New Evidence Available
Updated Recommendation
A new evidence synthesis was published:2024, Guidelines for the prevention, diagnosis, care and treatment for people with chronic hepatitis B infection.
View latest version (2024)Bibliographic Info
GuidelineConsolidated guidelines on HIV, viral hepatitis and STI prevention, diagnosis, treatment and care for key populations
Year of Publication2022
Issuing InstitutionWHO
Recommendation
Status
Retired
Recommended in favor
Conditional
Certainty of evidence
Moderate
WHO recommends that those who test positive for HBV infection (HBsAg positive) with an HBV DNA ≥ 5.3 log10 IU/mL (≥ 200,000 IU/mL) during pregnancy receive tenofovir prophylaxis from the 28th week of pregnancy until at least birth, to prevent vertical transmission of HBV. This is in addition to three-dose hepatitis B vaccination in all infants, including timely birth dose
Notes and Remarks
- 1.Countries that have not yet reached the 2020 goal of 1% HBsAg prevalence among children aged 5 years through vaccination would need to focus their efforts on increasing their vaccination coverage, including timely birth dose.
- 2.Temporary immunity may be obtained by administering HBIG for postexposure prophylaxis. HBIG prophylaxis in conjunction with hepatitis B vaccination may be of additional benefit for newborn infants whose mothers are HBeAg-positive
- 3.The clinical trials that evaluated the efficacy and safety of tenofovir prophylaxis also included hepatitis B immune globulin (HBIG) as an additional preventive strategy in both trial arms. In a number of settings (mostly in high income countries) where it is available, HBIG is used in addition to hepatitis B vaccination, including birth dose, to reduce the risk of mother-to-child transmission of HBV. However, HBIG is a blood product that has to be screened for infectious diseases. The costs are high, a cold chain is required and HBIG can be in short supply. In low and middle income countries, it may only be available when purchased by individuals.
- 4.As many countries are working towards dual elimination of perinatal HIV and syphilis infection, there are opportunities for efficiency gains and integration to also include elimination of mother-to-child transmission of HBV.
- 5.Programmes to test and treat eligible pregnant women need to be implemented in the context of universal health coverage, aiming for covering the highest proportion of women while reducing financial hardship.
- 6.Testing of pregnant women needs to take place under circumstances that prevent stigma and discrimination. Post-test counselling and education should be conducted on measures to reduce the risk of transmitting HBV to the infant, encouragement for partner testing and ensuring linkage to care of HBsAg-positive women to assess for eligibility for treatment for the mothers own health
- 7.Clinical assessment should include an evaluation of whether mothers would be eligible for treatment for their own health. However, in accordance with criteria in the 2015 WHO treatment guidelines, only a small proportion of women of childbearing age would be eligible for long-term treatment (20).
- 8.All eligible pregnant and breastfeeding women living with HBV infection can safely use tenofovir (36).
- 9.The diagnostic tests used need to meet quality, safety and performance standards (with regard to both analytical, diagnostic or clinical sensitivity and specificity)
- 10.In women with HIV/HBV infection, treatment with ART that contains TDF should be continued after pregnancy.
- 11.Tenofovir has no drug–drug interactions with HIV medications. Renal toxicity needs to be monitored when used with sofosbuvir/ledipasvir or sofosbuvir/ velpatasvir. Other potential drug–drug interactions can be checked on the internet site of the University of Liverpool (https://www.hep-druginteractions.org ).