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

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Collaborators: Gilead Sciences; Roche Pharma AG
• Treatments: Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Interferon-alpha; Interferons; Peginterferon alfa-2a; Tenofovir

Criteria

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