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1. Acceptability and feasibility of a screen-and-treat programme for hepatitis B virus infection in The Gambia: the Prevention of Liver Fibrosis and Cancer in Africa (PROLIFICA) study

Author

Harr Freeya Njai, Ramou Njie, Gibril Ndow, Aboubacar Kambi, Maimuna Mendy, Isabelle Chemin, Tumani Corrah, Saydiba Tamba, Maud Lemoine, Adam Jeng, Louise Sarr, Souleymane Mboup, Shevanthi Nayagam, Mark Thursz, Hilton Whittle, Jessica Howell, Penda Suso, Makie Taal, Amina Sow, Liliane Mpabanzi, Simon D. Taylor-Robinson, Yusuke Shimakawa, Ousman Nyan, William Stanger, Coumba Toure-Kane, Saunab Ghosh, Abdullah Jatta, Umberto D'Alessandro, Medical Research Council Unit The Gambia (MRC), St Mary's Hospital [London], Epidémiologie des Maladies Emergentes - Emerging Diseases Epidemiology, Pasteur-Cnam Risques infectieux et émergents (PACRI), Institut Pasteur [Paris]-Conservatoire National des Arts et Métiers [CNAM] (CNAM)-Institut Pasteur [Paris]-Conservatoire National des Arts et Métiers [CNAM] (CNAM), Centre International de Recherche contre le Cancer - International Agency for Research on Cancer (CIRC - IARC), Organisation Mondiale de la Santé / World Health Organization Office (OMS / WHO), Ministry of Health and Social Welfare [Banjul, The Gambia] (MOHSW), Centre de Recherche en Cancérologie de Lyon (UNICANCER/CRCL), Centre Léon Bérard [Lyon]-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Hôpital Aristide-Le-Dantec, School of Nutrition and Translational Research in Metabolism [Maastricht] (NUTRIM), Maastricht University [Maastricht], Royal Free Hospital [London, UK], Edward Francis Small Teaching Hospital [Banjul, Gambia] (EFSTH), London School of Hygiene and Tropical Medicine (LSHTM), We thank the European Commission for funding the programme, Gilead Sciences (USA) for providing tenofovir treatment for the patients, the MRC laboratories The Gambia unit, the local Ministry of Health and Social Welfare, and the National Public Health Laboratories for supporting the project, We also thank the French Research Agency on HIV/AIDS and viral hepatitis (ANRS) for supporting ML's work within the PROLIFICA project. We also acknowledge the support of the UK Medical Research Council and the UK Department for International Development who jointly funded (under the MRC/DFID Concordat agreement) the clinical research fellowship that supports SN. We acknowledge the support of the UK National Institute for Health Research Biomedical Research Centre at Imperial College London for infrastructure support., We thank all study participants and the PROLIFICA team, in particular Ignatius Baldeh, Famara Bojang, Amie Ceesay, Mavis Foster-Nyarko, Debbo Jallow, Sheriff Kolley, Yamundow Jallow Samba, Alagie Sanneh, Bakary Sanneh, Demba Sonko, Lamin Bojang, and Mamina Bojang. We thank Mariama Jammeh, the coordinator of the national blood bank programme, Debbie Garside, the project manager of PROLIFICA, Christian Bottomley for statistical advice, and Alexandra Davis for drafting the study map. We thank Mary Crofton and Patrick Ingiliz for their clinical contributions., We are grateful to our dear colleague Dr Harr Njai, who died before the study could be published. We miss her warm and radiant personality., Institut Pasteur [Paris] (IP)-Conservatoire National des Arts et Métiers [CNAM] (CNAM), HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-Institut Pasteur [Paris] (IP)-Conservatoire National des Arts et Métiers [CNAM] (CNAM), HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM), Gilead Sciences Inc, Imperial College Trust, Commission of the European Communities, Wellcome Trust, Imperial College Healthcare NHS Trust- BRC Funding, Medical Research Council (MRC), and Shimakawa, Yusuke

