Last updated on 06 November 2025
In brief
Treatment reduction strategies, such as dual therapy or sequential treatment, are used to maintain HIV control once an undetectable viral load has been achieved. However, there is a lack of data on these options for people co-infected with HIV and hepatitis B. The aim of this trial is to assess the safety of two treatment reduction strategies in co-infected patients whose HIV and HBV viral loads have been undetectable for more than 2 years on triple therapy.
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 :
- Reduction of previous triple antiviral therapy (containing TDF or TAF) to 4 consecutive days out of 7
- 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.