Table 3.
Descriptive Safety and Efficacy Results
| Safety Parameter | Control Arm (n = 6) | Rifampicin Arm (n = 21) | All (n = 27) |
|---|---|---|---|
| Any AE | 17 (in 6/6 infants) | 65 (in 20/21 infants) | 82 (in 26/27 infants) |
| Any SAE | 3 (in 3/6 infants) | 23 (in 13/21 infants) | 26 (in 16/27 infants) |
| Drug-related SAEs | 0 | 2 (in 2/21 infants) | 2 (in 2/27 infants) |
| Any drug-related AE | 0 | 5a (in 5/21 infants) | 5 (in 5/27 infants) |
| Grade 3 | – | 1 (in 1/21 infants) | 1 (in 1/27 infants) |
| Grade 4 | – | 1 (in 1/21 infants) | 1 (in 1/27 infants) |
| AEs leading to withdrawal | 0 | 0 | 0 |
| HIV Viral Load Data | Control Arm (n = 5) | Rifampicin Arm (n = 17) | All (n = 22)b |
|---|---|---|---|
| Undetectable HIV viral load on study day 180c | 1 (20%) | 6 (35%) | 6 (27%) |
| HIV viral load <1000 copies/mL on study day 180 | 5 (100%) | 13 (76%) | 18 (82%) |
The safety parameters are reported as number of reported outcomes followed by the percentage of infants with at least 1 reported outcome.
Abbreviations: AE, adverse event; HIV, human immunodeficiency virus; SAE, severe adverse event.
aThree alterations in liver function (including 1 grade 4 and 1 grade 3 AE) and 1 skin rash were considered possibly or potentially related to rifampicin, and 1 grade 2 liver alteration was considered possibly related to dolutegravir.
bViral load data at 180 days after enrollment in the main trial were unavailable for 4 infants, and 1 infant was on dolutegravir for less than 120 days.
cDetection limit varied between 20 and 150 copies/mL.