Renal function of participants in the Bangkok tenofovir study-Thailand, 2005-2012

Michael Martin, Suphak Vanichseni, Pravan Suntharasamai, Udomsak Sangkum, Philip A. Mock, Roman J. Gvetadze, Marcel Curlin, Manoj Leethochawalit, Sithisat Chiamwongpaet, Thitima Cherdtrakulkiat, Rapeepan Anekvorapong, Wanna Leelawiwat, Nartlada Chantharojwong, Janet M. McNicholl, Lynn A. Paxton, Somyot Kittimunkong, Kachit Choopanya

Research output: Contribution to journalArticle

31 Citations (Scopus)

Abstract

Background. Tenofovir disoproxil fumarate (tenofovir) has been associated with renal dysfunction in people infected with human immunodeficiency virus (HIV) receiving combination antiretroviral therapy. We reviewed data from an HIV preexposure prophylaxis trial to determine if tenofovir use was associated with changes in renal function in an HIV-uninfected population. Methods. During the trial, 2413 HIV-uninfected people who inject drugs were randomized to receive tenofovir or placebo. We assessed the renal function of trial participants with the Cockcroft-Gault, Modification of Diet in Renal Disease (MDRD), and Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equations using t tests for cross-sectional analysis and linear regression for longitudinal analysis. Results. Creatinine clearance and glomerular filtration rate (GFR) results were lower at 24, 36, 48, and 60 months in the tenofovir group compared with the placebo group. Results declined more in the tenofovir group than in the placebo group during follow-up using the Cockcroft-Gault (P <.001) and CKD-EPI (P = .007) equations, but not MDRD (P = .12). Creatinine clearance measured when study drug was stopped was lower in the tenofovir group than the placebo group (P <.001), but the difference resolved when tested a median of 20 months later (P = .12). Conclusions. We found small but significant decreases in cross-sectional measures of creatinine clearance and GFR in the tenofovir group compared with the placebo group and modest differences in downward trends in longitudinal analysis using the Cockcroft-Gault and CKD-EPI equations. These results suggest that with baseline assessments of renal function and routine monitoring of creatinine clearance during follow-up, tenofovir can be used safely for HIV preexposure prophylaxis. Clinical Trials Registration. NCT00119106.

Original languageEnglish (US)
Pages (from-to)716-724
Number of pages9
JournalClinical Infectious Diseases
Volume59
Issue number5
DOIs
StatePublished - Sep 1 2014
Externally publishedYes

Fingerprint

Tenofovir
Thailand
Kidney
Placebos
HIV
Creatinine
Chronic Renal Insufficiency
Diet Therapy
Epidemiology
Glomerular Filtration Rate

Keywords

  • Creatinine clearance
  • Glomerular filtration rate
  • Tenofovir disoproxil fumarate

ASJC Scopus subject areas

  • Infectious Diseases
  • Microbiology (medical)

Cite this

Martin, M., Vanichseni, S., Suntharasamai, P., Sangkum, U., Mock, P. A., Gvetadze, R. J., ... Choopanya, K. (2014). Renal function of participants in the Bangkok tenofovir study-Thailand, 2005-2012. Clinical Infectious Diseases, 59(5), 716-724. https://doi.org/10.1093/cid/ciu355

Renal function of participants in the Bangkok tenofovir study-Thailand, 2005-2012. / Martin, Michael; Vanichseni, Suphak; Suntharasamai, Pravan; Sangkum, Udomsak; Mock, Philip A.; Gvetadze, Roman J.; Curlin, Marcel; Leethochawalit, Manoj; Chiamwongpaet, Sithisat; Cherdtrakulkiat, Thitima; Anekvorapong, Rapeepan; Leelawiwat, Wanna; Chantharojwong, Nartlada; McNicholl, Janet M.; Paxton, Lynn A.; Kittimunkong, Somyot; Choopanya, Kachit.

In: Clinical Infectious Diseases, Vol. 59, No. 5, 01.09.2014, p. 716-724.

