Association Between the Occurrence of Adverse Drug Events and Modification of First-Line Highly Active Antiretroviral Therapy in Ghanaian HIV Patients
Introduction Patients initiated on highly active antiretroviral therapy (HAART) generally remain on medication indefinitely. A modification in the HAART regimen may become necessary because of possible acute or chronic toxicities, concomitant clinical conditions, development of virological failure o...
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description | Introduction
Patients initiated on highly active antiretroviral therapy (HAART) generally remain on medication indefinitely. A modification in the HAART regimen may become necessary because of possible acute or chronic toxicities, concomitant clinical conditions, development of virological failure or the advent of adverse drug events. The study documents adverse drug events of HIV-positive Ghanaian patients with HAART modifications. It also investigates the association between documented adverse drug events and HAART modification using an unmatched case–control study design.
Method
The study was conducted in the Fevers Unit of the Korle Bu Teaching Hospital and involved patients who attended the HIV Care Clinic between January 2004 and December 2009. Data from 298 modified therapy patients (cases) were compared with 298 continuing therapy patients (controls) who had been on treatment for at least 1 month before the end of study. Controls were sampled from the same database of a cohort of HIV-positive patients on HAART, at the time a case occurred, in terms of treatment initiation ±1 month. Data were obtained from patients’ clinical folders and the HIV clinic database linked to the pharmacy database. The nature of the documented adverse drug events of the cases was described and the association between the documented adverse drug events and HAART modification was determined by logistic regression with reported odds ratios (ORs) and their 95 % confidence interval (CI).
Results
Among the 298 modified therapy patients sampled in this study, 52.7 % of them had at least one documented adverse drug event. The most documented adverse drug event was anaemia, recorded in 18.5 % of modified therapy patients, all of whom were on a zidovudine-based regimen. The presence of documented adverse drug events was significantly associated with HAART modification [adjusted OR = 2.71 (95 % CI 2.11–3.48),
p
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doi_str_mv | 10.1007/s40264-016-0460-7 |
format | Article |
fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_5045837</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>4306770081</sourcerecordid><originalsourceid>FETCH-LOGICAL-c470t-104a9d2ed26e4b00fd0e4c470651e895fb1e9c8121b5053859d28d50359c91943</originalsourceid><addsrcrecordid>eNp1kcFuEzEQhi0EoiHwAFyQJS5cFsa7ttd7QQqlbSoFlUPhajne2cTVxg72blBehOfFq5SqIHHyYb75ZsY_Ia8ZvGcA9YfEoZS8ACYL4BKK-gmZMVY3BWt4-ZTMgDFeiIbJM_IipTsAUKVUz8lZWctKSdHMyK9FSsE6M7jg6SccfiJ6OmyR3lg7xojeIg0dXbQHjAnp5zhu6MUB_ZCo8S39ElrXOXtqz9yli2koVs4jXbrNtj_ShR3cAenCDy7iEMPBRdPT2y1Gsz9S5-nV1njjjKfL6-_0azZN8pfkWWf6hK_u3zn5dnlxe74sVjdX1-eLVWF5DUPBgJumLbEtJfI1QNcC8qkkBUPViG7NsLGKlWwtQFRKZFi1AirR2CZ_UjUnH0_e_bjeYWvz7Lye3ke3M_Gog3H674p3W70JBy2AC1XVWfDuXhDDjxHToHcuWex74zGMSTMlVcVUw6dZb_9B78IYfT5vohiUQmblnLATZWNIKWL3sAwDPaWuT6nrnLqeUtfTEm8eX_HQ8SfmDJQnIOWS32B8NPq_1t8Oz7kc</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1861025658</pqid></control><display><type>article</type><title>Association Between the Occurrence of Adverse Drug Events and Modification of First-Line Highly Active Antiretroviral Therapy in Ghanaian HIV Patients</title><source>MEDLINE</source><source>Springer Nature</source><creator>Tetteh, Raymond A. ; Nartey, Edmund T. ; Lartey, Margaret ; Mantel-Teeuwisse, Aukje K. ; Leufkens, Hubert G. M. ; Yankey, Barbara A. ; Dodoo, Alexander N. O.</creator><creatorcontrib>Tetteh, Raymond A. ; Nartey, Edmund T. ; Lartey, Margaret ; Mantel-Teeuwisse, Aukje K. ; Leufkens, Hubert G. M. ; Yankey, Barbara A. ; Dodoo, Alexander N. O.</creatorcontrib><description>Introduction
Patients initiated on highly active antiretroviral therapy (HAART) generally remain on medication indefinitely. A modification in the HAART regimen may become necessary because of possible acute or chronic toxicities, concomitant clinical conditions, development of virological failure or the advent of adverse drug events. The study documents adverse drug events of HIV-positive Ghanaian patients with HAART modifications. It also investigates the association between documented adverse drug events and HAART modification using an unmatched case–control study design.