Subjects
Liver Cirrhosis, Male, HBsAg, Blood Donors, medicine.disease_cause, Liver disease, MESH: Hepatitis B virus / immunology, 0302 clinical medicine, Epidemiology, Prevalence, EPIDEMIOLOGY, CRITERIA, Mass Screening, 030212 general & internal medicine, PROTECTION, MESH: Liver Cirrhosis / therapy, SUB-SAHARAN AFRICA, Public, Environmental & Occupational Health, 2. Zero hunger, MESH: Middle Aged, lcsh:Public aspects of medicine, Age Factors, General Medicine, Hepatitis B, Middle Aged, MESH: Mass Screening / methods, MESH: Liver Cirrhosis / diagnosis, 3. Good health, COMMUNITY, PROLIFICA investigators, MESH: Hepatitis B Surface Antigens / blood, CARRIAGE, MESH: Hepatitis B / diagnosis, MESH: Point-of-Care Systems, VACCINATION, 030211 gastroenterology & hepatology, Female, Gambia, MESH: Hepatitis B / epidemiology, Life Sciences & Biomedicine, 0605 Microbiology, Adult, MESH: Antiviral Agents, medicine.medical_specialty, Hepatitis B virus, MESH: Gambia / epidemiology, Point-of-Care Systems, Antiviral Agents, Communicable Diseases, 1117 Public Health and Health Services, 03 medical and health sciences, Sex Factors, MESH: Sex Factors, Internal medicine, medicine, Humans, Disease burden, Mass screening, MESH: Prevalence, MESH: Age Factors, Science & Technology, Hepatitis B Surface Antigens, MESH: Humans, business.industry, MESH: Blood Donors, lcsh:RA1-1270, MESH: Adult, Odds ratio, CARE, medicine.disease, MESH: Male, MESH: Communicable Diseases, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, SETTINGS, Immunology, Feasibility Studies, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, business, MESH: Feasibility Studies, MESH: Female
Abstract

Comment in : Screen-and-treat for chronic hepatitis B: an overdue issue for sub-Saharan Africa./Allain JP. Lancet Glob Health. 2016 Aug;4(8):e507-8. doi: 10.1016/S2214-109X(16)30140-1. PMID: 27443770; International audience; Background: Despite the introduction of immunisation for hepatitis B virus (HBV) in the 1990s, HBV-related morbidity and mortality remain high in sub-Saharan Africa. Identification and treatment of asymptomatic people with chronic HBV infection should reduce the disease burden. We therefore assessed the feasibility of a screen-and-treat programme for HBV infection in The Gambia, west Africa, and estimated the proportion of HBV-infected people who had significant liver disease in need of treatment.Methods: Between Dec 7, 2011, and Jan 24, 2014, individuals living in randomly selected communities in western Gambia were offered hepatitis B surface antigen (HBsAg) screening via a point-of-care test. The test was also offered to potential blood donors attending the central hospital in the capital, Banjul. HBsAg-positive individuals were invited for a comprehensive liver assessment and were offered treatment according to international guidelines. We defined linkage to care as visiting the liver clinic at least once. Eligibility for treatment was judged in accordance with the 2012 European Association for the Study of the Liver guidelines.Findings: HBsAg screening was accepted by 5980 (weighted estimate 68·9%, 95% CI 65·0-72·4) of 8170 adults from 27 rural and 27 urban communities and 5559 (81·4%, 80·4-82·3) of 6832 blood donors. HBsAg was detected in 495 (8·8%, 7·9-9·7) individuals in communities and 721 (13·0%, 12·1-13·9) blood donors. Prevalence was higher in men (239 [10·5%, 8·9-12·1] of 2328 men vs 256 [7·6%, 6·5-8·7] of 3652 women; p=0·004) and middle-aged participants. Linkage to care was high in the communities, with 402 (81·3%) of 495 HBsAg-positive individuals attending the clinic. However, only 300 (41·6%) of 721 HBsAg-positive people screened at the blood bank linked into care. Of those who attended the clinic, 18 (4·4%, 2·5-7·7) patients from the communities and 29 (9·7%, 6·8-13·6) from the blood bank were eligible for treatment. Male sex was strongly associated with treatment eligibility (odds ratio 4·35, 1·50-12·58; p=0·007).Interpretation: HBV infection remains highly prevalent in The Gambia. The high coverage of community-based screening, good linkage into care, and the small proportion of HBsAg carriers who need treatment suggest that large-scale screening and treatment programmes are feasible in sub-Saharan Africa.Funding: European Commission (FP7).

