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Review
. 2023 Jun 12;6(6):CD013653.
doi: 10.1002/14651858.CD013653.pub2.

Antivirals for prevention of hepatitis B virus mother-to-child transmission in human immunodeficiency virus positive pregnant women co-infected with hepatitis B virus

Emmanuel O Ugwu  1 , George U Eleje  2 , Angela O Ugwu  3 , Uchenna I Nwagha  4 , Joseph I Ikechebelu  5 , Uchenna A Umeh  6 , Henrietta U Okafor  7
Affiliations
Review

Antivirals for prevention of hepatitis B virus mother-to-child transmission in human immunodeficiency virus positive pregnant women co-infected with hepatitis B virus

Emmanuel O Ugwu et al. Cochrane Database Syst Rev. .

Abstract

Background: Hepatitis B virus (HBV)-human Immunodeficiency virus (HIV) co-infection promotes an aggressive disease course of HBV infection. In the only available non-Cochrane systematic review on antiviral therapy during pregnancy for prevention of mother-to-child transmission of HBV, none of the women studied had HBV-HIV co-infection but were either HBV- or HIV-seropositive. Treatment of HBV alone may develop HIV-strains that are resistant to non-nucleoside reverse transcriptase inhibitors. Accordingly, co-treatment of the HIV infection is recommended.

Objectives: To evaluate the benefits and harms of tenofovir-based antiviral combination regimens versus placebo, tenofovir alone, or non-tenofovir-based antiviral regimen either alone or in combination with HBV for the prevention of mother-to-child transmission of HBV in HIV-positive pregnant women co-infected with HBV.

Search methods: We searched the Cochrane Hepato-Biliary Group Controlled Trials Register, Cochrane Central Register of Controlled Trials, MEDLINE Ovid, Embase Ovid, LILACS (Bireme), Science Citation Index Expanded (Web of Science), and Conference Proceedings Citation Index-Science (Web of Science) on 30 January 2023. We manually searched the reference lists of included trials, searched on-line trial registries, and contacted experts in the field and pharmaceutical companies for any further potential trials.

Selection criteria: We aimed to include randomised clinical trials comparing tenofovir-based antiviral combination regimens (anti-HIV regimen with lopinavir-ritonavir therapy, or any other antiviral therapy, and two drugs with activity against HBV, specifically, tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF), plus lamivudine or emtricitabine) with placebo alone, or tenofovir alone, or non-tenofovir-based antiviral regimen (zidovudine, lamivudine, telbivudine, emtricitabine, entecavir, lopinavir-ritonavir, or any other antiviral therapy) either alone or in combination with at least two other antivirals.

Data collection and analysis: We used standard methodological procedures expected by Cochrane. Primary outcomes included all-cause infant mortality, proportion of infants with serious adverse events, proportion of infants with HBV mother-to-child transmission, all-cause maternal mortality, and proportion of mothers with serious adverse events. Secondary outcomes included proportion of infants with adverse events not considered serious, proportion of mothers with detectable HBV DNA (deoxyribonucleic acid) (before delivery), maternal hepatitis B e antigen (HBeAg) to HBe-antibody seroconversion (before delivery) and maternal adverse events not considered serious. We used RevMan Web to carry out analyses and presented results, where feasible, using a random-effects model and risk ratios (RR) with 95% confidence intervals (CIs). We performed sensitivity analysis. We assessed risk of bias using predefined domains, assessed the certainty of the evidence using GRADE, controlled risk of random errors with Trial Sequential Analysis, and presented outcome results in a summary of findings table.

Main results: Five completed trials were included, of which four trials contributed data to one or more of the outcomes. They included a total of 533 participants randomised to tenofovir-based antiviral combination regimens (196 participants) versus control (337 participants). The control groups received non-tenofovir-based antiviral regimens either as zidovudine alone (three trials) or as a combination of zidovudine, lamivudine and lopinavir-ritonavir (five trials). None of the trials used placebo or tenofovir alone. All trials were at unclear risk of bias. Four trials used intention-to-treat analyses. In the remaining trial, two participants in the intervention group and two in the control group were lost to follow-up. However, the outcomes of these four participants were not described. Tenofovir-based antiviral combination regimen versus control We are very uncertain about the effect of a tenofovir-based antiviral combination regimen versus control on all-cause infant mortality (RR 2.24, 95% CI 0.72 to 6.96; participants = 132; trials = 1; very low-certainty evidence); proportion of infants with serious adverse events (RR 1.76, 95% CI 1.27 to 2.43; participants = 132; trials = 1; very low-certainty evidence), and proportion of mothers with serious adverse events (RR 0.90, 95% CI 0.62 to 1.32; participants = 262; trials = 2; very low-certainty evidence). No trial reported data on the proportion of infants with HBV mother-to-child transmission and all-cause maternal mortality. We are also very uncertain about the effect of tenofovir-based antiviral combination regimens versus control on the proportion of infants with adverse events not considered serious (RR 0.94, 95% CI 0.06 to 13.68; participants = 31; trials = 1; very low-certainty evidence), and proportion of mothers with detectable HBV DNA (before delivery) (RR 0.66, 95% CI 0.42 to 1.02; participants = 169; trials = 2; very low-certainty evidence). No trial reported data on maternal hepatitis B e antigen (HBeAg) to HBe-antibody seroconversion (before delivery) and maternal adverse events not considered serious. All trials received support from industry.

