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Refining criteria for selecting candidates for a safe lopinavir/ritonavir or darunavir/ritonavir monotherapy in HIV-infected virologically suppressed patients.

Refining criteria for selecting candidates for a safe lopinavir/ritonavir or darunavir/ritonavir monotherapy in HIV-infected virologically suppressed patients.
Author Information (click to view)

Gianotti N, Cozzi-Lepri A, Antinori A, Castagna A, De Luca A, Celesia BM, Galli M, Mussini C, Pinnetti C, Spagnuolo V, d'Arminio Monforte A, Ceccherini-Silberstein F, Andreoni M, ,


Gianotti N, Cozzi-Lepri A, Antinori A, Castagna A, De Luca A, Celesia BM, Galli M, Mussini C, Pinnetti C, Spagnuolo V, d'Arminio Monforte A, Ceccherini-Silberstein F, Andreoni M, , (click to view)

Gianotti N, Cozzi-Lepri A, Antinori A, Castagna A, De Luca A, Celesia BM, Galli M, Mussini C, Pinnetti C, Spagnuolo V, d'Arminio Monforte A, Ceccherini-Silberstein F, Andreoni M, ,

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PloS one 2017 02 1312(2) e0171611 doi 10.1371/journal.pone.0171611

Abstract
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.

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