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7. Tenofovir Alafenamide Approved for Hepatitis B


In November the U.S. Food and Drug Administration (FDA) approved tenofovir alafenamide (TAF) for the treatment of hepatitis B, offering a new option that is easier on the bones and kidneys than the older version of tenofovir.

Gilead Science's tenofovir disoproxil fumarate (TDF or Viread) is among the most effective antiviral drugs for hepatitis B and the most widely used antiretrovirals for HIV. It is generally considered safe and well-tolerated, but it can cause bone loss soon after starting therapy and can lead to kidney problems in susceptible individuals.

TAF is a new pro-drug formulation that produces high levels of the active drug in liver cells and CD4 T-cells with smaller doses than TDF, which means lower concentrations in the blood and less drug exposure for the kidneys, bones, and other organs and tissues.

Research presented at the AASLD Liver Meeting showed that TAF matches TDF for antiviral activity against hepatitis B virus (HBV) but causes less bone mineral loss. Similarly, a pair of studies presented at the EASL International Liver Congress showed that TAF is as potent against HBV as TDF, but with less effect on bone and kidney biomarkers.

The FDA had already approved 3 TAF-containing coformulations for HIV treatment -- Genvoya (elvitegravir/cobicistat/TAF/emtricitabine), Odefsey (rilpivirine/TAF/emtricitabine), and Descovy (TAF/emtricitabine). The new stand-alone 25 mg TAF tablet will be marketed under the brand name Vemlidy.

This is the first approval of a new hepatitis B therapy in several years, and advances in treatment have lagged behind the recent rapid progress in hepatitis C treatment. Other therapies further back in the pipeline presented this year include the HBV core inhibitor NVR 3-778, the nucleic acid polymers REP 2139 and REP 21656, and the therapeutic HBV vaccine GS-4774.

NEXT: 8. More Treatment Options for More Types of HCV