Evaluation of hypophosphataemia in tenofovir disoproxil fumarate (TDF)-exposed and TDF-unexposed HIV-infected out-patients receiving highly active antiretroviral therapy

Kate Buchacz; John T. Brooks; Tony Tong; Anne C. Moorman; Rose K. Baker; S. D. Holmberg; A. Greenberg; Kathleen C. Wood; Carl Armon; James T. Richardson; Frank J. Palella; Joan S. Chmiel; Katharine A. Kirby; Janet Cheley; Tiffany Murphy; Kenneth A. Lichtenstein; Kenneth S. Greenberg; Benjamin Young; Barbara Widick; Cheryl Stewart; Peggy Zellner; Bienvenido G. Yangco; Kalliope Halkias; Arletis Lay; Douglas J. Ward; Charles A. Owen; Jack Fuhrer; Linda Ording-Bauer; Rita Kelly; Jane Esteves; Ellen M. Tedaldi; Ramona A. Christian; Linda Walker-Kornegay; Joseph B. Marzouk; Roger T. Phelps; Mark Rachel; Silver Sisneros; Richard M. Novak; Jonathan P. Uy; Andrea Wendrow

doi:10.1111/j.1468-1293.2006.00407.x

Evaluation of hypophosphataemia in tenofovir disoproxil fumarate (TDF)-exposed and TDF-unexposed HIV-infected out-patients receiving highly active antiretroviral therapy

Kate Buchacz^*, John T. Brooks, Tony Tong, Anne C. Moorman, Rose K. Baker, S. D. Holmberg, A. Greenberg, Kathleen C. Wood, Carl Armon, James T. Richardson, Frank J. Palella, Joan S. Chmiel, Katharine A. Kirby, Janet Cheley, Tiffany Murphy, Kenneth A. Lichtenstein, Kenneth S. Greenberg, Benjamin Young, Barbara Widick, Cheryl StewartPeggy Zellner, Bienvenido G. Yangco, Kalliope Halkias, Arletis Lay, Douglas J. Ward, Charles A. Owen, Jack Fuhrer, Linda Ording-Bauer, Rita Kelly, Jane Esteves, Ellen M. Tedaldi, Ramona A. Christian, Linda Walker-Kornegay, Joseph B. Marzouk, Roger T. Phelps, Mark Rachel, Silver Sisneros, Richard M. Novak, Jonathan P. Uy, Andrea Wendrow

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

33 Scopus citations

Abstract

Objectives: Cases of hypophosphataemia (often coincident with renal dysfunction) have been reported in HIV-infected patients taking tenofovir disoproxil fumarate (TDF), but randomized placebo-controlled trials of HIV-infected persons with normal baseline renal function have found a comparable incidence of hypophosphataemia in the TDF and placebo groups. We assessed the incidence of grade 2 and higher hypophosphataemia in the HIV Outpatient Study (HOPS). Methods: We analysed a prospective cohort of patients who initiated either a TDF-containing highly active antiretroviral therapy (HAART) regimen [TDF-exposed (TDF +) group; n =165] or a TDF-sparing HAART regimen [TDF-unexposed (TDF-) group; n =90], and who had normal baseline phosphate and creatinine values. Results: The TDF+and TDF-groups had comparable median follow-up times (10.9 vs 8.8 months, respectively; P =0.18) and number of phosphate measurements (median=3 for both) and were similar on most clinical and demographic factors. During follow up, 12.7% of TDF+ vs 6.7% of TDF-patients developed grade 2 hypophosphataemia (2.0-2.4 mg/dL), and 2.4% of TDF+ patients vs 0% of TDF-patients developed grade 3 hypophosphataemia (1.0-1.9 mg/dL); none developed grade 4 hypophosphataemia (<1.0 mg/dL). The incidence of grade 2 or higher hypophosphataemia was 16.7 per 100 person-years among TDF+ patients vs 8.0 per 100 person-years among TDF-patients (P = 0.11). Conclusions: The incidence of hypophosphataemia was somewhat elevated in HOPS patients who took TDF-containing HAART compared with those who took TDF-sparing HAART during the first 1 to 2 years of observation, but the difference was not statistically significant. Longer follow-up of a larger population is needed to determine if this trend towards an association achieves statistical significance and to evaluate the clinical consequences of hypophosphataemia.

