Table 2.
Efficacy endpoints for week 48: with available data1
| HIV RNA at week 48 | ||||||
|---|---|---|---|---|---|---|
| Study Arm | N with data | N miss | <50 copies/mL (n, % N with data) | <200 copies/mL (n, % N with data) | <400 copies/mL (n, % N with data) | |
| DRV/r + 2NRTI: stage 1+2 | 257 | 4 | 194 (75.5) | 222 (86.4) | 227 (88.3) | |
| DRV/r + DTG: stage 1+2 | 264 | 7 | 222 (84.1) | 246 (93.2) | 250 (94.7) | |
| DRV/r + 2NRTI: stage 2 |
206 | 3 | 147 (71.4) | 174 (84.5) | 179 (86.9) | |
| DRV/r + DTG: stage 2 | 209 | 7 | 177 (84.7) | 194 (92.8) | 198 (94.7) | |
| DTG + TDF/XTC: stage2 |
291 | 3 | 227 (78.0) | 252 (86.6) | 262 (90.0) | |
| Difference % [95% CI], P-value 2 | ||||||
| DRV/r + DTG vs DRV/r + 2NRTI | Stage 1 +2 | 8.6 [1.7, 15.5], P=0.004 | 6.8 [1.6, 12.0], P=0.01 | 6.4 [1.6, 11.4], P=0.01 | ||
| DTG + TDF/XTC vs DRV/r + 2NRTI: | Stage 2 | 6.7 [−1.2, 14.4], P=0.09 | 2.1 [−4.2, 8.4], P=0.52 | 3.1 [−2.6, 8.9], P=0.31 | ||
| Baseline HIV RNA <= 100,000 copies/mL | ||||||
| DRV/r + 2NRTI: stage 1+2 | 213 | 3 | 169 (79.3) | 188 (88.3) | 193 (90.6) | |
| DRV/r+DTG stage 1+2 | 210 | 5 | 181 (86.2) | 195 (92.9) | 198 (94.3) | |
| DRV/r + 2NRTI: stage 2 |
169 | 2 | 128 (75.7) | 146 (86.4) | 151 (89.4) | |
| DRV/r + DTG: stage 2 | 168 | 5 | 146 (86.9) | 156 (92.9) | 159 (94.6) | |
| DTG + TDF/XTC: stage 2 |
244 | 1 | 200 (82.0) | 217 (88.9) | 224 (91.8) | |
| Difference % [95% CI], P-value 2 | ||||||
| DRV/r + DTG vs DRV/r + 2NRTI: | Stage 1+2 | 6.9 [−0.3, 14.0], P=0.07 | 4.6 [−0.1, 10.2], P=0.13 | 3.7 [−1.3, 8.7], P=0.20 | ||
| DTG + TDF/XTC vs DRV/r + 2NRTI | Stage 2 | 6.2 [−1.8, 14.3], P=0.14 | 2.5 [−4.0, 9.0], P=0.45 | 2.5 [−3.3, 8.2], P=0.40 | ||
| Baseline HIV RNA >100,000 copies/mL | ||||||
| DRV/r + 2NRTI: stage 1+2 | 44 | 1 | 25 (56.8) | 34 (77.3) | 34 (77.3) | |
| DRV/r + DTG: stage 1+2 | 54 | 2 | 41 (75.9) | 51 (94.4) | 52 (96.3) | |
| DRV/r + 2NRTI: stage 2 |
34 | 1 | 19 (51.4) | 28 (75.7) | 28 (75.7) | |
| DRV/r + DTG: stage 2 | 41 | 2 | 31 (75.6) | 38 (92.7) | 39 (95.1) | |
| DTG + TDF/XTC: stage2 |
47 | 1 | 27 (57.5) | 35 (74.5) | 38 (80.9) | |
| Difference % [95% CI], P-value 2 | ||||||
| DRV/r + DTG vs DRV/r + 2NRTI: | Stage 1+2 | 19.1 [0.6, 37.7], P=0.05 | 17.2 [3.4, 31.0], P=0.02 | 19.0 [5.7, 33.3], P=0.01 | ||
| DTG + TDF/XTC vs DRV/r + 2NRTI | Stage 2 | 6.1 [−15.3, 27.5], P=0.66 | −1.2 [−19.8, 17.4], P=1.00 | 5.2 [−12.7, 23.0], P=0.60 | ||
1
Efficacy percentage excludes participants with missing RNA at week 48, efficacy endpoints were assessed following a modified intention to treat approach, excluding any participant randomised who did not commence ART.
2
P-value calculated using Fisher’s exact (two-sided) test.
DRV/r + 2NRTI (ritonavir boosted darunavir plus two nucleoside reverse transcriptase inhibitors); DRV/r + DTG (ritonavir boosted darunavir plus dolutegravir); DTG + TDF/XTC (dolutegravir plus tenofovir with either emtrictabine or lamivudine (XTC))