Method
The study was conducted in the Fevers Unit of the Korle Bu Teaching Hospital and involved patients who attended the HIV Care Clinic between January 2004 and December 2009. Data from 298 modified therapy patients (cases) were compared with 298 continuing therapy patients (controls) who had been on treatment for at least 1 month before the end of study. Controls were sampled from the same database of a cohort of HIV-positive patients on HAART, at the time a case occurred, in terms of treatment initiation ±1 month. Data were obtained from patients’ clinical folders and the HIV clinic database linked to the pharmacy database. The nature of the documented adverse drug events of the cases was described and the association between the documented adverse drug events and HAART modification was determined by logistic regression with reported odds ratios (ORs) and their 95 % confidence interval (CI).
Results
Among the 298 modified therapy patients sampled in this study, 52.7 % of them had at least one documented adverse drug event. The most documented adverse drug event was anaemia, recorded in 18.5 % of modified therapy patients, all of whom were on a zidovudine-based regimen. The presence of documented adverse drug events was significantly associated with HAART modification [adjusted OR = 2.71 (95 % CI 2.11–3.48),
p
< 0.001].
Conclusion
Among HIV patients on HAART, adverse drug events play a major role in treatment modification. Occurrence of adverse drug events may be used as a predictor for possible therapy modification. We recommend the institution of active pharmacovigilance in HIV treatment programmes as it permits the proper identification and characterisation of drug-related adverse events. This can help develop approaches towards their management and also justify therapy modifications.</description><identifier>ISSN: 0114-5916</identifier><identifier>EISSN: 1179-1942</identifier><identifier>DOI: 10.1007/s40264-016-0460-7</identifier><identifier>PMID: 27638659</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Acquired immune deficiency syndrome ; Adult ; AIDS ; Antiretroviral drugs ; Antiretroviral Therapy, Highly Active - adverse effects ; Antiretroviral Therapy, Highly Active - methods ; Antiretroviral Therapy, Highly Active - statistics & numerical data ; Case-Control Studies ; Consumer protection ; Drug Safety and Pharmacovigilance ; Drug-Related Side Effects and Adverse Reactions - epidemiology ; Drug-Related Side Effects and Adverse Reactions - etiology ; Female ; Ghana - epidemiology ; HIV ; HIV Infections - drug therapy ; Human immunodeficiency virus ; Humans ; Lentivirus ; Male ; Medicine ; Medicine & Public Health ; Middle Aged ; Original ; Original Research Article ; Pharmaceutical industry ; Pharmacology/Toxicology ; Retroviridae ; Side effects</subject><ispartof>Drug safety, 2016-11, Vol.39 (11), p.1139-1149</ispartof><rights>The Author(s) 2016</rights><rights>Copyright Springer Science & Business Media Nov 2016</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c470t-104a9d2ed26e4b00fd0e4c470651e895fb1e9c8121b5053859d28d50359c91943</citedby><cites>FETCH-LOGICAL-c470t-104a9d2ed26e4b00fd0e4c470651e895fb1e9c8121b5053859d28d50359c91943</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s40264-016-0460-7$$EPDF$$P50$$Gspringer$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s40264-016-0460-7$$EHTML$$P50$$Gspringer$$Hfree_for_read</linktohtml><link.rule.ids>230,314,780,784,885,27915,27916,41479,42548,51310</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27638659$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Tetteh, Raymond A.</creatorcontrib><creatorcontrib>Nartey, Edmund T.</creatorcontrib><creatorcontrib>Lartey, Margaret</creatorcontrib><creatorcontrib>Mantel-Teeuwisse, Aukje K.</creatorcontrib><creatorcontrib>Leufkens, Hubert G. M.</creatorcontrib><creatorcontrib>Yankey, Barbara A.</creatorcontrib><creatorcontrib>Dodoo, Alexander N. O.</creatorcontrib><title>Association Between the Occurrence of Adverse Drug Events and Modification of First-Line Highly Active Antiretroviral Therapy in Ghanaian HIV Patients</title><title>Drug safety</title><addtitle>Drug Saf</addtitle><addtitle>Drug Saf</addtitle><description>Introduction
