Assessment of Tenofovir effects on bone mineral density in chronic Hepatitis B patients non infected with HIV

Abstract

Hepatitis B is a major public health problem worldwide and is associated with considerable mortality rates. In order to prevent or delay the deleterious effects of chronic hepatitis B virus infection, patients should be followed closely and the antiviral therapy indicated according to specific recommendations. The available treatment inhibits viral replication and delay or interrupts the progression of liver inflammation and fibrosis. However, oral medications, also called nucleoside/nucleotide analogues, are long-term therapy and have possible side effects. Among these side effects, prolonged use of Tenofovir may lead to bone mineral density loss. This adverse effect has been well studied in HIV patients since Tenofovir is also used as antiretroviral drug. There are few studies assessing the effects of Tenofovir on bone health of hepatitis B monoinfected patients. The present project aims to evaluate the effects of Tenofovir, compared with those of other nucleoside/nucleotide analogues, on bone mineral density of hepatitis B patients. In these patients, bone mineral density will be evaluated by densitometry concomitantly with serum markers of bone metabolism. The patients will be grouped into categories according to the use of Tenofovir, in a group, or other nucleoside/nucleotide analogues, in other group. A third group, composed of hepatitis B infected subjects who did not use nucleoside/nucleotide analogues previously will serve as controls. Data collection will be performed after approval of the protocol study and also the informed consent by the research ethics committee. Statistical analysis will be performed by the use of parametric or non-parametric tests and correlation between variables according to their characteristics. (AU)