Search

Your search keyword '"C Abeli"' showing total 23 results
Start Over Author "C Abeli"
23 results on '"C Abeli"'

1. HBcAb Positivity Increases the Risk of Severe Hepatic Fibrosis Development in HIV/HCV-Positive Subjects from the ICONA Italian Cohort of HIV-Infected Patients

Author

Malagnino, Vincenzo, Cerva, Carlotta, Cingolani, Antonella, Ceccherini-Silberstein, Francesca, Vergori, Alessandra, Cuomo, Gianluca, Perno, Carlo Federico, Puoti, Massimo, d'Arminio Monforte, Antonella, Cozzi-Lepri, Alessandro, Andreoni, Massimo, Sarmati, Loredana, d’Arminio Monforte (President), Icona Fundation Study Group. Board of Directors: A., Antinori (Vice-President), A., Andreoni, M., Castagna, A., Castelli, F., Cauda, R., Di Perri, G., Galli, M., Iardino, R., Ippolito, G., Lazzarin, A., Marchetti, G. C., Rezza, G., von Schloesser, F., d’Arminio Monforte, P. Viale. Scientific Secretary: A., Antinori, A., Ceccherinisilberstein, F., Cozzi-Lepri, A., Girardi, E., Gori, A., Lo Caputo, S., Maggiolo, F., Mussini, C., Puoti, M., Antinori, C. F. Perno. Steering Committee: A., Bai, F., Bandera, A., Bonora, S., Borderi, M., Calcagno, A., Capobianchi, M. R., Ceccherini-Silberstein, F., Cicalini, S., Cingolani, A., Cinque, P., d’Arminio Monforte, A., Di Biagio, A., Gagliardini, R., Gianotti, N., Guaraldi, G., Lapadula, G., Lichtner, M., Lai, A., Madeddu, G., Marchetti, G., Merlini, E., Nozza, S., Perno, C. F., Piconi, S., Pinnetti, C., Quiros Roldan, E., Rossotti, R., Rusconi, S., Santoro, M. M., Saracino, A., Sarmati, L., Spagnuolo, V., Svicher, V., Taramasso, L., Cozzi-Lepri, Statistical and Monitoring Team: A., Fanti, I., Galli, L., Lorenzini, P., Rodanó, A., Macchia, M., Bove, A. Tavelli. Community Advisory Board: A., Camposeragna, A., Errico, M., Manfredini, M., Perziano, A., Carletti, V. Calvino. Biological Bank INMI: F., Carrara, S., Di Caro, A., Graziano, S., Petroni, F., Prota, G., Giacometti, S. Truffa. Participating Physicians and Centers: Italy: A., Costantini, A., Barocci (Ancona), V., Angarano, G., Monno, L., Milano (Bari), E., F. Maggiolo, C. Suardi (Bergamo), Viale, P., Donati, V., Verucchi (Bologna), G., Castelnuovo, F., Minardi, C., Quiros Roldan (Brescia), E., B. Menzaghi, C. Abeli (Busto Arsizio), L. Chessa, F. Pes (Cagliarti), B. Cacopardo, B. Celesia (Catania), J. Vecchiet, K. Falasca (Chieti), A. Pan, S. Lorenzotti (Cremona), L. Sighinolfi, D. Segala (Ferrara), P. Blanc, F. Vichi (Firenze), Cassola, G., Bassetti, M., Alessandrini, A., Bobbio, N., Mazzarello (Genova), G., M. Lichtner, L. Fondaco (Latina), P. Bonfanti, C. Molteni (Lecco), A. Chiodera, P. Milini (Macerata), G. Nunnari, G. Pellicanò (Messina), Rizzardini, G., Cannizzo, E. S., Moioli, M. C., Piolini, R., Bernacchia, D., Poli, A., Tincati (Milano), C., C. Mussini, C. Puzzolante (Modena), C. Migliorino, G. Lapadula (Monza), Sangiovanni, V., Borgia, G., Esposito, V., Di Flumeri, G., Gentile, I., Rizzo (Napoli), V., A. M. Cattelan, S. Marinello (Padova), A. Cascio, M. Trizzino (Palermo), D. Francisci, E. Schiaroli (Perugia), G. Parruti, F. Sozio (Pescara), C. Lazzaretti, R. Corsini (Reggio Emilia), Cristaudo, A., Vullo, V., Acinapura, R., Lamonica, S., Capozzi, M., Mondi, A., Rivano Capparuccia, M., Iaiani, G., Latini, A., Onnelli, G., Plazzi, M. M., De Girolamo, G., Vergori (Roma), A., M. Cecchetto, F. Viviani (Rovigo), G. Madeddu, A. De Vito (Sassari), B. Rossetti, F. Montagnani (Siena), A. Franco, R. Fontana Del Vecchio (Siracusa), Di Giuli (Terni), C., Caramello, P., Orofino, G. C., Sciandra (Torino), M., Londero (Udine), A., V. Manfrin, G. Battagin (Vicenza), G. Starnini, A. Ialungo (Viterbo)., Malagnino, V, Cerva, C, Cingolani, A, Ceccherini-Silberstein, F, Vergori, A, Cuomo, G, Perno, C, Puoti, M, D'Arminio Monforte, A, Cozzi-Lepri, A, Andreoni, M, Sarmati, L, Malagnino, V., Cerva, C., Cingolani, A., Ceccherini-Silberstein, F., Vergori, A., Cuomo, G., Perno, C. F., Puoti, M., D'Arminio Monforte, A., Cozzi-Lepri, A., Andreoni, M., Sarmati, L., ICONA Foundation Study, Group, Castagna, A., Malagnino V., Cerva C., Cingolani A., Ceccherini-Silberstein F., Vergori A., Cuomo G., Perno C.F., Puoti M., D'Arminio Monforte A., Cozzi-Lepri A., Andreoni M., and Sarmati L.A Castagna, F Castelli, R Cauda, G Di Perri, M Galli, R Iardino, G Ippolito, A Lazzarin, G C Marchetti, G Rezza, F von Schloesser, E Girardi, A Gori, S Lo Caputo, F Maggiolo, F Bai, A Bandera, S Bonora, M Borderi, A Calcagno, M R Capobianchi, S Cicalini, P Cinque, A Di Biagio, R Gagliardini, N Gianotti, G Guaraldi, G Lapadula, M Lichtner, A Lai, S Lo Caputo, G Madeddu, G Marchetti, E Merlini, C Mussini, S Nozza, S Piconi, C Pinnetti, E Quiros Roldan, R Rossotti, S Rusconi, M M Santoro, A Saracino, V Spagnuolo, V Svicher, L Taramasso, I Fanti, L Galli, P Lorenzini, A Rodanó, M Macchia, A Tavelli, A Bove, A Camposeragna, M Errico, M Manfredini, A Perziano, V Calvino, F Carletti, S Carrara, A Di Caro, S Graziano, F Petroni, G Prota, S Truffa, A Giacometti, A Costantini, V Barocci, G Angarano, L Monno, E Milano, C Suardi, V Donati, G Verucchi, F Castelnuovo, C Minardi, B Menzaghi, C Abeli, L Chessa, F Pes, B Cacopardo, B Celesia, J Vecchiet, K Falasca, A Pan, S Lorenzotti, L Sighinolfi, D Segala, P Blanc, F Vichi, G Cassola, M Bassetti, A Alessandrini, N Bobbio, G Mazzarello, M Lichtner, L Fondaco, P Bonfanti, C Molteni, A Chiodera, P Milini, G Nunnari, G Pellicanò, , G Rizzardini, E S Cannizzo, M C Moioli, R Piolini, D Bernacchia, A Poli, C Tincati, C Puzzolante, C Migliorino, G Lapadula, V Sangiovanni, G Borgia, V Esposito, G Di Flumeri, I Gentile, V Rizzo, A M Cattelan, S Marinello, A Cascio, M Trizzino, D Francisci, E Schiaroli, G Parruti, F Sozio, C Lazzaretti, R Corsini, A Antinori, A Cristaudo, V Vullo, R Acinapura, S Lamonica, M Capozzi, A Mondi, M Rivano Capparuccia, G Iaiani, A Latini, G Onnelli, M M Plazzi, G De Girolamo, M Cecchetto, F Viviani, G Madeddu, A De Vito, B Rossetti, F Montagnani, A Franco, R Fontana Del Vecchio, C Di Giuli, P Caramello, G C Orofino, M Sciandra, A Londero, V Manfrin, G Battagin, G Starnini, A Ialungo

