Tenofovir (all routes except local)

Neonatal death (< 28 days of life)

R analysis
id Study   Lib. in paper Exposition period    Study type  Control type 
 
Tags OR 95%CI x1/n1 x0/n0 no cases no exposed ROB Ref.
S5134
R13389
Floridia, 2018 Neonatal death (NOS) during pregnancy (anytime or not specified) cohort exposed to other treatment, sick Adjustment: No Control group: Abacavir/Lamivudine-based Exposed group: TDF/emtricitabine-based Indication: HIV 0.63 [0.15;2.68] 5/586   3/224 8 586
ref
S5153
R13441
Pintye, 2017 Neonatal death (within 3 days following live birth) during pregnancy (anytime or not specified) prospective cohort exposed to other treatment, sick Adjustment: Yes Control group: zidovudine/lamivudine-based Exposed group: TDF/lamivudine-based Indication: PrEP 0.68 [0.17;2.78] 3/-   4/- 7 -
ref
S5258
R13595
Zash (Controls exposed to other treatments), 2017 Neonatal death (< 28days) during pregnancy (anytime or not specified) retrospective cohort exposed to other treatment, sick Adjustment: No Control group: zidovudine/lamivudine-based Exposed group: TDF (mix or unspecified regimens) Indication: HIV 0.58 [0.37;0.90] C 46/3,463   35/1,532 81 3,463
ref
S5131
R13343
Fowler, 2016 Infant deaths through week 1 2nd and/or 3rd trimester randomized controlled trial exposed to other treatment, sick Adjustment: Randomisation Control group: zidovudine/lamivudine/lopinavir–ritonavir Exposed group: TDF/emtricitabine/lopinavir–ritonavir Indication: HIV 7.91 [1.80;34.88] C 15/341   2/346 17 341
ref
Total 4 studies 1.07 [0.36;3.16] 113 4,390
x1: number of endpoints among exposed, n1: number of exposed; x0: number of endpoints among non exposed, n0: number of non exposed; C: calculated odds ratio from numbers of events and effectives

Forest plot

StudyTE95% CIn casesn exposedweightROBABCDEF Floridia, 2018Floridia, 2018 0.63[0.15; 2.68]858622%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Pintye, 2017Pintye, 2017 0.68[0.17; 2.78]7-23%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Zash (Controls exposed to other treatments), 2017Zash, 2017 1 0.58[0.37; 0.90]813,46334%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Fowler, 2016Fowler, 2016 7.91[1.80; 34.88]1734122%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Total (4 studies) I2 = 73% 1.07[0.36; 3.16]1134,3900.220.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Controls exposed to other treatments;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.07[0.36; 3.16]1134,39073%NAFloridia, 2018 Pintye, 2017 Zash (Controls exposed to other treatments), 2017 Fowler, 2016 4 case control studiescase control studies 0 RCTRCT 7.91[1.80; 34.88]17341 -NAFowler, 2016 1 Type of controls exposed to other treatment, sickexposed to other treatment, sick 1.07[0.36; 3.16]1134,39073%NAFloridia, 2018 Pintye, 2017 Zash (Controls exposed to other treatments), 2017 Fowler, 2016 4 Tags Adjustment   - No  - No 0.58[0.38; 0.89]894,0490%NAFloridia, 2018 Zash (Controls exposed to other treatments), 2017 2   - Randomisation  - Randomisation 7.91[1.80; 34.88]17341 -NAFowler, 2016 1   - Yes  - Yes 0.68[0.17; 2.75]7- -NAPintye, 2017 1 Control group   - Abacavir/Lamivudine-based  - Abacavir/Lamivudine-based 0.63[0.15; 2.66]8586 -NAFloridia, 2018 1   - zidovudine/lamivudine/lopinavir–rit ...  - zidovudine/lamivudine/lopinavir–ritonavir 7.91[1.80; 34.88]17341 -NAFowler, 2016 1   - zidovudine/lamivudine-based  - zidovudine/lamivudine-based 0.58[0.38; 0.89]883,4630%NAPintye, 2017 Zash (Controls exposed to other treatments), 2017 2 Exposed group   - TDF (mix or unspecified regimens)  - TDF (mix or unspecified regimens) 0.58[0.37; 0.90]813,463 -NAZash (Controls exposed to other treatments), 2017 1   - TDF/emtricitabine/lopinavir–ritonavir  - TDF/emtricitabine/lopinavir–ritonavir 7.91[1.80; 34.88]17341 -NAFowler, 2016 1   - TDF/emtricitabine-based  - TDF/emtricitabine-based 0.63[0.15; 2.66]8586 -NAFloridia, 2018 1   - TDF/lamivudine-based  - TDF/lamivudine-based 0.68[0.17; 2.75]7- -NAPintye, 2017 1 Indication   - HIV  - HIV 1.29[0.28; 5.82]1064,39082%NAFloridia, 2018 Zash (Controls exposed to other treatments), 2017 Fowler, 2016 3   - PrEP  - PrEP 0.68[0.17; 2.75]7- -NAPintye, 2017 1 All studiesAll studies 1.07[0.36; 3.16]1134,39073%NAFloridia, 2018 Pintye, 2017 Zash (Controls exposed to other treatments), 2017 Fowler, 2016 40.220.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-2.52.50.9080.000Floridia, 2018Pintye, 2017Zash (Controls exposed to other treatments), 2017Fowler, 2016

Asymetry test p-value = NaN (by Egger's regression)

not enought points

p values plot
0.01.00.01.0

Sub-groups analysis using all included studies

excluded

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls exposed to other treatment, sick controlsexposed to other treatment, sick controls 1.07[0.36; 3.16]1134,39073%NAFloridia, 2018 Pintye, 2017 Zash (Controls exposed to other treatments), 2017 Fowler, 2016 40.510.01.0