Patients initiated on highly active antiretroviral therapy (HAART) generally remain on medication indefinitely. A modification in the HAART regimen may become necessary because of possible acute or chronic toxicities, concomitant clinical conditions, development of virological failure or the advent of adverse drug events. The study documents adverse drug events of HIV-positive Ghanaian patients with HAART modifications. It also investigates the association between documented adverse drug events and HAART modification using an unmatched case–control study design.
Method
The study was conducted in the Fevers Unit of the Korle Bu Teaching Hospital and involved patients who attended the HIV Care Clinic between January 2004 and December 2009. Data from 298 modified therapy patients (cases) were compared with 298 continuing therapy patients (controls) who had been on treatment for at least 1 month before the end of study. Controls were sampled from the same database of a cohort of HIV-positive patients on HAART, at the time a case occurred, in terms of treatment initiation ±1 month. Data were obtained from patients’ clinical folders and the HIV clinic database linked to the pharmacy database. The nature of the documented adverse drug events of the cases was described and the association between the documented adverse drug events and HAART modification was determined by logistic regression with reported odds ratios (ORs) and their 95 % confidence interval (CI).
Results
Among the 298 modified therapy patients sampled in this study, 52.7 % of them had at least one documented adverse drug event. The most documented adverse drug event was anaemia, recorded in 18.5 % of modified therapy patients, all of whom were on a zidovudine-based regimen. The presence of documented adverse drug events was significantly associated with HAART modification [adjusted OR = 2.71 (95 % CI 2.11–3.48),
p
< 0.001].
Conclusion
Among HIV patients on HAART, adverse drug events play a major role in treatment modification. Occurrence of adverse drug events may be used as a predictor for possible therapy modification. We recommend the institution of active pharmacovigilance in HIV treatment programmes as it permits the proper identification and characterisation of drug-related adverse events. This can help develop approaches towards their management and also justify therapy modifications.</description><subject>Acquired immune deficiency syndrome</subject><subject>Adult</subject><subject>AIDS</subject><subject>Antiretroviral drugs</subject><subject>Antiretroviral Therapy, Highly Active - adverse effects</subject><subject>Antiretroviral Therapy, Highly Active - methods</subject><subject>Antiretroviral Therapy, Highly Active - statistics & numerical data</subject><subject>Case-Control Studies</subject><subject>Consumer protection</subject><subject>Drug Safety and Pharmacovigilance</subject><subject>Drug-Related Side Effects and Adverse Reactions - epidemiology</subject><subject>Drug-Related Side Effects and Adverse Reactions - etiology</subject><subject>Female</subject><subject>Ghana - epidemiology</subject><subject>HIV</subject><subject>HIV Infections - drug therapy</subject><subject>Human immunodeficiency virus</subject><subject>Humans</subject><subject>Lentivirus</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Original</subject><subject>Original Research Article</subject><subject>Pharmaceutical industry</subject><subject>Pharmacology/Toxicology</subject><subject>Retroviridae</subject><subject>Side effects</subject><issn>0114-5916</issn><issn>1179-1942</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp1kcFuEzEQhi0EoiHwAFyQJS5cFsa7ttd7QQqlbSoFlUPhajne2cTVxg72blBehOfFq5SqIHHyYb75ZsY_Ia8ZvGcA9YfEoZS8ACYL4BKK-gmZMVY3BWt4-ZTMgDFeiIbJM_IipTsAUKVUz8lZWctKSdHMyK9FSsE6M7jg6SccfiJ6OmyR3lg7xojeIg0dXbQHjAnp5zhu6MUB_ZCo8S39ElrXOXtqz9yli2koVs4jXbrNtj_ShR3cAenCDy7iEMPBRdPT2y1Gsz9S5-nV1njjjKfL6-_0azZN8pfkWWf6hK_u3zn5dnlxe74sVjdX1-eLVWF5DUPBgJumLbEtJfI1QNcC8qkkBUPViG7NsLGKlWwtQFRKZFi1AirR2CZ_UjUnH0_e_bjeYWvz7Lye3ke3M_Gog3H674p3W70JBy2AC1XVWfDuXhDDjxHToHcuWex74zGMSTMlVcVUw6dZb_9B78IYfT5vohiUQmblnLATZWNIKWL3sAwDPaWuT6nrnLqeUtfTEm8eX_HQ8SfmDJQnIOWS32B8NPq_1t8Oz7kc</recordid><startdate>20161101</startdate><enddate>20161101</enddate><creator>Tetteh, Raymond A.