Background
Methods
The ANRS-12140 Pediacam study
Study population
Endpoints
Exposure variables
Statistical analysis
Results
Study population
N | % (n) or median (IQR) | |
---|---|---|
Male | 149 | 55.0 (82) |
Site of ART delivery | 149 | |
CME/FCB | 51.7 (77) | |
HLD | 22.2 (33) | |
CHE | 26.1 (39) | |
At 24 months after ART initiation (Study start) | ||
Age at 2 years after ART initiation | 149 | |
< 28 months (treatment initiated before age 4 months of age) | 50.3 (75) | |
[28–30[months (treatment initiated between age 4 and 6 months) | 30.2 (45) | |
≥ 30 months (treatment initiated from 6 months of age) | 19.5 (29) | |
Median in months (IQR) | 28.5 (27.1–30.0) | |
Time period | 149 | |
2010–2011 | 65.1 (97) | |
2012–2013 | 34.9 (52) | |
ART regimen | 149 | |
Lopinavir-based | 74.5 (111) | |
Nevirapine-based | 25.5 (38) | |
Children living with | 131 | |
Both parents | 38.9 (51) | |
Mother only | 36.7 (48) | |
Father only | 5.3 (7) | |
Other relatives | 19.1 (25) | |
Family size ≤ 5 people | 94 | 47.9 (45) |
Access at child’s home to | 94 | |
Refrigerator | 51.1 (48) | |
Running water | 39.4 (37) | |
Electricity | 93.6 (88) | |
CD4 percentage at 2 years after ART initiation | 131 | |
< 15 | 6.1 (8) | |
[15–20[ | 6.1 (8) | |
20–25[ | 14.5 (19) | |
≥ 25 | 73.3 (96) | |
Not measured | 13 | |
Median (IQR), N = 131 | 33.6 (24.5–41.6) | |
Virological status | ||
Achievement of confirmed virological success (CVS) within the first two years of ART | 149 | |
Yes (=2 VL < 1000 copies/mL for two consecutive measurements) | 77.2 (115) | |
No | 22.8 (34) | |
Virological status at 2 years (±3 months) after ART initiation | 134 | |
VL < 400 copies/mL | 67.2 (90) | |
VL ≥ 400 copies/mL | 32.8 (44) | |
VL not measured | 15 | |
Last viral load if not available at 2 years ± 3 months after ART initiation | 15 | |
VL < 400 copies/mL | 12 | |
VL ≥ 400 copies/mL | 3 |
Mortality and retention in care between two and five years after ART initiation
Viral load at 2 years (+/− 3 months) of antiretroviral treatment initiation | ||||||||
---|---|---|---|---|---|---|---|---|
All N = 149 | < 4 00 copies/mL N = 90 | ≥ 400 copies/mL N = 44 | Absence of viral load N = 15 | |||||
N | % | N | % | N | % | N | % | |
Death between 2 and 5 years of ART initiation | ||||||||
Yes | 5 | 3.4 | 0 | 0.0 | 2 | 8.5 | 3 | 20.0 |
No | 144 | 94.6 | 90 | 100.0 | 42 | 91.5 | 12 | 80.0 |
Virological status at 5 years (+/−3 months) after ART initiation | ||||||||
VL < 400 copies/mL | 99 | 66.4 | 68 | 75.6 | 28 | 63.6 | 3 | 20.0 |
VL ≥ 400 copies/mL | 22 | 14.8 | 9 | 10.0 | 12 | 27.3 | 1 | 6.7 |
Absence of VL if not dead at M60 | 23 | 15.4 | 13 | 14.4 | 2 | 4.6 | 8 | 53.3 |
Probability at 5 years (+/−3 months) after ART initiation, using Kaplan-Meier estimation method | ||||||||
Of maintaining virological success (Group 1) | 90 | 64.0 (30 events) | ||||||
Of achieving at least once VL < 400 copies/mL (Group 2) | 44 | 76.0 (30 events) | ||||||
CD4 percentage at 5 years of ART initiation | ||||||||
< 15 | 1 | 0.7 | 0 | 0.0 | 1 | 2.3 | 0 | 0.0 |
[15–20[ | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 |
