Table 1.
No. (%) of Patientsa |
|||
---|---|---|---|
Efavirenz (n = 421) | Nevirapine (n = 383) | P Valuesb | |
Age, median (IQR), y | 8.1 (6.0–10.5) | 7.0 (4.8–9.8) | <.001 |
| |||
Antiretroviral therapy initiated before 2008 | 299 (71.0) | 339 (88.5) | <.001 |
| |||
Female sex | 175 (43.5) | 227 (56.5) | <.001 |
| |||
Baseline CD4%, median (IQR) | (n = 409) 13 (8 to 20) | (n = 368) 15 (9 to 22) | .003c |
| |||
Baseline CDC immunologic categoryd | |||
1 | 34 (8.1) | 51 (13.3) | .03c |
| |||
2 | 123 (29.2) | 126 (32.9) | |
| |||
3 | 262 (62.2) | 203 (53.0) | |
| |||
Missing | 2 (0.5) | 3 (0.8) | |
| |||
Baseline CDC clinical categorye | |||
N | 29 (6.9) | 10 (2.6) | <.001c |
| |||
A | 40 (9.5) | 44 (11.5) | |
| |||
B | 84 (20.0) | 102 (26.6) | |
| |||
C | 164 (39.0) | 173 (45.2) | |
| |||
Missing | 104 (24.7) | 54 (14.1) | |
| |||
Baseline HIV RNA, copies/mL | (n = 115) | (n = 175) | |
| |||
Log10, median (IQR) | 5.2 (4.8 to 5.6) | 5.3 (4.9 to 5.7) | .32 |
| |||
>750 000 | 15 (13.0) | 16 (9.1) | .35 |
| |||
z Score, mean (SD) | |||
Height for age | (n = 358) −2.2 (1.3) | (n = 341) −2.6 (1.7) | <.001 |
| |||
Weight for height or body mass indexf | (n = 359) −1.0 (1.5) | (n = 340) −0.8 (1.4) | .16 |
Nucleoside reverse transcriptase inhibitors | |||
Zidovudine plus lamivudine | 380 (90.3) | 357 (93.2) | .18 |
| |||
Stavudine plus lamivudine | 34 (8.1) | 24 (6.3) | |
| |||
Tenofovir plus emtricitabine | 6 (1.4) | 1 (0.3) | |
| |||
Abacavir plus lamivudine | 1 (0.2) | 0 | |
| |||
Didanosine and stavudine | 0 | 1 (0.3) | |
| |||
Single-dose nevirapine | |||
Mother and/or baby received | 7 (1.7) | 11 (2.9) | .25 |
| |||
None or unknown | 414 (98.3) | 372 (97.1) | |
| |||
Treated for tuberculosis during antiretroviral therapy | |||
Yes | 65 (15.4) | 31 (8.1) | .001c |
| |||
No | 356 (84.6) | 348 (90.9) | |
| |||
Missing | 0 | 4 (1.0) | |
| |||
Pill count adherence, median (IQR), % doses takeng | (n = 287) 98 (97 to 99) | (n = 202) 98 (98 to 99) | .46 |
| |||
Never achieved virological suppression | 11 (2.6) | 20 (5.2) | .06 |
| |||
Died | 1 (0.2) | 1 (0.3) | .94 |
| |||
Lost to follow-up | 0 | 9 (2.4) | .002 |
Abbreviations: CDC, Centers for Disease Control and Prevention; HIV, human immunodeficiency virus; IQR, interquartile range.
Unless otherwise indicated.
The t test was used for normally distributed continuous data, the Wilcoxon rank sum test for nonparametric continuous data, and the χ2 test for dichotomous data.
Based on comparisons of available data only. Inclusion of missing data as an additional category led to minimal changes for all variables.
Defined by age-specific classifications based on CD4 cell absolute counts and percentage12; discordance was classified as the lower of the 2. When the CD4 cell percentage was missing, the CDC immunologic category was determined based on the CD4 cell absolute count alone. Category 1 indicates mild or no apparent immunologic suppression; category 2, moderate immunologic suppression; and category 3, severe immunologic suppression. For those children enrolled in the study, the following cutoffs applied for CD4 cell count and CD4 cell percentage, respectively, for those aged 3 to 5 years: category 1,1000 cells/μL or greater (≥25%), category 2, 500 to 999 cells/μL (15%–24%), category 3, less than 500 cells/μL (<15%); and for those aged 6 years or older: category 1, 500 cells/μL or greater (≥25%), category 2, 200 to 499 cells/μL (15%–24%), category 3, less than 200 cells/μL (<15%).
Category N indicates that the patient has not been symptomatic or had a single category A symptom; category A, mild symptoms; category B, moderate symptoms; and category C, severe symptoms.18
Body mass index was calculated as weight in kilograms divided by height in meters squared.
Repeated measures for the same patient were averaged.