Original language	English (US)
Pages (from-to)	451-456
Number of pages	6
Journal	HIV Medicine
Volume	7
Issue number	7
DOIs	https://doi.org/10.1111/j.1468-1293.2006.00407.x
State	Published - Oct 2006

Keywords

HAART
Renal disease
Serum phosphate
Tenofovir
Toxicity

ASJC Scopus subject areas

Infectious Diseases
Pharmacology (medical)
Health Policy

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1111/j.1468-1293.2006.00407.x

Cite this

Buchacz, K., Brooks, J. T., Tong, T., Moorman, A. C., Baker, R. K., Holmberg, S. D., Greenberg, A., Wood, K. C., Armon, C., Richardson, J. T., Palella, F. J., Chmiel, J. S., Kirby, K. A., Cheley, J., Murphy, T., Lichtenstein, K. A., Greenberg, K. S., Young, B., Widick, B., ... Wendrow, A. (2006). Evaluation of hypophosphataemia in tenofovir disoproxil fumarate (TDF)-exposed and TDF-unexposed HIV-infected out-patients receiving highly active antiretroviral therapy. HIV Medicine, 7(7), 451-456. https://doi.org/10.1111/j.1468-1293.2006.00407.x

@article{dd55c6c3662242d1b8dbeddd4387b507,

title = "Evaluation of hypophosphataemia in tenofovir disoproxil fumarate (TDF)-exposed and TDF-unexposed HIV-infected out-patients receiving highly active antiretroviral therapy",

abstract = "Objectives: Cases of hypophosphataemia (often coincident with renal dysfunction) have been reported in HIV-infected patients taking tenofovir disoproxil fumarate (TDF), but randomized placebo-controlled trials of HIV-infected persons with normal baseline renal function have found a comparable incidence of hypophosphataemia in the TDF and placebo groups. We assessed the incidence of grade 2 and higher hypophosphataemia in the HIV Outpatient Study (HOPS). Methods: We analysed a prospective cohort of patients who initiated either a TDF-containing highly active antiretroviral therapy (HAART) regimen [TDF-exposed (TDF +) group; n =165] or a TDF-sparing HAART regimen [TDF-unexposed (TDF-) group; n =90], and who had normal baseline phosphate and creatinine values. Results: The TDF+and TDF-groups had comparable median follow-up times (10.9 vs 8.8 months, respectively; P =0.18) and number of phosphate measurements (median=3 for both) and were similar on most clinical and demographic factors. During follow up, 12.7% of TDF+ vs 6.7% of TDF-patients developed grade 2 hypophosphataemia (2.0-2.4 mg/dL), and 2.4% of TDF+ patients vs 0% of TDF-patients developed grade 3 hypophosphataemia (1.0-1.9 mg/dL); none developed grade 4 hypophosphataemia (<1.0 mg/dL). The incidence of grade 2 or higher hypophosphataemia was 16.7 per 100 person-years among TDF+ patients vs 8.0 per 100 person-years among TDF-patients (P = 0.11). Conclusions: The incidence of hypophosphataemia was somewhat elevated in HOPS patients who took TDF-containing HAART compared with those who took TDF-sparing HAART during the first 1 to 2 years of observation, but the difference was not statistically significant. Longer follow-up of a larger population is needed to determine if this trend towards an association achieves statistical significance and to evaluate the clinical consequences of hypophosphataemia.",

