Efficacy and safety of tenofovir disoproxil fumarate treatment during the second or third trimester of pregnancy for preventing mother-to-infant transmission of hepatitis B virus: a meta-analysis
Bibliographic record
Abstract
Objective To systematically evaluate the efficacy and safety of tenofovir disoproxil fumarate(TDF) treatment during the second or third trimester of pregnancy for preventing mother-to-infant transmission of hepatitis B virus (HBV). Methods Randomized controlled trials (RCTs) and cohort studies on efficacy and safety of TDF in the second and third trimester of pregnancy for the prevention of mother-to- infant transmission of HBV were collected by searching related databases at home and abroad (up to July 20, 2019). Quality of RCTs and cohort studies were evaluated using bias risk assessment tool of Cochrane collaboration networks and Newcastle-Ottawa Scale, respectively. Meta-analysis was performed using RevMan 5.3 software. The continuous data were expressed using standardized mean difference (SMD) and its 95% confidence interval (CI). The effect values of meta-analysis of dichotomous variables were expressed using odds ratio (OR) and its 95%CI for effectiveness outcome or risk ratio (RR) and 95%CI for safety outcome. Results A total of 12 studies (2 RCTs and 10 cohort studies) were entered, including 1 326 HBV-infected mothers and their 1 281 infants, of which 729 mothers took TDF (the TDF group) and 597 mothers were without intervention or took placebo (the control group) in the second or third trimester of pregnancy. The results of quality evaluation showed that one of the 2 RCTs was at low risk of bias and the other one was at high risk of bias; 9 of the 10 cohort studies were of high quality and one was of medium quality. The meta analysis for effectiveness outcomes showed that the baseline HBV DNA level in patients in the TDF group was significantly higher than that in the control group (SMD=0.15, 95%CI: 0.04-0.26, P=0.008), the prenatal HBV DNA level in patients in the TDF group was significantly lower than that in the control group (SMD=-5.41, 95%CI: -7.26--3.56, P 0.05 for all), the difference in the incidence of postpartum alanine aminotransferase level rise between the TDF group and the control group was not statistically significant (P>0.05); the results of one study showed that the proportion of mothers with grade 1-2 asymptomatic creatine kinase increase in the TDF group was higher than that in the control group [7.2% (7/97) vs. 0 (0/100), P=0.006] and the differences in the incidence of other adverse pregnancy events and complications in the 2 groups were not statistically significant (P>0.05 for all). Conclusion The treatment of TDF in the second and third trimester of pregnancy can effectively prevent mother-to-infant transmission of HBV and has no significant impact on growth and development of the fetus. Key words: Tenofovir; Hepatitis B; Pregnancy; Infectious disease transmission, vertical; Maternal exposure; Safety; Meta-analysis
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.016 | 0.025 |
| Meta-epidemiology (narrow) | 0.004 | 0.002 |
| Meta-epidemiology (broad) | 0.025 | 0.057 |
| Bibliometrics | 0.007 | 0.005 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.004 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.003 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".