universiteitsweg 99, 3584 CG Utrecht</wicri:regionArea></affiliation></author><author><name sortKey="Leufkens, Hubert G M" sort="Leufkens, Hubert G M" uniqKey="Leufkens H" first="Hubert G. M." last="Leufkens">Hubert G. M. Leufkens</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Universiteitsweg 99, 3584 CG Utrecht, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Universiteitsweg 99, 3584 CG Utrecht</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff5">Medicines Evaluation Board, Utrecht, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Medicines Evaluation Board, Utrecht</wicri:regionArea></affiliation></author><author><name sortKey="Nortey, Priscilla A" sort="Nortey, Priscilla A" uniqKey="Nortey P" first="Priscilla A." last="Nortey">Priscilla A. Nortey</name><affiliation wicri:level="4"><nlm:aff id="Aff6">Department of Epidemiology and Disease Control, School of Public Health, University of Ghana, P.O. Box LG 25, Legon, Accra Ghana</nlm:aff><orgName type="university">Université du Ghana</orgName><country>Ghana</country><placeName><settlement type="city">Accra</settlement><settlement type="town">Legon (Ghana)</settlement><region type="region">Région du Grand Accra</region></placeName></affiliation></author><author><name sortKey="Dodoo, Alexander N O" sort="Dodoo, Alexander N O" uniqKey="Dodoo A" first="Alexander N. O." last="Dodoo">Alexander N. O. Dodoo</name><affiliation wicri:level="1"><nlm:aff id="Aff3">World Health Organisation Collaborating Centre for Advocacy and Training in Pharmacovigilance, Centre for Tropical Clinical Pharmacology & Therapeutics, School of Medicine and Dentistry, University of Ghana, P. O. Box GP 4236, Accra, Ghana</nlm:aff><country xml:lang="fr">Ghana</country><wicri:regionArea>World Health Organisation Collaborating Centre for Advocacy and Training in Pharmacovigilance, Centre for Tropical Clinical Pharmacology & Therapeutics, School of Medicine and Dentistry, University of Ghana, P. O. Box GP 4236, Accra</wicri:regionArea></affiliation></author></analytic><series><title level="j">BMC Public Health</title><idno type="eISSN">1471-2458</idno><imprint><date when="2015">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>There is strong evidence that post-exposure prophylaxis (PEP) with antiretroviral drugs in the timely management of occupational exposures sustained by healthcare workers decreases the risk of HIV infection and PEP is now widely used. Antiretroviral drugs have well documented toxicities and produce adverse events in patients living with HIV/AIDS. In the era of “highly active antiretroviral therapy”, non-adherence to treatment has been closely linked to the occurrence of adverse events in HIV patients and this ultimately influences treatment success but the influence of adverse events on adherence during PEP is less well studied.</p></sec><sec><title>Methods</title><p>Following the introduction of a HIV post-exposure prophylaxis program in the Korle-Bu Teaching Hospital in January 2005, the incidence of adverse events and adherence were documented in occupationally-exposed healthcare workers (HCWs) and healthcare students (HCSs). Cohort event monitoring was used in following-up on exposed HCWs/HCSs for the two study outcomes; adverse events and adherence. All adverse events reported were grouped by MedDRA system organ classification and then by preferred term according to prophylaxis regimen. Adherence was determined by the completion of prophylaxis schedule. Cox proportional regression analysis was applied to determine the factors associated with the cohort study outcomes. Differences in frequencies were tested using the Chi square test and <italic>p</italic> < 0.05 was considered statistically significant.