Subjects
HBsAg, medicine.medical_specialty, Hepatitis C virus, Liver fibrosis, Human immunodeficiency virus (HIV), OBI, medicine.disease_cause, anti-HBc, HBV, HIV/HBV coinfection, liver fibrosis, Gastroenterology, Major Articles, NO, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, Hiv infected patients, 030212 general & internal medicine, Hepatitis B virus, business.industry, liver fibrosi, virus diseases, Settore MED/17, digestive system diseases, Anti-HBc, HIV-HBV coinfection, HBV, Liver fibrosis, OBI, Infectious Diseases, AcademicSubjects/MED00290, HIV-HBV coinfection, Oncology, Cohort, 030211 gastroenterology & hepatology, business, Hepatic fibrosis
Abstract

Background The aim of this study was to investigate the impact of anti-HBc (HBcAb) positivity on the progression of liver fibrosis (Fibrosis-4 score >3.25) in the Italian cohort of HIV-infected individuals naïve to antiretroviral treatment (ICONA). Methods All patients with FIB-4 Results Patients who were HBcAb+/HCV-/HBs antigen (HBsAg)- and HCV+/HBcAb+/HBsAg- or HBsAg+/HBcAb+/HCV- had CD4+ cell counts below the nadir and significantly higher prevalence of AIDS diagnosis at baseline than the other groups (P < .0001). A Cox regression model adjusted for age, HIV transmission mode, country of birth, and alcohol consumption showed a higher relative risk (HR) of progression to FIB-4 >3.25 in HCV+/HBcAb+/HBsAg- patients (HR, 7.2; 95% CI, 3 8–13.64). Conclusions HBcAb+ contributes to liver damage in HIV+/HCV+/HBcAb+/HBsAg- subjects. A careful monitoring for signs of previous HBV infection is needed in this kind of patients.

