Table 3.
Secondary outcomes
| OT (n=291) | PI-mono (n=296) | Difference (95% CI)* | p value | ||
|---|---|---|---|---|---|
| Serious drug-related or disease-related complications | |||||
| Total | 8 (2·7%) | 15 (5·1%) | 2·3% (−0·8 to 5·4) | 0·15 | |
| Death† | 1 (0·3%) | 6 (2·0%) | 1·7% (−0·3 to 3·6) | 0·12 | |
| AIDS-defining event | 1 (0·3%) | 1 (0·3%) | 0·0% (−1·3 to 1·3) | 1·00 | |
| Serious non-AIDS event | 7 (2·4%) | 12 (4·1%) | 1·6% (−1·2 to 4·5) | 0·26 | |
| CD4 change (cells per mm3) | 93 (10) | 109 (9) | 16 (−11 to 42) | 0·30 | |
| Serious adverse event | 45 (15·5%) | 56 (18·9%) | 3·5% (−2·6 to 9·6) | 0·27 | |
| Total grade 3 or 4 adverse event | 159 (54·6%) | 137 (46·3%) | −8·4% (−16·4 to −0·3) | 0·043 | |
| Clinical grade 3 or 4 adverse event | 49 (16·8%) | 65 (22·0%) | 5·1% (−1·3 to 11·5) | 0·12 | |
| EGFR | |||||
| <60 mL/min per 1·73 m2‡ | 28/290 (9·7%) | 15/296 (5·1%) | −4·6% (−8·8 to −0·4) | 0·033 | |
| Change (mL/min per 1·73 m2) | −5·13 (0·67) | −3·83 (0·66) | 1·30% (−0·55 to 3·15) | 0·092 | |
| Symptomatic peripheral neuropathy§ | 44/283 (15·5%) | 46/289 (15·9%) | 0·4% (−5·6 to 6·3) | 0·90 | |
| Facial lipoatrophy¶ | 23/282 (8·2%) | 35/289 (12·1%) | 4·0% (−1·0 to 8·9) | 0·12 | |
| Abdominal fat accumulation¶ | 47/274 (17·2%) | 57/277 (20·6%) | 3·4% (−3·1 to 10·0) | 0·30 | |
| 10 year cardiovascular disease risk change | 1·32 (0·31) | 1·59 (0·31) | 0·27 (−0·58 to 1·12) | 0·52 | |
| Neurocognitive function change (NPZ-5 score) | 0·53 (0·04) | 0·52 (0·04) | −0·01 (−0·11 to 0·09) | 0·94 | |
| Quality of life change | |||||
| Mental health score | −0·75 (0·57) | −1·82 (0·54) | −1·07 (−2·61 to 0·47) | 0·17 | |
| Physical health score | −0·76 (0·53) | −1·17 (0·46) | −0·41 (−1·79 to 0·98) | 0·56 | |
Data are n (%), n/N (%), or mean (SE). Means are predicted means adjusted for baseline values. The numbers of patients are the numbers of patients having the specified event during the entire trial follow-up period. OT=ongoing triple therapy. PI-mono=protease inhibitor monotherapy. EGFR=estimated glomerular filtration rate.
Difference between PI-mono and OT. Absolute differences for binary outcomes or mean differences for continuous outcomes shown.
Causes of death were metastatic adenocarcinoma in the OT group and suicide, pulmonary embolism, breast carcinoma (recurrent), small-cell lung carcinoma, glioblastoma, and anal carcinoma in the PI-mono group (details in appendix p 4).
New episodes after baseline.
Symptomatic peripheral neuropathy at one or more of the post-baseline-scheduled follow-up assessments (irrespective of status at baseline).
Facial lipoatrophy present at one or more of the post-baseline-scheduled follow-up assessments (irrespective of status at baseline), assessed by a doctor or nurse; abdominal fat accumulation at last available assessment compared with baseline (irrespective of status at baseline), self-assessed by the patient.