Background: The main objective is to evaluate the efficacy and durability of lopinavir-ritonavir monotherapy (LPV/r-MT) in virologically controlled HIV-positive individuals switching from combination antiretroviral therapy (cART). Methods: Criteria to be included in this observational study were to have initiated for the first time LPV/r-MT after >= 2 consecutive HIV RNA <= 50 copies/ml achieved on a >= 3-drug-including regimen. The main end points were time to virological rebound (VR; defined in two ways: time of first of two consecutive viral load [VL]>50 and >200 copies/ml), time to discontinuation/intensification and time to experience either a single VL>200 copies/ml or discontinuation/intensification (treatment failure [TF]). Individuals' follow-up accrued from the date of starting LPV/r-MT to event or last available VL. Kaplan-Meier curves and Cox regression analyses were used. Results: A total of 228 individuals were included: median age 46 years (IQR 40-50), 36% females, 36% intravenous drug users and 25% HCV-coinfected. Median CD4(+) T-cell count at nadir was 215 cell/mm(3) (IQR 116-336) and at baseline was 615 cell/mm(3) (IQR 436-768). By 36 months after switching to LPV/r-MT, the proportion of individuals with VR (confirmed VL>200 copies/ml) was 11% and with TF was 35%. In the multivariable Cox model the factors associated with a lower risk of TF was the duration of viral suppression <50 copies/ml prior to baseline (ARH=0.92; 95% CI 0.85, 0.99; P=0.024, per 6 months longer) and having LPV/r as part of last cART (ARH=0.45; 95% CI 0.21, 0.95; P=0.037). Conclusions: In daily clinical practice, we confirm a relatively safe approach of treatment simplification to LPV-MT in a selected population with long-lasting virological control.

Durability of lopinavir/ritonavir monotherapy in individuals with viral load ≤50 copies/ml in an observational setting / A. d’Arminio Monforte, N. Gianotti, A. Cozzi-Lepri, C. Pinnetti, M. Andreoni, G.D. Perri, M. Galli, A. Poli, A. Costantini, G. Orofino, F. Maggiolo, G. Mazzarello, B.M. Celesia, F. Luciani, A. Lazzarin, L. Sighinolfi, G. Rizzardini, P. Bonfanti, C.F. Perno, A. Antinori, T.I.F. Cohort. - In: ANTIVIRAL THERAPY. - ISSN 1359-6535. - 19:3(2014), pp. 319-324. [10.3851/IMP2687]

Durability of lopinavir/ritonavir monotherapy in individuals with viral load ≤50 copies/ml in an observational setting

A. d’Arminio Monforte;M. Galli;P. Bonfanti;C. F. Perno;GORI, ANDREA
2014

Abstract

Background: The main objective is to evaluate the efficacy and durability of lopinavir-ritonavir monotherapy (LPV/r-MT) in virologically controlled HIV-positive individuals switching from combination antiretroviral therapy (cART). Methods: Criteria to be included in this observational study were to have initiated for the first time LPV/r-MT after >= 2 consecutive HIV RNA <= 50 copies/ml achieved on a >= 3-drug-including regimen. The main end points were time to virological rebound (VR; defined in two ways: time of first of two consecutive viral load [VL]>50 and >200 copies/ml), time to discontinuation/intensification and time to experience either a single VL>200 copies/ml or discontinuation/intensification (treatment failure [TF]). Individuals' follow-up accrued from the date of starting LPV/r-MT to event or last available VL. Kaplan-Meier curves and Cox regression analyses were used. Results: A total of 228 individuals were included: median age 46 years (IQR 40-50), 36% females, 36% intravenous drug users and 25% HCV-coinfected. Median CD4(+) T-cell count at nadir was 215 cell/mm(3) (IQR 116-336) and at baseline was 615 cell/mm(3) (IQR 436-768). By 36 months after switching to LPV/r-MT, the proportion of individuals with VR (confirmed VL>200 copies/ml) was 11% and with TF was 35%. In the multivariable Cox model the factors associated with a lower risk of TF was the duration of viral suppression <50 copies/ml prior to baseline (ARH=0.92; 95% CI 0.85, 0.99; P=0.024, per 6 months longer) and having LPV/r as part of last cART (ARH=0.45; 95% CI 0.21, 0.95; P=0.037). Conclusions: In daily clinical practice, we confirm a relatively safe approach of treatment simplification to LPV-MT in a selected population with long-lasting virological control.
lopinavir-ritonavir monotherapy; HIV suppression; maintenance; therapy; risk
Settore MED/17 - Malattie Infettive
ANTIVIRAL THERAPY
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/2434/253263
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