Published
2021

2. Durability of different initial regimens in HIV-infected patients starting antiretroviral therapy with CD4+ counts <200 cells/mm3 and HIV-RNA >5 log10 copies/mL

Author

Bruno Cacopardo, M. A. Ursitti, Claudio Maria Mastroianni, Emanuele Nicastri, R. Piolini, A. Antinori, Giustino Parruti, S. Truffa, Ivan Gentile, Giovanni Cassola, E. Girardi, I. Caramma, Andrea Calcagno, Laura Monno, A d'Arminio Monforte, R. Acinapura, Francesca Ceccherini-Silberstein, A. Di Biagio, Gabriella Verucchi, Alessandra Latini, Simone Marcotullio, Nicola Gianotti, C. Balotta, Camilla Tincati, M. C. Moioli, Alessandro Tavelli, Pietro Caramello, Carmen Rita Santoro, C. Abeli, A. Londero, F. Di Martino, R. Iardino, Stefano Bonora, M. Andreoni, A. Costantini, Raffaella Libertone, F. von Schloesser, G. Prota, Annalisa Saracino, Maria Grazia Cecchetto, Antonio Cristaudo, Mauro Zaccarelli, Carmela Pinnetti, Fabrizio Carletti, N. Abrescia, Andrea Giacometti, L. Gallo, Paolo Bonfanti, G. Angarano, E. Quiros Roldan, G. Pellizzer, F. Petrone, Giovanni Mazzarello, Silvia Nozza, R. Orlando, Franco Baldelli, Giovanni Guaraldi, Paola Meraviglia, Laura Sighinolfi, S. Carrara, D. Segala, Giuliano Rizzardini, C. Suardi, P. Piano, Mauro Sciandra, Daniela Francisci, A. De Luca, Patrizia Lorenzini, Paola Cinque, Tiziana Quirino, S. Graziano, Cristina Mussini, Massimo Galli, Giuseppe Ippolito, S. Lo Caputo, Benedetto Maurizio Celesia, C. Valeriani, Matteo Bassetti, Maria Rosaria Capobianchi, Claudio Viscoli, Vinicio Manfrin, Alessandro Chiodera, Alessandra Bandera, Guglielmo Borgia, Cinzia Puzzolante, Stefano Rusconi, Leonardo Calza, Valeria Belvisi, Francesca Vichi, Serena Quartu, Roberto Cauda, J. Vecchiet, Antonio Chirianni, A. Di Caro, P.E. Manconi, Stefania Cicalini, G. Magnani, M. Lichtner, Milensu Shanyinde, Stefano Savinelli, M. Puoti, Giulia Marchetti, Laura Carenzi, Carlo Federico Perno, Annalisa Ridolfo, G. Di Perri, F. Maggiolo, A Castagna, G. Orofino, Roberto Rossotti, Francesco Mazzotta, Gianmaria Baldin, Giovanni Lapadula, A. Rodano, V. Donati, Barbara Rossetti, F. Viviani, Adriana Ammassari, N. Bobbio, Adriano Lazzarin, C. Minardi, A. Alessandrini, Katia Falasca, Maria Stella Mura, Tamara Ursini, Andrea Gori, A. Cingolani, L. Maddaloni, Alessandro Cozzi-Lepri, Francesco Castelli, Iuri Fanti, Giordano Madeddu, E. Quiros, P. Viale, Marco Borderi, M. Capozzi, and Vincenzo Vullo

Subjects
Adult, Male, 0301 basic medicine, Microbiology (medical), medicine.medical_specialty, Anti-HIV Agents, Hepatitis C virus, Renal function, Integrase inhibitor, HIV Infections, medicine.disease_cause, Rate ratio, 03 medical and health sciences, 0302 clinical medicine, Antiretroviral Therapy, Highly Active, Internal medicine, Clinical endpoint, Humans, Medicine, Pharmacology (medical), Treatment Failure, 030212 general & internal medicine, Retrospective Studies, Pharmacology, AIDS-Related Opportunistic Infections, Coinfection, business.industry, Retrospective cohort study, Middle Aged, Viral Load, 030112 virology, CD4 Lymphocyte Count, Discontinuation, Treatment Outcome, Infectious Diseases, Cohort, Female, business
Abstract

ObjectivesOur aim was to investigate the durability of different initial regimens in patients starting ART with CD4+ counts 5 log10 copies/mL.MethodsThis was a retrospective study of HIV-infected patients prospectively followed in the ICONA cohort. Those who started ART with boosted protease inhibitors (bPIs), NNRTIs or integrase strand transfer inhibitors (InSTIs), with CD4+ 5 log10 copies/mL, were included. The primary endpoint was treatment failure (TF), a composite endpoint defined as virological failure (VF, first of two consecutive HIV-RNA >50 copies/mL after 6 months of treatment), discontinuation of class of the anchor drug or death. Independent associations were investigated by Poisson regression analysis in a model including age, gender, mode of HIV transmission, CDC stage, HCV and HBV co-infection, pre-treatment HIV-RNA, CD4+ count and CD4+/CD8+ ratio, ongoing opportunistic disease, fibrosis FIB-4 index, estimated glomerular filtration rate, haemoglobin, platelets, neutrophils, calendar year of ART initiation, anchor drug class (treatment group) and nucleos(t)ide backbone.ResultsA total of 1195 patients fulfilled the inclusion criteria: 696 started ART with a bPI, 315 with an InSTI and 184 with an NNRTI. During 2759 person-years of follow up, 642 patients experienced TF. Starting ART with bPIs [adjusted incidence rate ratio (aIRR) (95% CI) 1.62 (1.29–2.03) versus starting with NNRTIs; P ConclusionsIn patients starting ART with 5 log10 HIV-RNA copies/mL, the durability of regimens based on InSTIs was longer than that of NNRTI- and bPI-based regimens.

