Cabotegravir Plus Rilpivirine Long-acting Regimen in the Swiss HIV Cohort Study:Uptake, Outcome, and Risk Factors for Treatment Failures

University of Zurich600 enrolled

Overview

This study aims to characterize Swiss HIV Cohort Study participants initiating the CAB+RPV LA regimen, assess adherence to Swiss label indications, and describe treatment outcomes in this large, multicentre, heterogeneous, high-income setting. Moreover, the study aims to assess virological, immunological, demographic, clinical, and behavioural factors associated with viral failure under CAB+RPV LA regimen.

Study Type

OBSERVATIONAL

Enrollment

600

Conditions

HIV Infections

Interventions

VOCABRIA 30Mg TabletDRUG

CAB 30 mg Film-coated tablets

EDURANT 25Mg TabletDRUG

RPV 25 mg film-coated tablets

Cabotegravir Injectable SuspensionDRUG

CAB LA 600 mg prolonged release suspension for injection (3 mL)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participant in the SHCS * All SHCS participants initiating the CAB+RPV LA regimen * All SHCS participants on SOC oral regimen Exclusion Criteria: * Not participating in the SHCS

Locations (1)

University Hospital Zurich

Zurich, Switzerland

RECRUITING

Outcomes

Primary Outcomes

Proportion of individuals with viral blips

Proportion of individuals with viral blips (defined as one HIV-1 RNA \>50 and \<400 c/mL with a next HIV-1 RNA \<50 copies/ml)

Time frame: Month 24

Proportion of individuals with confirmed viral failures

Proportion of individuals with confirmed viral failures (defined as two consecutive HIV-1 RNA ≥ 50 c/mL)

Time frame: Month 24

Proportion of individuals switching off CAB+RPV LA to previous or another oral regimen

Proportion of individuals switching off CAB+RPV LA to previous or another oral regimen after HIV-1 RNA levels of \>50 to \<400 copies/mL and \>400 copies/mL

Time frame: Month 24

Time to viral failure

Overall time to confirmed viral failures (defined as two consecutive HIV-1 RNA ≥ 50 c/mL)

Time frame: Up to month 24

Proportion of participants who discontinue treatment due to drug-related reasons

Proportion of participants who discontinue treatment due drug-related reasons and re-suppression regimens (such as adverse events, confirmed viral failure, low level viremia or low blood concentration measurements) including the choice of re-suppression regimens.

Time frame: Month 24

Proportion of participants who discontinue treatment due to drug-unrelated reasons

Proportion of participants who discontinue treatment due drug-unrelated reasons and re-suppression regimens (such as patient wish, death, migration, and loss to follow-up) including the choice of re-suppression regimens.

Time frame: Month 24

Proportion of participants by characteristics

Central Contacts

Dominique L Braun, MD

CONTACT

0041442559196 dominique.braun@usz.ch

Jessy J Duran Ramirez, MSc

CONTACT

00410446341911 jessy.duranramirez@usz.ch

Data from ClinicalTrials.gov

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RPV LA 900 mg prolonged release suspension for injection (3 mL)

Intact proviral DNA assayBIOLOGICAL

HIV-1 latent reservoir size

Full-length sequencingBIOLOGICAL

Proviral DNA

\- Proportion of participants by socio-demographic and clinical characteristic(s) (e.g., by age, sex, body mass index, race, geographic origin, education, transmission mode, HIV-1 RNA levels, CD4 cell count, duration of HIV-1 infection, HIV-1 subtype, previous regimen, genotypic resistance profile, coinfections, lifestyle variables, and co-medications)

Time frame: Month 24

Overall adherence to Swiss label indication in CAB+RPV LA prescriptions

\- Overall adherence to Swiss label indication in CAB+RPV LA prescriptions between care providers, such as university hospital versus private physicians, and among nationwide centres

Time frame: Month 24

Overall adherence to the proposed injection schedules

\- Overall adherence to the proposed injection schedules quantified by deriving an CAB+RPV LA adherence threshold (e.g., accounting for any missed injection, daily oral bridging ART, and delayed injection of +7 days according to the Swiss label indication)

Time frame: Month 24

Proportion of participants by treatment adherence category

\- Proportion of participants by treatment adherence categories (e.g., optimal, sub-optimal, and poor adherence)

Time frame: Month 24

Secondary Outcomes

Investigate in-depth factors associated with viral blips and viral failure

Proportion of individuals by risk factor(s) (e.g., by body mass index, race, geographic origin, education, HIV-1 RNA levels, CD4 cell count, duration of HIV-1 infection, HIV-1 subtype, previous regimen, treatment adherence, CAB+RPV LA plasma concentrations measured at time of failure, genotypic resistance profile , lifestyle variables, and co-medications)

Time frame: Month 24

Measure intact proviral DNA as potential predictor for viral failure

Measure intact proviral DNA as potential predictor for viral failure among PWH initiating CAB+RPV LA regimen and compare with the matched control population on a SOC oral regimen

Time frame: Month 24

Assessment of resistance associated mutations from proviral DNA as potential predictor for viral failure

Assessment of resistance associated mutations from proviral DNA as potential predictor for viral failure among PWH initiating CAB+RPV LA regimen and compare with the matched control population on a SOC oral regimen

Time frame: Month 24