Study ANRS 0250s-BI-LIGHT

Objective of the trial

The main objective of this trial is to evaluate at 96 weeks the safety with respect to chronic viral hepatitis B control of 2 treatment reduction strategies for patients with previously controlled HIV-HBV co-infection on continuous triple therapy.

Evaluated strategies

The 2 reduction strategies assessed will be :

1. Reduction of previous triple antiviral therapy (containing TDF or TAF) to 4 consecutive days out of 7
2. Reduction of previous triple antiviral therapy (containing TDF or TAF) to continuous dual therapy without TDF or TAF but including 3TC in combination with Dolutegravir (DTG) or Darunavir boosted by ritonavir (DRVr)

Trial methodology

The trial will be interventional, sequential, Phase IIA equivalent, multicentre, open-label, randomised and non-comparative. It will evaluate, for 96 weeks, the safety in terms of HBV virological control of the 2 strategies for reducing antiviral treatment, in patients co-infected with HIV-1 and HBV, who have previously achieved prolonged virological success.

Primary endpoint

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.