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

History of Changes

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 Intervention Model: Single Group Assignment Masking: None (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:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Interferon Emtricitabine Tenofovir Peginterferon Alfa-2a Tenofovir Disoproxil Fumarate Truvada

U.S. FDA Resources

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) ( French National Agency for Research on AIDS and Viral Hepatitis ):

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 ]

Secondary Outcome Measures:

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


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 (Adult, Senior)
Sexes Eligible for Study:	All
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	Centre Hospitalier Universitaire Dijon
Study Chair:	Fabrice Carrat, MD	Inserm U 707 Paris France

More Information


Responsible Party:	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

Keywords provided by 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 ):


HIV and Hepatitis B coinfection Peg interferon tenofovir	emtricitabine Hepatitis B e Antigens Treatment Experienced

Additional relevant MeSH terms:


Hepatitis HIV Infections Hepatitis B Liver Diseases Digestive System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Hepadnaviridae Infections DNA Virus Infections	Hepatitis, Viral, Human Interferons Tenofovir Interferon-alpha Emtricitabine Peginterferon alfa-2a Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Antineoplastic Agents Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents

ClinicalTrials.gov processed this record on August 18, 2017

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