Research output: Contribution to journalArticle

Martin, M, Vanichseni, S, Suntharasamai, P, Sangkum, U, Mock, PA, Gvetadze, RJ, Curlin, M, Leethochawalit, M, Chiamwongpaet, S, Cherdtrakulkiat, T, Anekvorapong, R, Leelawiwat, W, Chantharojwong, N, McNicholl, JM, Paxton, LA, Kittimunkong, S & Choopanya, K 2014, 'Renal function of participants in the Bangkok tenofovir study-Thailand, 2005-2012', Clinical Infectious Diseases, vol. 59, no. 5, pp. 716-724. https://doi.org/10.1093/cid/ciu355
Martin M, Vanichseni S, Suntharasamai P, Sangkum U, Mock PA, Gvetadze RJ et al. Renal function of participants in the Bangkok tenofovir study-Thailand, 2005-2012. Clinical Infectious Diseases. 2014 Sep 1;59(5):716-724. https://doi.org/10.1093/cid/ciu355
Martin, Michael ; Vanichseni, Suphak ; Suntharasamai, Pravan ; Sangkum, Udomsak ; Mock, Philip A. ; Gvetadze, Roman J. ; Curlin, Marcel ; Leethochawalit, Manoj ; Chiamwongpaet, Sithisat ; Cherdtrakulkiat, Thitima ; Anekvorapong, Rapeepan ; Leelawiwat, Wanna ; Chantharojwong, Nartlada ; McNicholl, Janet M. ; Paxton, Lynn A. ; Kittimunkong, Somyot ; Choopanya, Kachit. / Renal function of participants in the Bangkok tenofovir study-Thailand, 2005-2012. In: Clinical Infectious Diseases. 2014 ; Vol. 59, No. 5. pp. 716-724.
@article{7a3a705d0dd4408c82fcad8371d427d2,
title = "Renal function of participants in the Bangkok tenofovir study-Thailand, 2005-2012",
abstract = "Background. Tenofovir disoproxil fumarate (tenofovir) has been associated with renal dysfunction in people infected with human immunodeficiency virus (HIV) receiving combination antiretroviral therapy. We reviewed data from an HIV preexposure prophylaxis trial to determine if tenofovir use was associated with changes in renal function in an HIV-uninfected population. Methods. During the trial, 2413 HIV-uninfected people who inject drugs were randomized to receive tenofovir or placebo. We assessed the renal function of trial participants with the Cockcroft-Gault, Modification of Diet in Renal Disease (MDRD), and Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equations using t tests for cross-sectional analysis and linear regression for longitudinal analysis. Results. Creatinine clearance and glomerular filtration rate (GFR) results were lower at 24, 36, 48, and 60 months in the tenofovir group compared with the placebo group. Results declined more in the tenofovir group than in the placebo group during follow-up using the Cockcroft-Gault (P <.001) and CKD-EPI (P = .007) equations, but not MDRD (P = .12). Creatinine clearance measured when study drug was stopped was lower in the tenofovir group than the placebo group (P <.001), but the difference resolved when tested a median of 20 months later (P = .12). Conclusions. We found small but significant decreases in cross-sectional measures of creatinine clearance and GFR in the tenofovir group compared with the placebo group and modest differences in downward trends in longitudinal analysis using the Cockcroft-Gault and CKD-EPI equations. These results suggest that with baseline assessments of renal function and routine monitoring of creatinine clearance during follow-up, tenofovir can be used safely for HIV preexposure prophylaxis. Clinical Trials Registration. NCT00119106.",
keywords = "Creatinine clearance, Glomerular filtration rate, Tenofovir disoproxil fumarate",
author = "Michael Martin and Suphak Vanichseni and Pravan Suntharasamai and Udomsak Sangkum and Mock, {Philip A.} and Gvetadze, {Roman J.} and Marcel Curlin and Manoj Leethochawalit and Sithisat Chiamwongpaet and Thitima Cherdtrakulkiat and Rapeepan Anekvorapong and Wanna Leelawiwat and Nartlada Chantharojwong and McNicholl, {Janet M.} and Paxton, {Lynn A.} and Somyot Kittimunkong and Kachit Choopanya",
year = "2014",
month = "9",
day = "1",
doi = "10.1093/cid/ciu355",
language = "English (US)",
volume = "59",
pages = "716--724",
journal = "Clinical Infectious Diseases",
issn = "1058-4838",
publisher = "Oxford University Press",
number = "5",

}

TY - JOUR

T1 - Renal function of participants in the Bangkok tenofovir study-Thailand, 2005-2012

AU - Martin, Michael

AU - Vanichseni, Suphak

AU - Suntharasamai, Pravan

AU - Sangkum, Udomsak

AU - Mock, Philip A.

