Journal article
Tenofovir Use and Renal Insufficiency among Pregnant and General Adult Population of HIV-infected, ART-Naive Individuals in Lilongwe, Malawi
PloS one, Vol.7(7), pp.e41011-e41011
07/27/2012
DOI: 10.1371/journal.pone.0041011
PMCID: PMC3407169
PMID: 22848422
Abstract
Background: The Malawian government recently changed its prevention of mother-to-child transmission (PMTCT) regimen and plans to change its first-line antiretroviral therapy (ART) regimen to Tenofovir(TDF)/Lamivudine/Efavirenz as a fixed-dose combination tablet. Implementation could be challenging if baseline creatinine clearance (CrCl) screening were required to assess renal function prior to TDF therapy. Our goal is to determine predictors of CrCl<50 ml/min among HIV-infected, ART-naive individuals.
Methodology: Data on HIV-infected, ART-naive adults screened for enrollment into 5 HIV clinical trials in Lilongwe, Malawi were combined for a pooled analysis of predictors for CrCl<50 ml/min. CrCl was derived from the Cockroft-Gault equation. Multivariable logistic regression modeled the association of age, body mass index (BMI), hemoglobin, CD4 cell count <350 cells/mm(3), gender, and pregnancy with CrCl<50 ml/min.
Results: The analysis included 3508 patients with values for creatinine clearance. Most subjects were female (90.6%) with a median age of 26 years (IQR 22-29). The median CD4 cell count was 444 (IQR 298.0-561.0), and 85.2% percent of women in our study were pregnant. Few patients had CrCl<50 ml/min (n = 38, 1.1%). A BMI less than 18.5 in non-pregnant females (OR = 8.87, 95% CI = 2.45-32.09)) was associated with CrCl<50 ml/min. Hemoglobin level higher than 10 g/dL in males (OR = 0.69, 95% CI = 0.56-0.86) and non-pregnant females (OR = 0.21, 95% CI = 0.04-0.97) was protective against CrCl<50 ml/min.
Discussion: Our findings indicate few patients would be excluded from a TDF-based antiretroviral regimen, suggesting baseline creatinine clearance assessment may not be necessary for implementation. However, in ART settings individuals with low BMI or anemia could potentially be at increased risk for lower CrCl.
Details
- Title: Subtitle
- Tenofovir Use and Renal Insufficiency among Pregnant and General Adult Population of HIV-infected, ART-Naive Individuals in Lilongwe, Malawi
- Creators
- Derek C. Johnson - University of MalawiCharles Chasela - University of MalawiMadalitso Maliwichi - University of MalawiAlbert Mwafongo - University of MalawiAdesola Akinkuotu - University of MalawiAgness Moses - University of MalawiDenise J. Jamieson - Centers for Disease Control and PreventionAthena P. Kourtis - Centers for Disease Control and PreventionCaroline C. King - Centers for Disease Control and PreventionCharlie van der Horst - University of MalawiMina C. Hosseinipour - University of Malawi
- Resource Type
- Journal article
- Publication Details
- PloS one, Vol.7(7), pp.e41011-e41011
- DOI
- 10.1371/journal.pone.0041011
- PMID
- 22848422
- PMCID
- PMC3407169
- NLM abbreviation
- PLoS One
- ISSN
- 1932-6203
- eISSN
- 1932-6203
- Publisher
- Public Library Science
- Number of pages
- 7
- Grant note
- Fogarty International Clinical Research Scholars and Fellows (FICRS-F) Program
- Language
- English
- Date published
- 07/27/2012
- Academic Unit
- Obstetrics and Gynecology; VPMA - Administration
- Record Identifier
- 9984446266702771
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