390: Prevention of hepatitis B in sub-Saharan Africa: a decision analytic model for the birth dose vaccine

Background: Hepatitis B virus (HBV) remains endemic throughout sub-Saharan Africa despite the widespread availability of effective vaccines. We evaluated the feasibility of adding HBV testing and treatment of pregnant women and birth-dose vaccination of HBV-exposed infants to the HIV prevention of MTCT (PMTCT) program infrastructure in the Democratic Republic of the Congo (DRC), where HBV treatment and birth-dose vaccination programs are not established. Methods: As part of the HIV PMTCT program at two maternity centers in Kinshasa, DRC, pregnant women were screened for HBV at routine prenatal care registration. Pregnant women with high viral load and/or HBeAg positivity were offered tenofovir disoproxil fumarate (TDF). HBV-exposed infants received a birth-dose of HBV vaccine within 24 hours of life. The primary endpoint was the feasibility and acceptability of the study. Results: Of 4,016 women screened, 109 (2.7%) were HBsAg-positive. Ten of 91 (11.1%) women evaluated had high-risk disease. Of 88 infants, 60 (68.2%) received a birth-dose vaccine; of these, 46 (76.7%) received a timely birth-dose. No cases of HBV MTCT were observed in our cohort. There were no serious adverse events associated with TDF nor with birth-dose vaccine. The study procedures were highly acceptable (>80%) among mothers. Conclusions: Adding HBV screening and treatment of pregnant women and infant birth-dose vaccination to existing HIV PMTCT platforms is feasible in countries like the DRC. Birth-dose vaccination against HBV integrated within the current Expanded Programme on Immunization (EPI) and HIV PMTCT program could accelerate progress toward HBV elimination in Africa.

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Impact of Introducing Hepatitis B Birth Dose Vaccines into the Infant Immunization Program in Burkina Faso: Study Protocol for a Stepped Wedge Cluster Randomized Trial (NéoVac Study)

Vaccines ◽

10.3390/vaccines9060583 ◽

2021 ◽

Vol 9 (6) ◽

pp. 583

Author(s):

Haoua Tall ◽

Pierrick Adam ◽

Abdoul Salam Eric Tiendrebeogo ◽

Jeanne Perpétue Vincent ◽

Laura Schaeffer ◽

...

Keyword(s):

Hepatitis B ◽

Burkina Faso ◽

Health Center ◽

Sub Saharan Africa ◽

Stepped Wedge ◽

Immunization Program ◽

Birth Dose ◽

Sub Saharan ◽

Cluster Randomized ◽

The Impact

To achieve global hepatitis elimination by 2030, it is critical to prevent the mother-to-child transmission (MTCT) of hepatitis B virus (HBV). Since 2009, the WHO has recommended administering hepatitis B vaccine to all neonates within 24 h of birth to prevent MTCT. However, many countries in sub-Saharan Africa only provide hepatitis B immunization at the age of 6, 10, and 14 weeks or 8, 12, and 16 weeks using a combined vaccine. To accelerate the introduction of the hepatitis B birth dose vaccine (HepB-BD) into sub-Saharan Africa, it is critical to establish to what extent the addition of HepB-BD can further reduce HBV transmission in areas where three-dose infant vaccination has been implemented. We therefore designed a study to evaluate the impact, acceptability, and cost-effectiveness of incorporating the HepB-BD into the routine immunization program in a real-life field condition in Burkina Faso, where the hepatitis B vaccination is currently scheduled at 8-12-16 weeks. Through a multidisciplinary approach combining epidemiology, anthropology, and health economics, the Neonatal Vaccination against Hepatitis B in Africa (NéoVac) study conducts a pragmatic stepped wedge cluster randomized controlled trial in rural areas of the Hauts-Bassins Region. The study was registered in ClinicalTrials.gov (identifier: NCT04029454). A health center is designated as a cluster, and the introduction of HepB-BD will be rolled out sequentially in 24 centers. Following an initial period in which no health center administers HepB-BD, one center will be randomly allocated to incorporate HepB-BD. Then, at a regular interval, another center will be randomized to cross from the control to the intervention period, until all 24 centers integrate HepB-BD. Pregnant women attending antenatal care will be systematically invited to participate. Infants born during the control period will follow the conventional immunization schedule (8-12-16 weeks), while those born in the interventional period will receive HepB-BD in addition to the routine vaccines (0-8-12-16 weeks). The primary outcome, the proportion of hepatitis B surface antigen (HBsAg) positivity in infants aged at 9 months, will be compared between children born before and after HepB-BD introduction. The study will generate data that may assist governments and stakeholders in sub-Saharan Africa to make evidence-based decisions about whether to add HepB-BD into the national immunization programs.

