Efficacy and tolerability of switching to a dual therapy with darunavir/ritonavir plus raltegravir in HIV-infected patients with HIV-1 RNA ≤50 ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2017-05-05

AUTHORS

Giordano Madeddu, Stefano Rusconi, Alessandro Cozzi-Lepri, Simona Di Giambenedetto, Stefano Bonora, Alessia Carbone, Andrea De Luca, Nicola Gianotti, Antonio Di Biagio, Andrea Antinori, for the Icona Foundation Study Group

ABSTRACT

BackgroundNucleos(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.ObjectivesWe 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 designTreatment-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.ResultsWe 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).ConclusionsDRV/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. More... »

PAGES

521-528

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s15010-017-1018-z

DOI

http://dx.doi.org/10.1007/s15010-017-1018-z

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1085184421

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/28477212


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24 schema:description BackgroundNucleos(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.ObjectivesWe 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 designTreatment-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.ResultsWe 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).ConclusionsDRV/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.
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31 CD4 count
32 CP
33 Cox regression model
34 DRV/r
35 HIV
36 HIV RNA
37 HIV-1
38 HIV-1 RNA
39 ICONA Foundation Study cohort
40 Kaplan-Meier curves
41 MMC
42 NRTI-sparing regimens
43 ObjectivesWe
44 PI failure
45 RNA
46 ResultsWe
47 age
48 antiretroviral therapy
49 cells/mmc
50 clinical setting
51 cohort
52 copies/
53 copies/mL
54 count
55 current regimen
56 curves
57 darunavir/ritonavir
58 definition
59 different definitions
60 discontinuation
61 dual therapy
62 efficacy
63 factors
64 failure
65 female gender
66 females
67 gender
68 good tolerability
69 hepatitis
70 improvement
71 inhibitor toxicity
72 load
73 long-term success
74 lower risk
75 mL
76 median age
77 men
78 model
79 months
80 older age
81 older patients
82 options
83 patients
84 population
85 possible improvements
86 probability
87 probability of VF
88 raltegravir
89 regimen
90 regimens
91 regression models
92 risk
93 ritonavir
94 setting
95 sex
96 single viral load
97 start
98 strategies
99 study
100 study cohort
101 success
102 therapy
103 threat
104 time
105 tolerability
106 toxicity
107 treatment failure
108 viral load
109 virological failure
110 years
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