Long-Acting Cabotegravir and Rilpivirine in People Living With HIV-1 Subtype A6: A Real-World Retrospective Study (LACRIS)

Pomeranian Medical University Szczecin

Status: Not yet enrolling

Conditions: HIV-1 Subtype B Infection; Human Immunodeficiency Virus (HIV)-1 Infection; HIV-1 Subtype A6 Infection; Virologically Suppressed HIV-1 Infection Receiving Long-Acting Antiretroviral Therapy

Treatments: Drug: Cabotegravir Plus Rilpivirine Long-Acting Injectable

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07370649

LACRIS

Details and patient eligibility

About

This study evaluates the real-world effectiveness and safety of a long-acting injectable HIV treatment consisting of cabotegravir and rilpivirine in people living with HIV-1. The focus is on individuals with HIV-1 subtype A6, which is common in Eastern Europe and among people who acquired HIV in that region, and on comparison with individuals with subtype B and those with an unknown subtype.

Although long-acting cabotegravir and rilpivirine are widely used and effective, limited real-world data are available on how well this treatment works in people with HIV-1 subtype A6. This is important because subtype A6 has been suggested as a potential risk factor for treatment failure, but current evidence is inconclusive.

The study uses existing medical records from treatment centers in Poland, Germany, and the Czech Republic. It includes adults with HIV who have received at least one injection of long-acting cabotegravir and rilpivirine and follows their clinical outcomes for up to 24 months. Researchers will assess viral suppression, treatment persistence, adherence to injection schedules, and reasons for treatment discontinuation.

The results of this study will help clinicians better understand whether HIV-1 subtype A6 affects treatment outcomes and whether knowing a patient's HIV subtype is important when deciding to switch to long-acting injectable therapy. The findings may support safer and more effective use of this treatment in diverse patient populations.

Full description

This is a multicentre, international, real-world, retrospective observational study designed to evaluate clinical outcomes of long-acting injectable cabotegravir plus rilpivirine (CAB/RPV LA) in adults living with HIV-1. The study is conducted at HIV treatment centers in Poland, Germany, and the Czech Republic and is based on routinely collected clinical data from electronic medical records and paper charts.

The study population includes treatment-experienced individuals aged 18 years or older who received at least one dose of CAB/RPV LA in routine clinical practice. Participants are grouped according to HIV-1 subtype: subtype A6, subtype B, and unknown subtype. Individuals with known subtype A6 are matched with individuals with subtype B using propensity score matching to reduce the impact of confounding factors. Participants with unknown subtype are analyzed as an unmatched group.

Clinical data are collected from the time of CAB/RPV LA initiation (index date) and from follow-up visits closest to 6, 12, 18, and 24 months after initiation. Outcomes assessed include treatment persistence, adherence to injection schedules, discontinuation rates and reasons for discontinuation, and measures of virologic effectiveness. Virologic outcomes include viral suppression, viral rebound, and confirmed virologic failure as defined by standard HIV RNA criteria.

For participants with unknown HIV-1 subtype, proviral DNA genotyping is performed after initial descriptive analyses to explore whether knowledge of HIV-1 subtype has prognostic relevance for clinical outcomes. Genotypic data are analyzed descriptively and may inform additional exploratory analyses.

As this is a retrospective, non-interventional study using existing clinical data, no study-specific treatment interventions are performed. Safety data collection is limited to adverse events leading to treatment discontinuation, reflecting routine clinical practice. The study aims to provide clinically relevant real-world evidence on the use of CAB/RPV LA across different HIV-1 subtypes, with particular focus on subtype A6.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of HIV-1 infection
• Age ≥18 years at the time of initiation of long-acting cabotegravir plus rilpivirine (CAB/RPV LA)
• Received at least one dose of CAB/RPV LA as part of routine clinical care
• Availability of relevant clinical data in medical records for retrospective analysis
• Signed informed consent for use of clinical data
• Agreement to provide an additional blood sample for proviral DNA genotyping, if HIV-1 subtype was unknown at treatment initiation

Exclusion criteria

- Lack of patient consent for use of clinical data for research purposes

Trial design

250 participants in 3 patient groups

HIV-1 subtype A6

Description:

This cohort includes adults living with HIV-1 with a confirmed subtype A6 infection who received at least one dose of long-acting injectable cabotegravir plus rilpivirine (CAB/RPV LA) as part of routine clinical care. Participants are treatment-experienced and include individuals with suppressed or unsuppressed viral load at treatment initiation. Clinical outcomes, including virologic effectiveness, treatment persistence, adherence, and discontinuation, are assessed retrospectively using existing medical records. This cohort is matched with the subtype B cohort using propensity score methods.

Treatment:

Drug: Cabotegravir Plus Rilpivirine Long-Acting Injectable

HIV-1 Subtype B Cohort

Description:

This cohort consists of adults living with HIV-1 with a confirmed subtype B infection who received long-acting injectable cabotegravir plus rilpivirine (CAB/RPV LA) in routine clinical practice. Participants are selected and matched to the subtype A6 cohort based on predefined confounding variables, including age, gender, body mass index category, and CD4 cell nadir. Outcomes are evaluated retrospectively to provide a comparative real-world context for the subtype A6 cohort.

Treatment:

Drug: Cabotegravir Plus Rilpivirine Long-Acting Injectable

HIV-1 Subtype Unknown Cohort

Description:

This cohort includes adults living with HIV-1 who received long-acting injectable cabotegravir plus rilpivirine (CAB/RPV LA) and had no documented HIV-1 subtype at the time of treatment initiation. Participants are analyzed as an unmatched descriptive group. Retrospective clinical outcome data are collected from medical records. For selected participants, proviral DNA genotyping from blood samples is performed after initial analyses to explore the clinical relevance of HIV-1 subtype knowledge prior to switching to long-acting injectable therapy.

Treatment:

Drug: Cabotegravir Plus Rilpivirine Long-Acting Injectable