Table 1.
Risk of bias assessment of the included studies
| Authors | Participants | Study design | Bioanalytical | Endpoints/follow-up | Gradinga | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Both HIV+ and HIV− TB groups included | Total number of participants | HIV and TB confirmation tests described | Number of participants CD4 < 200 cells/µL or CD4% < 12 | Proportion of HIV-positive participants receiving ART | Absorption test conducted | PK-altering comorbidities taken into account | Interacting (non-ART) comedication described | Given dose in mg/kg known per group | DOT | Validated analytical determination | Specimen handling described | Number of plasma samples | Method of AUC calculation | AUC calculation | Cmax calculation | AUC and Cmax data stratified per arm | Number of participants lost to follow-up or died | Risk of bias (high, medium or low) | |
| Antwi et al. [32] | + | 113 | + | +/− | 0/59 | − | − | − | + | + | + | + | 5 | Noncompartmental | +/− | + | + | 6 | Medium |
| Bekker et al. [45] | + | 39 | +/− | 0 | 5/5 | − | − | − | + | + | + | + | 6 | Noncompartmental | +/− | + | + | 2 | Medium |
| Chideya et al. [52] | + | 225 | + | 84 | − | − | − | − | − | + | + | + | 3 | Noncompartmental | − | − | +/− | 17 | High |
| Choudri et al. [39] | + | 29 | +/− | 8 | 0/14 | + | + | + | − | + | + | + | 9 | Noncompartmental | + | + | + | − | Low |
| Conte et al. [40] | + | 80 | +/− | +/− | 0/40 | − | + | + | − | +/− | + | + | 2 | NA | NA | − | − | 0 | High |
| Conte et al. [46] | + | 40 | +/− | − | 10/20 | − | + | + | − | +/− | + | + | 3 | NA | NA | − | − | − | High |
| Denti et al. [41] | + | 100 | + | +/− | 0/50 | − | − | − | − | + | + | + | 3 | Model-based | + | + | − | 8 | Medium |
| Graham et al. [42] | + | 45 | + | − | 0/18 | − | +/− | − | + | + | + | + | 7 | Noncompartmental | + | + | +/− | − | Medium |
| Gurumurthy et al. [22] | + | 41 | +/− | +/− | 0/28 | − | − | − | + | + | + | − | 5 | Noncompartmental | + | + | + | − | Medium |
| Gurumurthy et al. [23] | + | 99 | + | +/− | 0/66 | + | + | + | − | + | + | + | 0 | NA | NA | NA | NA | − | Medium |
| Jaruratanasirikul [35] | − | 8 | +/− | 0 | − | − | + | − | − | − | − | +/− | 14 | Noncompartmental | + | + | − | − | High |
| Jeremiah et al. [43] | + | 100 | + | +/− | 0/50 | − | − | − | − | + | + | + | 3 | Model-based | + | + | + | 8 | Medium |
| Jönsson et al. [44] | + | 189 | − | − | 0/24 | − | − | − | − | + | + | + | 10 | Model-based | − | − | − | 0 | High |
| McIlleron et al. [24] | + | 142 | − | − | 0/9 | − | − | + | + | + | + | + | 10 | Model-based | + | + | + | − | Medium |
| Mukherjee et al. [47] | + | 56 | + | +/− | 19/24 | − | + | − | + | + | + | + | 4 | Noncompartmental | − | + | + | − | Medium |
| Van Oosterhout et al. [48] | + | 47 | + | +/− | 14/30 | − | +/− | − | − | − | + | + | 9 | Model-based | + | + | + | − | Medium |
| Peloquin et al. [34] | − | 26 | + | 23 | 4/26 | − | + | + | + | + | +/− | + | 1 | NA | NA | NA | NA | 0 | High |
| Perlman et al. [36] | − | 48 | + | 36 | − | − | + | + | + | + | + | + | 3 | Noncompartmental | − | + | NA | 5 | Medium |
| Perlman et al. [37] | − | 59 | + | 39 | − | − | + | + | + | + | + | + | 3 | Model-based | − | + | NA | 5 | Medium |
| Ramachandran et al. [38] | − | 77 | + | +/− | 45/77 | − | − | − | + | + | + | + | 5 | Noncompartmental | +/− | + | NA | 5 | Medium |
| Ramachandran et al. [49] | + | 161 | + | +/− | 45/77 | − | − | − | + | + | + | + | 5 | Noncompartmental | +/− | + | + | − | Medium |
| Requena-Mendez et al. [19] | + | 79 | − | +/− | 8/29 | − | + | − | + | + | + | + | 2 | NA | − | + | +/− | 29 | Medium |
| Requena-Mendez et al. [25] | + | 82 | − | − | − | − | + | − | − | + | − | + | 2 | Noncompartmental | − | + | + | 8 | High |
| Rockwood et al. [50] | + | 100 | + | 29 | 50/65 | − | − | − | + | + | + | + | 7 | Model-based | + | + | + | 8 | Low |
| Sahai et al. [33] | + | 48 | − | 24 | 0/36 | + | + | + | + | + | + | + | 13 | Model-based | + | + | + | − | Low |
| Schaaf et al. [51] | + | 60 | +/− | − | 2/21 | − | − | − | − | + | + | + | 5 | Noncompartmental | +/− | + | + | 6 | Medium |
| Taylor and Smith [26] | + | 27 | − | 13 | 0/13 | − | + | + | + | + | + | + | 19 | Noncompartmental | + | + | + | − | Low |
NA not applicable, ART antiretroviral therapy, DOT directly observed therapy, TB tuberculosis, PK pharmacokinetic, AUC area under the concentration–time curve, Cmax peak concentration, + present, − absent or not provided, +/− partially/incomplete
AUC calculation: (1) Model-based and AUC > (0–8 h) = +; (2) noncompartmental and AUC > (0–8 h) and ≥ 5 plasma samples = +; (3) noncompartmental and AUC ≤ (0–8 h) and ≥ 5 plasma samples = +/−; (4) noncompartmental and AUC > (0–8 h) and < 5 plasma samples = +/−; (5) model-based and AUC ≤ (0–8 h) = +/−; (6) noncompartmental and AUC ≤ (0–8 h) and < 5 plasma samples = −
aGrading of the studies was performed based on the risk of bias: 1–6 points, high risk of bias; 7–9 points, medium risk of bias; 10–12 points, low risk of bias. Note: in the absence of a validated risk of bias assessment of pharmacokinetic studies, our strategy was based on the summary of strength and weaknesses of the included studies