You have full access to this open access article. Tenofovir disoproxil fumarate TDF demonstrated potent and sustainable antiviral efficacy and a good safety profile in patients with chronic hepatitis B CHB in controlled clinical trials. Real-world data are important to confirm effectiveness and safety data in patient populations encountered in routine clinical practice. Clinical, virologic, biochemical, compliance, and safety data were collected. Data from consecutive patients from 58 centers were analyzed.
TDF was well tolerated over the month study, including in 14 women who became pregnant during the study. Median estimated glomerular filtration rate did not change markedly from baseline irrespective of prior treatment history.
TDF demonstrated potent virologic and biochemical responses across a broad range of patients reflective of routine clinical practice. The safety profile was consistent with results from pivotal trials. Chronic infection with hepatitis B virus HBV represents a major global health problem, responsible for around , deaths worldwide, largely through serious liver-related sequelae [ 1 ]. A French survey of patient mortality related to hepatitis B and C estimated that deaths were attributed to HBV infection, corresponding to 2.
Many studies have demonstrated the correlation between viral load and the risk of developing cirrhosis and hepatocellular carcinoma HCC [ 5 β 8 ]. Tenofovir disoproxil fumarate TDF is a potent nucleotide analog recommended as a first-line therapy for CHB in international and national guidelines [ 9 β 11 ].
No drug resistance to TDF has been observed. Published data from real-world studies with TDF, which include the highly diverse patients encountered in routine practice, are lacking, and are mostly retrospective, but are required in order to confirm and expand upon the results of clinical trials [ 16 , 17 ]. VIREAL is a multicenter, non-interventional, prospective study to assess the long-term effectiveness and safety of TDF treatment in a real-life cohort of patients with CHB managed in routine clinical settings in France.
