Efficacy of Tenofovir and Emtricitabine in ARV-naive Patients With HIV/HBV Co-infection

The HIV Netherlands Australia Thailand Research Collaboration

Status and phase: Completed; Phase 2

Conditions: Hepatitis B Virus; HIV Infections

Treatments: Drug: Emtricitabine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00476463

HIV-NAT 023

Details and patient eligibility

About

Combination therapy with anti-HBV activity may both increase HBV suppression rates and reduce emergence of resistant strains. Several new therapeutic agents are currently in development, however combination therapy trials in the HBV-infected population have only recently commenced. No such trials have been undertaken in the HIV/HBV co-infected population.

Full description

The primary study objective is to compare HBV DNA suppression to levels below the limit of detection (<400 copies/ml) by week 48 in each treatment group. Virological and clinical anti-HBV efficacy of tenofovir and emtricitabine in antiretroviral naive patients with HIV/HBV co-infection.

Enrollment: 24 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent
• Documented HIV infection (positive serology for HIV-1 and detectable HIV-1 RNA)
• Age 18 - 70 years
• HBV DNA > 106 copies/ml
• HBsAg positive for > 6 months

In case documented duration of HBsAg seropositive is less than 6 months (this situation is most likely to occur in patients newly presenting to the HIV-outpatient clinic) the patient is eligible if the patient is:

1. HBsAg positive and

2. HBc core IgM antibody negative and

3. the liver biopsy gives evidence for a chronic active hepatitis. Thus making it likely that this patient has acquired the HBV infection more than 6 months ago.

   • ALT < 10 x ULN
   • Creatinine <= 2.0mg/dl
   • Platelet count >= 50,000/mm3
   • HIV-1 therapy naive
   • No prior exposure to anti-HBV agents (LAM, adefovir, TDF) although prior IFN treatment allowed

Exclusion criteria

• HCV-RNA positive or Anti-HAV IgM positive
• Acute hepatitis (serum ALT > 1000 U/L)
• Prior LAM, TDF, or ADV therapy
• Active opportunistic infection
• Other causes of chronic liver disease identified ( autoimmune hepatitis, haemochromatosis, Wilsons disease, alfa-1-antitrypsin deficiency)
• Concurrent malignancy requiring cytotoxic chemotherapy
• Decompensated or Child's C cirrhosis
• Alfa-fetoprotein (AFP) > 3X ULN (unless negative CT scan or MRI within 3 months of entry date)
• Pregnancy or lactation
• Any other condition which in the opinion of the investigator might interfere with compliance or outcome of the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

1

Active Comparator group

Description:

AZT+FTC+EFV

Treatment:

Drug: Emtricitabine

2

Active Comparator group

Description:

TDF+FTC+EFV

Treatment:

Drug: Emtricitabine