Katlama C, Astriti M, Marcelin AG, Ait-Mohand H, Schneider L, Agher R, Ghosn J, Bricaire F, Costagliola D, Calvez V, Peytavin G, Duvivier C; IAS Conference on HIV Pathogenesis and Treatment (2nd : 2003 : Paris, France).

Antivir Ther. 2003; 8 (Suppl.1): abstract no. 560.

Pitie Salpetriere Hospital

OBJECTIVE: To evaluate the efficacy and tolerance of ritonavir/indi-navir (RTV/IDV) 100/400 mg twice daily in combination with two nucleoside analogues (NRTIs) in antiretroviral (ARV) naive patients. Design and methods: Pilot, single-arm study, including untreated patients with plasma HIV RNA (VL) >5000 copies/ml (cp/ml). CD4 cell counts and VL were evaluated at weeks (W) 4, 12, 24 and every 3 months until W48. The primary endpoint was the proportion (%) of patients with VL <400 cp/ml at W48. Intent-to-treat (ITT) (missing values or change in treatment as failure) and on treatment (OT) analyses were performed. RESULTS: 40 patients (26 males/14 females) were enrolled. Seventeen patients were from sub-Saharan Africa (42.5%). Baseline median VL was 5.36 log10 cp/ml, CD4 was 84 cells/mm3 and 33 % of the patients were in CDC stage C. At W48, by ITT, the % pts with VL <400 cp/ml was 65% (26/40; 95% CI, 48-79%) and 50% with VL <50 cp/ml. By OT, the % pts with VL <400 cp/ml was 96% (26/27; 95% CI, 81-100%) and 74% with VL <50 cp/ml. The median decrease in VL was -3.79 log10 cp/ml and the median increase in CD4 was +164 cells/mm3. Discontinuation before W48 occurred in 13 patients: eight patients (22%) for drug-related adverse events, one patient's will, one patient for simplification after W24 and three patients (7.5%) were lost to follow-up. IDV and RTV plasma trough concentrations (Cmin) were performed in 31/40 patients, with 90% of patients having an adequate level as defined by IDV Cmin >150 ng/ml. Median Cmin at W4 for IDV and for RTV respectively was 429 ng/ml (5-2662 ng/ml) and 431 ng/ml (30-3165 ng/ml). CONCLUSIONS: RTV/IDV 100 mg/400 mg bid is an effective and safe first-line antiretroviral therapy in combination with two NRTIs. The simplicity and low cost of RTV/IDV is of major interest particularly in countries with limited resources.

Publication Types:

• Meeting Abstracts

Keywords:

• AIDS Vaccines
• Acquired Immunodeficiency Syndrome
• Africa South of the Sahara
• Antiretroviral Therapy, Highly Active
• CD4 Lymphocyte Count
• Drug Therapy, Combination
• Female
• HIV Infections
• HIV Seropositivity
• Humans
• Indinavir
• Male
• Ritonavir
• drug therapy
• therapy

Other ID:

• GWAIDS0023218

UI: 102262842

From Meeting Abstracts