TY - JOUR
T1 - Efficacy and tolerability of switching to a dual therapy with darunavir/ritonavir plus raltegravir in HIV-infected patients with HIV-1 RNA ≤50 cp/mL
AU - Madeddu, G.
AU - Rusconi, Stefano
AU - Cozzi-Lepri, Alessandro
AU - Di Giambenedetto, Simona
AU - Bonora, Stefano
AU - Carbone, Alessia
AU - De Luca, Andrea
AU - Gianotti, Nicola
AU - Di Biagio, Antonio
AU - Antinori, A.
AU - d’Arminio Monforte, A.
AU - Antinori, A.
AU - Galli, M.
AU - Ippolito, G.
AU - Lazzarin, A.
AU - Perno, C. F.
AU - Castagna, A.
AU - Girardi, E.
AU - Ammassari, A.
AU - Calcagno, A.
AU - Capobianchi, M. R.
AU - Cinque, P.
AU - Nozza, S.
AU - Santoro, M. M.
AU - Zaccarelli, M.
AU - Galli, L.
AU - Lorenzini, P.
AU - Rodano, A.
AU - Carletti, F.
AU - Carrara, S.
AU - Di Caro, A.
AU - Graziano, S.
AU - Prota, G.
AU - Quartu, S.
AU - Truffa, S.
AU - Donati, V.
AU - Viscoli, C.
AU - Castelli, A. P.
AU - Gori, A.
AU - Magnani, G.
AU - Cristaudo, A.
AU - Cicalini, S.
AU - Nicastri, E.
AU - Acinapura, R.
AU - Capozzi, M.
AU - Libertone, R.
AU - Latini, A.
AU - Mura, M. S.
AU - De Luca, A.
AU - Sciandra, M.
AU - for the Icona Foundation Study Group
PY - 2017/8/1
Y1 - 2017/8/1
N2 - Background: Nucleos(t)ide reverse transcriptase inhibitors (NRTI) toxicity may represent a threat for long-term success of combined antiretroviral therapy. Some studies have suggested a possible improvement of NRTI-related toxicity after switching to NRTI-sparing regimens. Objectives: We aimed to explore the efficacy and tolerability of switching to darunavir/ritonavir (DRV/r) plus raltegravir (RAL) while having a viral load (VL) ≤50 copies/mL in the clinical setting. Study design: Treatment-experienced HIV 1-infected patients enrolled in the ICONA Foundation Study cohort were included if they switched their current regimen to DRV/r + RAL with a HIV-RNA ≤50 copies/mL. Different definitions of virological failure (VF) and treatment failure (TF) were employed. Kaplan–Meier curves and Cox regression models were performed to estimate time to event probability. Results: We included 72 HIV-infected patients, 22 (31%) of these were female, 31 (43%) men who have sex with men (MSM) amd 15 (21%) had hepatitis co-infections. Median age was 44 (IQR: 35-50) years amd CD4 count was 389 (IQR 283-606) cells/mmc. Median follow-up time for TF was 24 (IQR 9–31) months. Twenty-five discontinuations occurred (60% simplifications); only 2 (8%) were toxicity-driven (lipid elevations). The probability of VF (confirmed VL >50 copies/mL) was estimated at 7% [95% confidence interval (CI) 1–13%] by 12 and 9% (95% CI 2–16%) by 24 months. When considering TF, we found a probability of stop/intensification/single VL > 200 copies/mL of 13% (95% CI 1–17%) and 22% (95% CI 11–33%) by 12 and 24 months. Female gender (adjusted relative hazard, ARH = 0.10; 95% CI 0.01–0.74; p = 0.024) and older age (AHR = 0.50 per 10 years older; 95% CI 0.25–0.99; p = 0.045) were associated with a lower risk of TF. A previous PI failure was strongly associated with TF (AHR = 52.6, 95% CI 3.6–779; p = 0.004). Conclusions: DRV/r + RAL is a valuable NRTI-sparing option, especially in female and older patients, with a relatively low risk of VF and good tolerability after 2 years since start in an ART-experienced population. However, previous PI-failure should be a limiting factor for this strategy.
AB - Background: Nucleos(t)ide reverse transcriptase inhibitors (NRTI) toxicity may represent a threat for long-term success of combined antiretroviral therapy. Some studies have suggested a possible improvement of NRTI-related toxicity after switching to NRTI-sparing regimens. Objectives: We aimed to explore the efficacy and tolerability of switching to darunavir/ritonavir (DRV/r) plus raltegravir (RAL) while having a viral load (VL) ≤50 copies/mL in the clinical setting. Study design: Treatment-experienced HIV 1-infected patients enrolled in the ICONA Foundation Study cohort were included if they switched their current regimen to DRV/r + RAL with a HIV-RNA ≤50 copies/mL. Different definitions of virological failure (VF) and treatment failure (TF) were employed. Kaplan–Meier curves and Cox regression models were performed to estimate time to event probability. Results: We included 72 HIV-infected patients, 22 (31%) of these were female, 31 (43%) men who have sex with men (MSM) amd 15 (21%) had hepatitis co-infections. Median age was 44 (IQR: 35-50) years amd CD4 count was 389 (IQR 283-606) cells/mmc. Median follow-up time for TF was 24 (IQR 9–31) months. Twenty-five discontinuations occurred (60% simplifications); only 2 (8%) were toxicity-driven (lipid elevations). The probability of VF (confirmed VL >50 copies/mL) was estimated at 7% [95% confidence interval (CI) 1–13%] by 12 and 9% (95% CI 2–16%) by 24 months. When considering TF, we found a probability of stop/intensification/single VL > 200 copies/mL of 13% (95% CI 1–17%) and 22% (95% CI 11–33%) by 12 and 24 months. Female gender (adjusted relative hazard, ARH = 0.10; 95% CI 0.01–0.74; p = 0.024) and older age (AHR = 0.50 per 10 years older; 95% CI 0.25–0.99; p = 0.045) were associated with a lower risk of TF. A previous PI failure was strongly associated with TF (AHR = 52.6, 95% CI 3.6–779; p = 0.004). Conclusions: DRV/r + RAL is a valuable NRTI-sparing option, especially in female and older patients, with a relatively low risk of VF and good tolerability after 2 years since start in an ART-experienced population. However, previous PI-failure should be a limiting factor for this strategy.
KW - Antiretroviral therapy
KW - Darunavir/ritonavir
KW - Efficacy
KW - NRTI-sparing regimen
KW - Raltegravir
KW - Tolerability
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U2 - 10.1007/s15010-017-1018-z
DO - 10.1007/s15010-017-1018-z
M3 - Article
AN - SCOPUS:85018792712
VL - 45
SP - 521
EP - 528
JO - Infection
JF - Infection
SN - 0300-8126
IS - 4
ER -