Published
2019

3. 96-week results of a dual therapy with darunavir/ritonavir plus rilpivirine once a day vs triple therapy in patients with suppressed viraemia: virological success and non-HIV related morbidity evaluation

Author

C. Abeli, Giuseppe Bruno, Marco Annovazzi Lodi, Valentina Di Cristo, Maria Vittoria Cossu, Paolo Maggi, Maria Letizia Oreni, Paola Vitiello, Elisa Colella, Anna Volpe, Fulvio Adorni, Stefano Bonora, Stefano Rusconi, Renato Maserati, and Micol Ferrara

Subjects
Oncology, endocrine system, medicine.medical_specialty, Dual therapy, Darunavir+Ritonavir, Immunovirological success, business.industry, Rilpivirine, Limiting, chemistry.chemical_compound, Infectious Diseases, chemistry, Internal medicine, Toxicity, medicine, HIV-1, Pharmacology (medical), In patient, Safety, business, Darunavir, medicine.drug
Abstract

Antiretroviral therapies have been tested with the goal of maintaining virological suppression with a particular attention in limiting drug-related toxicity. With this aim we designed the DUAL study: a randomized, open-label, multicenter, 96 weeks-long pilot exploratory study in virologically suppressed HIV-1+ patients with the aim of evaluating the immunovirological success and the impact on non-HIV related morbidity of switching to a dual therapy with darunavir-ritonavir (DRV/r) and rilpivirine (RPV). We recruited patients who received a PI/r-containing HAART for >=6 months, HIV-RNA < 50 cp/mL for >=3 months, eGFR > 60 mL/min/1,73m2, without DRV or RPV RAMs. We randomized patients in arm A: RPV + DRV/r QD or arm B: ongoing triple therapy. The primary endpoint has been defined as the percentage of patients with HIV-RNA < 50 cp/mL at week 48 (ITT). VACS index, Framingham CVD risk (FRS) and urinary RBP (uRBP) were calculated. We used Chi-square or Fisher statistics for categorical variables and Mann-Whitney U for continuous ones. Forty-one patients were enrolled (22 in arm A, 14 in arm B, plus 5 screening failures): 30 patients reached 96 weeks: 100% had HIV-RNA < 50 cp/mL in arm A versus 91.7% in arm B. Similar changes were observed in median CD4/mL between baseline and week 96 (+59 versus - 31, p: n.s.). Thirty-one in arm A and 23 in arm B adverse events took place, whereas only 1 was serious (arm A: turbinate hypertrophy, unrelated to HAART). Among the 6 discontinuations (3 in A, 3 in B), only 1 was related to adverse event (arm A: G3 depression, insomnia, weakness). VACS index, median FRS and median uRBP values did not vary from baseline to week 96. At 96-weeks all patients switched to a QD 2-drug regimen based on DRV/r + RPV maintained HIV-RNA suppression, but a single patient who showed a virological failure at week 4. CD4 counts increased overtime without significant differences between the two arms. The novel dual regimen was well tolerated with the same amount of discontinuation as the control arm. VACS index, FRS and uRBP did not differ between arms at week 96.

Published
2020

4. Switching from TDF to TAF or dual therapy (DT)-based regimens in HIV-infected individuals with viral load <= 50 copies/ml: does eGFR matter?

Author

Vergori, A, Gagliardini, R, Gianotti, N, Gori, A, Lichtner, M, Saracino, A, A De Vito, Cascio, A, A Di Biagio, A d'Arminio Monforte, Antinori, A, A Cozzi-Lepri on behalf of the ICONA Foundation Study Network, Giacometti, A., Costantini, A., Barocci, V., Angarano, G., Monno, L., Milano, E., F. Maggiolo, C. Suardi, Viale, P., Donati, V., Verucchi, G., Castelnuovo, F., Minardi, C., Quiros Roldan, E., B. Menzaghi, C. Abeli, L. Chessa, F. Pes, B. Cacopardo, B. Celesia, J. Vecchiet, K. Falasca (Chieti), A. Pan, S. Lorenzotti, Sighinolfi, L., Segala, Daniela, P. Blanc, F. Vichi, Cassola, G., Bassetti, M., Alessandrini, A., Bobbio, N., Mazzarello, G., M. Lichtner, L. Fondaco (Latina), P. Bonfanti, C. Molteni, A. Chiodera, P. Milini, G. Nunnari, G. Pellicanò, d’Arminio Monforte, A., Galli, M., Lazzarin, A., Rizzardini, G., Puoti, M., Castagna, A., Cannizzo, E. S., Moioli, M. C., Piolini, R., Bernacchia, D., Poli, A., Tincati, C., Mussini, C., Puzzolante, C., C. Migliorino, G. Lapadula, Sangiovanni, V., Borgia, G., Esposito, V., Di Flumeri, G., Gentile, I., Rizzo, V., A. M. Cattelan, S. Marinello, A. Cascio, C. Colomba, D. Francisci, E. Schiaroli, G. Parruti, F. Sozio, C. Lazzaretti, R. Corsini, Andreoni, M., Antinori, A., Cauda, R., Cristaudo, A., Vullo, V., Acinapura, R., Lamonica, S., Capozzi, M., Mondi, A., Cingolani, A., Rivano Capparuccia, M., Iaiani, G., Latini, A., Onnelli, G., Plazzi, M. M., De Girolamo, G., Vergori, A., M. Cecchetto, F. Viviani, G. Madeddu, A. De Vito, B. Rossetti, F. Montagnani, A. Franco, R. Fontana Del Vecchio, Di Giuli, C., Caramello, P., Di Perri, G., Bonora, S., Orofino, G. C., Sciandra, M., C. Tascini, A. Londer, V. Manfrin, G. Battagin, and G. Starnini, A. Ialungo

