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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Truvada ® (200 mg tablet of 300 mg of emtricitabine + tenofovir DF) Dosage 1 tablet taken orally once a day
Pegasys ® injection 180μg Dosage: A subcutaneous injection per week
Service des Maladies Infectieuses CHU
Dijon, France
Service d'Hépato-Gastroentérologie Hopital Hôtel-Dieu
Lyon, France
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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.