Tenofovir (all routes except local)

Microcephaly / Small head circumference for gestational age

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.
S5172
R13479		 Williams, 2020 Microcephaly (head circumference Z score <–2) for 6–36 months old (SMARTT criteria) (2ndary outcome) 1st trimester cohort exposed to other treatment, sick Adjustment: Yes Control group: non-TDF (mix or unspecified regimens) Exposed group: TDF (mix or unspecified regimens) Indication: HIV 1.21 [0.72;2.05] -/827   41/1,764 32 827
ref
S5160
R13459		 Pintye, 2015 6-week z-scores for head circumference-for-age (HCAZ) < −2 SD during pregnancy (anytime or not specified) retrospective cohort exposed to other treatment, sick Adjustment: Yes Control group: zidovudine/lamivudine/nevirapine Exposed group: TDF/lamivudine-based Indication: HIV 2.07 [0.27;16.06] 2/51   2/104 4 51
ref
S5124
R13305		 Siberry, 2012 Small birth head circumference (z-scores <−1.50 (< 6.7th percentile)) during pregnancy (anytime or not specified) cohort exposed to other treatment, sick Adjustment: Yes Control group: non-TDF (mix or unspecified regimens) Exposed group: TDF (mix or unspecified regimens) Indication: HIV 0.82 [0.53;1.28] 41/293   75/447 116 293
ref
Total 3 studies 0.98 [0.71;1.37] 152 1,171
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 Williams, 2020Williams, 2020 1.21[0.72; 2.05]3282740%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Pintye, 2015Pintye, 2015 2.07[0.27; 16.06]4513%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Siberry, 2012Siberry, 2012 0.82[0.53; 1.28]11629357%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Total (3 studies) I2 = 0% 0.98[0.71; 1.37]1521,1710.25.01.0ROB: 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 0.98[0.71; 1.37]1521,1710%NAWilliams, 2020 Pintye, 2015 Siberry, 2012 3 case control studiescase control studies 0 Type of controls exposed to other treatment, sickexposed to other treatment, sick 0.98[0.71; 1.37]1521,1710%NAWilliams, 2020 Pintye, 2015 Siberry, 2012 3 Tags Adjustment   - Yes  - Yes 0.98[0.71; 1.37]1521,1710%NAWilliams, 2020 Pintye, 2015 Siberry, 2012 3 Control group   - non-TDF (mix or unspecified regimens)  - non-TDF (mix or unspecified regimens) 0.97[0.66; 1.42]1481,12020%NAWilliams, 2020 Siberry, 2012 2   - zidovudine/lamivudine/nevirapine  - zidovudine/lamivudine/nevirapine 2.07[0.27; 15.96]451 -NAPintye, 2015 1 Exposed group   - TDF (mix or unspecified regimens)  - TDF (mix or unspecified regimens) 0.97[0.66; 1.42]1481,12020%NAWilliams, 2020 Siberry, 2012 2   - TDF/lamivudine-based  - TDF/lamivudine-based 2.07[0.27; 15.96]451 -NAPintye, 2015 1 Indication   - HIV  - HIV 0.98[0.71; 1.37]1521,1710%NAWilliams, 2020 Pintye, 2015 Siberry, 2012 3 All studiesAll studies 0.98[0.71; 1.37]1521,1710%NAWilliams, 2020 Pintye, 2015 Siberry, 2012 30.25.01.0

Publication bias and p-hacking diagnosis

funnel plot

Funnel plot not drawn. Less than 3 points.

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

not enought points

p values plot

Funnel plot not drawn. Less than 3 points.

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 0.98[0.71; 1.37]1521,1710%NAWilliams, 2020 Pintye, 2015 Siberry, 2012 30.510.01.0