Table 8GRADE evidence profile – TDF 300 mg during pregnancy to prevent HBV mother-to-child transmission (MTCT)

Number of studiesDesignQuality assessmentNumber of patientsEffectQuality
LimitationsInconsistencyIndirectnessImprecisionPublication biasOtherAVT (%)No AVT (%)OR (95% CI)Absolute (95% CI)
HBsAg positivity at 6–12 months
5Randomized controlled trials (RCTs)SeriousNo seriousNo seriousNo seriousNot able to examine publication biasN/A1/349 (0.3)23/337 (6.8)0.10 (0.03–0.35)80 fewer per 1000 (10–140 fewer)Moderatea
14Non-RCTsNo seriousNo seriousNo seriousNo seriousEvidence of possible publication bias/small study effectsMagnitude of the effect21/723 (2.9)88/499 (17.6)0.17 (0.10–0.29)140 fewer per 1000 (80–200 fewer)Lowb
HBV DNA positivity at 6–12 months
4RCTsSeriousNo seriousNo seriousNo seriousNot able to examine publication biasN/A1/319 (0.3)20/307 (6.5)0.11 (0.03–0.43)70 fewer per 1000 (0–150 fewer)Moderatec
7Non-RCTsNo seriousNo seriousNo seriousNo seriousNot able to examine publication biasMagnitude of the effect0/451 (0.0)38/308 (12.3)0.06 (0.02–0.19)110 fewer per 1000 (50–170 fewer)Moderated
Infant safety: neonatal deaths
5RCTsSeriousNo seriousNo seriousNo seriousNot able to examine publication biasN/A2/367 (0.5)1/350 (0.3)-0 (10 fewer – 10 more)Moderatee
14Non-RCTsNo seriousNo seriousNo seriousNo seriousNo evidence of publication biasNone0/712 (0.0)0/508 (0.0)-0 (10 fewer – 10 more)Lowf
Infant safety: prematurity
4RCTsSeriousNo seriousNo seriousNo seriousNot able to examine publication biasN/A11/337 (3.3)16/320 (5.0)-10 fewer (30 fewer – 20 more)Moderateg
4Non-RCTsNo seriousNo seriousNo seriousNo seriousNot able to examine publication biasNone8/285 (2.8)6/159 (3.8)-10 more(30 fewer to 40 more)Lowh
Infant safety: congenital abnormalities
5RCTsSeriousNo seriousNo seriousNo seriousNot able to examine publication biasN/A2/367 (0.5)3/350 (0.9)-0 (20 fewer – 10 more)Moderatei
9Non-RCTsNo seriousNo seriousNo seriousNo seriousNot able to examine publication biasNone2/435 (0.5)2/337 (0.6)-0 (20 fewer – 20 more)Lowj
Infant safety: bone mineral density
1RCTsNo seriousN/ANo seriousSeriousNot able to examine publication biasN/AN/AN/A-−0.006 g/cm2 (−0.019 to 0.007 g/cm2); p=0.38)Lowk
Maternal safety: miscarriage and stillbirth
5RCTsSeriousNo seriousNo seriousNo seriousNot able to examine publication biasN/A3/372 (0.8)0/362 (0.0)-10 more (10 fewer – 20 more)Moderatel
14Non-RCTsNo seriousNo seriousNo seriousNo seriousNo evidence of publication biasNone0/570 (0.0)1/520 (0.2)-0 (10 fewer – 10 more)Lowm
Maternal safety: postpartum haemmorhage
3RCTsSeriousNo seriousNo seriousNo seriousNot able to examine publication biasN/A4/177 (2.3)5/172 (2.9)-0 (30 fewer – 30 more)Moderaten
3Non-RCTsNo seriousNo seriousNo seriousNo seriousNot able to examine publication biasNone5/188 (2.7)3/84 (3.6)-0 (40 fewer – 40 more)Lowo
Maternal safety: HBV flare after treatment discontinuation
3RCTsNo seriousNo seriousNo seriousSeriousNot able to examine publication biasN/A16/311 (5.1)11/309 (3.6)-20 more (10 fewer – 50 more)Moderatep
3Non-RCTsNo seriousNo seriousNo seriousSeriousNot able to examine publication biasNone18/107 (16.8)9/73 (12.3)-40 fewer (160 fewer – 70 more)Very lowq
a

Downgrading due to “serious” study design limitations (all RCTs had <=4 of 8 criteria with low risk of bias, the rest being unclear or high).

b

Downgrading due to possible publication bias/small study effects, upgrading due to magnitude of effect.

c

Downgrading due to “serious” study design limitations (all RCTs had <=4 of 8 criteria with low risk of bias, the rest being unclear or high).

d

Upgrading due to magnitude of effect

e

Downgrading due to “serious” study design limitations (all RCTs had <=4 of 8 criteria with low risk of bias, the rest being unclear or high).

f

No upgrading or downgrading

g

Downgrading due to “serious” study design limitations (all RCTs had <=4 of 8 criteria with low risk of bias, the rest being unclear or high).

h

No upgrading or downgrading

i

Downgrading due to “serious” study design limitations (all RCTs had <=4 of 8 criteria with low risk of bias, the rest being unclear or high).

j

No upgrading or downgrading

k

Downgrading due to inability to examine certain elements (e.g. inconsistency), and for imprecision due to the fact that there was only one RCT included.

l

Downgrading due to “serious” study design limitations (all RCTs had <=4 of 8 criteria with low risk of bias, the rest being unclear or high).

m

No upgrading or downgrading

n

Downgrading due to “serious” study design limitations (all RCTs had <=4 of 8 criteria with low risk of bias, the rest being unclear or high).

o

No upgrading or downgrading

p

Downgrading due to imprecision

q

Downgrading due to imprecision

From: Web Annex A, Systematic review of the efficacy and safety of antiviral therapy during pregnancy

Cover of Prevention of Mother-to-Child Transmission of Hepatitis B Virus: Guidelines on Antiviral Prophylaxis in Pregnancy
Prevention of Mother-to-Child Transmission of Hepatitis B Virus: Guidelines on Antiviral Prophylaxis in Pregnancy.
Geneva: World Health Organization; 2020 Jul.
© World Health Organization 2020.

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