Back to Search
Start Over
Expanded Multivariable Models to Assist Patient Selection for Long-Acting Cabotegravir + Rilpivirine Treatment: Clinical Utility of a Combination of Patient, Drug Concentration, and Viral Factors Associated With Virologic Failure.
- Source :
- Clinical Infectious Diseases; 11/15/2023, Vol. 77 Issue 10, p1423-1431, 9p
- Publication Year :
- 2023
-
Abstract
- Background Previously reported post hoc multivariable analyses exploring predictors of confirmed virologic failure (CVF) with cabotegravir + rilpivirine long-acting (CAB + RPV LA) were expanded to include data beyond week 48, additional covariates, and additional participants. Methods Pooled data from 1651 participants were used to explore dosing regimen (every 4 or every 8 weeks), demographic, viral, and pharmacokinetic covariates as potential predictors of CVF. Prior dosing regimen experience was accounted for using 2 populations. Two models were conducted in each population—baseline factor analyses exploring factors known at baseline and multivariable analyses exploring baseline factors plus postbaseline model-predicted CAB/RPV trough concentrations (4 and 44 weeks postinjection). Retained factors were evaluated to understand their contribution to CVF (alone or in combination). Results Overall, 1.4% (n = 23/1651) of participants had CVF through 152 weeks. The presence of RPV resistance-associated mutations, human immunodeficiency virus-1 subtype A6/A1, and body mass index ≥30 kg/m<superscript>2</superscript> were associated with an increased risk of CVF (P <.05 adjusted incidence rate ratio), with participants with ≥2 of these baseline factors having a higher risk of CVF. Lower model-predicted CAB/RPV troughs were additional factors retained for multivariable analyses. Conclusions The presence of ≥2 baseline factors (RPV resistance-associated mutations, A6/A1 subtype, and/or body mass index ≥30 kg/m<superscript>2</superscript>) was associated with increased CVF risk, consistent with prior analyses. Inclusion of initial model-predicted CAB/RPV trough concentrations (≤first quartile) did not improve the prediction of CVF beyond the presence of a combination of ≥2 baseline factors, reinforcing the clinical utility of the baseline factors in the appropriate use of CAB + RPV LA. [ABSTRACT FROM AUTHOR]
- Subjects :
- HIV infections
COMBINATION drug therapy
GENETIC mutation
PATIENT selection
VIRAL load
MULTIVARIATE analysis
REVERSE transcriptase inhibitors
RILPIVIRINE
ANTIRETROVIRAL agents
DISEASE incidence
TREATMENT failure
RISK assessment
FACTOR analysis
DESCRIPTIVE statistics
RESEARCH funding
PREDICTION models
BODY mass index
HIV
THERAPEUTICS
EVALUATION
Subjects
Details
- Language :
- English
- ISSN :
- 10584838
- Volume :
- 77
- Issue :
- 10
- Database :
- Complementary Index
- Journal :
- Clinical Infectious Diseases
- Publication Type :
- Academic Journal
- Accession number :
- 173688234
- Full Text :
- https://doi.org/10.1093/cid/ciad370