Efficacy and Safety of TDF+3TC+EFV in Adults With HIV/HBV Coinfection

Summary

This is a Phase 4 single-arm, post-marketing clinical trial evaluating the efficacy and safety of tenofovir disoproxil fumarate, lamivudine and efavirenz in adults with human immunodeficiency virus-1 and hepatitis B virus coinfection.

Timeline

Start

2011-02

Primary completion

2013-06

Completion

2013-06

Publications

• Background G Matthews, A Avihingsanon, S Lewin, and others. Tenofovir-based Highly Active Antiretroviral Therapy (HAART) is associated with high rates of HBV DNA suppression and HBeAg seroconversion in Thai HIV-HBV coinfected patients. 59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD 2008). San Francisco. October 31-November 4, 2008. Abstract 907. O Lada, A Gervais, M Branger, and others. De Novo Combination Therapy of Tenofovir Disoproxil Fumarate (TDF) Plus Lamivudine (LAM) or TDF Plus Emtricitabine (FTC) Is Associated With Early Virologic Response in HIV/HBV Co-Infected Patients. 59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD 2008). San Francisco. October 31-November 4, 2008. Abstract 922.
• Wu YS, Zhang WW, Ling XM, Yang L, Huang SB, Wang XC, Wu H, Cai WP, Wang M, Wang H, Liu YF, He HL, Wei FL, Wu ZY, Zhang FJ. Efficacy and Safety of Tenofovir and Lamivudine in Combination with Efavirenz in Patients Co-infected with Human Immunodeficiency Virus and Hepatitis B Virus in China. Chin Med J (Engl). 2016 Feb 5;129(3):304-8. doi: 10.4103/0366-6999.174509.

Drugs

Indications