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.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •Previous treatment by tenofovir and lamivudine or emtricitabine more than 6 months
排除标准
- •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
研究组 & 干预措施
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
干预措施: TRUVADA (EMTRICITABINE + TENOFOVIR DF) (Drug)
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
干预措施: PEGASYS 180μg (Interféron pégylé alpha -2a) (Biological)
结局指标
主要结局
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
时间窗: at Week 72
次要结局
- Immunological and virological evolution of HIV infection.(between Day 0 and Week 144)
- Safety(between Day 0 and Week 144)
- proportion of patients with negative HBe antigen.(at Week 72 and Week 144)
- 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)
- Quality of life(Day 0, Week 12, Week 24, Week 48, Week 72)
- 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 HBV DNA under 2.3 log 10 copies per ml.(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)
- Treatment adherence(Day 0 to Week 144)