Etravirine is a non-
nucleoside reverse transcriptase inhibitor used in combination with other antiretrovirals for the treatment of
HIV infection. Given previous conflicting results aim of this study was to investigate whether
etravirine plasma exposure was associated with virological outcome. Adult HIV-positive patients starting
etravirine with detectable HIV viral loads were included if highly adherent (<90% of the doses) and if steady-state plasma concentrations were available (measured through a validated HPLC-PDA method). Virological success was defined as reaching and maintaining viral suppression (HIV
RNA <50copies/mL) during follow up. Fifty-nine (84.7% male) patients were included: baseline CD4+ T-lymphocyte and HIV
RNA were 276cells/μL (101-419) and 3.99Log10copies/mL (3.11-4.91), respectively.
Darunavir/
ritonavir (n=21, 35.6%) and
raltegravir plus
maraviroc (n=33, 55.9%) were the most common associated antiretrovirals. 240 trough samples were available (3-7 per patient);
etravirine trough concentrations (Ctrough) and weighted genotypic inhibitory quotients (wgIQ) were 426ng/mL (266-763) and 408ng/mL/mutation (227-663), respectively. Virological success was observed in 49 patients (83.1%). Genotypic sensitivity of associated drugs (GSS) ⩾2 (p=0.03),
etravirine Ctrough >300ng/mL (p=0.02) and
etravirine wgIQ >276ng/mL/mutation (p=0.02) were associated with virological success; at multivariate Cox proportional analysis
etravirine wgIQ <276ng/mL/mutation (p=0.012) and baseline CD4 <200cell/μL (p=0.043) were independently associated with virological failure. In a cohort of experienced patients
etravirine exposure as well as immune status were associated with virological success; two cut off values (300ng/mL and 276ng/mL) were proposed for
etravirine Ctrough and wgIQ and need to be confirmed in prospective studies.