Table 3. Factors associated with a) switching to second-line therapy (n=437) and b) first treatment interruption with undetectable viral load (n=429*).
| Factor** | a) Switch to second-line | b) Treatment interruption with undetectable viral load |
||||
|---|---|---|---|---|---|---|
| Rate per 100 pyar (events/pyar)*** |
Adjusted hazard ratio (95% CI) |
p value | Rate per 100 pyar (events/pyar)*** |
Adjusted hazard ratio (95% CI) | p value | |
| Type of initial ART | ||||||
| 3-drug NNRTI-based | 3.9 (18/464) | 1.00 | 3.6 (15/419) | 1.00 | ||
| 4-drug NNRTI-based | 2.1 (5/236) | 0.41 (0.15-1.14) | 0.5 (1/217) | 0.18 (0.02-1.50) | ||
| Boosted PI + 2 NRTIs | 1.3 (2/154) | 0.26 (0.06-1.19) | 2.9 (4/137) | 0.67 (0.19-2.39) | ||
| Unboosted PI + 2/3 NRTIs | 5.4 (45/837) | 1.41 (0.78-2.53) | 1.4 (11/765) | 0.53 (0.22-1.25) | ||
| PI + NNRTI + NRTI / 3 NRTIs | 3.7 (7/187) | 0.99 (0.40-2.45) | 0.033 | 2.1 (36/1697) | 0.73 (0.24-2.23) | 0.40 |
| Viral suppression | ||||||
| Before viral load <400c/mL | 1.9 (27/1398) | 1.00 | **** | **** | ||
| After initial viral load <400c/mL | 10.4 (50/481) | 0.23 (0.15-0.37) | <0.001 | |||
| Viral rebound ***** | ||||||
| Before confirmed rebound | 5.7 (22/386) | 1.00 | 2.2 (6/267) | 1.00 | ||
| After initial confirmed rebound | 0.4 (4/1012) | 22.80 (5.47- 95.14) |
<0.001 | 3.0 (29/978) | 0.48 (0.19-1.19) | 0.11 |
CI, confidence interval; ART, antiretroviral therapy; NNRTI, non-nucleoside reverse transcriptase inhibitor; NRTI, nucleoside reverse transcriptase inhibitor; PI, protease inhibitor; pyar, person-years
Analyses exclude 8 children enrolled in the PENTA 11 treatment interruption trial.
Results are only presented for factors with p value <0.1 associated separately with either switching and/or treatment interruption.
Rates are conditional on a child being alive and still in study follow-up, and the rate of treatment interruption with undetectable viral load further conditional on having not had a treatment interruption with detectable viral load
Since the outcome is treatment interruption with viral load <400c/mL, the effect of viral load <400c/m cannot be assessed.
Based on 319 children for analysis of switching to second-line therapy and 329 children for analysis of treatment interruption who had a viral load <400c/mL before experiencing the outcome of interest. Follow-up time was considered from the date of initial viral load <400c/mL.