Published
2016
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2. The gamma-glutamyl transpeptidase to platelet ratio (GPR) predicts significant liver fibrosis and cirrhosis in patients with chronic HBV infection in West Africa

Author

Muriel Vray, Shevanthi Nayagam, Robert D. Goldin, Umberto D'Alessandro, Jo Lloyd, Ramou Njie, Yusuke Shimakawa, Penda Suso, Mark Thursz, Vincent Mallet, Makie Taal, Graham S Cooke, Gibril Ndow, Mustapha Khalil, Maud Lemoine, Harr-Freeya Njai, Papa Saliou Mbaye, Medical Research Council Unit The Gambia (MRC), Imperial College London, Epidémiologie des Maladies Emergentes - Emerging Diseases Epidemiology, Pasteur-Cnam Risques infectieux et émergents (PACRI), Institut Pasteur [Paris]-Conservatoire National des Arts et Métiers [CNAM] (CNAM)-Institut Pasteur [Paris]-Conservatoire National des Arts et Métiers [CNAM] (CNAM), Edward Francis Small Teaching Hospital [Banjul, Gambia] (EFSTH), Ministry of Health and Social Welfare [Banjul, The Gambia] (MOHSW), Hôpital Principal de Dakar, Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Institut Pasteur [Paris], Université Paris Descartes - Paris 5 (UPD5), The study in The Gambia is part of the PROLIFICA programme funded by the European commission: EC FP7, P34114. The study in Senegal was funded by the ANRS (National Institute of Research on AIDS and Viral Hepatitis), France., The authors thank the MRC laboratories The Gambia unit, the local ministry of health and social welfare for supporting the project, all the study participants, the PROLIFICA team: in particular Ignatius Baldeh, Famara Bojang, Amie Ceesay, Mavis Foster-Nyarko, Debbo Jallow, Abdulie Jatta, Adam Jeng, Sheriff Kolley, Yamundow Jallow Samba, Alagie Sanneh, Bakary, Sanneh, Demba Sonko, Lamin Bojang, Saydiba Tamba and Debbie Garside, the project manager of the PROLIFICA programme. The authors also thank Professor Dominique Valla for his precious recommendations on haemostatic precautions before liver biopsy in the local resource-constrained setting. The authors also thank Dr Philippe Sultanik for his contributions to statistical analysis and Dr Patrick Ingiliz for his constructive comments and suggestions., European Project: 265994,EC:FP7:HEALTH,FP7-AFRICA-2010,PROLIFICA(2011), Institut Pasteur [Paris] (IP)-Conservatoire National des Arts et Métiers [CNAM] (CNAM), HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-Institut Pasteur [Paris] (IP)-Conservatoire National des Arts et Métiers [CNAM] (CNAM), HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM), Institut Pasteur [Paris] (IP), Imperial College Healthcare NHS Trust- BRC Funding, Commission of the European Communities, and Medical Research Council (MRC)