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Untreated highly viraemic pregnant women from Asia or sub-Saharan Africa often transmit hepatitis B virus despite serovaccination to newborns

Liver International ◽

10.1111/liv.12561 ◽

2014 ◽

Vol 35 (2) ◽

pp. 409-416 ◽

Cited By ~ 12

Author(s):

Pierre Sellier ◽

Sarah Maylin ◽

Rishma Amarsy ◽

Marie-Christine Mazeron ◽

Lucile Larrouy ◽

...

Keyword(s):

Hepatitis B Virus ◽

Hepatitis B ◽

Pregnant Women ◽

Sub Saharan Africa ◽

B Virus ◽

Sub Saharan

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Treatment of chronic hepatitis B in sub-Saharan Africa: 1-year results of a pilot program in Ethiopia

BMC Medicine ◽

10.1186/s12916-018-1229-x ◽

2018 ◽

Vol 16 (1) ◽

Cited By ~ 6

Author(s):

Hailemichael Desalegn ◽

Hanna Aberra ◽

Nega Berhe ◽

Bitsatab Mekasha ◽

Kathrine Stene-Johansen ◽

...

Keyword(s):

Chronic Hepatitis ◽

Hepatitis B ◽

Chronic Hepatitis B ◽

Sub Saharan Africa ◽

Pilot Program ◽

Sub Saharan

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O-051: Cost-effectiveness of the controlled temperature chain for the hepatitis B birth dose vaccine in a variety of global settings

Journal of Viral Hepatitis ◽

10.1111/jvh.45_12922 ◽

2018 ◽

Vol 25 ◽

pp. 32-32

Keyword(s):

Cost Effectiveness ◽

Hepatitis B ◽

Birth Dose ◽

Dose Vaccine

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Hepatitis B virus activity in untreated hepatitis B e antigen–negative human immunodeficiency virus–hepatitis B virus co-infected patients from sub-Saharan Africa

Transactions of the Royal Society of Tropical Medicine and Hygiene ◽

10.1093/trstmh/trz021 ◽

2019 ◽

Vol 113 (8) ◽

pp. 437-445

Author(s):

Anders Boyd ◽

Menan Gerard Kouamé ◽

Laura Houghtaling ◽

Raoul Moh ◽

Delphine Gabillard ◽

...

Keyword(s):

