When to start highly active antiretroviral therapy in chronically HIV-infected patients: Evidence from the ICONA study

Alessandro Cozzi Lepri, Andrew N. Phillips, Antonella d Arminio Monforte, Francesco Castelli, Andrea Antinori, Andrea De Luca, Patrizio Pezzotti, Francesco Alberici, Antonietta Cargnel, Piero Grima, Rita Piscopo, Tullio Prestileo, Giorgio Scalise, Marco Vigevani, Mauro Moroni

Research output: Contribution to journalArticle

91 Citations (Scopus)

Abstract

Objectives: To compare the response to highly active antiretroviral therapy (HAART) in individuals starting HAART at different CD4 cell counts. Design: The mean increase in CD4 cell count and rate of virological failure after commencing HAART were measured in antiretroviral-naive patients (1421) in a large, non-randomized multicentre, observational study in Italy (ICONA). Clinical endpoints were also evaluated in a subset of patients who started HAART with a very low CD4 cell count. Results: After 96 weeks of therapy, the mean rise in CD4 cell count was 280, 281 and 186 × 106 cells/I in patients starting HAART with a CD4 cell count <200, 201-350 and > 350 × 106 cells/I, respectively. Patients starting HAART with a CD4 cell count <200 × 106 cells/I tended to have a higher risk of subsequent virological failure [relative hazard (RH), 1.15; 95% confidence interval (CI), 0.93-1.42] compared with patients starting with > 350 × 106 cells/I. There was no difference in risk between the 201-350 and the > 350 × 106 cells/I groups (RH, 1.0; 95% Cl, 0.79-1.29). The incidence of new Al DS-defining diseases/death in patients who started HAART with a CD4 count <50 was 0.03/person-year (95% Cl, 0.10-0.33) during the time in which the patient's CD4 cell count had been raised to > 200 × 106 cells/I. Conclusions: There was no clear immunological or virological advantage in starting HAART at a CD4 cell count > 350 rather than at 200-350 × 106 cells/I. The increase in CD4 cells restored by HAART is meaningful in that they are associated with reduced risk of disease/death.

Original languageEnglish
Pages (from-to)983-990
Number of pages8
JournalAIDS (London, England)
Volume15
Issue number8
DOIs
Publication statusPublished - May 25 2001

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Highly Active Antiretroviral Therapy
CD4 Lymphocyte Count
HIV
Italy
Multicenter Studies
Observational Studies
Incidence

Keywords

  • CD4 cell count
  • Highly active antiretroviral therapy
  • Immunological response
  • Virological response

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

Cite this

When to start highly active antiretroviral therapy in chronically HIV-infected patients : Evidence from the ICONA study. / Lepri, Alessandro Cozzi; Phillips, Andrew N.; Monforte, Antonella d Arminio; Castelli, Francesco; Antinori, Andrea; De Luca, Andrea; Pezzotti, Patrizio; Alberici, Francesco; Cargnel, Antonietta; Grima, Piero; Piscopo, Rita; Prestileo, Tullio; Scalise, Giorgio; Vigevani, Marco; Moroni, Mauro.

In: AIDS (London, England), Vol. 15, No. 8, 25.05.2001, p. 983-990.

Research output: Contribution to journalArticle

Lepri, AC, Phillips, AN, Monforte, ADA, Castelli, F, Antinori, A, De Luca, A, Pezzotti, P, Alberici, F, Cargnel, A, Grima, P, Piscopo, R, Prestileo, T, Scalise, G, Vigevani, M & Moroni, M 2001, 'When to start highly active antiretroviral therapy in chronically HIV-infected patients: Evidence from the ICONA study', AIDS (London, England), vol. 15, no. 8, pp. 983-990. https://doi.org/10.1097/00002030-200105250-00006
Lepri, Alessandro Cozzi ; Phillips, Andrew N. ; Monforte, Antonella d Arminio ; Castelli, Francesco ; Antinori, Andrea ; De Luca, Andrea ; Pezzotti, Patrizio ; Alberici, Francesco ; Cargnel, Antonietta ; Grima, Piero ; Piscopo, Rita ; Prestileo, Tullio ; Scalise, Giorgio ; Vigevani, Marco ; Moroni, Mauro. / When to start highly active antiretroviral therapy in chronically HIV-infected patients : Evidence from the ICONA study. In: AIDS (London, England). 2001 ; Vol. 15, No. 8. pp. 983-990.
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AU - Phillips, Andrew N.

AU - Monforte, Antonella d Arminio

AU - Castelli, Francesco

AU - Antinori, Andrea

AU - De Luca, Andrea

AU - Pezzotti, Patrizio

AU - Alberici, Francesco

AU - Cargnel, Antonietta

AU - Grima, Piero

AU - Piscopo, Rita

AU - Prestileo, Tullio

AU - Scalise, Giorgio

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AU - Moroni, Mauro

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N2 - Objectives: To compare the response to highly active antiretroviral therapy (HAART) in individuals starting HAART at different CD4 cell counts. Design: The mean increase in CD4 cell count and rate of virological failure after commencing HAART were measured in antiretroviral-naive patients (1421) in a large, non-randomized multicentre, observational study in Italy (ICONA). Clinical endpoints were also evaluated in a subset of patients who started HAART with a very low CD4 cell count. Results: After 96 weeks of therapy, the mean rise in CD4 cell count was 280, 281 and 186 × 106 cells/I in patients starting HAART with a CD4 cell count <200, 201-350 and > 350 × 106 cells/I, respectively. Patients starting HAART with a CD4 cell count <200 × 106 cells/I tended to have a higher risk of subsequent virological failure [relative hazard (RH), 1.15; 95% confidence interval (CI), 0.93-1.42] compared with patients starting with > 350 × 106 cells/I. There was no difference in risk between the 201-350 and the > 350 × 106 cells/I groups (RH, 1.0; 95% Cl, 0.79-1.29). The incidence of new Al DS-defining diseases/death in patients who started HAART with a CD4 count <50 was 0.03/person-year (95% Cl, 0.10-0.33) during the time in which the patient's CD4 cell count had been raised to > 200 × 106 cells/I. Conclusions: There was no clear immunological or virological advantage in starting HAART at a CD4 cell count > 350 rather than at 200-350 × 106 cells/I. The increase in CD4 cells restored by HAART is meaningful in that they are associated with reduced risk of disease/death.

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