Abstract
Background: Hepatitis B virus (HBV) remains endemic throughout sub-Saharan Africa despite the widespread availability of effective childhood vaccines. In the Democratic Republic of the Congo, HBV treatment and birth-dose vaccination programmes are not established. We, therefore, aimed to evaluate the feasibility and acceptability of adding HBV testing and treatment of pregnant women as well as the birth-dose vaccination of HBV-exposed infants to the HIV prevention of mother-to-child transmission programme infrastructure in the Democratic Republic of the Congo. Methods: We did a feasibility study in two maternity centres in Kinshasa: Binza and Kingasani. Using the already established HIV prevention of mother-to-child transmission programme at these two maternity centres, we screened pregnant women for HBV infection at routine prenatal care registration. Those who tested positive and had a gestational age of 24 weeks or less were included in this study. Eligible pregnant women with a high viral load (≥200 000 IU/mL or HBeAg positivity, or both) were considered as having HBV of high risk of mother-to-child transmission and initiated on oral tenofovir disoproxil fumarate (300 mg/day) between 28 weeks and 32 weeks of gestation and continued through 12 weeks post partum. All HBV-exposed infants received a birth-dose of monovalent HBV vaccine (Euvax-B Pediatric: Sanofi Pasteur, Seoul, South Korea; 0·5 mL) within 24 h of life. All women were followed up for 24 weeks post partum, when they completed an exit questionnaire that assessed the acceptability of study procedures. The primary outcomes were the feasibility of screening pregnant women to identify those at high risk for HBV mother-to-child transmission and to provide them with antiviral prophylaxis, the feasibility of administrating the birth-dose vaccine to exposed infants, and the acceptability of this prevention programme. This study is registered with ClinicalTrials.gov, NCT03567382. Findings: Between Sept 24, 2018, and Feb 22, 2019, 4016 women were approached and screened. Of these pregnant women, 109 (2·7%) were positive for HBsAg. Of the 109 women, 91 (83%) met the eligibility criteria for participation. However, only data from 90 women—excluding one woman who had a false pregnancy—were included in the study analysis. The median overall age of the enrolled women was 31 years (IQR 25–34) and the median overall gestational age was 19 weeks (15–22). Ten (11%) of 91 women evaluated had high-risk HBV infection. Nine (90%) of the ten pregnant women with high-risk HBV infection received tenofovir disoproxil fumarate and one (10%) refused therapy and withdrew from the study; five (56%) of the nine women achieved viral suppression (ie, <200 000 IU/mL) on tenofovir disoproxil fumarate therapy by the time of delivery and the remaining four (44%) had decreased viral loads from enrolment to delivery. A total of 88 infants were born to the 90 enrolled women. Of the 88 infants, 60 (68%) received a birth-dose vaccine; of these, 46 (77%) received a timely birth-dose vaccine. No cases of HBV mother-to-child transmission were observed. No serious adverse events associated with tenofovir disoproxil fumarate nor with the birth-dose vaccine were reported. Only one (11%) of nine women reported dizziness during the course of tenofovir disoproxil fumarate therapy. The study procedures were considered highly acceptable (>80%) among mothers. Interpretation: Adding HBV screening and treatment of pregnant women and infant birth-dose vaccination to existing HIV prevention of mother-to-child transmission platforms is feasible in countries such as the Democratic Republic of the Congo. Birth-dose vaccination against HBV infection integrated within the current Expanded Programme on Immunisation and HIV prevention of mother-to-child transmission programme could accelerate progress toward HBV elimination in Africa. Funding: Gillings Innovation Laboratory award and the National Institutes of Health. Translations: For the French and Lingala translations of the abstract see Supplementary Materials section.
| Original language | English (US) |
|---|---|
| Pages (from-to) | e1600-e1609 |
| Journal | The Lancet Global Health |
| Volume | 9 |
| Issue number | 11 |
| DOIs | |
| State | Published - Nov 2021 |
Funding
PT and JBP report support from the American Society of Tropical Medicine and Hygiene–Burroughs Wellcome Fund awards, outside the submitted work. PT, RJ, and JBP report research support from Gilead Sciences, outside the submitted work. JBP reports grants from the US National Institutes of Health (NIH), outside the submitted work. CEM reports a grant from the Infectious Diseases Society of America, outside the submitted work. RJ reports consulting fees from Dynavax, outside the submitted work; membership on the American Association for the Study of Liver Diseases (AASLD)–Infections Diseases Society of America Hepatitis C Virus Guidelines panel and the AASLD Viral Hepatitis Elimination Task Force; and a stipend from Elsevier for editorial services as Co-Editor-in-Chief of Clinical Therapeutics. GC is an employee and shareholder of Abbott Laboratories. JBP reports research support from WHO and honoraria from Virology Education, outside the submitted work. All other authors declare no competing interests. This study was funded by the Gillings Innovation Laboratory award. The Gillings Innovation Laboratory award was funded by the 2007 Gillings Gift to the University of North Carolina?Chapel Hill's Gillings School of Global Public Health. Abbott Laboratories provided HBV reagents free of charge for this study. The HIV prevention of mother-to-child transmission study whose infrastructure was leveraged for this project was supported by an NIH grant (NICHD R01HD087993). Tenofovir diphosphate testing was done by the University of North Carolina Center for AIDS Research Clinical Pharmacology and Analytical Chemistry Core, an NIH funded programme (P30AI050410). PT received support from an NIH grant (NIAID K08AI148607). CEM received support for this study from an NIH grant (NIGMS T32GM008719) and a fellowship from the University of North Carolina Graduate School. We thank all of the women who participated in this study. We also thank the staff at the Binza and Kingasani maternity clinics, and provincial and national health authorities. We are grateful for the support we have received from administrative staff at the University of North Carolina and at Kinshasa School of Public Health. We also thank David Wohl for helpful advice and the University of North Carolina Clinical Pharmacology and Analytical Chemistry Core for supporting the tenofovir diphosphate assays. We grieve the loss of Prof Steven Meshnick, who had a major role in this study and whose vision and mentorship were critical to its success. This study was funded by the Gillings Innovation Laboratory award. The Gillings Innovation Laboratory award was funded by the 2007 Gillings Gift to the University of North Carolina–Chapel Hill's Gillings School of Global Public Health. Abbott Laboratories provided HBV reagents free of charge for this study. The HIV prevention of mother-to-child transmission study whose infrastructure was leveraged for this project was supported by an NIH grant (NICHD R01HD087993). Tenofovir diphosphate testing was done by the University of North Carolina Center for AIDS Research Clinical Pharmacology and Analytical Chemistry Core, an NIH funded programme (P30AI050410). PT received support from an NIH grant (NIAID K08AI148607). CEM received support for this study from an NIH grant (NIGMS T32GM008719) and a fellowship from the University of North Carolina Graduate School. We thank all of the women who participated in this study. We also thank the staff at the Binza and Kingasani maternity clinics, and provincial and national health authorities. We are grateful for the support we have received from administrative staff at the University of North Carolina and at Kinshasa School of Public Health. We also thank David Wohl for helpful advice and the University of North Carolina Clinical Pharmacology and Analytical Chemistry Core for supporting the tenofovir diphosphate assays. We grieve the loss of Prof Steven Meshnick, who had a major role in this study and whose vision and mentorship were critical to its success.
ASJC Scopus subject areas
- General Medicine
