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oai:repisalud.isciii.es:20.500.12105/252422024-10-23T09:55:47Zcom_20.500.12105_15322com_20.500.12105_2051col_20.500.12105_16958
Repisalud author Gutierrez-Valencia, Alicia author Trujillo-Rodriguez, Maria author Fernandez-Magdaleno, Tamara author Espinosa, Nuria author Viciana, Pompeyo author López-Cortés, Luis F 2024-10-23T09:55:47Z 2024-10-23T09:55:47Z 2018 http://hdl.handle.net/10668/12115 https://hdl.handle.net/20.500.12105/25242 29430854 10.1002/jia2.25072 1758-2652 Journal of the International AIDS Society Introduction: When darunavir (DRV) 800 mg is boosted with 150 mg cobicistat (DRVcobi), DRV trough concentration (Ctrough) is about 30% lower as compared to 100 mg ritonavir (DRVrtv). DRVcobi shows similar virological efficacy as DRVrtv when combined with two nucleos(t)ide analogue reverse-transcriptase inhibitors, but it is unknown whether a lower DRV Ctrough would undermine the effectiveness of DRVcobi when given as monotherapy (mtDRVcobi). Methods: Prospective observational study on virologically suppressed HIV-infected subjects who switched to mtDRVcobi . Virological failure was defined as two consecutive HIV-RNA >200 copies/mL. Efficacy was evaluated by intention-to-treat (ITT) and on-treatment (OT) analyses, and compared with data from a previous cohort of subjects on mtDRVrtv conducted at our centre. Plasma DRV Ctrough was measured using LC-MS/MS. Results: A total of 234 subjects were enrolled. At week 96, the efficacy rates were 67.8% (CI95 , 61.8 to 73.7) by ITT and 86.9% (CI95 , 78.0 to 87.7) by OT analyses. The corresponding rates in our historical DRVrtv controls were 67.6% (CI95 , 60.0 to 75.2) and 83.6% (CI95 : 77.2 to 90.0). A total of 135 DRV determinations were performed in 83 subjects throughout the follow-up period, with a median plasma DRV Ctrough of 1305 ng/mL (range, 150 to 5895) compared with 1710 ng/mL (range, 200 to 3838) in subjects on monotherapy with DRVrtv (p = 0.05). Conclusions: DRV Ctrough was lower in HIV-infected subjects receiving DRVcobi than with DRVrtv . However, this did not appear to influence the efficacy of DRVcobi , when administered as monotherapy. eng Ctrough Darunavir Cobicistat Monotherapy Pharmacokinetic Ritonavir Darunavir/cobicistat showing similar effectiveness as darunavir/ritonavir monotherapy despite lower trough concentrations. research article