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The majority of hepatitis B virus (HBV)-infected patients require life-long therapy, but there are long-term safety concerns with use of first-line oral agents tenofovir disoproxil fumarate (TDF) and entecavir. In companion industry-funded phase III noninferiority trials, researchers investigated the effectiveness and safety of the novel prodrug, tenofovir alafenamide (TAF), which may reduce toxicity compared with TDF.
In both studies, researchers randomized HBV-infected patients to receive oral TAF 25 mg or TDF 300 mg once daily in a 2:1 ratio. One study involved 875 patients who were hepatitis B e antigen (HBeAg)-positive and the other involved 426 patients who were HBeAg-negative. All patients also received a placebo matching the unassign…