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

This study has been completed.
Sponsor:
Collaborators:
Gilead Sciences
Roche Pharma AG
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) ( French National Agency for Research on AIDS and Viral Hepatitis )
ClinicalTrials.gov Identifier:
NCT00391638
First received: October 23, 2006
Last updated: January 14, 2015
Last verified: January 2015
  Purpose

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.


Condition Intervention Phase
Hepatitis B
HIV Infections
Drug: TRUVADA (EMTRICITABINE + TENOFOVIR DF)
Biological: PEGASYS 180μg (Interféron pégylé alpha -2a)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures:
  • 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 [ Time Frame: at Week 72 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • proportion of patients with negative HBe antigen. [ Time Frame: at Week 72 and Week 144 ] [ Designated as safety issue: No ]
  • proportion of patients with HBV DNA under 2.3 log 10 copies per ml. [ Time Frame: at Week 72 and Week 144 ] [ Designated as safety issue: No ]
  • proportion of seroconversion HBs. [ Time Frame: at Week 72 and Week 144 ] [ Designated as safety issue: No ]
  • proportion of patients with no more HBs antigen. [ Time Frame: at Week 72 and Week 144 ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: before tenofovir treatment, duration of tenofovir treatment before study ] [ Designated as safety issue: No ]
  • Biological evolution and histological of hepatic activity and fibrosis. [ Time Frame: at day 0 and Week 72 ] [ Designated as safety issue: No ]
  • Biochemical response (ALT at normal value). [ Time Frame: at Week 72 and Week 144 ] [ Designated as safety issue: No ]
  • proportion of patients with :seroconversion HBe and HBV DNA below 2.3 log 10 copies per ml [ Time Frame: at Week 48 ] [ Designated as safety issue: No ]
  • HBV and HIV resistance mutations to tenofovir DF and Emtricitabine. [ Time Frame: at Week 72 ] [ Designated as safety issue: No ]
  • Immunological and virological evolution of HIV infection. [ Time Frame: between Day 0 and Week 144 ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: between Day 0 and Week 144 ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: Day 0, Week 12, Week 24, Week 48, Week 72 ] [ Designated as safety issue: No ]
  • Treatment adherence [ Time Frame: Day 0 to Week 144 ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: January 2007
Study Completion Date: October 2012
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HIV antiretroviral therapy, TRUVADA , PEGASYS 180μg
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
Drug: TRUVADA (EMTRICITABINE + TENOFOVIR DF)
Truvada ® (200 mg tablet of 300 mg of emtricitabine + tenofovir DF) Dosage 1 tablet taken orally once a day
Biological: PEGASYS 180μg (Interféron pégylé alpha -2a)
Pegasys ® injection 180μg Dosage: A subcutaneous injection per week

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391638

Locations
France
Service des Maladies Infectieuses CHU
Dijon cedex, France, 21079
Service d'Hépato-Gastroentérologie Hopital Hôtel-Dieu
Lyon Cedex 02, France, 69288
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Gilead Sciences
Roche Pharma AG
Investigators
Principal Investigator: Lionel Piroth, MD CHU Dijon France
Study Chair: Fabrice Carrat, MD Inserm U 707 Paris France
  More Information

No publications provided

Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) ( French National Agency for Research on AIDS and Viral Hepatitis )
ClinicalTrials.gov Identifier: NCT00391638     History of Changes
Other Study ID Numbers: 2006-004137-15, ANRS HB 01 EMVIPEG
Study First Received: October 23, 2006
Last Updated: January 14, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
HIV and Hepatitis B coinfection
Peg interferon
tenofovir
emtricitabine
Hepatitis B e Antigens
Treatment Experienced

Additional relevant MeSH terms:
Hepatitis B
DNA Virus Infections
Digestive System Diseases
Hepadnaviridae Infections
Hepatitis
Hepatitis, Viral, Human
Liver Diseases
Virus Diseases
Emtricitabine
Interferon-alpha
Interferons
Peginterferon alfa-2a
Tenofovir
Tenofovir disoproxil
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2015