Subjects
HIV, Tenofovir alafenamide, Tenofovir disoproxil fumarate, Antiretroviral therapy, eGFR, Dual therapy, Dual therapy, Tenofovir disoproxil fumarate, eGFR, HIV, Tenofovir alafenamide, NO, Antiretroviral therapy
Published
2020

5. Dual Therapy with Darunavir/rtv Plus Rilpivirine QD versus Triple Therapy in Patients with Suppressed Viraemia: Evaluation of Virological Efficacy and Non-HIV Related Morbidity at 48 Weeks

Author

S. Rusconi, V. Di Cristo, F. Adorni, R. Maserati, M. Annovazzi Lodi, N. Ladisa, P. Maggi, A. Volpe, P. Vitiello, C. Abeli, S. Bonora, M. Ferrara, M.V. Cossu, E. Colella, and M. Galli

Subjects
Clinical trial, Efficacy, HIV, Safety, Antiretroviral therapy
Abstract

Objectives: The DUAL study is a phase III, randomized, open-label, multicenter, 96 weeks-long pilot study in virologically suppressed HIV-1+ patients with the aim of evaluating the efficacy and the impact on non-HIV related morbidity of switching to a dual therapy with darunavir-ritonavir (DRV/r) and rilpivirine (RPV). Methods: We recruited patients who received a PI/r-containing HAART for >=6 months, HIV-RNA< 50 cp/mL for >=3 months, eGFR>60 mL/min/1,73m2, without DRV or RPV RAMs. We randomized patients in arm A: RPV+DRV/r QD or arm B: triple therapy. Primary endpoint: percentage of patients with HIV-RNA< 50 cp/mL at week 48 (ITT). VACS index, Framingham CVD risk (FRS) and urinary RBP were calculated. We used Chi-square or Fisher statistics for categorical variables and Mann-Whitney U for continuous ones. Results: Forty-two patients were enrolled (23 in arm A, 14 in arm B, plus 5 screening failures): 26 patients reached 48 weeks: 17/17 had HIV-RNA< 50 cp/mL in arm A versus 8/9 in arm B (Figure). One patient in arm A showed detectable HIV-RNA at baseline (955 cp/mL), reported scarce adherence and was discontinued at week 4. Similar changes were observed in median CD4/mL between baseline and week 48 (-14 versus -116, p n.s.). Thirty-one in arm A and 20 in arm B adverse events took place, whereas only 1 serious (arm A, unrelated to HAART). Among the 7 discontinuations (4 in A, 3 in B), only 1 was related to adverse event (arm A: G3 depression, insomnia, weakness). The tolerability parameters (FRS, VACS index, uRBP) did not vary from baseline to week 48.

Published
2017

6. Efficacy and safety of boosted and unboosted atazanavir-containing antiretroviral regimens in real life: results from a multicentre cohort study

Author

C Abeli, Canio Martinelli, C Grosso, Giovanni Penco, Paolo Bonfanti, E Gianelli, Francesca Vichi, Patrizia Marconi, Giordano Madeddu, Elena Ricci, L Palvarini, R Giuntini, Tiziana Quirino, and Giovanni Francesco Pellicanò

Subjects
medicine.medical_specialty, Therapeutic regimen, business.industry, Health Policy, Surgery, Atazanavir, Infectious Diseases, Internal medicine, Cohort, Medicine, In real life, Pharmacology (medical), Observational study, business, Adverse effect, human activities, Viral load, Cohort study, medicine.drug
Abstract

Background Atazanavir (ATV) has demonstrated high efficacy and safety in both treatment-naive and treatment-experienced patients. Some comparative data are available on the durability of ritonavir-boosted (ATV/r) and unboosted formulations, but there are no data on clinicians' motivations for choosing one or another in everyday practice. The aim of this study was to evaluate the long-term efficacy of boosted and unboosted ATV in a cohort of treatment-experienced patients. Methods All patients included in the study were enrolled in an observational cohort within the Surveillance Cohort Long-Term Toxicity Antiretrovirals (SCOLTA) Project. Data on CD4 cell count, HIV viral load, metabolic parameters and adverse events of grade 3–4 are collected through an on-line system every six months. The duration of treatment with ATV was evaluated using the Kaplan–Meier curve and boosted and unboosted regimens were compared using the log-rank test. Results A total of 509 patients starting ATV as a component of their antiretroviral therapy were enrolled in the SCOLTA Project at the time of the study. Boosted ATV was received by 379 patients (74.5%) while 130 (25.5%) were treated with the unboosted formulation. The last therapeutic regimen did not influence the choice of ATV formulation. The mean observational time was 23.9 months. At the end of follow-up, 58.5% of patients on unboosted ATV and 58.1% of patients on ATV/r continued the treatment and no statistically significant differences were observed for ATV durability between the formulations or among the single causes of therapy interruption. Conclusions Our results suggest that, in unselected clinical settings, ATV-containing antiretroviral therapy is durable and safe in both its formulations.