keywords = "HAART, Renal disease, Serum phosphate, Tenofovir, Toxicity",

author = "Kate Buchacz and Brooks, {John T.} and Tony Tong and Moorman, {Anne C.} and Baker, {Rose K.} and Holmberg, {S. D.} and A. Greenberg and Wood, {Kathleen C.} and Carl Armon and Richardson, {James T.} and Palella, {Frank J.} and Chmiel, {Joan S.} and Kirby, {Katharine A.} and Janet Cheley and Tiffany Murphy and Lichtenstein, {Kenneth A.} and Greenberg, {Kenneth S.} and Benjamin Young and Barbara Widick and Cheryl Stewart and Peggy Zellner and Yangco, {Bienvenido G.} and Kalliope Halkias and Arletis Lay and Ward, {Douglas J.} and Owen, {Charles A.} and Jack Fuhrer and Linda Ording-Bauer and Rita Kelly and Jane Esteves and Tedaldi, {Ellen M.} and Christian, {Ramona A.} and Linda Walker-Kornegay and Marzouk, {Joseph B.} and Phelps, {Roger T.} and Mark Rachel and Silver Sisneros and Novak, {Richard M.} and Uy, {Jonathan P.} and Andrea Wendrow",

year = "2006",

month = oct,

doi = "10.1111/j.1468-1293.2006.00407.x",

language = "English (US)",

volume = "7",

pages = "451--456",

journal = "HIV Medicine",

issn = "1464-2662",

publisher = "Wiley-Blackwell",

number = "7",

}

Buchacz, K, Brooks, JT, Tong, T, Moorman, AC, Baker, RK, Holmberg, SD, Greenberg, A, Wood, KC, Armon, C, Richardson, JT, Palella, FJ , Chmiel, JS, Kirby, KA, Cheley, J, Murphy, T, Lichtenstein, KA, Greenberg, KS, Young, B, Widick, B, Stewart, C, Zellner, P, Yangco, BG, Halkias, K, Lay, A, Ward, DJ, Owen, CA, Fuhrer, J, Ording-Bauer, L, Kelly, R, Esteves, J, Tedaldi, EM, Christian, RA, Walker-Kornegay, L, Marzouk, JB, Phelps, RT, Rachel, M, Sisneros, S, Novak, RM, Uy, JP & Wendrow, A 2006, 'Evaluation of hypophosphataemia in tenofovir disoproxil fumarate (TDF)-exposed and TDF-unexposed HIV-infected out-patients receiving highly active antiretroviral therapy', HIV Medicine, vol. 7, no. 7, pp. 451-456. https://doi.org/10.1111/j.1468-1293.2006.00407.x

TY - JOUR

T1 - Evaluation of hypophosphataemia in tenofovir disoproxil fumarate (TDF)-exposed and TDF-unexposed HIV-infected out-patients receiving highly active antiretroviral therapy

AU - Buchacz, Kate

AU - Brooks, John T.

AU - Tong, Tony

AU - Moorman, Anne C.

AU - Baker, Rose K.

AU - Holmberg, S. D.

AU - Greenberg, A.

AU - Wood, Kathleen C.

AU - Armon, Carl

AU - Richardson, James T.

AU - Palella, Frank J.

AU - Chmiel, Joan S.

AU - Kirby, Katharine A.

AU - Cheley, Janet

AU - Murphy, Tiffany

AU - Lichtenstein, Kenneth A.

AU - Greenberg, Kenneth S.

AU - Young, Benjamin

AU - Widick, Barbara

AU - Stewart, Cheryl

AU - Zellner, Peggy

AU - Yangco, Bienvenido G.

AU - Halkias, Kalliope

AU - Lay, Arletis

AU - Ward, Douglas J.

AU - Owen, Charles A.

AU - Fuhrer, Jack

AU - Ording-Bauer, Linda

AU - Kelly, Rita

AU - Esteves, Jane

AU - Tedaldi, Ellen M.

AU - Christian, Ramona A.

AU - Walker-Kornegay, Linda

AU - Marzouk, Joseph B.

AU - Phelps, Roger T.

AU - Rachel, Mark

AU - Sisneros, Silver

AU - Novak, Richard M.

AU - Uy, Jonathan P.