</creator><creator>Nartey, Edmund T.</creator><creator>Lartey, Margaret</creator><creator>Mantel-Teeuwisse, Aukje K.</creator><creator>Leufkens, Hubert G. M.</creator><creator>Yankey, Barbara A.</creator><creator>Dodoo, Alexander N. O.</creator><general>Springer International Publishing</general><general>Springer Nature B.V</general><scope>C6C</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>4T-</scope><scope>7RV</scope><scope>7T2</scope><scope>7TK</scope><scope>7U7</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>C1K</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7U2</scope><scope>7U9</scope><scope>H94</scope><scope>5PM</scope></search><sort><creationdate>20161101</creationdate><title>Association Between the Occurrence of Adverse Drug Events and Modification of First-Line Highly Active Antiretroviral Therapy in Ghanaian HIV Patients</title><author>Tetteh, Raymond A. ; Nartey, Edmund T. ; Lartey, Margaret ; Mantel-Teeuwisse, Aukje K. ; Leufkens, Hubert G. M. ; Yankey, Barbara A. ; Dodoo, Alexander N. O.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c470t-104a9d2ed26e4b00fd0e4c470651e895fb1e9c8121b5053859d28d50359c91943</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Acquired immune deficiency syndrome</topic><topic>Adult</topic><topic>AIDS</topic><topic>Antiretroviral drugs</topic><topic>Antiretroviral Therapy, Highly Active - adverse effects</topic><topic>Antiretroviral Therapy, Highly Active - methods</topic><topic>Antiretroviral Therapy, Highly Active - statistics & numerical data</topic><topic>Case-Control Studies</topic><topic>Consumer protection</topic><topic>Drug Safety and Pharmacovigilance</topic><topic>Drug-Related Side Effects and Adverse Reactions - epidemiology</topic><topic>Drug-Related Side Effects and Adverse Reactions - etiology</topic><topic>Female</topic><topic>Ghana - epidemiology</topic><topic>HIV</topic><topic>HIV Infections - drug therapy</topic><topic>Human immunodeficiency virus</topic><topic>Humans</topic><topic>Lentivirus</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Original</topic><topic>Original Research Article</topic><topic>Pharmaceutical industry</topic><topic>Pharmacology/Toxicology</topic><topic>Retroviridae</topic><topic>Side effects</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Tetteh, Raymond A.</creatorcontrib><creatorcontrib>Nartey, Edmund T.</creatorcontrib><creatorcontrib>Lartey, Margaret</creatorcontrib><creatorcontrib>Mantel-Teeuwisse, Aukje K.</creatorcontrib><creatorcontrib>Leufkens, Hubert G. M.</creatorcontrib><creatorcontrib>Yankey, Barbara A.</creatorcontrib><creatorcontrib>Dodoo, Alexander N. O.</creatorcontrib><collection>SpringerOpen</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Docstoc</collection><collection>ProQuest Nursing & Allied Health Database</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>ProQuest Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>AUTh Library subscriptions: ProQuest Central</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>PML(ProQuest Medical Library)</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>Safety Science and Risk</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Drug safety</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Tetteh, Raymond A.</au><au>Nartey, Edmund T.</au><au>Lartey, Margaret</au><au>Mantel-Teeuwisse, Aukje K.</au><au>Leufkens, Hubert G. M.</au><au>Yankey, Barbara A.</au><au>Dodoo, Alexander N. O.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Association Between the Occurrence of Adverse Drug Events and Modification of First-Line Highly Active Antiretroviral Therapy in Ghanaian HIV Patients</atitle><jtitle>Drug safety</jtitle><stitle>Drug Saf</stitle><addtitle>Drug Saf</addtitle><date>2016-11-01</date><risdate>2016</risdate><volume>39</volume><issue>11</issue><spage>1139</spage><epage>1149</epage><pages>1139-1149</pages><issn>0114-5916</issn><eissn>1179-1942</eissn><abstract>Introduction
