Table 1.
Baseline characteristics
| Switch group (N = 291) | No-switch group (N = 143) | p value | |
|---|---|---|---|
| Male, n (%) | 268 (92.1) | 134 (93.7) | 0.55 |
| Age, mean years (SD) | 42 (9.6) | 40 (9.7) | 0.008 |
| Race, n (%) | 0.45 | ||
| White | 231 (79.4) | 109 (76.2) | |
| Non-White | 60 (20.6) | 34 (23.1) | |
| Ethnicity, n (%) | 0.78 | ||
| Hispanic or Latino | 30 (10.3) | 16 (11.2) | |
| Serious mental illnessa | 48 (16.5) | 16 (11.2) | 0.14 |
| VACS Index Scoreb, mean (SD) | 8.7 (10.4) | 7.6 (9.3) | 0.34 |
| Asymptomatic, n (%) | 225 (77.3) | 115 (80.4) | 0.46 |
| CD4 cell count (cells per µL), mean (SD) | 586 (210.3) | 593 (224.6) | 0.99 |
| Years since HIV diagnosis, mean (SD) | 6.0 (4.3) | 5.0 (2.9) | 0.16 |
| Years since first antiretroviral therapy use, mean (SD) | 4.0 (1.9) | 3.0 (1.7) | 0.55 |
| On first antiretroviral therapy regimen at randomization, n (%) | 263 (90.4) | 130 (90.9) | 0.86 |
| NNRTI at randomization, n (%) | 0.13 | ||
| Efavirenz | 232 (79.7) | 106 (74.1) | |
| Co-formulated efavirenz, emtricitabine, and tenofovir DF | 222 (76.3) | 100 (69.9) | |
| Nevirapine | 47 (16.2) | 27 (18.9) | |
| Rilpivirine | 9 (3.1) | 10 (7.0) | |
| Co-formulated rilpivirine, emtricitabine, and tenofovir DF | 7 (2.4) | 9 (6.3) | |
| Etravirine | 3 (1.0) | 0 (0.0) | |
| HIV-SI symptom countc, mean (SD) | 4.9 (5.2) | 3.8 (4.6) | 0.038 |
| CES-D total depressive symptom scored, mean (SD) | 9.8 (9.3) | 8.9 (8.6) | 0.34 |
| STAI-State anxietye, mean (SD) | 32.8 (10.6) | 30.8 (9.2) | 0.22 |
| STAI-Trait anxietye, mean (SD) | 33.8 (11.1) | 32.6 (9.6) | 0.51 |
| SF-36 PCSf, mean (SD) | 55.3 (5.9) | 56.0 (4.7) | 0.50 |
| SF-36 MCSf, mean (SD) | 50.0 (10.4) | 51.7 (9.0) | 0.19 |
For categorical data, p value was from the Cochran–Mantel–Haenszel (CMH) test (using the general association statistic). For continuous data, p value was from the two-sided Wilcoxon rank sum test. P value comparing NNRTI at randomization compared the distribution of all four NNRTIs (efavirenz, nevirapine, rilpivirine, and etravirine) and did not focus on individual NNRTIs
CES-D Center for Epidemiological Studies Depression, NNRTI non-nucleoside reverse transcriptase inhibitor, SD standard deviation, SF-36 MCS Short Form 36 Mental Component Summary, SF-36 PCS Short Form 36 Physical Component Summary, STAI State Trait Anxiety Inventory, VACS Veterans Aging Cohort Study
aSerious mental illness is defined as a medical history of at least one of the following diagnoses reported by the study investigator: major depression, anxiety, schizophrenia, bipolar disorder, post-traumatic stress disorder, or other psychosis
bVACS Index is a score derived from the patient’s age, CD4 cell count, HIV-1 RNA level, hemoglobin value, platelet count, aspartate and alanine transaminase levels, serum creatinine value, and a positive hepatitis C infection status at one specific time point
cThe HIV-SI bothersome symptom count is a summation of the presence of the individual HIV-SI items and ranges from 0 to 26, with higher counts indicating more bothersome symptoms
dThe CES-D total score ranges from 0 to 60, with higher scores indicated greater depression severity
eScores for both scales of the STAI range from 20 to 80, with higher scores indicating greater anxiety severity
fSF-36 PCS and MCS are scored from 0 to 100, with higher scores indicating better health