Table 2. Rates of toxicity per stavudine dosage group and time of stavudine exposure.
No. of events(%) | Months on ART to event [IQR] | Toxicity rate/100 PY(95% CI) | [3-6] month toxicity rate/100 PY (95% CI) | [6-12] month toxicity rate/100 PY(95% CI) | [12-18] month toxicity rate/100 PY(95% CI) | [18-24] month toxicity rate/100 PY(95% CI) | [24-48] month toxicity rate/100 PY(95% CI) | |
ALL-CAUSE TOXICITY | ||||||||
Stavudine 40mg | 1056(13.5) | 15.1[9.0-23.1] | 9.63(9.07-10.23) | 6.01(5.28-6.84)n = 227 | 13.22(11.97-14.60)n = 387 | 13.33(11.82-15.04)n = 264 | 9.56(7.96-11.47)n = 115 | 5.88(4.59-7.52)n = 63 |
Only SA | 1044(13.5) | 15.1[9.0-23.2] | 9.57(9.01-10.17) | 5.94(5.21-6.78)n = 223 | 13.12(11.87-14.50)n = 382 | 13.27(11.76-14.98)n = 262 | 9.49(7.60-11.40)n = 114 | 5.88(4.59-7.53)n = 63 |
Stavudine 30mg | 3822(9.3) | 12.6[6.9-20.6] | 7.41(7.18-7.65) | 5.70(5.37-6.04) n = 1109 | 10.20(9.67-10.76) n = 1361 | 7.87(7.29-8.49)n = 669 | 6.08(5.43-6.80)n = 305 | 7.24(6.55-8.01)n = 378 |
Only SA | 3,682(9.2) | 12.6[6.9-20.7] | 7.31(7.08-7.55) | 5.74(5.41-6.09) n = 1088 | 10.16(9.62-10.72) n = 1317 | 7.42(6.86-8.03)n = 616 | 5.77(5.14-6.48)n = 286 | 7.22(6.53-7.99)n = 375 |
Total | 4878(10.0) | 13.0[7.2-21.1] | 7.80(7.59-8.03) | 5.75(5.45-6.07) n = 1,336 | 10.74(10.25-11.26) n = 1748 | 8.90(8.35-9.49)n = 933 | 6.75(6.13-7.43)n = 420 | 7.01(6.39-7.70)n = 441 |
Total SA | 4726(9.9) | 13.0[7.1-21.2] | 7.71(7.50-7.94) | 5.77(5.47-6.09) n = 1311 | 10.70(10.21-11.22) n = 1699 | 8.54(8.00-9.13)n = 878 | 6.50(5.89-7.17)n = 400 | 6.99(6.37-7.68)n = 438 |
SPECIFIC TOXICITY | ||||||||
Stavudine 40mg | 882(11.3) | 15.2[9.1-23.3] | 8.00(7.49-8.55) | 5.05(4.39-5.82)n = 191 | 11.37(10.21-12.65)n = 334 | 10.98(9.61-12.53)n = 219 | 7.47(6.09-9.18)n = 91 | 4.30(3.23-5.72)n = 47 |
Only SA | 871(11.2) | 15.2[9.1-23.4] | 7.94(7.43-8.48) | 5.01(4.34-5.78)n = 188 | 11.26(10.11-12.55)n = 329 | 10.91(9.55-12.47)n = 217 | 7.40(6.02-9.10)n = 90 | 4.30(3.23-5.72)n = 47 |
Stavudine 30mg | 3346(8.2) | 12.7[7.0-20.7] | 6.46(6.25-6.68) | 4.93(4.62-5.25)n = 959 | 8.86(8.37-9.37)n = 1186 | 7.02(6.48-7.61)n = 601 | 5.39(4.79-6.07)n = 273 | 6.17(5.53-6.87)n = 327 |
Only SA | 3,219(8.1) | 12.6[6.9-20.9] | 6.36(6.14-6.58) | 4.95(4.64-5.28)n = 939 | 8.81(8.31-9.33)n = 1146 | 6.63(6.10-7.20)n = 554 | 5.10(4.51-5.76)n = 255 | 6.16(5.52-6.86)n = 325 |
Total | 4228(8.7) | 13.1[7.2-21.2] | 6.73(6.53-6.94) | 4.95(4.6-5.24)n = 1150 | 9.31(8.85-9.79)n = 1520 | 7.77(7.26-8.32)n = 820 | 5.79(5.23-6.42)n = 364 | 5.85(5.28-6.47)n = 374 |
Total SA | 4090(8.6) | 13.1[7.2-21.4] | 6.64(6.44-6.85) | 4.96(4.68-5.26) n = 1127 | 9.26(8.80-9.74)n = 1475 | 7.45(6.94-8.00)n = 771 | 5.55(4.99-6.17)n = 345 | 5.84(5.27-6.46)n = 372 |
Note: CI, confidence interval; IQR, interquartile range; PY, person-years of follow-up; SA, sub-Saharan Africa.