Safety and antiviral activity of emtricitabine (FTC) for the treatment of chronic hepatitis B infection: a two-year study.

Abstract

BACKGROUND/AIMS:

The aim of this study was to evaluate long term safety and antiviral activity of different doses of emtricitabine given once daily to patients chronically infected with hepatitis B.

METHODS:

Eligible patients were randomized in a double-blind, parallel study to evaluate 25, 100 or 200 mg once daily doses of emtricitabine for 48 weeks. Patients were then followed for an additional 48 weeks on open-label 200 mg emtricitabine. Serum HBV DNA, ALT, and hepatitis B serology were measured at regular intervals over the 2 years. Resistance surveillance was performed after 1 and 2 years on viremic samples, i.e. > 4700 copies/mL.

RESULTS:

Emtricitabine was well tolerated and produced a dose proportional antiviral response. After 2 years, 53% of the patients had serum HBV DNA < or = 4700 copies/mL, 33% seroconverted to anti-HBe and 85% had normal ALT. Eighteen percent of the patients who had received 200 mg emtricitabine for 2 years developed resistance mutations.

CONCLUSIONS:

Emtricitabine was well tolerated and demonstrated a potent antiviral response for up to 2 years in patients with chronic hepatitis B infection. Based on these data, 200 mg emtricitabine once daily was chosen as the optimal dose for future hepatitis B studies.

• Authors: Robert G Gish, Huy Trinh, Nancy Leung, Francis K L Chan, Michael W Fried, Teresa L Wright, Chia Wang, Jane Anderson, Elsa Mondou, Andrea Snow, Jeff Sorbel, Franck Rousseau, Lawrence Corey
• Journal: Journal of hepatology (J Hepatol) Vol. 43 Issue 1 Pg. 60-6 (Jul 2005) ISSN: 0168-8278 [Print] Netherlands
• PMID: 15922478 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Antiviral Agents
• DNA, Viral
• Hepatitis B e Antigens
• Deoxycytidine
• Alanine Transaminase
• Emtricitabine

Topics

• Adult
• Alanine Transaminase (blood)
• Antiviral Agents (administration & dosage, adverse effects, therapeutic use)
• DNA, Viral (blood)
• Deoxycytidine (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Drug Administration Schedule
• Emtricitabine
• Female
• Follow-Up Studies
• Hepacivirus (genetics, immunology)
• Hepatitis B e Antigens (blood)
• Hepatitis B, Chronic (blood, drug therapy, virology)
• Humans
• Male
• Middle Aged
• Treatment Outcome