Antiretroviral therapy using zidovudine, lamivudine, and efavirenz in South Africa

Tolerability and clinical events

Christopher Hoffmann, Katherine L. Fielding, Salome Charalambous, Mark Sulkowski, Craig Innes, Chloe L Thio, Richard E Chaisson, Gavin J. Churchyard, Alison D. Grant

Research output: Contribution to journalArticle

Abstract

OBJECTIVE: To describe the safety and tolerability of zidovudine, lamivudine, and efavirenz in a low-income setting. DESIGN: We conducted a prospective cohort study in a workplace HAART programme in South Africa, which uses a first-line regimen of efavirenz, zidovudine, and lamivudine and provides routine clinical and laboratory monitoring 6-monthly pre-HAART and at 2, 6, 12, 24, 36, 48 weeks during HAART. METHODS: We assessed the incidence of specified clinical and laboratory events (AIDS Clinical Trials Group grade 3 or higher) and associated regimen changes, hospitalizations, and deaths one year before HAART initiation and one year on-HAART using person-year analysis. RESULTS: Between November 2002 and October 2005, 853 subjects (98% male, median age 40 years, and median CD4 cell count at HAART initiation 186 cells/μl) met enrollment criteria. The incidence of events on-HAART was higher than pre-HAART for neutropenia and nausea/vomiting. Dizziness was common early after HAART initiation (not evaluated pre-HAART). Of those with neutropenia, 88% had no apparent clinical consequences. The incidence of anemia, hepatotoxicity, peripheral neuropathy, and rash was similar or higher pre-HAART than on-HAART. Mean hemoglobin rose during the time on-HAART and was higher at 24 and 48 weeks than at baseline (P <0.001). DISCUSSION: This regimen was well tolerated with a short-term increase in neutropenia, nausea, and probably neurocerebellar events. Most significantly, in contrast to reports from high-income countries, we observed a long-term improvement in the hemoglobin concentration.

Original languageEnglish (US)
Pages (from-to)67-74
Number of pages8
JournalAIDS
Volume22
Issue number1
DOIs
StatePublished - Jan 2008

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efavirenz
Lamivudine
Zidovudine
Highly Active Antiretroviral Therapy
South Africa
Therapeutics
Neutropenia
Nausea
Incidence
Hemoglobins

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

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Antiretroviral therapy using zidovudine, lamivudine, and efavirenz in South Africa : Tolerability and clinical events. / Hoffmann, Christopher; Fielding, Katherine L.; Charalambous, Salome; Sulkowski, Mark; Innes, Craig; Thio, Chloe L; Chaisson, Richard E; Churchyard, Gavin J.; Grant, Alison D.

In: AIDS, Vol. 22, No. 1, 01.2008, p. 67-74.

Research output: Contribution to journalArticle

Hoffmann, Christopher ; Fielding, Katherine L. ; Charalambous, Salome ; Sulkowski, Mark ; Innes, Craig ; Thio, Chloe L ; Chaisson, Richard E ; Churchyard, Gavin J. ; Grant, Alison D. / Antiretroviral therapy using zidovudine, lamivudine, and efavirenz in South Africa : Tolerability and clinical events. In: AIDS. 2008 ; Vol. 22, No. 1. pp. 67-74.
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T2 - Tolerability and clinical events

AU - Hoffmann, Christopher

AU - Fielding, Katherine L.

AU - Charalambous, Salome

AU - Sulkowski, Mark

AU - Innes, Craig

AU - Thio, Chloe L

AU - Chaisson, Richard E

AU - Churchyard, Gavin J.

AU - Grant, Alison D.

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AB - OBJECTIVE: To describe the safety and tolerability of zidovudine, lamivudine, and efavirenz in a low-income setting. DESIGN: We conducted a prospective cohort study in a workplace HAART programme in South Africa, which uses a first-line regimen of efavirenz, zidovudine, and lamivudine and provides routine clinical and laboratory monitoring 6-monthly pre-HAART and at 2, 6, 12, 24, 36, 48 weeks during HAART. METHODS: We assessed the incidence of specified clinical and laboratory events (AIDS Clinical Trials Group grade 3 or higher) and associated regimen changes, hospitalizations, and deaths one year before HAART initiation and one year on-HAART using person-year analysis. RESULTS: Between November 2002 and October 2005, 853 subjects (98% male, median age 40 years, and median CD4 cell count at HAART initiation 186 cells/μl) met enrollment criteria. The incidence of events on-HAART was higher than pre-HAART for neutropenia and nausea/vomiting. Dizziness was common early after HAART initiation (not evaluated pre-HAART). Of those with neutropenia, 88% had no apparent clinical consequences. The incidence of anemia, hepatotoxicity, peripheral neuropathy, and rash was similar or higher pre-HAART than on-HAART. Mean hemoglobin rose during the time on-HAART and was higher at 24 and 48 weeks than at baseline (P <0.001). DISCUSSION: This regimen was well tolerated with a short-term increase in neutropenia, nausea, and probably neurocerebellar events. Most significantly, in contrast to reports from high-income countries, we observed a long-term improvement in the hemoglobin concentration.

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