B20-B24
Conditions
Interventions
Group 1: All potential participants were already set up on BIC/FTC/TAF before participating in the study, regardless of the study project. The data required for the study will be collected and analyze
Sponsors
ICH Study Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Written informed consent - Confirmed HIV-1 diagnosis - Treatment with BIC/FTC/TAF historically or currently (initiation of BIC/FTC/TAF at least three months prior to the approval by an ethics committee) - More than one major respectively clinically relevant (acquired or primary) RAM documented by historical viral RNA genotype resistance testing at any time prior to BIC/FTC/TAF use, including at least one RAM that is clinically relevant for BIC, FTC, or TAF before BIC/FTC/TAF use (for BIC: major INSTI RAM or at least “potential low-level resistance” (PLLR), for FTC or TAF: PLLR, according to the Stanford HIV Database). - At least one follow-up HIV-1 RNA measurement while on BIC/FTC/TAF
Exclusion criteria
Exclusion criteria: - Treatment with additional ARVs in combination with BIC/FTC/TAF - Documentation of RAMs in proviral DNA only - Treatment with comedication contraindicated according to the Summary of Product Characteristics (SmpC). - Participants receiving BIC/FTC/TAF in a clinical study before marketing authorization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BIC/FTC/TAF effectiveness, persistence and emergence of viral resistance •Number/percentage of virologic suppression (HIV-1 RNA 200 copies/mL or one measurement HIV-1 RNA >200 copies/mL followed by discontinuation of BIC/FTC/TAF treatment) at years 1 (overall, and separately for viremic and non-viremic participants; M=E approach; Esser 2024). A)Non-viremic individuals (subjects with two consecutive measurements of HIV-1-RNA 50 copies/mL at and before baseline or one HIV-1 RNA measurement >200 copies/mL at baseline) •Incident detection of (new) RAMs against INSTI or NRTI during retrospective follow-up, under treatment with BIC/FTC/TAF, by sequencing of viral RNA in serum/plasma. As RAM testing results will be collected retrospectively, these data will be limited to resistance testing on a routine basis (at the discretion of the caregiver). | — |
Secondary
| Measure | Time frame |
|---|---|
| • Number/percentage of virologic suppression (HIV-1 RNA 200 copies/mL or one measurement HIV-1 RNA >200 copies/mL followed by discontinuation of BIC/FTC/TAF treatment) at months 3, 6 and years 2, 3 and until last observation (overall and separately for viremic and non-viremic participants; M=E approach). • Time to viral rebound (one measurement HIV-1 RNA >1000 copies/mL) from first measurement on BIC/FTC/TAF to last available viral load on BIC/FTC/TAF will be analysed using a competing-risks analysis modelling a cumulative incidence function (CIF) in non-viremic participants • Identify and describe participants with blips (defined as single viral load between 50 and 200 copies/mL and viral suppression before and after the blip event) • Evaluation of proviral DNA HIV-1 sequences extracted from PBMCs of routinely drawn blood in a central lab (Interpretation of resistance test results will also be made using the most recent version of the Stanford algorithm HIVdb version (https://hivdb.stanford.edu/), taking into account intact or defective proviruses. • Describe resistance profile in terms of detectable RAMs (absolute and relative number of all RAMs, historically known RAMs, newly detected RAMs in the proviral archive) measured after consent of the participant. | — |
Countries
Germany
Contacts
Public ContactEva Wolf (MPH)
Eurofins MUC Research GmbH
Outcome results
None listed