Table 5. Clinical outcome of LPV/r treatment of patients stratified according to different VL and CD4 levels at baseline.
| VL (cp/ml) | >100,000 | 10,000–100,000 | <10,000 | P | ||||||||
| CD4 (Cells/µl) | <200 | 200–500 | >500 | <200 | 200–500 | >500 | <200 | 200–500 | >500 | Gr 1 vs. Gr 4 | Gr 1 vs. Gr 7 | Gr 1 vs. Gr 9 |
| Group (Number) | Gr 1 (181) | Gr 2 (57) | Gr 3 (13) | Gr 4 (78) | Gr 5 (68) | Gr 6 (7) | Gr 7 (69) | Gr 8 (92) | Gr 9 (42) | |||
| Time since diagnosis (Years; median) | 5.2 | 3.4 | 3.7 | 5.7 | 5.6 | 8.8 | 4.4 | 5.7 | 6.9 | 0.4 | 0.3 | 0.2 |
| Time on Kaletra (Months; median) | 26.1 | 24.4 | 33.7 | 25.7 | 26.6 | 44.1 | 20.4 | 16.6 | 10.7 | 0.2 | 0.2 | 0.03 |
| LPV 1st PI (%) | 98(55) | 32(55) | 7 (58) | 38(49) | 27(40) | 0 | 37(61) | 45(51) | 8(19) | 0.4 | 0.4 | <0.0001 |
| VL_start (cp/ml; median) | 513,000 | 282,500 | 390,000 | 44,700 | 38,450 | 47,300 | 2,140 | 518 | 399 | 0.003 | <0.0001 | <0.0001 |
| VL_end (cp/ml; median) | 399 | 399 | 225 | 399 | 399 | 399 | 399 | 399 | 399 | 0.6 | 0.8 | 1 |
| VL dec (cp/ml; median) | 463,101 | 270,891 | 389,508 | 37,501 | 31,251 | 35,201 | 1,703 | 119 | 0 | 0.3 | 0.2 | 0.6 |
| CD4_ start (cells/µl; median) | 77 | 284 | 649 | 108 | 276 | 542 | 121 | 298 | 718 | 0.2 | 0.5 | <0.0001 |
| Last CD4 (cells/µl; median) | 263 | 490 | 949 | 215 | 425 | 852 | 231 | 423 | 710 | 0.5 | 0.6 | 0.1 |
| ΔCD4 (cells/µl; median) | 165 | 199 | 313 | 129 | 122 | 25 | 112 | 79 | −6 | 0.6 | 0.5 | <0.0001 |
| Stopped (%) | 49 (28) | 19 (33) | 6 (50) | 27(35) | 17 (25) | 0 | 21 (34) | 25 (29) | 3 (7) | 0.2 | 0.5 | <0.05 |
| Genotyped (% of total) | 46(26) | 15(26) | 3(25) | 24(31) | 15(22) | 2(29) | 20(33) | 6(7) | 4(10) | 0.4 | 0.3 | <0.0001 |
| Resistance to LPV/r (% of genotyped) | 13(28) | 3(20) | 1(33) | 9(38) | 2(4) | 1(50) | 2(20) | 3(50) | 1(25) | 0.4 | 0.5 | 1 |
| Side Effects | 13(7) | 4(7) | 0 | 7(9%) | 4(6) | 0 | 7(12.5) | 13(15.5) | 5(12) | 0.6 | 0.3 | 0.4 |
| Exitus | 8 (4) | 0 | 0 | 2(3%) | 2(3) | 0 | 0 | 1(1) | 0 | 0.7 | 0.2 | 0.4 |
Patients were stratified according to VL: above 100,000 cp/ml; between 10 and 100 thousands cp/ml and below 10,000 cp/ml when starting LPV/r. Each group was further divided according to baseline CD4 count: below 200 cells/µl; between 200 and 500 cells/µl and above 500 cell/µl, creating altogether 9 groups. Group 9 (VL below 10,000 cp/ml and CD4 counts more than 500 cell/µl) was significantly different from the other groups in two parameters: shorter time on LPV/r treatment and lower percent of patients receiving LPV/r as first PI. As the median VL of this group was initially below detection level and baseline CD4 count above 700, no further decline in viral load could be observed and the lack of further increase in CD4 was also expected.
cp/ml – copies/ml; Gr – group; VL –Viral Load.