TY - JOUR
T1 - Simplification of Antiretroviral Treatment from Darunavir/Ritonavir Monotherapy to Darunavir/Cobicistat Monotherapy: Effectiveness and Safety in Routine Clinical Practice
AU - Santos, José R.
AU - Curran, Adrian
AU - Navarro-Mercade, Jordi
AU - Ampuero, Mario F.
AU - Pelaez, Pablo
AU - Pérez-Alvarez, Nuria
AU - Clotet, Bonaventura
AU - Paredes, Roger
AU - Moltó, José
PY - 2019/6/1
Y1 - 2019/6/1
N2 - © 2019, Mary Ann Liebert, Inc., publishers 2019. Our aim was to evaluate the effectiveness and safety of darunavir/cobicistat (DRV/c) monotherapy as an antiretroviral treatment simplification strategy in HIV-infected patients already on suppressive darunavir/ritonavir (DRV/r) monotherapy in routine clinical practice. We conducted a retrospective multicenter study including all adult patients switched from DRV/r monotherapy to DRV/c monotherapy while HIV-1 RNA was <50 copies/mL and who had at least one follow-up visit. The primary endpoint was the percentage of patients remaining free of treatment failure (TF), defined as discontinuation of monotherapy for any reason, including loss of follow-up. Virological failure (VF) was defined as a confirmed HIV-1 RNA ≥50 copies/mL or any change in the regimen after a single determination with HIV-1 RNA ≥50 copies/mL. Changes in renal function parameters and lipid profile were also evaluated. Factors associated with VF were analyzed using Cox regression. In this study, 173 subjects were included. The median (interquartile range) time of follow-up was 58 (50-67) weeks. Overall, 90% of patients remained free of TF during follow-up. Ten (6%) patients discontinued DRV/c monotherapy for nonvirological reasons and eight (5%) developed VF. No DRV-related mutations were identified in patients with VF. A decrease in triglyceride levels (p = .006) and estimated glomerular filtration rate (p = .005) were observed during follow-up. The presence of blips and CD4+ nadir <100 cells/mm3 were predictors of VF. In conclusion, switching to DRV/c monotherapy seems to be safe and effective in routine clinical practice in HIV-infected patients undergoing suppressive DRV/r monotherapy.
AB - © 2019, Mary Ann Liebert, Inc., publishers 2019. Our aim was to evaluate the effectiveness and safety of darunavir/cobicistat (DRV/c) monotherapy as an antiretroviral treatment simplification strategy in HIV-infected patients already on suppressive darunavir/ritonavir (DRV/r) monotherapy in routine clinical practice. We conducted a retrospective multicenter study including all adult patients switched from DRV/r monotherapy to DRV/c monotherapy while HIV-1 RNA was <50 copies/mL and who had at least one follow-up visit. The primary endpoint was the percentage of patients remaining free of treatment failure (TF), defined as discontinuation of monotherapy for any reason, including loss of follow-up. Virological failure (VF) was defined as a confirmed HIV-1 RNA ≥50 copies/mL or any change in the regimen after a single determination with HIV-1 RNA ≥50 copies/mL. Changes in renal function parameters and lipid profile were also evaluated. Factors associated with VF were analyzed using Cox regression. In this study, 173 subjects were included. The median (interquartile range) time of follow-up was 58 (50-67) weeks. Overall, 90% of patients remained free of TF during follow-up. Ten (6%) patients discontinued DRV/c monotherapy for nonvirological reasons and eight (5%) developed VF. No DRV-related mutations were identified in patients with VF. A decrease in triglyceride levels (p = .006) and estimated glomerular filtration rate (p = .005) were observed during follow-up. The presence of blips and CD4+ nadir <100 cells/mm3 were predictors of VF. In conclusion, switching to DRV/c monotherapy seems to be safe and effective in routine clinical practice in HIV-infected patients undergoing suppressive DRV/r monotherapy.
KW - DRV/c
KW - DRV/r
KW - PI monotherapy
KW - routine clinical practice
KW - simplification strategy
KW - NUCLEOSIDE ANALOGS
KW - HIV-1 INFECTION ANALYSIS
KW - PROTEASE INHIBITOR MONOTHERAPY
KW - INITIAL TREATMENT
KW - OPEN-LABEL
KW - TENOFOVIR DISOPROXIL FUMARATE
KW - DOUBLE-BLIND
KW - TRIPLE THERAPY
KW - MONET TRIAL
KW - ELVITEGRAVIR/COBICISTAT/EMTRICITABINE/TENOFOVIR DF
UR - http://www.mendeley.com/research/simplification-antiretroviral-treatment-darunavirritonavir-monotherapy-darunavircobicistat-monothera
U2 - 10.1089/aid.2018.0178
DO - 10.1089/aid.2018.0178
M3 - Article
VL - 35
SP - 513
EP - 518
JO - AIDS Research and Human Retroviruses
JF - AIDS Research and Human Retroviruses
SN - 0889-2229
IS - 6
ER -