A boosted protease inhibitors (Pis) strategy with Ritonavir (RTV) 100 mg /Indinavir (IDV) 400 mg in HIV-1 infected patients in Mali (Bamako): The NOGOMA Study .
Introduction: Boosted PIs are widely recognised as standard use of PIs in terms of better efficacy and simplicity. To evaluate the efficacy, the tolerability and the feasibility of using boosted RTV/IDV (100 /400 mg bid) in Africa despite poor facilities to store RTV as recommended.
Methods: In a prospective open-label study, patients with plasma HIV-RNA (VL) <400cp/ml, receiving IDV (800 mg tid) with two NRTIs were switched to RTV/IDV (100/400 mg bid). Clinical follow-up was performed monthly. CD4 count, standard biochemistry, IDV Cmin and VL were performed before the switch (D-28), at week 4 (W4), W24, W48. Primary end-point was the percentage of patients remaining with VL<400cp/ml at W24.
Results: Thirty patients with a median time on IDV treatment of 12 months and median [range] CD4 baseline at 244 cells/mm3 [18-636] were enrolled. One patient discontinued RTV at Day-2 for digestive intolerance. RTV was stored in a fridge for 18 patients (62%), in traditional earthenware jar or in thermos flasks for 11 (38%) patients. With IDV 800 mg tid, the median IDV Cmin was 191 ng/ml [12-404]; after switch to RTV/IDV (100/400 mg bid), median IDV Cmin was 519 ng/ml [24-2475] at W4 and 500 ng/ml [156-1660] at W24 (p<0.001). The percentage of patients achieving adequate therapeutic concentration of IDV (>150ng/ml) was 62% at D-28, 89% at W4 and 100% at W24 (p=0.007). VL remained <400cp/ml in all patients at W4 and in all but one (97%) at W24 (VL: 2420 cp/ml). The median CD4 increase at W24 was +58 cells/mm3 [-168;+362] (p<0.001). No significant related drug side effect was recorded, in particular no nephrolitiasis.
Conclusions: Despite local conditions, the use of IDV/RTV 400/100mg bid was feasible, potent, safe and costless. This data should facilitate the use of boosted PI regimen in countries with limited resources.
Cisse M.1, Canestri A.2, Marcelin A.-G.3, Peytavin G.4, Dalban C.5, Traore E.1, Traore O.1, Koita V.1, Diallo F.1, Sidibé M.6, Bougoudogo F.7, Costagliola D.5, Calvez V.3, Sylla A.1, Katlama C.2, Tubiana R.2
1ARCAD/CESAC- Centre de Soins, d'Animation et de Conseil pour les personnes VIH/SIDA, Bamako, Mali, 2Service Maladies Infectieuses, Hôpital Pitié-Salpetriere, Inserm U720, Université Pierre et Marie Curie, Paris, France, 3Service de Virologie, Hôpital Pitié-Salpetriere, Université Pierre et Marie Curie, Paris, France, 4Service de Pharmacologie, Hôpital Bichat Claude Bernard., Paris, France, 5INSERM U720, Hôpital Pitié-Salpetriere, Université Pierre et Marie Curie, Paris, France, 6Service d’Immuno-virologie, Hôpital du Point G., Bamako, Mali, 7Institut National de Recherche en Santé Publique-INRSP., Bamako, Mali