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Safety and antiviral activity of emtricitabine (FTC) for the treatment of chronic hepatitis B infection: A two-year study
- Source :
- Journal of Hepatology. 43:60-66
- Publication Year :
- 2005
- Publisher :
- Elsevier BV, 2005.
-
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 200mg once daily doses of emtricitabine for 48 weeks. Patients were then followed for an additional 48 weeks on open-label 200mg 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. >4700copies/mL. Results Emtricitabine was well tolerated and produced a dose proportional antiviral response. After 2 years, 53% of the patients had serum HBV DNA ≤4700copies/mL, 33% seroconverted to anti-HBe and 85% had normal ALT. Eighteen percent of the patients who had received 200mg 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, 200mg emtricitabine once daily was chosen as the optimal dose for future hepatitis B studies.
- Subjects :
- Adult
Male
medicine.medical_specialty
Hepacivirus
medicine.disease_cause
Emtricitabine
Antiviral Agents
Deoxycytidine
Gastroenterology
Drug Administration Schedule
Hepatitis B, Chronic
Double-Blind Method
Internal medicine
medicine
Humans
Hepatitis B e Antigens
Hepatitis B virus
Prothrombin time
Dose-Response Relationship, Drug
Hepatology
biology
medicine.diagnostic_test
Reverse-transcriptase inhibitor
business.industry
Alanine Transaminase
Middle Aged
Hepatitis B
medicine.disease
Treatment Outcome
Alanine transaminase
DNA, Viral
Immunology
Toxicity
biology.protein
Female
Viral disease
business
Follow-Up Studies
medicine.drug
Subjects
Details
- ISSN :
- 01688278
- Volume :
- 43
- Database :
- OpenAIRE
- Journal :
- Journal of Hepatology
- Accession number :
- edsair.doi.dedup.....83b35b1157ef5a508916c71aaa5b9dc3