About this trial
The main objective of this study is to evaluate at 96 weeks the safety with respect to hepatitis B control of 2 treatment reduction strategies for patients with previously controlled HIV-HBV co-infection on continuous triple therapy
Eligibility criteria
Qualifiers
HIV-1-HBV co-infection (positive HIV-1 serology associated with 2 positive HBsAg serologies within more than 6 months);
Age ≥ 18 years
Fibroscan less than 6 months < 9kPa
Current daily antiretroviral tritherapy not modified for ≥ 12 months must including tenofovir disoproxil fumarate (TDF) 245mg or tenofovir alafenamide fumarate (TAF -25mg) associated to lamivudine (3TC - 300mg) or emtricitabine (FTC - 200mg) and a NNRTI or PI/r or INSTI to choose from
Disqualifiers
HIV-2 infection;
HIV and/or HBV genotype not compatible with dual therapy DTG-3TC or DRVr-3TC;
HBeAg+;
Fibrosis history at stage F3-F4 in pre-therapy evaluated by PBH, fibrotest and/or fibroscan with a value of Elastometry ≥ 9kPa;
Trial design
Treatments tested in this trial
- TDF - 245mg or TAF -25mg associated to 3TC - 300mg or FTC - 200mg and a NNRTI or PI/r or INSTI
- Dual therapy with 3TC in combination with DTG or ritonavir-boosted Darunavir (rDVR)