To report the tolerance of indinavir combined with ritonavir (IDV/r 800/100mg) twice daily (bid) in sub-Saharan African HIV-infected adults.
Prospective cohort study.
HAART-naïves patients started zidovudine plus lamivudine plus IDV/r 800/100mg bid. Follow-up included: standardised documentation of morbidity; CD4+ cell count, creatininemia, plasma HIV-1 RNA, and IDV minimal plasma concentration (Cmin) measurements at month-1 (M1), M3 and M6.
70 HIV-1 infected adults (68 women, median CD4 235/mm3) started HAART. At M6, 63% had undetectable viral load, and the median gain in CD4 since baseline was +128/mm3. During the first six months, 21 patients experimented 23 treatment modifications (reduction to IDV/r 400/100mg bid: n=11; switch for efavirenz: n=11; zidovudine replaced by stavudine: n=1), including 22 for digestive intolerance and one for severe anaemia. At M1, M3 and M6, 67, 59 and 48 patients were still receiving IDV/r 800/100 mg bid, of whom 70%, 72% and 60% had IDV Cmin above 5 ng/mL, respectively. In these patients, at M1, M3 and M6, the mean (± SD) IDV Cmin, were 3431 ± 3835ng/ml, 2288 ± 2116ng/ml and 1543 ± 2398ng/ml, respectively. There was no renal insufficiency of any grade, and no symptom of urinary stones.
The IDV/r 800/100mg bid containing regimen led to high IDV Cmin, and high rate of digestive intolerance. There was a surprising lack of nephrological side-effects during the 6 months of follow-up, supporting the hypothesis that nephrological tolerance of IDV might be higher in sub-Saharan African individuals than in American or European ones.