[20–25[ | 7 | 4.7 | 5 | 5.6 | 1 | 2.3 | 1 | 6.7 |
≥ 25 | 115 | 77.2 | 74 | 82.2 | 38 | 63.6 | 3 | 20.0 |
Not measured if not dead at M60 | 21 | 14.1 | 11 | 12.2 | 2 | 4.6 | 8 | 53.3 |
Immunological status at five years of antiretroviral treatment
Virologic control at five years of antiretroviral treatment
Factors associated with virological success at five years of antiretroviral treatment
Baseline characteristics at 2 years +/− 3 months after ART initiation | Univariate analysis VL < 400 cp/mL at 5 years +/− 3 months after ART initiation | Multivariate analysis (logistic regression) | ||||||
---|---|---|---|---|---|---|---|---|
N | n | % | Crude OR (95%CI) | p | Adjusted OR (95%CI) | p | N2 | |
142 | ||||||||
Gender | ||||||||
Male | 65 | 39 | 60.0 | 1 | 0.041 | 0.122 | ||
Female | 79 | 60 | 76.0 | 2.1 (1.0–4.4) | 1.9 (0.9–4.2) | |||
Site of ART delivery | ||||||||
CME/FCB | 74 | 47 | 63.5 | 1 | 0.056 | 1 | 0.102 | |
HLD | 30 | 19 | 63.3 | 0.8 (0.3–18) | 0.7 (0.3–1.8) | |||
CHE | 40 | 33 | 82.5 | 2.8 (1.0–7.6) | 2.4 (0.8–7.2) | |||
Age | ||||||||
< 28 months (treatment initiated before age of 4 months) | 72 | 50 | 69.4 | 1 | 0.855 | |||
≥ 28 months (treatment initiated from age of 4 months) | 72 | 49 | 68.1 | 0.9 (0.5–1.9) | ||||
Calendar period | ||||||||
2010–2011 | 91 | 63 | 69.2 | 1 | 0.923 | 1 | 0.206 | |
2012–2013 | 53 | 36 | 67.9 | 1.0 (0.5–2.0) | 1.8 (0.7–4.4) | |||
Virological response within the first two years of ART | ||||||||
Absence of confirmed virological success | 29 | 15 | 51.7 | 1 | 0.010 | 1 | 0.033 | |
Achievement of confirmed virological success at least once (= 2 VL < 1000 copies/mL for two consecutive measurements) | 115 | 84 | 73.0 | 3.0 (1.3–6.9) | 2.7 (1.1–6.8) | |||
Virological status | ||||||||
VL ≥ 400 copies/mL or not measured | 54 | 29 | 53.7 | 1 | 0.061 | |||
VL < 400 copies/mL | 90 | 70 | 77.7 | 2.2 (0.9–4.8) | ||||
Children living with(1) | ||||||||
Mother or father | 96 | 77 | 80.2 | |||||
Other relatives | 23 | 23 | 100.0 | |||||
Availability of refrigerator in the household | ||||||||
No | 40 | 34 | 85.0 | 1 | 0.939 | |||
Yes | 44 | 36 | 81.8 | 1.0 (0.4–2.6) | ||||
Access to electricity at home(1) | ||||||||
No | 5 | 3 | 60.0 | |||||
Yes | 79 | 67 | 84.8 | |||||
Access to water at home(1) | ||||||||
No | 52 | 42 | 80.9 | 1 | 0.876 | |||
Yes | 32 | 28 | 87.5 | 1.0 (0.4–3.0) | ||||
History of hospitalization, diarrhea, infectious disease, or convulsions within the last 3 months before the M60 visit | ||||||||
No | 75 | 59 | 78.7 | 1 | 0.975 | |||
Yes | 45 | 37 | 82.2 | 1.0 (0.5–2.3) | ||||
CD4 percentage(2) | ||||||||
< 25% | 30 | 29 | 96.2 | 1 | 0.221 | |||
≥ 25% | 89 | 70 | 78.7 | 0.5 (0.2–1.5) | ||||
ART regimen | ||||||||
Lopinavir-based | 106 | 77 | 72.6 | 1 | 0.117 | 1 | 0.155 | |
Nevirapine-based | 38 | 22 | 57.9 | 0.5 (0.2–1.2) | 0.5 (0.2–1.3) | |||
Number of missed doses within the last 3 days before M60 visit | ||||||||
≥ 1 missed dose | 95 | 77 | 81.1 | 1 | 0.076 | 1 | 0.075 | |
No missed dose | 30 | 22 | 73.3 | 2.8 (0.9–8.7) | 2.7 (0.9–10.4) |