AU - Gvetadze, Roman J.

AU - Curlin, Marcel

AU - Leethochawalit, Manoj

AU - Chiamwongpaet, Sithisat

AU - Cherdtrakulkiat, Thitima

AU - Anekvorapong, Rapeepan

AU - Leelawiwat, Wanna

AU - Chantharojwong, Nartlada

AU - McNicholl, Janet M.

AU - Paxton, Lynn A.

AU - Kittimunkong, Somyot

AU - Choopanya, Kachit

PY - 2014/9/1

Y1 - 2014/9/1

N2 - Background. Tenofovir disoproxil fumarate (tenofovir) has been associated with renal dysfunction in people infected with human immunodeficiency virus (HIV) receiving combination antiretroviral therapy. We reviewed data from an HIV preexposure prophylaxis trial to determine if tenofovir use was associated with changes in renal function in an HIV-uninfected population. Methods. During the trial, 2413 HIV-uninfected people who inject drugs were randomized to receive tenofovir or placebo. We assessed the renal function of trial participants with the Cockcroft-Gault, Modification of Diet in Renal Disease (MDRD), and Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equations using t tests for cross-sectional analysis and linear regression for longitudinal analysis. Results. Creatinine clearance and glomerular filtration rate (GFR) results were lower at 24, 36, 48, and 60 months in the tenofovir group compared with the placebo group. Results declined more in the tenofovir group than in the placebo group during follow-up using the Cockcroft-Gault (P <.001) and CKD-EPI (P = .007) equations, but not MDRD (P = .12). Creatinine clearance measured when study drug was stopped was lower in the tenofovir group than the placebo group (P <.001), but the difference resolved when tested a median of 20 months later (P = .12). Conclusions. We found small but significant decreases in cross-sectional measures of creatinine clearance and GFR in the tenofovir group compared with the placebo group and modest differences in downward trends in longitudinal analysis using the Cockcroft-Gault and CKD-EPI equations. These results suggest that with baseline assessments of renal function and routine monitoring of creatinine clearance during follow-up, tenofovir can be used safely for HIV preexposure prophylaxis. Clinical Trials Registration. NCT00119106.

AB - Background. Tenofovir disoproxil fumarate (tenofovir) has been associated with renal dysfunction in people infected with human immunodeficiency virus (HIV) receiving combination antiretroviral therapy. We reviewed data from an HIV preexposure prophylaxis trial to determine if tenofovir use was associated with changes in renal function in an HIV-uninfected population. Methods. During the trial, 2413 HIV-uninfected people who inject drugs were randomized to receive tenofovir or placebo. We assessed the renal function of trial participants with the Cockcroft-Gault, Modification of Diet in Renal Disease (MDRD), and Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equations using t tests for cross-sectional analysis and linear regression for longitudinal analysis. Results. Creatinine clearance and glomerular filtration rate (GFR) results were lower at 24, 36, 48, and 60 months in the tenofovir group compared with the placebo group. Results declined more in the tenofovir group than in the placebo group during follow-up using the Cockcroft-Gault (P <.001) and CKD-EPI (P = .007) equations, but not MDRD (P = .12). Creatinine clearance measured when study drug was stopped was lower in the tenofovir group than the placebo group (P <.001), but the difference resolved when tested a median of 20 months later (P = .12). Conclusions. We found small but significant decreases in cross-sectional measures of creatinine clearance and GFR in the tenofovir group compared with the placebo group and modest differences in downward trends in longitudinal analysis using the Cockcroft-Gault and CKD-EPI equations. These results suggest that with baseline assessments of renal function and routine monitoring of creatinine clearance during follow-up, tenofovir can be used safely for HIV preexposure prophylaxis. Clinical Trials Registration. NCT00119106.

KW - Creatinine clearance

KW - Glomerular filtration rate

KW - Tenofovir disoproxil fumarate

UR - http://www.scopus.com/inward/record.url?scp=84906271688&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84906271688&partnerID=8YFLogxK

U2 - 10.1093/cid/ciu355

DO - 10.1093/cid/ciu355

M3 - Article

C2 - 24829212

AN - SCOPUS:84906271688

VL - 59

SP - 716

EP - 724

JO - Clinical Infectious Diseases

JF - Clinical Infectious Diseases

SN - 1058-4838

IS - 5

ER -