Authors' conclusions: We do not know what the effects of tenofovir-based antiviral combination regimens are on all-cause infant mortality, proportion of infants with serious adverse events and proportion of mothers with serious adverse events, proportion of infants with adverse events not considered serious, and proportion of mothers with detectable HBV DNA before delivery because the certainty of evidence was very low. Only one or two trials, with insufficient power, contributed data for analyses. We lack randomised clinical trials at low risk of systematic and random errors, and fully reporting all-cause infant mortality, serious adverse events and reporting on clinical and laboratory outcomes, such as infants with HBV mother-to-child transmission, all-cause maternal mortality, maternal hepatitis B e antigen (HBeAg) to HBe-antibody seroconversion before delivery and maternal adverse events not considered serious.

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Conflict of interest statement

EOU: has no known conflicts of interest. AOU: has no known conflicts of interest. GUE: has no known conflicts of interest. UIN: has no known conflicts of interest. JII: has no known conflicts of interest. UAU: has no known conflicts of interest. HUO: has no known conflicts of interest.

Figures

1
1
PRISMA flow chart diagram of the searches for studies on prevention of mother‐to‐child transmission of HBV in HBV‐positive women coinfected with HIV. Date of last search 30 January 2023.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
4
4
Proportion of mothers with serious adverse events The Trial Sequential Analysis (TSA) of the random‐effects meta‐analysis on the effect of a tenofovir‐based antiviral combination regimens versus control on the proportion of mothers with serious adverse events included two trials. The diversity‐adjusted required information size (DARIS) was calculated based on an event proportion in the control group of 34% (59/176), a relative risk reduction (RRR) of 20%, an alpha (type I error) of 3.3%, a beta (type II error) of 10% (90% power), and a trial diversity of 1%. The required information size was 2162 participants. The actual accrued number of participants was 270, which is only 12.5% of the DARIS and a TSA‐adjusted 95% CI of 0.19 to 4.20. The solid blue curve represents the cumulative meta‐analysis Z‐score, and the inward sloping red curves represent the adjusted threshold for statistical significance according to the two‐sided Lan‐DeMets trial sequential monitoring boundaries. The blue cumulative Z‐curve did not cross the trial sequential monitoring boundary for benefit or harm. This means that we cannot say anything about the effects of tenofovir‐based antiviral combination regimens on serious adverse events because of insufficient trial data.
5
5
Proportion of mothers with detectable HBV DNA (before delivery) The Trial Sequential Analysis (TSA) of the random‐effects meta‐analysis on the effect of a tenofovir‐based antiviral combination regimen versus control on the proportion of mothers with detectable HBV DNA (before delivery) included two trials. The diversity‐adjusted required information size (DARIS) was calculated based on an event proportion in the control group of 36% (38/105), a relative risk reduction (RRR) of 20%, an alpha (type I error) of 2.5%, a beta (type II error) of 10% (90% power), and a trial diversity of 0%. The required information size was 2098 participants. The actual accrued number of participants was 169, which is only 8% of the DARIS and a TSA‐adjusted 95% CI of 0.11 to 3.91. The solid blue curve represents the cumulative meta‐analysis Z‐score, and the inward sloping red curves represent the adjusted threshold for statistical significance according to the two‐sided Lan‐DeMets trial sequential monitoring boundaries. The blue cumulative Z‐curve did not cross the trial sequential monitoring boundary for benefit or harm due to few data. Therefore, the current evidence is insufficient to conclude if the administration of tenofovir‐based antiviral combination regimens will affect the level of detectable HBV DNA in mothers before delivery.
1.1
1.1. Analysis
Comparison 1: Tenofovir‐based antiviral combination regimens versus placebo or tenofovir alone or non‐tenofovir‐based antiviral regimen, Outcome 1: All‐cause infant mortality at longest follow‐up
1.2
1.2. Analysis
Comparison 1: Tenofovir‐based antiviral combination regimens versus placebo or tenofovir alone or non‐tenofovir‐based antiviral regimen, Outcome 2: Proportion of infants with serious adverse events
1.3
1.3. Analysis
Comparison 1: Tenofovir‐based antiviral combination regimens versus placebo or tenofovir alone or non‐tenofovir‐based antiviral regimen, Outcome 3: Proportion of mothers with serious adverse events
1.4
1.4. Analysis
Comparison 1: Tenofovir‐based antiviral combination regimens versus placebo or tenofovir alone or non‐tenofovir‐based antiviral regimen, Outcome 4: Proportion of infants with adverse events not considered serious
1.5
1.5. Analysis
Comparison 1: Tenofovir‐based antiviral combination regimens versus placebo or tenofovir alone or non‐tenofovir‐based antiviral regimen, Outcome 5: Proportion of mothers with detectable HBV DNA (before delivery)
See this image and copyright information in PMC

Update of

  • doi: 10.1002/14651858.CD013653

References

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