Fifth International Congress Drug Therapy in HIV Infection 22-26 October, 2000 Glasgow, UK

When to start HAART in chronically HIV-infected patients? A collection of pieces of evidence from the I.CO.N.A. study

A. Cozzi Lepri¹, A.N. Phillips¹, A. d’ Arminio Monforte², S. Muro2, A. De Luca², P. Pezzotti², P. Vigano 2, A. Orani², S. d’ Elia 2 and M. Moroni^2
1Royal Free and University College Medical School, London, UK; ²Italian COhort of patients Naïve to Antiretroviral (I.CO.N.A.) Study Group, Italy

Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL3.5
AIDS 2000, Oct 22-26;14(Suppl. 4);S3

When to start highly active antiretroviral therapy (HAART) in asymptomatic HIV infection remains a crucial question. Current UK guidelines indicate that a CD4 count of 350 cells/µl is a reasonable level at which therapy may be started. We used a large clinical database (the Italian COhort of patients Naïve to Antiretroviral) to investigate whether patients starting HAART with high CD4 count have a superior immunological and virological response to therapy compared to patients starting with low CD4 count.

Primary endpoints were: increase in CD4 count, time to virological failure and rate of AIDS/death after HAART. Mean CD4 count increase and time to virological failure were compared in patients starting HAART with a CD4 count < 200, 201–350, and > 350 cells/µl. Incidence of AIDS/death according to the most recent CD4 count was also evaluated in people starting HAART with CD4< 50.

1329 previously naïve patients who started HAART are included. After 24 months of therapy the mean rise in CD4 count was 296, 312 and 151 cells/µl in patients starting HAART with a CD4 count < 200, 201–350, and > 350, respectively. Patients starting HAART with a CD4 count < 200 had a higher risk of subsequent virological failure (RH = 1.33 95% CI: 1.02–1.73) compared to patients starting with a CD4 count > 350. In contrast, there was no difference in risk of virological failure between patients starting with a CD4 201–350 and those starting with a CD4 > 350 (RH = 1.01 95% CI: 0.74–1.39). The rate of new AIDS defining diseases or death in patients who started HAART with a CD4 < 50 was of 0.03 per person-year (95% CI: 0.00–1.32) during time in which patients’ CD4 count had been raised to > 200 cells/µ.

This non-randomised study could only address some aspects related to the issue of when to start HAART in asymptomatic infection. However, our data show no clear immunological or virological advantage in starting HAART at a CD4 count > 350 rather than starting when CD4 count ranges between 200 and 350. They also confirm that CD4 count rises are clinically meaningful, in that they are associated with reduced risk of AIDS and death.

Presenting author: A. Cozzi Lepri

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2000-10-22
PL3-5

Originally published in AIDS Volume 14, Supplement 4 and hosted with permission of the publisher Lippincott Williams & Wilkins, 250 Waterloo Road, London, SE1 8RD, UK. Tel: +44 (0)20 7981 0700 Fax: +44 (0) 7981 0701

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