Extrait

Background and study aims Hepatitis B virus (HBV) is a virus which causes long term liver damage in people all over the world. It is very common in much of sub-Saharan Africa and southeast Asia. Some countries have more than 10% of the entire population with the virus. Zambia is a country with a high HBV prevalence – approximately 10%. HBV causes liver cirrhosis and liver cancer after several decades of infection, but now this is preventable. We know that the best way to treat people who have active HBV infection is to give them powerful drugs that stop the virus replicating. The old drugs that used to be used to treat hepatitis B (such as lamivudine) are very cheap but they are not very powerful and many people develop resistance to them so that they stop working after a period of time. The new drugs that are used to treat hepatitis B are more powerful and most people do not develop resistance. However the new drugs may have more side effects in the long term and they are much more expensive. In many infections we know that starting treatment with a powerful drug and then reducing the treatment to a weaker drug is very effective. In London a pilot study of this approach has been tried in patients with hepatitis B with success in most cases. Specifically we took people who had been treated with the expensive new drug tenofovir and who were responding to treatment and we changed them to treatment with the weaker, cheaper, probably safer drug lamivudine. The great majority responded very well. We now want to find out if this way of treating hepatitis B works in Lusaka, Zambia. Who can participate? 80 Zambian adults, both sexes and aged 18 years or more, with HBV infection, already with evidence of some liver damage (using a marker in blood called ALT). What does the study involve? You will take tenofovir, the best single drug currently available, for 12 months to suppress the virus, then step down to lamivudine treatment. Our evidence suggests that after a period of complete viral suppression lamivudine failure may be much less likely. You will be monitored very closely during the 6 months after stepping down to lamivudine. What are the possible benefits and risks of participating? The main benefit is that you will receive at least 18 months of powerful antiviral therapy. The principal risks are associated with the liver biopsy (bleeding, but only 1 in 3000 have this problem), and the possibility that the infection may flare up aggressively at the end of the study. Our past experience suggests that this is very uncommon. If successful, this approach could lead to a much more affordable treatment approach for Africans with HBV infection, of whom there are many tens of thousands. Where is the study run from? This is a single centre study run from the University Teaching Hospital in Lusaka. When is the study starting and how long is it expected to run for? January 2014 to December 2015 Who is funding the study? UK Medical Research Council Who is the main contact? Professor Graham Foster, principal investigator Professor Paul Kelly and Dr Bright Nsokolo, chief investigators in Lusaka

Critère d'inclusion

• Hepatitis B Infection

Liens

• isrctn
• ictrp