The U.S. Food and Drug Administration (FDA) has approved Vemlidy (tenofovir alafenamide, or TAF) to treat adults with chronic hepatitis B virus (HBV) who have compensated cirrhosis of the liver, Medscape reports.
Vemlidy is the brand name for a new version of the generic drug tenofovir. Viread (tenofovir disoproxil fumarate, or TDF), which is the brand name for the older version of tenofovir, is already approved to treat hep B.
Vemlidy has already been approved as a component of combination-tablet treatments for HIV. This is the first version of the drug approved as a stand-alone tablet.
Becase Vemlidy more effectively targets cells, a dose one tenth that of Viread is needed to treat hep B. This results in lowered toxicity because of less drug in the bloodstream.
The FDA approved Vemlidy based on two international Phase III studies, known as Study 108 and Study 110, that compared the drug with Viread. These trials included 1,298 people with chronic hep B, some of whom had been treated for hep B before and others who hadn’t. The FDA looked at data about the participants once they’d been treated for 48 weeks.
The studies showed that Vemlidy was comparable in efficacy to Viread. Similar proportions of the participants had a hep B viral load below 29 at the 48-week point.
Those who received Vemlidy saw improvements in indicators of bone and kidney health compared with those receiving Viread. Those on the new drug also were more inclined to see their alanine aminotransferase (ALT, an enzyme whose levels indicate liver health) levels normalize.
Both drugs were generally well tolerated.
To read the Medscape article, click here (free registration with the site is required).
To read a press release about the approval, click here.