Efficacy and Tolerance of Peg-interferon Alpha 2a Added to Tenofovir and Emtricitabine in AgHBe Positive HBV-HIV Co-infected Patients (HB01EMVIPEG)

French National Agency for Research on AIDS and Viral Hepatitis

Status and phase: Completed; Phase 3; Phase 2

Conditions: Hepatitis B; HIV Infections

Treatments: Drug: TRUVADA (EMTRICITABINE + TENOFOVIR DF); Biological: PEGASYS 180μg (Interféron pégylé alpha -2a)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00391638

ANRS HB 01 EMVIPEG

2006-004137-15

Details and patient eligibility

About

HBe seroconversion is an important goal for anti-HBV treatment, since it is associated with a non progressive liver infection and a better clinical outcome. However, the rate of HBe seroconversion is low in HIV-HBV co-infected patients, mostly treated by tenofovir and emtricitabine. This study will evaluate the efficacy and the safety of a one-year Peg-interferon alpha 2a additional treatment in patients already treated by tenofovir and emtricitabine without reaching HBe seroconversion.

Full description

Many HBV-HIV co-infected patients are currently treated with dual activity drugs such as tenofovir and emtricitabine, often in combination. However, despite the potent antiviral activity of these drugs, the rate of HBe seroconversion is quite low, and not always sustained over time. HBe seroconversion is an important goal for anti-HBV treatment, since it is associated with a non progressive liver infection and a better clinical outcome. On the other hand, treatments with antiviral and immuno-modulator activity such as Peg-interferon, are infrequently used in co-infected patients, despite promising data in the field of HBV mono-infection with increased rates and sustained HBe seroconversions. This pilot study will evaluate the efficacy and the safety of a one-year Peg-interferon alpha 2a additional treatment (180 micro-g once a week, by injection), in 55 patients already treated by tenofovir and emtricitabine for at least 6 months, and who did not reached HBe seroconversion

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HIV infection
• Karnofsky above 80 per cent
• Stable ARV since 4 months
• CD4 above 200 per mm3
• ARN VIH below 10000 copies per ml
• hepatitis B chronic with : positive antigenaemia HBe and negative antiHBe, positive DNA HBV before or under tenofovir treatment, DNA HBV negative or below 10000 copies per ml at W-8.
• Previous treatment by tenofovir and lamivudine or emtricitabine more than 6 months

Exclusion criteria

• HIV 2 infection
• Hepatitis C or D
• Opportunistic infection
• Alcool consummation more than 50g/d
• Cirrhosis
• Pregnancy or plan of pregnancy
• Breastfeeding
• Immunosuppressive or modulating of the immune response treatment
• Other Hepatitis B treatments than tenofovir, lamivudine or emtricitabine since 6 months
• Malabsorption
• Exclusive HIV therapy with Truvada
• Evolutive cancer under chemotherapy

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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56 participants in 1 patient group

HIV antiretroviral therapy, TRUVADA , PEGASYS 180μg

Experimental group

Description:

Week-8 up Week0: HIV antiretroviral therapy Week 0 up Week 48: HIV antiretroviral therapy + TRUVADA + PEGASYS 180μg Week 48 up Week 72: HIV antiretroviral therapy + TRUVADA Week 72 up Week 144: HIV antiretroviral therapy

Treatment:

Biological: PEGASYS 180μg (Interféron pégylé alpha -2a)

Drug: TRUVADA (EMTRICITABINE + TENOFOVIR DF)