Management of chronic hepatitis B in Africa: is a one-stop assessment of liver disease enough? The MATCH-B study

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Infection with hepatitis B virus (HBV) is a major public health issue worldwide with about 250 million people chronically infected. HBV is an important cause of severe liver disease including liver cancer, which has a poor prognostic. Although an effective vaccine is available to prevent HBV transmission, many people are not vaccinated in particular in Africa and get infected with a risk of serious hepatic complications. The World Health Organization (WHO) has recently recognized HBV infection as an important health threat and has called for scaling up screening and treatment interventions for hepatitis B globally in order to control HBV-related mortality by 2030 and eventually eliminate the infection. Significant progress has been made in the management of HBV-infected patients. A highly effective treatment is now available at low cost in many countries and is recommended to the most severe patients with active hepatitis. However in developing countries, which account for 80% of the HBV epidemic, interventions to fight against hepatitis B are very limited. In Africa about 80 million people are estimated to be chronically infected with HBV. Yet screening and treatment interventions and research activities to fight against hepatitis B are almost inexistent in Africa. The complexity and high cost of the current international recommendations for the management of hepatitis B represent one of the barriers to scale up HBV screening and treatment interventions in Africa. The first screen-and-treat programme for hepatitis B in Africa called PROLIFICA (Prevention of Liver Fibrosis and Cancer in Africa) has been set up in 2011 in Gambia and Senegal. With the support of the Gambian and Senegalese Ministries of Health and the local communities, the programme has been very successful: almost 20,000 persons have been screened for HBV and about 2,000 infected persons have been offered clinical assessment, and 283 given antiviral treatment. PROLIFICA has also generated unique data on chronic hepatitis B in Africa, which have informed the WHO and the local Ministries of Health on the burden of hepatitis B in West Africa. The study demonstrated that the vast majority of HBV-infected adults in West Africa have inactive or mild hepatitis and do not require immediate treatment. However, whether these patients remain so without liver disease progression in mid- to long-term or do they require regular follow-up as they may develop liver complications is unknown in Africa. In addition whether HBV antiviral therapy is effective and safe to control liver complications has never been demonstrated. Within the following study, we propose to re-assess the liver disease of the 2,108 patients (untreated or treated) previously enrolled in the PROLIFICA programme. We will re-invite each patient previously enrolled in the programme in Gambia and Senegal for a comprehensive liver assessment. Infected subjects with liver disease progression will be given treatment. This study will therefore address two key unknown questions for Africa: 1/ What is the rate of liver disease progression in African patients with inactive or mild hepatitis B exposed to the African environment and can they be offered a limited monitoring? 2/ Is HBV antiviral therapy effective and safe to reduce hepatic liver complications in patients with active chronic hepatitis B in Africa? If we demonstrate that patients diagnosed to have inactive or mild hepatitis B at one single time point have no significant liver disease progression over time, it may be unnecessary to do the conventional frequent follow-up for the millions of patients with mild hepatitis B in Africa. This will save considerable amount of resources since healthcare resources are seriously limited in Africa. We believe that our study will also promote awareness on hepatitis B and its findings will eventually contribute to the development of simplified guidelines for the management of HBV infection in Africa.