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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.
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 / Madeddu G, Rusconi S, Cozzi-Lepri A, Di Giambenedetto S, Bonora S, Carbone A, De Luca A, Gianotti N, Di Biagio A, Antinori A;d'Arminio Monforte A, Andreoni M, Angarano G, Antinori A, Castelli F, Cauda R, Di Perri G, Galli M, Iardino R, Ippolito G, Lazzarin A, Perno CF, von Schloesser F, Viale P, Castagna A, Ceccherini-Silberstein F, Cozzi-Lepri A, Girardi E, Lo Caputo S, Mussini C, Puoti M, Ammassari A, Balotta C, Bandera A, Bonfanti P, Borderi M, Calcagno A, Calza L, Capobianchi MR, Cingolani A, Cinque P, Lichtner A, Madeddu G, Maggiolo F, Marchetti G, Marcotullio S, Monno L, Nozza S, Quiros Roldan E, Rossotti R, Rusconi S, Santoro MM, Saracino A, Zaccarelli M, Fanti I, Galli L, Lorenzini P, Rodano A, Shanyinde M, Tavelli A, Carletti F, Carrara S, Di Caro A, Graziano S, Petrone F, Prota G, Quartu S, Truffa S, Giacometti A, Costantini A, Valeriani C, Santoro C, Suardi C, Donati V, Verucchi G, Minardi C, Quirino T, Abeli C, Manconi PE, Piano P, Cacopardo B, Celesia B, Vecchiet J, Falasca K, Sighinolfi L, Segala D, Mazzotta F, Vichi F, Cassola G, Viscoli C, Alessandrini A, Bobbio N, Mazzarello G, Mastroianni C, Belvisi V, Caramma I, Chiodera A, Castelli AP, Rizzardini G, Ridolfo AL, Piolini R, Salpietro S, Carenzi L, Moioli MC, Tincati C, Puzzolante C, Gori A, Guaraldi G, Lapadula G, Abrescia N, Chirianni A, Borgia G, Di Martino F, Maddaloni L, Gentile I, Orlando R, Cascio A, Colomba C, Baldelli F, Francisci D, Parruti G, Ursini T, Magnani G, Ursitti MA, Vullo V, Cristaudo A, Baldin G, Cicalini S, Gallo L, Nicastri E, Acinapura R, Capozzi M, Libertone R, Savinelli S, Latini A, Iaiani G, Fontanelli Sulekova L, Cecchetto M, Viviani F, Mura MS, De Luca A, Rossetti B, Caramello P, Orofino GC, Bonora S, Sciandra M, Bassetti M, Londero A, Pellizzer G, Manfrin V.. - In: INFECTION. - ISSN 0300-8126. - STAMPA. - 45:4(2017), pp. 521-528. [10.1007/s15010-017-1018-z]
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.
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.
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 / Madeddu G, Rusconi S, Cozzi-Lepri A, Di Giambenedetto S, Bonora S, Carbone A, De Luca A, Gianotti N, Di Biagio A, Antinori A;d'Arminio Monforte A, Andreoni M, Angarano G, Antinori A, Castelli F, Cauda R, Di Perri G, Galli M, Iardino R, Ippolito G, Lazzarin A, Perno CF, von Schloesser F, Viale P, Castagna A, Ceccherini-Silberstein F, Cozzi-Lepri A, Girardi E, Lo Caputo S, Mussini C, Puoti M, Ammassari A, Balotta C, Bandera A, Bonfanti P, Borderi M, Calcagno A, Calza L, Capobianchi MR, Cingolani A, Cinque P, Lichtner A, Madeddu G, Maggiolo F, Marchetti G, Marcotullio S, Monno L, Nozza S, Quiros Roldan E, Rossotti R, Rusconi S, Santoro MM, Saracino A, Zaccarelli M, Fanti I, Galli L, Lorenzini P, Rodano A, Shanyinde M, Tavelli A, Carletti F, Carrara S, Di Caro A, Graziano S, Petrone F, Prota G, Quartu S, Truffa S, Giacometti A, Costantini A, Valeriani C, Santoro C, Suardi C, Donati V, Verucchi G, Minardi C, Quirino T, Abeli C, Manconi PE, Piano P, Cacopardo B, Celesia B, Vecchiet J, Falasca K, Sighinolfi L, Segala D, Mazzotta F, Vichi F, Cassola G, Viscoli C, Alessandrini A, Bobbio N, Mazzarello G, Mastroianni C, Belvisi V, Caramma I, Chiodera A, Castelli AP, Rizzardini G, Ridolfo AL, Piolini R, Salpietro S, Carenzi L, Moioli MC, Tincati C, Puzzolante C, Gori A, Guaraldi G, Lapadula G, Abrescia N, Chirianni A, Borgia G, Di Martino F, Maddaloni L, Gentile I, Orlando R, Cascio A, Colomba C, Baldelli F, Francisci D, Parruti G, Ursini T, Magnani G, Ursitti MA, Vullo V, Cristaudo A, Baldin G, Cicalini S, Gallo L, Nicastri E, Acinapura R, Capozzi M, Libertone R, Savinelli S, Latini A, Iaiani G, Fontanelli Sulekova L, Cecchetto M, Viviani F, Mura MS, De Luca A, Rossetti B, Caramello P, Orofino GC, Bonora S, Sciandra M, Bassetti M, Londero A, Pellizzer G, Manfrin V.. - In: INFECTION. - ISSN 0300-8126. - STAMPA. - 45:4(2017), pp. 521-528. [10.1007/s15010-017-1018-z]