Subjects
Liver Cirrhosis, Male, Pathology, Cirrhosis, MESH: Biomarkers / blood, Biopsy, Gastroenterology, Severity of Illness Index, MESH: Biopsy, 0302 clinical medicine, Fibrosis, SIMPLE NONINVASIVE INDEX, FIBROSIS, Gamma-glutamyltransferase, MESH: Hepatitis B, Chronic* / complications, MESH: Middle Aged, biology, medicine.diagnostic_test, TRANSIENT ELASTOGRAPHY, gamma-Glutamyltransferase, Hepatitis B, Middle Aged, FIBROTEST, MESH: Liver Cirrhosis* / etiology, MESH: Predictive Value of Tests, 3. Good health, MESH: Biomarkers / analysis, Africa, Western, MESH: Hepatitis B, Chronic* / pathology, Liver, Dimensional Measurement Accuracy, 030220 oncology & carcinogenesis, Predictive value of tests, Liver biopsy, Area Under Curve, HEPATITIS B, 030211 gastroenterology & hepatology, Female, Life Sciences & Biomedicine, CHRONIC HEPATITIS-B, Adult, medicine.medical_specialty, AMINOTRANSFERASE, BIOMARKERS, STIFFNESS MEASUREMENT, MESH: Africa, Western / epidemiology, MESH: Liver / pathology, 03 medical and health sciences, Hepatitis B, Chronic, MESH: gamma-Glutamyltransferase* / blood, Predictive Value of Tests, MESH: Liver Cirrhosis* / diagnosis, Internal medicine, MESH: Severity of Illness Index, medicine, Humans, DIAGNOSTIC-ACCURACY, MESH: Patient Acuity, MESH: Platelet Count / methods, Science & Technology, MESH: Humans, Gastroenterology & Hepatology, business.industry, FibroTest, Platelet Count, Patient Acuity, 1103 Clinical Sciences, MESH: Adult, MESH: Hepatitis B, Chronic* / diagnosis, medicine.disease, MESH: Male, MARKER, MESH: Liver Cirrhosis* / pathology, biology.protein, 1114 Paediatrics and Reproductive Medicine, MESH: Area Under Curve, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, VIRAL-HEPATITIS, MESH: Dimensional Measurement Accuracy, Transient elastography, business, MESH: Female, MESH: gamma-Glutamyltransferase* / analysis
Abstract

International audience; Background: Simple and inexpensive non-invasive fibrosis tests are highly needed but have been poorly studied in sub-Saharan Africa.Methods: Using liver histology as a gold standard, we developed a novel index using routine laboratory tests to predict significant fibrosis in patients with chronic HBV infection in The Gambia, West Africa. We prospectively assessed the diagnostic accuracy of the novel index, Fibroscan, aspartate transaminase-to-platelet ratio index (APRI), and Fib-4 in Gambian patients with CHB (training set) and also in French and Senegalese CHB cohorts (validation sets).Results: Of 135 consecutive treatment-naïve patients with CHB who had liver biopsy, 39% had significant fibrosis (Metavir fibrosis stage ≥F2) and 15% had cirrhosis (F4). In multivariable analysis, gamma-glutamyl transpeptidase (GGT) and platelet count were independent predictors of significant fibrosis. Consequently, GGT-to-platelet ratio (GPR) was developed. In The Gambia, the area under the receiver operating characteristic curve (AUROC) of the GPR was significantly higher than that of APRI and Fib-4 to predict ≥F2, ≥F3 and F4. In Senegal, the AUROC of GPR was significantly better than Fib-4 and APRI for ≥F2 (0.73, 95% CI 0.59 to 0.86) and better than Fib-4 and Fibroscan for ≥F3 (0.93, 0.87 to 0.99). In France, the AUROC of GPR to diagnose ≥F2 (0.72, 95% CI 0.59 to 0.85) and F4 (0.87, 0.76 to 0.98) was equivalent to that of APRI and Fib-4.Conclusions: The GPR is a more accurate routine laboratory marker than APRI and Fib-4 to stage liver fibrosis in patients with CHB in West Africa. The GPR represents a simple and inexpensive alternative to liver biopsy and Fibroscan in sub-Saharan Africa.

Published
2016
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