Interventional, multicenter, open-label, randomized, non-comparative trial evaluating the safety, in terms of HBV virological control, of 2 antiviral treatment relief strategies, in patients co-infected with the HIV-1 and HBV viruses

co-infected with the HIV-1 and HBV viruses

The primary endpoint was the proportion of participants with HBV virological failure at 96 weeks. Failure was defined as two successive HBV viral load measurements >10 IU/mL or one HBV viral load measurement above the detection threshold followed by permanent discontinuation of the strategy or follow-up in the trial.

• HBV virological success rate at 48 weeks, • HIV virological success rate at 48 and 96 weeks, • Time to virological failure (rebound HBV and/or HIV viral load), • The rate of participants with at least one HBV viral load blip until S48 and until S96, • Selection of HBV resistance mutations at the time of virological failure, • Incidence of grade 3 or higher adverse events of grade 3 or higher, incidence of adverse events and incidence of strategy discontinuation of the strategy at W48 and W96, • Evolution of CD4 and CD8 T lymphocytes, and the CD4/CD8 ratio from W0 to W48 and W96, • Evolution of metabolic parameters (total cholesterol, LDL-c, HDL-c, triglycerides and fasting blood sugar) from W0 to W48 and W96, • Participants' compliance with treatment (self-questionnaire) at S0, S12, S24, S48, S72 and S96, • Participants' quality of life using the Pro-Qol self-questionnaire at S0, S12, S24, S48, S72 and S96, HBV virological success rate at 96 weeks between arms

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