</p></sec><sec><title>Results</title><p>A total of 228 exposed HCWs/HCSs were followed up during the study, made up of 101 exposed HCWs/HCSs administered lamivudine/zidovudine (3TC/AZT) for 3 days; 75 exposed HCWs/HCSs administered lamivudine/zidovudine (3TC/AZT) for 28 days; and 52 exposed HCWs/HCSs administered lamivudine/zidovudine/lopinavir-ritonavir (3TC/AZT/LPV-RTV) for 28 days. The frequency of adverse events was 28 % (<italic>n</italic> = 28) in exposed HCWs/HCSs administered 3TC/AZT for 3 days, 91 % (<italic>n</italic> = 68) in exposed HCWs/HCSs administered 3TC/AZT for 28 days and 96 % (<italic>n</italic> = 50) in exposed HCWs/HCSs administered 3TC/AZT/LPV-RTV for 28 days. Nausea was the most commonly reported adverse events in all three regimens. Adherence was complete in all exposed HCWs/HCSs administered 3TC/AZT for 3days, 56 % (<italic>n</italic> = 42) in exposed HCWs/HCSs administered 3TC/AZT for 28 days and 62 % (<italic>n</italic> = 32) in exposed HCWs/HCSs administered 3TC/AZT/LPV-RTV for 28 days. In the Cox regression multi-variate analysis, exposed HCWs/HCSs administered 3TC/AZT for 3 days were 70 % less likely to report adverse events compared with exposed HCWs/HCSs administered 3TC/AZT for 28 days (Adjusted HR = 0.30 [95 % CI, 0.18-0.48], <italic>p</italic> < 0.001). Exposed HCWs/HCSs administered 3TC/AZT for 3 days were 75 % more likely to adhere to the schedule compared with exposed HCWs/HCSs administered 3TC/AZT for 28 days (Adjusted HR = 1.75 [95 % CI, 1.16-2.66], <italic>p</italic> = 0.008).</p></sec><sec><title>Conclusion</title><p>The intolerance to adverse events was cited as the sole reason for truncating PEP, thereby indicating the need for adequate, appropriate and effective counselling, education, active follow-up (possibly through mobile /phone contact) and management of adverse events. Education on the need to complete PEP schedule (especially for exposed HCWs/HCSs on 28-day schedule) can lead to increased adherence, which is very critical in minimizing the risk of HIV sero-conversion. The present results also indicate that cohort event monitoring could be an effective pharmacovigilance tool in monitoring adverse events in exposed HCWs/HCSs on HIV post-exposure prophylaxis.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Gerberding, Jl" uniqKey="Gerberding J">JL Gerberding</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Cardo, Dm" uniqKey="Cardo D">DM Cardo</name></author><author><name sortKey="Culver, Dh" uniqKey="Culver D">DH Culver</name></author><author><name sortKey="Ciesielski, Ca" uniqKey="Ciesielski C">CA Ciesielski</name></author><author><name sortKey="Srivastava, Pu" uniqKey="Srivastava P">PU Srivastava</name></author><author><name sortKey="Marcus, R" uniqKey="Marcus R">R Marcus</name></author><author><name sortKey="Abiteboul, D" uniqKey="Abiteboul D">D Abiteboul</name></author><author><name 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<front><journal-meta><journal-id journal-id-type="nlm-ta">BMC Public Health</journal-id><journal-id journal-id-type="iso-abbrev">BMC Public Health</journal-id><journal-title-group><journal-title>BMC Public Health</journal-title></journal-title-group><issn pub-type="epub">1471-2458</issn><publisher><publisher-name>BioMed Central</publisher-name><publisher-loc>London</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">26092496</article-id><article-id pub-id-type="pmc">4474444</article-id><article-id pub-id-type="publisher-id">1928</article-id><article-id pub-id-type="doi">10.1186/s12889-015-1928-6</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group></article-categories><title-group><article-title>Adverse events and adherence to HIV post-exposure prophylaxis: a cohort study at the Korle-Bu Teaching Hospital in Accra, Ghana</article-title></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name><surname>Tetteh</surname><given-names>Raymond A.