Real-world data confirm TDF efficacy for HBV

Mar 10 2016

By Shreeya Nanda

Treatment with tenofovir disoproxil fumarate (TDF) elicits sustained virological responses and exhibits a favourable safety profile in a diverse population of patients with chronic hepatitis B virus (HBV) infection, shows a French routine clinical practice study.

Patrick Marcellin, from Hôpital Beaujon in Clichy, and fellow VIREAL investigators say that "the main strength of the study is the diversity of the patient population meaning the results are relevant to real-world patients and to other countries with similar management strategies and HBV demographics."

They enrolled 440 treatment-naïve or previously treated patients with hepatitis B e antigen (HBeAg)-negative or -positive chronic HBV who were initiating TDF, either alone or in combination with another agent, at the discretion of their treating physician.

After 12 months of treatment, 92% of 308 participants with available data achieved a virological response, defined as HBV DNA levels below 69 IU/mL, with 96% of 259 patients attaining a response by 36 months. The rates of virological response at these timepoints were similar for treatment-naïve and -experienced patients.

The team points out that a virological response was achieved by more than 90% of evaluable participants by 36 months regardless of HBeAg status, treatment history or whether TDF was given as monotherapy or combination therapy.

Normalisation of alanine aminotransferase (ALT) levels occurred in 76.8% of patients at month 12 and in 78.0% at month 36. A similar proportion of treatment-naïve and -experienced patients achieved ALT normalisation at both timepoints.

Forty-five percent of 80 patients positive for HBeAg at baseline lost the antigen during the course of the study. And 14 patients lost the hepatitis B surface antigen (HBsAg), while seven achieved HBsAg seroconversion.

TDF treatment was well tolerated, with a toxicity profile comparable to that reported in clinical trials, say Marcellin et al. Drug-related adverse events were reported by 41 patients and 23 discontinued as a result of toxicity.

Although the researchers noted a "slight decline" in mean serum creatinine levels, creatinine clearance and estimated glomerular filtration rate over the treatment period relative to baseline, they urge that statistical comparisons be "viewed with caution due to the high proportion of missing data".

The safety population included 14 women who were pregnant, and TDF therapy in these patients was not associated with any drug-related side effects during pregnancy, neonatal complications or birth defects, the team writes in Digestive Diseases and Sciences.

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