Tenofovir (all routes except local)

Very low birth weight (< 1500g)

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
R13385
Floridia, 2018 Very low birth weight (<1,500 g) 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 0.53 [0.24;1.17] 15/540   11/214 26 540
ref
S5155
R13464
Rough, 2018 Very low birth weight (< 1,500 g) during pregnancy (anytime or not specified) prospective cohort exposed to other treatment, sick Adjustment: Yes Control group: zidovudine/lamivudine-based Exposed group: TDF/emtricitabine-based Indication: HIV 0.69 [0.36;1.31] 17/960   32/1,593 49 960
ref
S5211
R13517
Malaba, 2017 Very low birth weight (< 1,500 g) during pregnancy (anytime or not specified) prospective cohort unexposed, disease free Adjustment: No Control group: Unexposed, disease free Exposed group: TDF/emtricitabine-based Indication: HIV 1.77 [0.53;5.92] C 24/1,266   3/278 27 1,266
ref
S5131
R13346
Fowler, 2016 Very low birth weight (<1500 grams) 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 3.11 [0.62;15.54] C 6/301   2/308 8 301
ref
Total 4 studies 0.93 [0.48;1.81] 110 3,067
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 0.53[0.24; 1.17]2654031%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Rough, 2018Rough, 2018 0.69[0.36; 1.31]4996036%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Malaba, 2017Malaba, 2017 1.77[0.53; 5.92]271,26620%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Fowler, 2016Fowler, 2016 3.11[0.62; 15.54]830113%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Total (4 studies) I2 = 47% 0.93[0.48; 1.81]1103,0670.210.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 0.93[0.48; 1.81]1103,06747%NAFloridia, 2018 Rough, 2018 Malaba, 2017 Fowler, 2016 4 case control studiescase control studies 0 RCTRCT 3.11[0.62; 15.54]8301 -NAFowler, 2016 1 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.77[0.53; 5.92]271,266 -NAMalaba, 2017 1 exposed to other treatment, sickexposed to other treatment, sick 0.79[0.38; 1.63]831,80147%NAFloridia, 2018 Rough, 2018 Fowler, 2016 3 Tags Adjustment   - No  - No 0.88[0.27; 2.86]531,80663%NAFloridia, 2018 Malaba, 2017 2   - Randomisation  - Randomisation 3.11[0.62; 15.54]8301 -NAFowler, 2016 1   - Yes  - Yes 0.69[0.36; 1.32]49960 -NARough, 2018 1 Control group   - Abacavir/Lamivudine-based  - Abacavir/Lamivudine-based 0.53[0.24; 1.17]26540 -NAFloridia, 2018 1   - Unexposed, disease free  - Unexposed, disease free 1.77[0.53; 5.92]271,266 -NAMalaba, 2017 1   - zidovudine/lamivudine/lopinavir–rit ...  - zidovudine/lamivudine/lopinavir–ritonavir 3.11[0.62; 15.54]8301 -NAFowler, 2016 1   - zidovudine/lamivudine-based  - zidovudine/lamivudine-based 0.69[0.36; 1.32]49960 -NARough, 2018 1 Exposed group   - TDF/emtricitabine/lopinavir–ritonavir  - TDF/emtricitabine/lopinavir–ritonavir 3.11[0.62; 15.54]8301 -NAFowler, 2016 1   - TDF/emtricitabine-based  - TDF/emtricitabine-based 0.75[0.43; 1.31]1022,76627%NAFloridia, 2018 Rough, 2018 Malaba, 2017 3 Indication   - HIV  - HIV 0.93[0.48; 1.81]1103,06747%NAFloridia, 2018 Rough, 2018 Malaba, 2017 Fowler, 2016 4 All studiesAll studies 0.93[0.48; 1.81]1103,06747%NAFloridia, 2018 Rough, 2018 Malaba, 2017 Fowler, 2016 40.210.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-1.91.90.9850.000Floridia, 2018Rough, 2018Malaba, 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 unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.77[0.53; 5.92]271,266 -NAMalaba, 2017 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls 0.79[0.38; 1.63]831,80147%NAFloridia, 2018 Rough, 2018 Fowler, 2016 30.510.01.0