FDA Expands Viread Indication to Chronic Hepatitis B

The FDA has approved a new indication for Gilead’s Viread as a treatment for chronic hepatitis B in adults.

Available as an HIV treatment in the U.S. since 2001, Viread (tenofovir disoproxil fumarate) was approved for the hepatitis B indication in the EU, Turkey, Australia and New Zealand earlier this year, the company says in a statement, and a marketing application is pending in Canada.

Viread, a nucleotide analog reverse transcriptase and HBV polymerase inhibitor, blocks an enzyme that the hepatitis B virus needs to replicate in liver cells. The recommended dose for chronic hepatitis B is one 300-mg tablet a day.

Gilead’s Hepsera (adefovir dipivoxil) is the most prescribed oral agent for chronic hepatitis B in the U.S., according to the company.

Two ongoing Phase III clinical trials comparing Viread with Hepsera found that chronic hepatitis B patients on Viread achieved a higher rate of complete treatment response compared with patients taking Hepsera, according to the company, which says the two drugs should not be used together.

Doctors probably will prescribe Viread for new patients starting treatment, Cara Miller, Gilead spokeswoman, said. “I would expect for patients who are already on Hepsera and doing well that their physicians would keep them on it,” she added.