AU - Wendrow, Andrea

PY - 2006/10

Y1 - 2006/10

N2 - Objectives: Cases of hypophosphataemia (often coincident with renal dysfunction) have been reported in HIV-infected patients taking tenofovir disoproxil fumarate (TDF), but randomized placebo-controlled trials of HIV-infected persons with normal baseline renal function have found a comparable incidence of hypophosphataemia in the TDF and placebo groups. We assessed the incidence of grade 2 and higher hypophosphataemia in the HIV Outpatient Study (HOPS). Methods: We analysed a prospective cohort of patients who initiated either a TDF-containing highly active antiretroviral therapy (HAART) regimen [TDF-exposed (TDF +) group; n =165] or a TDF-sparing HAART regimen [TDF-unexposed (TDF-) group; n =90], and who had normal baseline phosphate and creatinine values. Results: The TDF+and TDF-groups had comparable median follow-up times (10.9 vs 8.8 months, respectively; P =0.18) and number of phosphate measurements (median=3 for both) and were similar on most clinical and demographic factors. During follow up, 12.7% of TDF+ vs 6.7% of TDF-patients developed grade 2 hypophosphataemia (2.0-2.4 mg/dL), and 2.4% of TDF+ patients vs 0% of TDF-patients developed grade 3 hypophosphataemia (1.0-1.9 mg/dL); none developed grade 4 hypophosphataemia (<1.0 mg/dL). The incidence of grade 2 or higher hypophosphataemia was 16.7 per 100 person-years among TDF+ patients vs 8.0 per 100 person-years among TDF-patients (P = 0.11). Conclusions: The incidence of hypophosphataemia was somewhat elevated in HOPS patients who took TDF-containing HAART compared with those who took TDF-sparing HAART during the first 1 to 2 years of observation, but the difference was not statistically significant. Longer follow-up of a larger population is needed to determine if this trend towards an association achieves statistical significance and to evaluate the clinical consequences of hypophosphataemia.

AB - Objectives: Cases of hypophosphataemia (often coincident with renal dysfunction) have been reported in HIV-infected patients taking tenofovir disoproxil fumarate (TDF), but randomized placebo-controlled trials of HIV-infected persons with normal baseline renal function have found a comparable incidence of hypophosphataemia in the TDF and placebo groups. We assessed the incidence of grade 2 and higher hypophosphataemia in the HIV Outpatient Study (HOPS). Methods: We analysed a prospective cohort of patients who initiated either a TDF-containing highly active antiretroviral therapy (HAART) regimen [TDF-exposed (TDF +) group; n =165] or a TDF-sparing HAART regimen [TDF-unexposed (TDF-) group; n =90], and who had normal baseline phosphate and creatinine values. Results: The TDF+and TDF-groups had comparable median follow-up times (10.9 vs 8.8 months, respectively; P =0.18) and number of phosphate measurements (median=3 for both) and were similar on most clinical and demographic factors. During follow up, 12.7% of TDF+ vs 6.7% of TDF-patients developed grade 2 hypophosphataemia (2.0-2.4 mg/dL), and 2.4% of TDF+ patients vs 0% of TDF-patients developed grade 3 hypophosphataemia (1.0-1.9 mg/dL); none developed grade 4 hypophosphataemia (<1.0 mg/dL). The incidence of grade 2 or higher hypophosphataemia was 16.7 per 100 person-years among TDF+ patients vs 8.0 per 100 person-years among TDF-patients (P = 0.11). Conclusions: The incidence of hypophosphataemia was somewhat elevated in HOPS patients who took TDF-containing HAART compared with those who took TDF-sparing HAART during the first 1 to 2 years of observation, but the difference was not statistically significant. Longer follow-up of a larger population is needed to determine if this trend towards an association achieves statistical significance and to evaluate the clinical consequences of hypophosphataemia.

KW - HAART

KW - Renal disease

KW - Serum phosphate

KW - Tenofovir

KW - Toxicity

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U2 - 10.1111/j.1468-1293.2006.00407.x

DO - 10.1111/j.1468-1293.2006.00407.x

M3 - Article

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AN - SCOPUS:33747657216

SN - 1464-2662

VL - 7

SP - 451

EP - 456

JO - HIV Medicine

JF - HIV Medicine

IS - 7

ER -

Evaluation of hypophosphataemia in tenofovir disoproxil fumarate (TDF)-exposed and TDF-unexposed HIV-infected out-patients receiving highly active antiretroviral therapy

Abstract

Keywords

ASJC Scopus subject areas

UN SDGs

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