Published
2010

7. Outcome of a Second-Line Protease Inhibitor–Containing Regimen in Patients Failing or Intolerant of a First Highly Active Antiretroviral Therapy

Author

L. Testa, Sara Melzi, Elisabetta Chiesa, Teresa Bini, Fulvio Adorni, B. Castelnuovo, Salvatore Sollima, A d'Arminio Monforte, C. Abeli, and Marco Bongiovanni

Subjects
Adult, Male, medicine.medical_specialty, Time Factors, Anti-HIV Agents, protease inhibitors, Pharmacology, second-line regimens, Pharmacotherapy, Indinavir, Internal medicine, HIV Seropositivity, medicine, virologic failure, Humans, Pharmacology (medical), Treatment Failure, Adverse effect, Saquinavir, Acquired Immunodeficiency Syndrome, Nelfinavir, Ritonavir, business.industry, intolerance/toxicity, HIV Protease Inhibitors, Discontinuation, CD4 Lymphocyte Count, Regimen, Treatment Outcome, Infectious Diseases, Toxicity, RNA, Viral, Drug Therapy, Combination, Female, business, medicine.drug, Follow-Up Studies
Abstract

The outcome of second-line protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) was investigated in 263 patients who were failed by (n = 148) or intolerant of (n = 115) a first HAART regimen. The endpoints were virologic failure (decline in HIV RNA 34 years versus less than or equal to 34 years: 95% CI, 0.42-0.88), a saquinavir-containing first HAART (HR 0.57 versus indinavir: 95% CI, 0.34-0.93) and change due to intolerance/toxicity (HR 0.58 versus failure: 95% CI, 0.35-0.98). The independent variables predictive of discontinuation due to intolerance/toxicity were the reason for switching (HR 1.79 intolerance versus failure: 95% CI, 1.02-3.16) and the first protease inhibitor (PI) regimen (HR 0.42 ritonavir versus indinavir: 95% CI, 0.22-0.80). Given that patients who are failed by a first regimen are at high risk of having rescue therapy fail as well, second-line regimens including therapies directed by testing of drug resistance patterns of clinical viral isolates are warranted. Patients experiencing toxicity due to a first PI-containing regimen are at risk of toxicity to other PIs and should be addressed to PI-sparing HAART.

Published
2000

8. Clinical outcome and predictive factors of failure of highly active antiretroviral therapy in antiretroviral-experienced patients in advanced stages of HIV-1 infection

Author

Mauro Moroni, C. Abeli, Teresa Bini, d'Arminio Monforte A, L. Testa, Elisabetta Chiesa, Claudia Balotta, Massimo Musicco, Salvatore Sollima, Fulvio Adorni, Moscatelli Gc, Massimo Galli, and Stefano Rusconi

Subjects
Adult, Male, medicine.medical_specialty, genetic structures, Anti-HIV Agents, Immunology, HIV Infections, Indinavir, Observation, Cohort Studies, Highly active antiretroviral therapy, Acquired immunodeficiency syndrome (AIDS), Internal medicine, medicine, Humans, Immunology and Allergy, Sida, Saquinavir, Ritonavir, biology, business.industry, HIV Protease Inhibitors, medicine.disease, biology.organism_classification, Confidence interval, CD4 Lymphocyte Count, Discontinuation, Surgery, Infectious Diseases, Treatment failure, Relative risk, HIV-1, RNA, Viral, Drug Therapy, Combination, Female, business, Compliance, medicine.drug
Abstract

Objective: To verify the effectiveness of highly active antiretroviral therapy (HAART) and to identify any factors predictive of clinical outcome in a clinical setting. Design: Observational study. Methods: Treatment failure (i.e., the occurrence of new or recurrent AIDS-defining events, death or any definitive discontinuation) and the course of CD4+ cell counts and HIV RNA copies were evaluated in 250 heavily pretreated HIV-infected patients starting HAART [153 with indinavir (IDV), 55 with ritonavir (RTV), 43 with saquinavir (SQV)]. Univariate and multivariate analyses were performed to identify predictors of worse outcome. Results: During a median follow-up of 8 months, 75 patients (30%) had treatment failure because of the occurrence of an AIDS-defining event or death (n = 24), inefficacy (n = 24), or severe intolerance (n = 27). Twenty new and six recurrent AIDS-defining events, and nine deaths occurred (six out of 20 AIDS-defining events and two out of nine deaths within 1 month of treatment). CD4+ counts were above 200 x 10 6 /l at AIDS diagnosis in only two patients. None of the SQV patients, 12 (7.8%) of the IDV patients, and 15 (27.3%) of the RTV-treated patients were considered non-compliant. The SQV-containing regimens independently correlated with treatment failure (relative risk, 2.46; 95% confidence interval, 1.20-5.03; versus IDV). Low compliance partially determined outcome in RTV-treated patients; both severe immunodepression and AIDS at baseline were predictive of treatment failure. There was a 10-fold increase in CD4+ cell counts in the patients treated with IDV and RTV; the best virological outcome occurred in IDV-treated patients, with 68.4% of patients showing undetectable HIV RNA copies after 6 months. Conclusions: HAART was effective in 70% of patients; low compliance and previous AIDS diagnosis represented predictive factors of therapy failure.

Published
1998

9. Maraviroc as intensification strategy in HIV-1 positive patients with deficient immunological response: An Italian randomized clinical trial

Author

Alessandro Soria, Manuela Morosi, C. Abeli, Chiara Tommasi, Marco Montano, Esther Merlini, Amedeo Capetti, Manuela Colafigli, Massimo Di Pietro, Giulia Marchetti, Giustino Parruti, Antonio Di Biagio, Daniela Francisci, Gabriella d'Ettorre, Silvia Mosti, Paola Meraviglia, Francesca Bai, Elisa Colella, Anna Rita Buonomini, Fulvio Adorni, Giancarlo Orofino, Stefano Bonora, Luca Butini, Stefano Rusconi, Marco D’Annunzio, Pamela Tau, Paola Vitiello, Silvia Di Nardo Stuppino, and Emanuele Focà

