[569] LONG-TERM EVALUATION OF d4T, dI AND EFV IN ANTIRETROVIRAL NAÏVE PATIENTS IN SENEGAL. ANRS 12-06/IMEA 012 TRIAL

2nd International AIDS Society Conference on HIV Pathogenesis and Treatment

Paris, France - July 13 - 16, 2003

[TITLE:] LONG-TERM EVALUATION OF d4T, dI AND EFV IN ANTIRETROVIRAL NAÏVE PATIENTS IN SENEGAL. ANRS 12-06/IMEA 012 TRIAL

[AUTHOR(S):] A Canestri¹, A Ndir², M Vray⁴, PS Sow², S Mboup², A Faye Niang², PM Gueye², I Lanièce², JP Coulaud¹, I Ndoye², E Delaporte³, PM Girard¹ and R Landman¹
¹IMEA, Paris France; ²CNLS Dakar, Sénégal; ³IRD, Montpellier France; and ⁴Institut Pasteur, Paris, France

IAS Conf HIV Pathog Treat 2003 Jul 13-16;2nd: Abstract No. 569
Antiviral Therapy 2003; 8(Suppl. 1):S338

[ABSTRACT:] Background: To assess long-term efficacy and tolerance of a stavudine (d4T), didanosine EC (ddI) and efavirenz (EFV) combination in patients with advanced immune deficiency in Senegal.

Methods: Multicentre 18-month pilot trial recruiting 40 HIV-1 infected patients. Intent to treat analysis.

Inclusion criteria and treatment: CD4<350 cells/mm³ (with no lower limit) and plasma HIV1-RNA >30,000 copies/ml. d4T (30/40 mg bid), EFV and ddI were taken at bedtime (ddI 250/400 mg and EFV 600 mg qd).

Results: 23 females, 17 males were included; mean age (±SD) was 36±7 years; mean body weight was 55±9 kg; 47% and 53 % were CDC stage B and C, respectively. Mean CD4 cells count was 133±92 /mm³ and plasma HIV1-RNA was 5.5±0.4 log10 copies/ml at baseline. Five cases of new CDC stage C events were observed: 2 Kaposi’s sarcoma, 1 MAC, 1 presumed PCP, 1 TB. Eight deaths occurred: 5 HIV-disease related and 3 non-HIV related, in 8 pts who had baseline CD4 count below 125/ mm³. Mean increase in CD4 cells count was 179±135 cells/mm³ (n=31) and 185±119 cells/mm³ (n=21) at M12 and M18, respectively. Mean log decrease in plasma HIV-1-RNA was 3.3±1.0 (n=28) and 3.1±1.1 (n=24) at M12 and M18, respectively. Plasma HIV1-RNA was below 500 copies/ml in 82% and 71% of pts at M12 and M18, respectively. Main adverse events were: peripheral neuropathy grade 1–2 (n=18), grade 3–4 (n=5) requiring d4T and ddI interruption; dizziness due to efavirenz (n=14) with temporary interruption in only one case.

Conclusions: These final results indicate: 1) Similar rate of virological efficacy compared to other HAART regimens in symptomatic patients with low CD4 count; 2) Peripheral neuropathy is a limiting factor for a d4T and ddI combination in this advanced population; and 3) A high case fatality rate (20%) in patients with low CD4 count.

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