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 language | English |
|---|---|
| Pages (from-to) | 983-990 |
| Number of pages | 8 |
| Journal | AIDS (London, England) |
| Volume | 15 |
| Issue number | 8 |
| DOIs | |
| Publication status | Published - May 25 2001 |
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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 journal › Article
}
TY - JOUR
T1 - When to start highly active antiretroviral therapy in chronically HIV-infected patients
T2 - Evidence from the ICONA study
AU - Lepri, Alessandro Cozzi
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
AU - Vigevani, Marco
AU - Moroni, Mauro
PY - 2001/5/25
Y1 - 2001/5/25
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.
AB - 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.
KW - CD4 cell count
KW - Highly active antiretroviral therapy
KW - Immunological response
KW - Virological response
UR - http://www.scopus.com/inward/record.url?scp=0035947350&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0035947350&partnerID=8YFLogxK
U2 - 10.1097/00002030-200105250-00006
DO - 10.1097/00002030-200105250-00006
M3 - Article
C2 - 11399980
AN - SCOPUS:0035947350
VL - 15
SP - 983
EP - 990
JO - AIDS
JF - AIDS
SN - 0269-9370
IS - 8
ER -