Subjects
Oncology, Genetics and Molecular Biology (all), maraviroc, Human immunodeficiency virus (HIV), medicine.disease_cause, Biochemistry, law.invention, chemistry.chemical_compound, Randomized controlled trial, law, Antiretroviral Therapy, Highly Active, middle aged, heterocyclic compounds, humans, Multidisciplinary, Medicine (all), adult, virus diseases, viral load, female, Medicine, RNA, Viral, CD8-positive t-lymphocytes, Viral load, CD4-positive T-lymphocytes, Research Article, HIV infections, viral, endocrine system, medicine.medical_specialty, Science, antiretroviral therapy, Biology, Adult, Anti-HIV Agents, Biomarkers, CD4 Lymphocyte Count, CD4-Positive T-Lymphocytes, CD8-Positive T-Lymphocytes, Cyclohexanes, Female, HIV Infections, HIV-1, Humans, Interleukin-7, Ki-67 Antigen, Male, Middle Aged, Treatment Outcome, Triazoles, Viral Load, Immunocompromised Host, Agricultural and Biological Sciences (all), Biochemistry, Genetics and Molecular Biology (all), Immune system, Pharmacotherapy, male, health services administration, Internal medicine, medicine, cardiovascular diseases, ki-67 antigen, triazoles, highly active, Maraviroc, immunocompromised host, interleukin-7, biomarkers, CD4 lymphocyte count, anti-HIV agents, cyclohexanes, RNA, viral, treatment outcome, antiretroviral therapy, highly active, Clinical trial, Increased risk, chemistry, Immunology, RNA
Abstract

BackgroundImmunological non-responders (INRs) lacked CD4 increase despite HIV-viremia suppression on HAART and had an increased risk of disease progression. We assessed immune reconstitution profile upon intensification with maraviroc in INRs.MethodsWe designed a multi-centric, randomized, parallel, open label, phase 4 superiority trial. We enrolled 97 patients on HAART with CD4+ResultsBy W48 both groups displayed a CD4 increase without a significant inter-group difference. A statistically significant change in CD8 favored patients in arm HAART+maraviroc versus HAART at W12 (p=.009) and W48 (p=.025). The CD4>200/µL and CD4>200/µL + CD4 gain ≥ 25% end-points were not satisfied at W12 (p=.24 and p=.619) nor at W48 (p=.076 and p=.236). Patients continuing HAART displayed no major changes in parameters of T-cell homeostasis and activation. Maraviroc-receiving patients experienced a significant rise in circulating IL-7 by W48 (p=.01), and a trend in temporary reduction in activated HLA-DR+CD38+CD4+ by W12 (p=.06) that was not maintained at W48.ConclusionsMaraviroc intensification in INRs did not have a significant advantage in reconstituting CD4 T-cell pool, but did substantially expand CD8. It resulted in a low rate of treatment discontinuations.Trial registrationClinicalTrials.gov NCT00884858 http://clinicaltrials.gov/show/NCT00884858.

Published
2013

10. Maraviroc intensification for HIV-1-positive immunological non-responders (INRs) despite virological suppression during HAART

Author

Stefano Rusconi, Anna Rita Buonomini, A Di Pietro, Gabriella d'Ettorre, C. Abeli, M. D’Annunzio, Amedeo Capetti, M Capasso, Chiara Tommasi, Alessandro Soria, Emanuele Focà, Giulia Marchetti, G. Orofino, Stefano Bonora, Paola Vitiello, Paola Meraviglia, S Farina, MP Trotta, Elisa Colella, Fulvio Adorni, Esther Merlini, L. Butini, A. Di Biagio, and Daniela Francisci

Subjects
medicine.medical_specialty, business.industry, virologic response, HIV, immunological response, HAART, Maraviroc, Public Health, Environmental and Occupational Health, Human immunodeficiency virus (HIV), Viremia, CD38, medicine.disease, medicine.disease_cause, Gastroenterology, Non responders, chemistry.chemical_compound, Infectious Diseases, Pharmacotherapy, Acquired immunodeficiency syndrome (AIDS), chemistry, Internal medicine, Immunology, medicine, Oral Presentation, business, CD8
Abstract

Purpose: 15-30% of HAART-treated HIV-1-positive patients (pts) lack CD4+ increase despite full HIV viremia suppression. The increased risk for INR to progress till AIDS led us to investigate maraviroc (MVC) as a tool to intensify HAART in terms of immunological recovery. Methods: Randomised, multicentre, proof-of-concept study enrolling 100 pts divided into 2 arms (1:1), A:HAART+MVC, B:HAART. Inclusion criteria were: CD4 count ≥200 cells/µL and/or a recovery of CD4 cells

Published
2010

11. Observational study on HIV-infected subjects failing HAART receiving tenofovir plus didanosine as NRTI backbone

Author

A. De Luca, Cristina Mussini, Elisabetta Chiesa, Antonella Castagna, A. Matti, Carlo Torti, C. Abeli, Nicola Gianotti, Paola Cicconi, A d'Arminio Monforte, Marco Bongiovanni, Amedeo Capetti, Mauro Zaccarelli, A. Di Biagio, Andrea Antinori, Patrizia Marconi, Valeria Tirelli, Paola Nasta, Francesca Gatti, Bongiovanni, M., Gianotti, N., Chiesa, E., Nasta, P., Cicconi, P., Capetti, A., Di Biagio, A., Matti, A., Tirelli, V., Marconi, P., De Luca, A., Mussini, C., Gatti, F., Zaccarelli, M., Abeli, C., Torti, C., Antinori, A., Castagna, Antonella, and D'arminio Monforte, A.

