Prednisolone does not prevent hypersensitivity reactions in antiretroviral drug regimens containing abacavir with or without nevirapine

F. W N M Wit, R. Wood, A. Horban, M. Beniowski, R. E. Schmidt, G. Gray, A. Lazzarin, A. Lafeuillade, D. Paes, H. Carlier, L. Van Weert, C. De Vries, R. Van Leeuwen, J. M A Lange

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Abstract

Objectives: To determine the effect of adjuvant prednisolone use on the development of abacavir (ABC)- and nevirapine (NVP)-associated hypersensitivity reactions (HSR). Methods: Randomized open-label study in antiretroviral-naive adult HIV-1 infected patients using a factorial design in which NVP and/or hydroxyurea (HU) and/or prednisolone are added to a regimen of ABC, zidovudine and lamivudine. Prednisolone (40 mg once daily) was added for the first 2 weeks of treatment. As it was difficult to distinguish ABC-associated HSR from NVP-associated HSR, these events were treated as a composite endpoint. The odds ratio (OR) of developing HSR for prednisolone-use was calculated with and without stratification by NVP and/or HU. Logistic regression was performed to identify risk factors for developing HSR. Results: Of the 229 patients 115 were randomized to prednisolone and 114 to noprednisolone; 19 (17%) and 11 (10%) patients, respectively, developed HSR. The expected prevention of HSR by prednisolone use was not observed. In fact use of prednisolone showed an increased risk for HSR although this did not reach statistical significance [OR, 1.82; 95% confidence interval (Cl), 0.82-4.03]. There was a higher incidence of HSR in the NVP group than in the non-NVP group (20% versus 6%; P = 0.002). An additional risk factor identified in a multivariate logistic model was a high baseline CD4 cell count (OR, 1.26 per 100 × 106cells/l increase; 95% Cl, 1.06-1.51). Conclusions: The simultaneous start of ABC and NVP in first-line antiretroviral regimens should be avoided because of a high (20%) incidence of HSR. Short-term therapy with prednisolone did not prevent HSR in patients using ABC with or without NVP.

Original languageEnglish
Pages (from-to)2423-2429
Number of pages7
JournalAIDS (London, England)
Volume15
Issue number18
DOIs
Publication statusPublished - Dec 7 2001

Fingerprint

Nevirapine
Prednisolone
Hypersensitivity
Pharmaceutical Preparations
Hydroxyurea
Odds Ratio
abacavir
Logistic Models
Zidovudine
Incidence
CD4 Lymphocyte Count
HIV-1

Keywords

  • Abacavir
  • HIV-1
  • Hypersensitivity reaction
  • Nevirapine
  • Prednisolone
  • Rash
  • Toxicity

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

Cite this

Prednisolone does not prevent hypersensitivity reactions in antiretroviral drug regimens containing abacavir with or without nevirapine. / Wit, F. W N M; Wood, R.; Horban, A.; Beniowski, M.; Schmidt, R. E.; Gray, G.; Lazzarin, A.; Lafeuillade, A.; Paes, D.; Carlier, H.; Van Weert, L.; De Vries, C.; Van Leeuwen, R.; Lange, J. M A.

In: AIDS (London, England), Vol. 15, No. 18, 07.12.2001, p. 2423-2429.

Research output: Contribution to journalArticle

Wit, FWNM, Wood, R, Horban, A, Beniowski, M, Schmidt, RE, Gray, G, Lazzarin, A, Lafeuillade, A, Paes, D, Carlier, H, Van Weert, L, De Vries, C, Van Leeuwen, R & Lange, JMA 2001, 'Prednisolone does not prevent hypersensitivity reactions in antiretroviral drug regimens containing abacavir with or without nevirapine', AIDS (London, England), vol. 15, no. 18, pp. 2423-2429. https://doi.org/10.1097/00002030-200112070-00010
Wit, F. W N M ; Wood, R. ; Horban, A. ; Beniowski, M. ; Schmidt, R. E. ; Gray, G. ; Lazzarin, A. ; Lafeuillade, A. ; Paes, D. ; Carlier, H. ; Van Weert, L. ; De Vries, C. ; Van Leeuwen, R. ; Lange, J. M A. / Prednisolone does not prevent hypersensitivity reactions in antiretroviral drug regimens containing abacavir with or without nevirapine. In: AIDS (London, England). 2001 ; Vol. 15, No. 18. pp. 2423-2429.
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abstract = "Objectives: To determine the effect of adjuvant prednisolone use on the development of abacavir (ABC)- and nevirapine (NVP)-associated hypersensitivity reactions (HSR). Methods: Randomized open-label study in antiretroviral-naive adult HIV-1 infected patients using a factorial design in which NVP and/or hydroxyurea (HU) and/or prednisolone are added to a regimen of ABC, zidovudine and lamivudine. Prednisolone (40 mg once daily) was added for the first 2 weeks of treatment. As it was difficult to distinguish ABC-associated HSR from NVP-associated HSR, these events were treated as a composite endpoint. The odds ratio (OR) of developing HSR for prednisolone-use was calculated with and without stratification by NVP and/or HU. Logistic regression was performed to identify risk factors for developing HSR. Results: Of the 229 patients 115 were randomized to prednisolone and 114 to noprednisolone; 19 (17{\%}) and 11 (10{\%}) patients, respectively, developed HSR. The expected prevention of HSR by prednisolone use was not observed. In fact use of prednisolone showed an increased risk for HSR although this did not reach statistical significance [OR, 1.82; 95{\%} confidence interval (Cl), 0.82-4.03]. There was a higher incidence of HSR in the NVP group than in the non-NVP group (20{\%} versus 6{\%}; P = 0.002). An additional risk factor identified in a multivariate logistic model was a high baseline CD4 cell count (OR, 1.26 per 100 × 106cells/l increase; 95{\%} Cl, 1.06-1.51). Conclusions: The simultaneous start of ABC and NVP in first-line antiretroviral regimens should be avoided because of a high (20{\%}) incidence of HSR. Short-term therapy with prednisolone did not prevent HSR in patients using ABC with or without NVP.",
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T1 - Prednisolone does not prevent hypersensitivity reactions in antiretroviral drug regimens containing abacavir with or without nevirapine

