Table 3.
Incidence of targeted clinical diagnoses and laboratory toxicities for each dual nucleoside reverse-transcriptase inhibitor (NRTI) regimen.
| Cohort, regimen | Time exposed to regimen, person-years |
Subjects with targeted finding,a no. (%) |
IR (95% CI) |
|---|---|---|---|
| Fullb | |||
| ZDV/3TC (n = 1336) | 2189.5 | 27 (2.0) | 1.23 (0.81–1.79) |
| ZDV/ddI (n = 1022) | 1982.5 | 19 (1.9) | 0.96 (0.58–1.50) |
| d4T/3TC (n = 1154) | 2653.7 | 47 (4.1) | 1.77 (1.30–2.36) |
| d4T/ddI (n = 772) | 1516.5 | 25 (3.2) | 1.65 (1.07–2.43) |
| ddI/3TC (n = 258) | 336.4 | 10 (3.9) | 2.97 (1.43–5.47) |
| Laboratoryc | |||
| ZDV/3TC (n = 584) | 1396.5 | 119 (20.4) | 8.52 (7.06–10.20) |
| ZDV/ddI (n = 386) | 1029.2 | 57 (14.8) | 5.54 (4.19–7.18) |
| d4T/3TC (n = 688) | 2219.1 | 202 (29.4) | 9.10 (7.89–10.45) |
| d4T/ddI (n = 439) | 1216.3 | 111 (25.3) | 9.13 (7.51–10.99) |
| ddI/3TC (n = 118) | 234.2 | 24 (20.3) | 10.2 (6.57–15.25) |
NOTE. CI, exact 95% confidence interval based on Poisson distribution; d4T, stavudine; ddI, didanosine; IR, incidence rate per 100 person-years of exposure; 3TC, lamivudine; ZDV, zidovu-dine.
a
Clinical diagnosis or laboratory test abnormality.
b
All age-eligible subjects who met the study criteria described in the Methods section.
c
The subset of subjects monitored for laboratory test abnormalities, defined as having ≥1 targeted laboratory evaluation while receiving the dual NRTI regimen of interest (or in the month after stopping therapy).