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

Information source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis B; HIV Infections

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

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: French National Agency for Research on AIDS and Viral Hepatitis

Official(s) and/or principal investigator(s):
Lionel Piroth, MD, Principal Investigator, Affiliation: CHU Dijon France
Fabrice Carrat, MD, Study Chair, Affiliation: Inserm U 707 Paris France

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.

Clinical Details

Official title: Pilot Study on Efficacy and Tolerance of Peg-interferon Alpha-2a (Pegasys) Added to Tenofovir DF and Emtricitabine (Truvada) in AGHBe Positive HBV-HIV Co-infected Patients. ANRS HB 01 EMVIPEG.

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: proportion of patients with seroconversion HBe (loose of HBe antigen and acquisition of HBe antibody) and HBV DNA below 2.3 log10 copies per ml

Secondary outcome:

proportion of patients with negative HBe antigen.

proportion of patients with HBV DNA under 2.3 log 10 copies per ml.

proportion of seroconversion HBs.

proportion of patients with no more HBs antigen.

proportion of patients with HBV DNA below 2.3 log 10 copies per ml in relation with 3TC resistance or not before tenofovir treatment; increased of ALT before tenofovir treatment;duration of tenofovir treatment before study.

Biological evolution and histological of hepatic activity and fibrosis.

Biochemical response (ALT at normal value).

proportion of patients with :seroconversion HBe and HBV DNA below 2.3 log 10 copies per ml

HBV and HIV resistance mutations to tenofovir DF and Emtricitabine.

Immunological and virological evolution of HIV infection.

Safety

Quality of life

Treatment adherence

Detailed 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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Service des Maladies Infectieuses CHU, Dijon cedex 21079, France

Service d'Hépato-Gastroentérologie Hopital Hôtel-Dieu, Lyon Cedex 02 69288, France

Additional Information

Starting date: January 2007
Last updated: January 14, 2015

Page last updated: August 23, 2015

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