AU - Wit, F. W N M

AU - Wood, R.

AU - Horban, A.

AU - Beniowski, M.

AU - Schmidt, R. E.

AU - Gray, G.

AU - Lazzarin, A.

AU - Lafeuillade, A.

AU - Paes, D.

AU - Carlier, H.

AU - Van Weert, L.

AU - De Vries, C.

AU - Van Leeuwen, R.

AU - Lange, J. M A

PY - 2001/12/7

Y1 - 2001/12/7

N2 - Objectives: To determine the effect of adjuvant prednisolone use on the development of abacavir (ABC)- and nevirapine (NVP)-associated hypersensitivity reactions (HSR). Methods: Randomized open-label study in antiretroviral-naive adult HIV-1 infected patients using a factorial design in which NVP and/or hydroxyurea (HU) and/or prednisolone are added to a regimen of ABC, zidovudine and lamivudine. Prednisolone (40 mg once daily) was added for the first 2 weeks of treatment. As it was difficult to distinguish ABC-associated HSR from NVP-associated HSR, these events were treated as a composite endpoint. The odds ratio (OR) of developing HSR for prednisolone-use was calculated with and without stratification by NVP and/or HU. Logistic regression was performed to identify risk factors for developing HSR. Results: Of the 229 patients 115 were randomized to prednisolone and 114 to noprednisolone; 19 (17%) and 11 (10%) patients, respectively, developed HSR. The expected prevention of HSR by prednisolone use was not observed. In fact use of prednisolone showed an increased risk for HSR although this did not reach statistical significance [OR, 1.82; 95% confidence interval (Cl), 0.82-4.03]. There was a higher incidence of HSR in the NVP group than in the non-NVP group (20% versus 6%; P = 0.002). An additional risk factor identified in a multivariate logistic model was a high baseline CD4 cell count (OR, 1.26 per 100 × 106cells/l increase; 95% Cl, 1.06-1.51). Conclusions: The simultaneous start of ABC and NVP in first-line antiretroviral regimens should be avoided because of a high (20%) incidence of HSR. Short-term therapy with prednisolone did not prevent HSR in patients using ABC with or without NVP.

AB - Objectives: To determine the effect of adjuvant prednisolone use on the development of abacavir (ABC)- and nevirapine (NVP)-associated hypersensitivity reactions (HSR). Methods: Randomized open-label study in antiretroviral-naive adult HIV-1 infected patients using a factorial design in which NVP and/or hydroxyurea (HU) and/or prednisolone are added to a regimen of ABC, zidovudine and lamivudine. Prednisolone (40 mg once daily) was added for the first 2 weeks of treatment. As it was difficult to distinguish ABC-associated HSR from NVP-associated HSR, these events were treated as a composite endpoint. The odds ratio (OR) of developing HSR for prednisolone-use was calculated with and without stratification by NVP and/or HU. Logistic regression was performed to identify risk factors for developing HSR. Results: Of the 229 patients 115 were randomized to prednisolone and 114 to noprednisolone; 19 (17%) and 11 (10%) patients, respectively, developed HSR. The expected prevention of HSR by prednisolone use was not observed. In fact use of prednisolone showed an increased risk for HSR although this did not reach statistical significance [OR, 1.82; 95% confidence interval (Cl), 0.82-4.03]. There was a higher incidence of HSR in the NVP group than in the non-NVP group (20% versus 6%; P = 0.002). An additional risk factor identified in a multivariate logistic model was a high baseline CD4 cell count (OR, 1.26 per 100 × 106cells/l increase; 95% Cl, 1.06-1.51). Conclusions: The simultaneous start of ABC and NVP in first-line antiretroviral regimens should be avoided because of a high (20%) incidence of HSR. Short-term therapy with prednisolone did not prevent HSR in patients using ABC with or without NVP.

KW - Abacavir

KW - HIV-1

KW - Hypersensitivity reaction

KW - Nevirapine

KW - Prednisolone

KW - Rash

KW - Toxicity

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