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| ID | Type | Description | Link |
|---|---|---|---|
| ANRS HB 01 EMVIPEG |
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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
| Roche Pharma AG | INDUSTRY |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV antiretroviral therapy, TRUVADA , PEGASYS 180μg | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRUVADA (EMTRICITABINE + TENOFOVIR DF) | Drug | Truvada ® (200 mg tablet of 300 mg of emtricitabine + tenofovir DF) Dosage 1 tablet taken orally once a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at Week 72 |
| Measure | Description | Time Frame |
|---|---|---|
| proportion of patients with negative HBe antigen. | at Week 72 and Week 144 | |
| proportion of patients with HBV DNA under 2.3 log 10 copies per ml. | at Week 72 and Week 144 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lionel Piroth, MD | Centre Hospitalier Universitaire Dijon | Principal Investigator |
| Fabrice Carrat, MD | Inserm U 707 Paris France | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service des Maladies Infectieuses CHU | Dijon | 21079 | France | |||
| Service d'Hépato-Gastroentérologie Hopital Hôtel-Dieu |
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| PEGASYS 180μg (Interféron pégylé alpha -2a) | Biological | Pegasys ® injection 180μg Dosage: A subcutaneous injection per week |
|
| proportion of seroconversion HBs. |
| at Week 72 and Week 144 |
| proportion of patients with no more HBs antigen. | 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. | before tenofovir treatment, duration of tenofovir treatment before study |
| Biological evolution and histological of hepatic activity and fibrosis. | at day 0 and Week 72 |
| Biochemical response (ALT at normal value). | at Week 72 and Week 144 |
| proportion of patients with :seroconversion HBe and HBV DNA below 2.3 log 10 copies per ml | at Week 48 |
| HBV and HIV resistance mutations to tenofovir DF and Emtricitabine. | at Week 72 |
| Immunological and virological evolution of HIV infection. | between Day 0 and Week 144 |
| Safety | between Day 0 and Week 144 |
| Quality of life | Day 0, Week 12, Week 24, Week 48, Week 72 |
| Treatment adherence | Day 0 to Week 144 |
| Lyon |
| 69288 |
| France |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| D000068679 | Emtricitabine |
| D000068698 | Tenofovir |
| C100416 | peginterferon alfa-2a |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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