Madeddu G, Rusconi S, Cozzi-Lepri A, Di Giambenedetto S, Bonora S, Carbone A, De Luca A, Gianotti N, Di Biagio A, Antinori A;d'Arminio Monforte A, Andreoni M, Angarano G, Antinori A, Castelli F, Cauda R, Di Perri G, Galli M, Iardino R, Ippolito G, Lazzarin A, Perno CF, von Schloesser F, Viale P, Castagna A, Ceccherini-Silberstein F, Cozzi-Lepri A, Girardi E, Lo Caputo S, Mussini C, Puoti M, Ammassari A, Balotta C, Bandera A, Bonfanti P, Borderi M, Calcagno A, Calza L, Capobianchi MR, Cingolani A, Cinque P, Lichtner A, Madeddu G, Maggiolo F, Marchetti G, Marcotullio S, Monno L, Nozza S, Quiros Roldan E, Rossotti R, Rusconi S, Santoro MM, Saracino A, Zaccarelli M, Fanti I, Galli L, Lorenzini P, Rodano A, Shanyinde M, Tavelli A, Carletti F, Carrara S, Di Caro A, Graziano S, Petrone F, Prota G, Quartu S, Truffa S, Giacometti A, Costantini A, Valeriani C, Santoro C, Suardi C, Donati V, Verucchi G, Minardi C, Quirino T, Abeli C, Manconi PE, Piano P, Cacopardo B, Celesia B, Vecchiet J, Falasca K, Sighinolfi L, Segala D, Mazzotta F, Vichi F, Cassola G, Viscoli C, Alessandrini A, Bobbio N, Mazzarello G, Mastroianni C, Belvisi V, Caramma I, Chiodera A, Castelli AP, Rizzardini G, Ridolfo AL, Piolini R, Salpietro S, Carenzi L, Moioli MC, Tincati C, Puzzolante C, Gori A, Guaraldi G, Lapadula G, Abrescia N, Chirianni A, Borgia G, Di Martino F, Maddaloni L, Gentile I, Orlando R, Cascio A, Colomba C, Baldelli F, Francisci D, Parruti G, Ursini T, Magnani G, Ursitti MA, Vullo V, Cristaudo A, Baldin G, Cicalini S, Gallo L, Nicastri E, Acinapura R, Capozzi M, Libertone R, Savinelli S, Latini A, Iaiani G, Fontanelli Sulekova L, Cecchetto M, Viviani F, Mura MS, De Luca A, Rossetti B, Caramello P, Orofino GC, Bonora S, Sciandra M, Bassetti M, Londero A, Pellizzer G, Manfrin V.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11585/626055
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simulazione ASN
Il report seguente simula gli indicatori relativi alla propria produzione scientifica in relazione alle soglie ASN 2023-2025 del proprio SC/SSD. Si ricorda che il superamento dei valori soglia (almeno 2 su 3) è requisito necessario ma non sufficiente al conseguimento dell'abilitazione. La simulazione si basa sui dati IRIS e sugli indicatori bibliometrici alla data indicata e non tiene conto di eventuali periodi di congedo obbligatorio, che in sede di domanda ASN danno diritto a incrementi percentuali dei valori. La simulazione può differire dall'esito di un’eventuale domanda ASN sia per errori di catalogazione e/o dati mancanti in IRIS, sia per la variabilità dei dati bibliometrici nel tempo. Si consideri che Anvur calcola i valori degli indicatori all'ultima data utile per la presentazione delle domande.
La presente simulazione è stata realizzata sulla base delle specifiche raccolte sul tavolo ER del Focus Group IRIS coordinato dall’Università di Modena e Reggio Emilia e delle regole riportate nel DM 589/2018 e allegata Tabella A. Cineca, l’Università di Modena e Reggio Emilia e il Focus Group IRIS non si assumono alcuna responsabilità in merito all’uso che il diretto interessato o terzi faranno della simulazione. Si specifica inoltre che la simulazione contiene calcoli effettuati con dati e algoritmi di pubblico dominio e deve quindi essere considerata come un mero ausilio al calcolo svolgibile manualmente o con strumenti equivalenti.
