Efficacy and Safety of TDF+3TC+EFV in Adults With HIV/HBV Coinfection
Efficacy and Safety of TDF+3TC+EFV in Adults With HIV/HBV Coinfection
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.
HIV/HBV co-infections are frequently observed due to shared routes of transmission. TDF and
 3TC are nucleotide analogues that can inhibit both HIV and HBV DNA polymerases. There is
 higher risk to cause drug resistance in treating HBV or HIV infection with 3TC or TDF
 monotherapy than combination trerapy. Combination tharapy could decreases drug resistance.
 China's HIV epidemic remains one of low prevalence overall, but with pockets of high
 infection among specific sub-populations and in some localities. China has a very high
 endemicity for hepatitis B too. A substantial proportion of HIV-infected individuals are
 co-infected with HBV. TDF + 3TC + EFV will be a common regimen for HIV/HBV co-infected
 Chinese individuals.

 The purpose of this study of this study is to determine whether TDF will be safe for patients
 with HIV and HBV co-infection and the combination of TDF+3TC+EFV will suppress HIV and HBV
 viral load below LDL at week 48 of treatment in patients with HIV and HBV co-infeciton.This
 study will enroll 100 adult subjects and follow these patients for 48 weekes.There will be
 one enrollment visit(baseline) and visits at 2,4,8,12,24,36,48 weeks after initiation of the
 study regimen.
Inclusion Criteria:

 -  Serologically-confirmed HIV and HBV infection

 -  Willingness to participate in a clinical trial

 -  No previous or current use of antiretroviral regimen

 -  Clinical conditions stable

 -  Blood creatinine less than 3 times the upper limit of normal values. HBV
 DNA>1000copies/ml, Tbil<34umol/L,ALT<400U/L

 -  With clinical indications for HAART

 Exclusion Criteria:

 -  Patient refuses to sign the consent to participate

 -  Unwillingness to adhere to visit schedule or maintain adherence with medications

 -  Illnesses so serve as to likely require hospitalization

 -  With other conditions that not suitable to be enrolled will be subject to medical
 review