Human Immunodeficiency Virus ◽

Hepatitis B Virus ◽

Hepatitis B ◽

Hbv Dna ◽

Sub Saharan Africa ◽

Hepatitis B E Antigen ◽

Hiv Rna ◽

B Virus ◽

Immunodeficiency Virus ◽

Sub Saharan

Abstract Background In human immunodeficiency virus (HIV) and hepatitis B virus (HBV) co-infected patients from sub-Saharan Africa with hepatitis B e antigen (HBeAg)-negative status, data are limited on the evolution of HBV activity when antiretroviral treatment (ART) is absent. Methods A total of 43 HBeAg-negative co-infected patients not indicated for ART (per concomitant World Health Organization recommendations) were followed during participation in a randomized controlled trial in Côte d’Ivoire. Chronic HBeAg-negative phases were classified at yearly visits and defined as ‘infection’ (HBV DNA ≤10 000 copies/mL and normal alanine aminotransferase [ALT]) or ‘hepatitis’ (HBV DNA >10 000 copies/mL and/or above normal ALT). Dispersion in HBV DNA and ALT levels during follow-up was assessed using interquartile range (IQR) regression. Results During a median 25 months (IQR 19–31), 17 (40%) patients consistently had ‘infection’, 5 (12%) consistently had ‘hepatitis’ and 21 (48%) fluctuated between phases. Wider dispersion in HBV DNA over time was associated with higher baseline HIV RNA (p=0.02) and higher baseline HBV DNA levels (p=0.008), while wider dispersion in ALT was associated with higher baseline HIV RNA (p<0.001), higher baseline ALT levels (p=0.02) and baseline hepatitis surface antigen >4.0 log10 IU/mL (p=0.02). Conclusions HBV activity is common with HBeAg-negative status, whose variation is partly linked to HIV replication. Fluctuations in disease phase make it difficult to assess the risk of morbidity and mortality after ART initiation.

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Non-invasive fibrosis markers for chronic hepatitis B in sub-Saharan Africa

Liver International ◽

10.1111/liv.13410 ◽

2017 ◽

Vol 37 (11) ◽

pp. 1738-1738 ◽

Cited By ~ 3

Author(s):

Rui Huang ◽

Bei Jia ◽

Guiyang Wang ◽

Chao Wu

Keyword(s):

Chronic Hepatitis ◽

Hepatitis B ◽

Chronic Hepatitis B ◽

Sub Saharan Africa ◽

Non Invasive ◽

Sub Saharan

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The risk of hepatitis B virus infection by transfusion in Kumasi, Ghana

Blood ◽

10.1182/blood-2002-04-1084 ◽

2003 ◽

Vol 101 (6) ◽

pp. 2419-2425 ◽

Cited By ~ 102

Author(s):

Jean-Pierre Allain ◽

Daniel Candotti ◽

Kate Soldan ◽

Francis Sarkodie ◽

Bruce Phelps ◽

...

Keyword(s):

Hepatitis B Virus ◽

Hepatitis B ◽

Blood Donors ◽

Hepatitis B Surface Antigen ◽

Hbv Dna ◽

Hbv Infection ◽

Sub Saharan Africa ◽

B Virus ◽

Sub Saharan ◽

Hbv Transmission

The risk of hepatitis B virus (HBV) transmission by transfusion in sub-Saharan Africa is considered to be relatively low, and testing of blood donors is often not done or is done relatively poorly. To re-examine this attitude, we identified HBV chronically infected blood donors from a major hospital in Ghana with a range of hepatitis B surface antigen (HBsAg) assays. Test efficacy was estimated using HBV DNA as a gold standard, and the risk of HBV infection in blood recipients was estimated for different testing strategies. Particle agglutination, dipstick, and enzyme immunoassay (EIA) HBsAg screening detected 54%, 71%, and 97% of HBV infectious donors, respectively. The risk of HBV transmission to recipients less than 10 years old ranged between 1:11 and 1:326 with blood unscreened and screened by EIA, respectively. For older recipients, the risk decreased a further 4-fold because of the high frequency of natural exposure to HBV. A total of 98% of HBsAg-confirmed positive samples contained HBV DNA. HBV DNA load was less than 1 × 104 IU/mL in 75% of HBsAg-reactive samples, most of them anti-HBe reactive. Approximately 0.5% of HBsAg-negative but anti-HBc-positive samples contained HBV DNA. The use of sensitive HBsAg tests is critical to prevent transfusion transmission of HBV infection to young children in a population with a 15% prevalence of chronic HBV infection in blood donors. However, this will not have much effect on the prevalence of this infection unless other strategies to protect children from infection are also advanced in parallel.

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