Cutrell AG, Schapiro JM, Perno CF, Kuritzkes DR, Quercia R, Patel P, Polli JW, Dorey D, Wang Y, Wu S, van Eygen V, Crauwels H, Ford SL, Baker M, Talarico CL, Clair MST, Jeffrey J, White CT, Vanveggel S, Vandermeulen K, Margolis DA, Aboud M, Spreen WR, van Lunzen J. Predictors of HIV-1 virologic failure to long-acting cabotegravir and rilpivirine: a multivariable analysis across three phase 3 studies. AIDS. 2021 Mar 16. doi: 10.1097/QAD.0000000000002883. Epub ahead of print. PMID: 33730748.
Efficacy and safety of long-acting (LA) cabotegravir (CAB) and rilpivirine (RPV) dosed intramuscularly every 4 or 8 weeks has been demonstrated in three Phase 3 trials. Factors associated with virologic failure at Week 48 were evaluated post hoc.
Data from 1039 adults naive to CAB+RPV LA were pooled in a multivariable analysis to examine the influence of baseline viral and participant factors, dosing regimen, and drug concentrations on confirmed virologic failure (CVF) occurrence using a logistic regression model. In a separate model, baseline factors statistically associated with CVF were further evaluated to understand CVF risk when present alone or in combination.
CVF is an infrequent multifactorial event, with a rate of ∼1% in the LA arms across Phase 3 studies (FLAIR, ATLAS, and ATLAS-2 M) through Week 48. Presence of ≥2 of proviral RPV RAMs, HIV-1 subtype A6/A1, and/or BMI ≥30 kg/m2 was associated with increased CVF risk. These findings support the use of CAB+RPV LA in routine clinical practice.