</given-names></name><address><email>r_niiatetteh@yahoo.com</email></address><xref ref-type="aff" rid="Aff1"></xref><xref ref-type="aff" rid="Aff2"></xref></contrib><contrib contrib-type="author"><name><surname>Nartey</surname><given-names>Edmund T.</given-names></name><address><email>etnartey@chs.edu.gh</email></address><xref ref-type="aff" rid="Aff3"></xref></contrib><contrib contrib-type="author"><name><surname>Lartey</surname><given-names>Margaret</given-names></name><address><email>malart38@yahoo.com</email></address><xref ref-type="aff" rid="Aff4"></xref></contrib><contrib contrib-type="author"><name><surname>Mantel-Teeuwisse</surname><given-names>Aukje K.</given-names></name><address><email>A.K.Mantel@uu.nl</email></address><xref ref-type="aff" rid="Aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Leufkens</surname><given-names>Hubert G. M.</given-names></name><address><email>H.G.M.Leufkens@uu.nl</email></address><xref ref-type="aff" rid="Aff1"></xref><xref ref-type="aff" rid="Aff5"></xref></contrib><contrib contrib-type="author"><name><surname>Nortey</surname><given-names>Priscilla A.</given-names></name><address><email>prisnorts@yahoo.co.uk</email></address><xref ref-type="aff" rid="Aff6"></xref></contrib><contrib contrib-type="author"><name><surname>Dodoo</surname><given-names>Alexander N. O.</given-names></name><address><email>alexooo@yahoo.com</email></address><xref ref-type="aff" rid="Aff3"></xref></contrib><aff id="Aff1"><label></label>Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Universiteitsweg 99, 3584 CG Utrecht, The Netherlands</aff><aff id="Aff2"><label></label>Pharmacy Department, Korle-Bu Teaching Hospital, P.O. Box KB 77, Korle-Bu, Accra Ghana</aff><aff id="Aff3"><label></label>World Health Organisation Collaborating Centre for Advocacy and Training in Pharmacovigilance, Centre for Tropical Clinical Pharmacology & Therapeutics, School of Medicine and Dentistry, University of Ghana, P. O. Box GP 4236, Accra, Ghana</aff><aff id="Aff4"><label></label>Department of Medicine, School of Medicine and Dentistry, University of Ghana, P. O. Box GP 4236, Accra, Ghana</aff><aff id="Aff5"><label></label>Medicines Evaluation Board, Utrecht, The Netherlands</aff><aff id="Aff6"><label></label>Department of Epidemiology and Disease Control, School of Public Health, University of Ghana, P.O. Box LG 25, Legon, Accra Ghana</aff></contrib-group><pub-date pub-type="epub"><day>20</day><month>6</month><year>2015</year></pub-date><pub-date pub-type="pmc-release"><day>20</day><month>6</month><year>2015</year></pub-date><pub-date pub-type="collection"><year>2015</year></pub-date><volume>15</volume><elocation-id>573</elocation-id><history><date date-type="received"><day>2</day><month>1</month><year>2015</year></date><date date-type="accepted"><day>10</day><month>6</month><year>2015</year></date></history><permissions><copyright-statement>© Tetteh et al. 2015</copyright-statement><license license-type="open-access"><license-p>This is an Open Access article distributed under the terms of the Creative Commons Attribution License (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/4.0">http://creativecommons.org/licenses/by/4.0</ext-link>), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/publicdomain/zero/1.0/">http://creativecommons.org/publicdomain/zero/1.0/</ext-link>) applies to the data made available in this article, unless otherwise stated.</license-p></license></permissions><abstract id="Abs1"><sec><title>Background</title><p>There is strong evidence that post-exposure prophylaxis (PEP) with antiretroviral drugs in the timely management of occupational exposures sustained by healthcare workers decreases the risk of HIV infection and PEP is now widely used. Antiretroviral drugs have well documented toxicities and produce adverse events in patients living with HIV/AIDS. In the era of “highly active antiretroviral therapy”, non-adherence to treatment has been closely linked to the occurrence of adverse events in HIV patients and this ultimately influences treatment success but the influence of adverse events on adherence during PEP is less well studied.