Patients initiated on highly active antiretroviral therapy (HAART) generally remain on medication indefinitely. A modification in the HAART regimen may become necessary because of possible acute or chronic toxicities, concomitant clinical conditions, development of virological failure or the advent of adverse drug events. The study documents adverse drug events of HIV-positive Ghanaian patients with HAART modifications. It also investigates the association between documented adverse drug events and HAART modification using an unmatched case–control study design.
Method
The study was conducted in the Fevers Unit of the Korle Bu Teaching Hospital and involved patients who attended the HIV Care Clinic between January 2004 and December 2009. Data from 298 modified therapy patients (cases) were compared with 298 continuing therapy patients (controls) who had been on treatment for at least 1 month before the end of study. Controls were sampled from the same database of a cohort of HIV-positive patients on HAART, at the time a case occurred, in terms of treatment initiation ±1 month. Data were obtained from patients’ clinical folders and the HIV clinic database linked to the pharmacy database. The nature of the documented adverse drug events of the cases was described and the association between the documented adverse drug events and HAART modification was determined by logistic regression with reported odds ratios (ORs) and their 95 % confidence interval (CI).
Results
Among the 298 modified therapy patients sampled in this study, 52.7 % of them had at least one documented adverse drug event. The most documented adverse drug event was anaemia, recorded in 18.5 % of modified therapy patients, all of whom were on a zidovudine-based regimen. The presence of documented adverse drug events was significantly associated with HAART modification [adjusted OR = 2.71 (95 % CI 2.11–3.48),
p
< 0.001].
Conclusion
Among HIV patients on HAART, adverse drug events play a major role in treatment modification. Occurrence of adverse drug events may be used as a predictor for possible therapy modification. We recommend the institution of active pharmacovigilance in HIV treatment programmes as it permits the proper identification and characterisation of drug-related adverse events. This can help develop approaches towards their management and also justify therapy modifications.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>27638659</pmid><doi>10.1007/s40264-016-0460-7</doi><tpages>11</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Acquired immune deficiency syndrome Adult AIDS Antiretroviral drugs Antiretroviral Therapy, Highly Active - adverse effects Antiretroviral Therapy, Highly Active - methods Antiretroviral Therapy, Highly Active - statistics & numerical data Case-Control Studies Consumer protection Drug Safety and Pharmacovigilance Drug-Related Side Effects and Adverse Reactions - epidemiology Drug-Related Side Effects and Adverse Reactions - etiology Female Ghana - epidemiology HIV HIV Infections - drug therapy Human immunodeficiency virus Humans Lentivirus Male Medicine Medicine & Public Health Middle Aged Original Original Research Article Pharmaceutical industry Pharmacology/Toxicology Retroviridae Side effects |
title | Association Between the Occurrence of Adverse Drug Events and Modification of First-Line Highly Active Antiretroviral Therapy in Ghanaian HIV Patients |
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