Refining criteria for selecting candidates for a safe lopinavir/ritonavir or darunavir/ritonavir monotherapy in HIV-infected virologically suppressed patients.
OBJECTIVE:The primary objective of this study was to estimate the incidence of treatment failure (TF) to protease inhibitor monotherapies (PI/r-MT) with lopinavir/ritonavir (LPV/r) or darunavir/ritonavir (DRV/r). DESIGN:A multicenter cohort of HIV-infected patients with viral load (VL) ≤50 copies/mL...
| Main Authors: | , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Public Library of Science (PLoS)
2017-01-01
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| Series: | PLoS ONE |
| Online Access: | http://europepmc.org/articles/PMC5305227?pdf=render |
| _version_ | 1811309881762775040 |
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| author | Nicola Gianotti Alessandro Cozzi-Lepri Andrea Antinori Antonella Castagna Andrea De Luca Benedetto Maurizio Celesia Massimo Galli Cristina Mussini Carmela Pinnetti Vincenzo Spagnuolo Antonella d'Arminio Monforte Francesca Ceccherini-Silberstein Massimo Andreoni Icona Foundation Study and mono-PI/r database Study Cohorts |
| author_facet | Nicola Gianotti Alessandro Cozzi-Lepri Andrea Antinori Antonella Castagna Andrea De Luca Benedetto Maurizio Celesia Massimo Galli Cristina Mussini Carmela Pinnetti Vincenzo Spagnuolo Antonella d'Arminio Monforte Francesca Ceccherini-Silberstein Massimo Andreoni Icona Foundation Study and mono-PI/r database Study Cohorts |
| author_sort | Nicola Gianotti |
| collection | DOAJ |
| description | OBJECTIVE:The primary objective of this study was to estimate the incidence of treatment failure (TF) to protease inhibitor monotherapies (PI/r-MT) with lopinavir/ritonavir (LPV/r) or darunavir/ritonavir (DRV/r). DESIGN:A multicenter cohort of HIV-infected patients with viral load (VL) ≤50 copies/mL, who underwent a switch from any triple combination therapy to PI/r-MT with either LPV/r or DRV/r. METHODS:VL was assessed in each center according to local procedures. Residual viremia was defined by any HIV-RNA value detectable below 50 copies/mL by a Real-Time PCR method. Standard survival analysis was used to estimate the rate of TF (defined by virological failure or interruption of monotherapy or reintroduction of combination therapy). A multivariable Cox regression analysis with automatic stepwise procedures was used to identify factors independently associated with TF among nadir and baseline CD4+ counts, residual viremia, time spent with <50 HIV-RNA copies/mL before switch, history of virological failure, HCV co-infection, being on a PI/r and hemoglobin concentrations at baseline. RESULTS:Six hundred ninety patients fulfilled the inclusion criteria and were included in this analysis. Their median follow-up was 20 (10-37) months. By month 36, TF occurred in 176 (30.2%; 95% CI:25.9-34.5) patients. Only CD4+ nadir counts (adjusted hazard ratio [aHR] = 2.03 [95% CI: 1.35, 3.07] for counts ≤100 vs. >100 cells/μL) and residual viremia (aHR = 1.48 [95% CI: 1.01-2.17] vs. undetectable VL) were independently associated to TF. CONCLUSIONS:Residual viremia and nadir CD4+ counts <100 cells/μL should be regarded as the main factors to be taken into account before considering switching to a PI/r-MT. |
| first_indexed | 2024-04-13T09:48:44Z |
| format | Article |
| id | doaj.art-b5a6974fa76049699847a298a86c3185 |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2024-04-13T09:48:44Z |