</p></sec><sec><title>Methods</title><p>Following the introduction of a HIV post-exposure prophylaxis program in the Korle-Bu Teaching Hospital in January 2005, the incidence of adverse events and adherence were documented in occupationally-exposed healthcare workers (HCWs) and healthcare students (HCSs). Cohort event monitoring was used in following-up on exposed HCWs/HCSs for the two study outcomes; adverse events and adherence. All adverse events reported were grouped by MedDRA system organ classification and then by preferred term according to prophylaxis regimen. Adherence was determined by the completion of prophylaxis schedule. Cox proportional regression analysis was applied to determine the factors associated with the cohort study outcomes. Differences in frequencies were tested using the Chi square test and <italic>p</italic> < 0.05 was considered statistically significant.</p></sec><sec><title>Results</title><p>A total of 228 exposed HCWs/HCSs were followed up during the study, made up of 101 exposed HCWs/HCSs administered lamivudine/zidovudine (3TC/AZT) for 3 days; 75 exposed HCWs/HCSs administered lamivudine/zidovudine (3TC/AZT) for 28 days; and 52 exposed HCWs/HCSs administered lamivudine/zidovudine/lopinavir-ritonavir (3TC/AZT/LPV-RTV) for 28 days. The frequency of adverse events was 28 % (<italic>n</italic> = 28) in exposed HCWs/HCSs administered 3TC/AZT for 3 days, 91 % (<italic>n</italic> = 68) in exposed HCWs/HCSs administered 3TC/AZT for 28 days and 96 % (<italic>n</italic> = 50) in exposed HCWs/HCSs administered 3TC/AZT/LPV-RTV for 28 days. Nausea was the most commonly reported adverse events in all three regimens. Adherence was complete in all exposed HCWs/HCSs administered 3TC/AZT for 3days, 56 % (<italic>n</italic> = 42) in exposed HCWs/HCSs administered 3TC/AZT for 28 days and 62 % (<italic>n</italic> = 32) in exposed HCWs/HCSs administered 3TC/AZT/LPV-RTV for 28 days. In the Cox regression multi-variate analysis, exposed HCWs/HCSs administered 3TC/AZT for 3 days were 70 % less likely to report adverse events compared with exposed HCWs/HCSs administered 3TC/AZT for 28 days (Adjusted HR = 0.30 [95 % CI, 0.18-0.48], <italic>p</italic> < 0.001). Exposed HCWs/HCSs administered 3TC/AZT for 3 days were 75 % more likely to adhere to the schedule compared with exposed HCWs/HCSs administered 3TC/AZT for 28 days (Adjusted HR = 1.75 [95 % CI, 1.16-2.66], <italic>p</italic> = 0.008).</p></sec><sec><title>Conclusion</title><p>The intolerance to adverse events was cited as the sole reason for truncating PEP, thereby indicating the need for adequate, appropriate and effective counselling, education, active follow-up (possibly through mobile /phone contact) and management of adverse events. Education on the need to complete PEP schedule (especially for exposed HCWs/HCSs on 28-day schedule) can lead to increased adherence, which is very critical in minimizing the risk of HIV sero-conversion. The present results also indicate that cohort event monitoring could be an effective pharmacovigilance tool in monitoring adverse events in exposed HCWs/HCSs on HIV post-exposure prophylaxis.</p></sec></abstract><kwd-group xml:lang="en"><title>Keywords</title><kwd>HIV Post-exposure prophylaxis</kwd><kwd>Adverse event</kwd><kwd>Adherence</kwd><kwd>Cohort event monitoring</kwd></kwd-group><custom-meta-group><custom-meta><meta-name>issue-copyright-statement</meta-name><meta-value>© The Author(s) 2015</meta-value></custom-meta></custom-meta-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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