Background
Methods
Study overview
Sample storage
Sample selection
Statistical methods
Results
Baseline characteristics
Factor | Overall | Viral load substudy |
---|---|---|
Monitoring randomisation | ||
LCM | 1,502 (50%) | 882 (50%) |
CDM | 1,505 (50%) | 880 (50%) |
Gender | ||
Male | 1,051 (35%) | 587 (33%) |
Female | 1,956 (65%) | 1,175 (67%) |
Age at ART initiation (years) Median (IQR) | 37 (32 – 42) | 37 (32 – 43) |
CD4 at ART initiation (cells/mm3) | ||
Median (IQR) | 86 (32 – 140) | 83 (31 – 137) |
0-49 | 996 (33%) | 585 (33%) |
50-99 | 725 (24%) | 440 (25%) |
100-149 | 687 (23%) | 400 (23%) |
150-200 | 599 (20%) | 337 (19%) |
Viral load at ART initiation (copies/mL) | ||
Missing | - | 452 (26%) |
<30,000 | - | 132 (10%) |
30,000 – 100,000 | - | 181 (10%) |
100,000 – 300,000 | - | 373 (21%) |
300,000 – 700,000 | - | 340 (19%) |
>700,000 | - | 284 (16%) |
First-line ARTa
| ||
TDF | 2,196 (73%) | 1,104 (63%) |
NVP | 520 (17%) | 404 (23%) |
ABC | 291 (10%) | 254 (14%) |
TB in 12 months prior to enrolment | 737 (25%) | 421 (24%) |
Centre | ||
Entebbe, Uganda | 914 (30%) | 543 (31%) |
Kampala, Uganda | 1,159 (39%) | 809 (46%) |
Harare, Zimbabwe | 934 (31%) | 410 (23%) |
Adherence at week 48 | ||
0 – 50% | 106 (4%) | 68 (4%) |
50 – 67% | 175 (6%) | 108 (6%) |
67 – 75% | 251 (8%) | 152 (9%) |
75 – 83% | 456 (15%) | 264 (15%) |
83 – 92% | 876 (29%) | 523 (30%) |
>92% | 1,134 (38%) | 645 (37%) |
Missing | 9 (0%) | 2 (0%) |
Durability of virological suppression
Factor | Univariable HR |
p-value | Multivariable HR (95% CI) |
p-value |
---|---|---|---|---|
Monitoring randomisation | ||||
LCM | 1.00 | - | 1.00 | - |
CDM | 1.07 | 0.45 | 1.11 (0.93 - 1.35) | 0.25 |
Gender | ||||
Male | 1.00 | - | 1.00 | - |
Female | 0.80 | 0.02 | 0.79 (0.65 - 0.95) | 0.01 |
Initial ART | ||||
TDF | 1.00 | <0.0001 | 1.00 | <0.0001 |
NVP | 0.49 | - | 0.48 (0.38 - 0.62) | - |
ABC | 1.18 | - | 1.27 (1.02 - 1.59) | - |
TB in 12 months prior to enrolment | 1.13 | 0.26 | 1.07 (0.86 - 1.33) | 0.52 |
Age (per 10 years older) | 0.73 | <0.0001 | 0.73 (0.64 - 0.84) | <0.0001 |
Baseline CD4 (per 100 cells/mm3 higher) | 0.60 | <0.0001 | 0.64 (0.54 - 0.75) | <0.0001 |
Baseline viral load (log10 copies/mL) | 1.02 | 0.84 | 1.01 (0.84 - 1.22) | 0.89 |
Adherence in previous 48 weeksa (per 10% higher) | 0.89 | <0.0001 | 0.89 (0.84 - 0.94) | <0.0001 |
Sensitivity analyses
Default | Sensitivity 1 | Sensitivity 3 | ||||||
---|---|---|---|---|---|---|---|---|
VF ≥ 200 cps/mL | VF ≥ 200 cps/mL | VF ≥ 1,000 cps/mL | VF ≥ 10,000 cps/mL | |||||
Multivariable HR (95% CI) |
p-value | Multivariable HR (95% CI) |
p-value | Multivariable HR (95% CI) |
p-value | Multivariable HR (95% CI) |
p-value | |
Monitoring randomisation | ||||||||
LCM | 1.00 | - | 1.00 | - | 1.00 | - | 1.00 | - |
CDM | 1.11 (0.93 – 1.34) | 0.25 | 1.16 (0.98 – 1.38) | 0.09 | 1.14 (0.94 – 1.37) | 0.19 | 1.18 (0.96 – 1.45) | 0.11 |
Gender | ||||||||
Male | 1.00 | - | 1.00 | - | 1.00 | - | 1.00 | - |
Female | 0.79 (0.65 – 0.95) | 0.01 | 0.84 (0.70 – 1.01) | 0.06 | 0.78 (0.64 – 0.95) | 0.01 | 0.77 (0.62 – 0.95) | 0.02 |
Initial ART | ||||||||
TDF | 1.00 | <0.0001 | 1.00 | <0.0001 | 1.00 | <0.0001 | 1.00 | <0.0001 |
NVP | 0.48 (0.38 – 0.62) | - | 0.49 (0.39 – 0.62) | - | 0.49 (0.38 – 0.63) | - | 0.50 (0.38 – 0.65) | - |
ABC | 1.27 (1.02 – 1.59) | - | 1.23 (0.99 – 1.52) | - | 1.23 (0.97 – 1.55) | - | 1.00 (0.76 – 1.31) | - |
TB in 12 months prior to enrolment | 1.07 (0.86 – 1.33) | 0.52 | 1.07 (0.88 – 1.32) | 0.47 | 1.08 (0.86 – 1.36) | 0.49 | 1.15 (0.91 – 1.46) | 0.24 |
Age (per 10 years older) | 0.73 (0.64 – 0.84) | <0.0001 | 0.77 (0.68 – 0.88) | <0.0001 | 0.70 (0.61 – 0.81) | <0.0001 | 0.69 (0.60 – 0.80) | <0.0001 |
Baseline CD4 (per 100 cells/mm3 higher) | 0.64 (0.54 – 0.75) | <0.0001 | 0.67 (0.57 – 0.78) | <0.0001 | 0.60 (0.50 – 0.72) | <0.0001 | 0.52 (0.43 – 0.64) | <0.0001 |
Baseline viral load (log10 copies/mL) | 1.01 (0.84 – 1.22) | 0.89 | 0.99 (0.83 – 1.18) | 0.91 | 1.02 (0.84 – 1.24) | 0.82 | 1.02 (0.82 – 1.25) | 0.88 |
Adherence in previous 48 weeksa (per 10% higher) | 0.89 (0.84 – 0.94) | <0.0001 | 0.90 (0.85 – 0.94) | <0.0001 | 0.89 (0.84 – 0.94) | <0.0001 | 0.88 (0.82 – 0.94) | <0.0001 |