| publishDate | 2017-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj.art-b5a6974fa76049699847a298a86c31852022-12-22T02:51:39ZengPublic Library of Science (PLoS)PLoS ONE1932-62032017-01-01122e017161110.1371/journal.pone.0171611Refining criteria for selecting candidates for a safe lopinavir/ritonavir or darunavir/ritonavir monotherapy in HIV-infected virologically suppressed patients.Nicola GianottiAlessandro Cozzi-LepriAndrea AntinoriAntonella CastagnaAndrea De LucaBenedetto Maurizio CelesiaMassimo GalliCristina MussiniCarmela PinnettiVincenzo SpagnuoloAntonella d'Arminio MonforteFrancesca Ceccherini-SilbersteinMassimo AndreoniIcona Foundation Study and mono-PI/r database Study CohortsOBJECTIVE:The primary objective of this study was to estimate the incidence of treatment failure (TF) to protease inhibitor monotherapies (PI/r-MT) with lopinavir/ritonavir (LPV/r) or darunavir/ritonavir (DRV/r). DESIGN:A multicenter cohort of HIV-infected patients with viral load (VL) ≤50 copies/mL, who underwent a switch from any triple combination therapy to PI/r-MT with either LPV/r or DRV/r. METHODS:VL was assessed in each center according to local procedures. Residual viremia was defined by any HIV-RNA value detectable below 50 copies/mL by a Real-Time PCR method. Standard survival analysis was used to estimate the rate of TF (defined by virological failure or interruption of monotherapy or reintroduction of combination therapy). A multivariable Cox regression analysis with automatic stepwise procedures was used to identify factors independently associated with TF among nadir and baseline CD4+ counts, residual viremia, time spent with <50 HIV-RNA copies/mL before switch, history of virological failure, HCV co-infection, being on a PI/r and hemoglobin concentrations at baseline. RESULTS:Six hundred ninety patients fulfilled the inclusion criteria and were included in this analysis. Their median follow-up was 20 (10-37) months. By month 36, TF occurred in 176 (30.2%; 95% CI:25.9-34.5) patients. Only CD4+ nadir counts (adjusted hazard ratio [aHR] = 2.03 [95% CI: 1.35, 3.07] for counts ≤100 vs. >100 cells/μL) and residual viremia (aHR = 1.48 [95% CI: 1.01-2.17] vs. undetectable VL) were independently associated to TF. CONCLUSIONS:Residual viremia and nadir CD4+ counts <100 cells/μL should be regarded as the main factors to be taken into account before considering switching to a PI/r-MT.http://europepmc.org/articles/PMC5305227?pdf=render |
| spellingShingle | Nicola Gianotti Alessandro Cozzi-Lepri Andrea Antinori Antonella Castagna Andrea De Luca Benedetto Maurizio Celesia Massimo Galli Cristina Mussini Carmela Pinnetti Vincenzo Spagnuolo Antonella d'Arminio Monforte Francesca Ceccherini-Silberstein Massimo Andreoni Icona Foundation Study and mono-PI/r database Study Cohorts Refining criteria for selecting candidates for a safe lopinavir/ritonavir or darunavir/ritonavir monotherapy in HIV-infected virologically suppressed patients. PLoS ONE |
| title | Refining criteria for selecting candidates for a safe lopinavir/ritonavir or darunavir/ritonavir monotherapy in HIV-infected virologically suppressed patients. |
| title_full | Refining criteria for selecting candidates for a safe lopinavir/ritonavir or darunavir/ritonavir monotherapy in HIV-infected virologically suppressed patients. |
| title_fullStr | Refining criteria for selecting candidates for a safe lopinavir/ritonavir or darunavir/ritonavir monotherapy in HIV-infected virologically suppressed patients. |
| title_full_unstemmed | Refining criteria for selecting candidates for a safe lopinavir/ritonavir or darunavir/ritonavir monotherapy in HIV-infected virologically suppressed patients. |
| title_short | Refining criteria for selecting candidates for a safe lopinavir/ritonavir or darunavir/ritonavir monotherapy in HIV-infected virologically suppressed patients. |
| title_sort | refining criteria for selecting candidates for a safe lopinavir ritonavir or darunavir ritonavir monotherapy in hiv infected virologically suppressed patients |
| url | http://europepmc.org/articles/PMC5305227?pdf=render |
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