Subjects
Male, Enfuvirtide, Drug Resistance, HIV Infections, Pharmacology, Gastroenterology, chemistry.chemical_compound, Retrospective Studie, Abacavir, Organophosphonate, Antiretroviral Therapy, Highly Active, Hiv infected, HIV Infection, Viral, Didanosine, virus diseases, General Medicine, Middle Aged, Resistance mutation, Reverse Transcriptase Inhibitor, AIDS, Infectious Diseases, Treatment Outcome, Combination, Reverse Transcriptase Inhibitors, Drug Therapy, Combination, Female, Sequence Analysis, Human, medicine.drug, Microbiology (medical), Adult, medicine.medical_specialty, Efavirenz, Adenine, Anti-HIV Agents, CD4 Lymphocyte Count, DNA, Viral, Drug Resistance, Viral, HIV-1, Humans, Mutation, Organophosphonates, Retrospective Studies, Sequence Analysis, DNA, Tenofovir, Antiretroviral Therapy, HIV, tenofovir, Drug Therapy, Internal medicine, medicine, Highly Active, business.industry, Anti-HIV Agent, DNA, chemistry, Observational study, business
Abstract

We evaluated the efficacy of tenofovir (TDF) - and didanosine (ddI)-containing backbones in HIV-infected experienced subjects. We included in the study 245 subjects who started a TDF/ddI-containing HAART with HIV-RNA > 3 log10cp/ml and an available genotypic resistance test at baseline. At baseline, median CD4 counts and HIV-RNA were 278 cell/mmc and 4.32 log10cp/ml, respectively. Seventy-four subjects (30.2%) discontinued TDF and/or ddI, 23 of them for drug-related toxicities or intolerance. One-hundred and twenty-six (51.4%) subjects achieved virologic success (HIV-RNA < 50 copies/ml in two consecutive determinations) in a median time of 6.1 months; higher HIV-RNA levels (HR: 0.66, 95% CI: 0.54- 0.79, p < 0.001 for each additional log10copies/ml), and the total number of mutations either for PI and NNRTI at baseline (HR: 0.87, 95% CI: 0.81-0.92, p < 0.001 for each additional mutation) were both predictors of virologic success. M184V was marginally associated with virologic success (HR: 1.34, 95% CI: 0.94-1.90, p = 0.10 vs no M184V), whilst the number of TAMs was not associated. One-hundred-thirty-three (54.3%) subjects achieved immunologic success (increase of ≥ 100 cells/mm3from baseline) in a median time of 7.5 months; immunologic success was associated with HIV-RNA levels at baseline (HR: 0.91, 95% CI: 0.79-0.98, p = 0.04 for each additional log10copies/ml), the total number of mutations either for PI or NNRTI (HR: 0.91, 95% CI: 0.85-0.98, p = 0.01 for each additional mutation) and CD4 count at baseline (HR: 1.11, 95% CI: 1.00-1.23, p = 0.05 for each additional 100 cells/mm3). Results obtained by the on-treatment analyses were comparable. In our study, HAART containing TDF/ddI seem associated with a virologic and immunologic response, when such regimens are chosen according to a genotypic resistance test. © 2007 Urban & Vogel.

Published
2007

12. CD4 cell counts at the third month of HAART may predict clinical failure

Author

Moscatelli Gc, Massimo Galli, Valeria Testori, Massimo Musicco, B. Castelnuovo, Antonella d'Arminio Monforte, L. Testa, Mauro Moroni, C. Abeli, Salvatore Sollima, Teresa Bini, Fulvio Adorni, Stefano Rusconi, Luca Meroni, and Elisabetta Chiesa

Subjects
Adult, Male, medicine.medical_specialty, Time Factors, Multivariate analysis, genetic structures, Anti-HIV Agents, medicine.medical_treatment, Immunology, Population, HIV Infections, Highly active antiretroviral therapy, Internal medicine, medicine, Humans, Immunology and Allergy, Treatment Failure, education, Clinical failure, Aged, Acquired Immunodeficiency Syndrome, education.field_of_study, Chemotherapy, AIDS-Related Opportunistic Infections, Proportional hazards model, business.industry, HIV, 3-month CD4 cell count, Middle Aged, Viral Load, Prognosis, Confidence interval, CD4 Lymphocyte Count, Surgery, Regimen, Infectious Diseases, Clinical research, Drug Therapy, Combination, Female, business, Viral load
Abstract

The objective was to evaluate the influence of immunological and virological markers on clinical outcome in patients receiving their first highly active antiretroviral therapy (HAART) regimen. Observational study of 585 patients initiating HAART in a clinical setting. Clinical failure was defined as the occurrence of new or recurrent AIDS-defining events or death and was analysed by means of intention-to-treat univariate and multivariate analyses. An adjusted Cox regression model was used to evaluate the effect of 3-month CD4 cell counts on clinical outcome. Clinical failure occurred in 55 patients (9.4%) during a median follow-up of 483 days (range 33--1334 days): 45 new AIDS--defining events (ADEs) in 38 ADE recurrence in six and death in 11. Twenty-four of the 45 new ADEs (53.4%) occurred during the first 3 months of HAART and 11 of 45 (24.4%) in the presence of CD4 cell counts > 200 x 10/6 cells/l. The mean (median range) CD4 counts were 144 x 10/6 cells/l (128 4--529) in patients with and 322 x 10/6 cells/l (288 14--1162) in patients without clinical failure (P < 0.0001). Moreover the proportion of patients with mean CD4 cell counts < 200 x 10/6 cells/l was higher in those experiencing subsequent clinical failure (x/2 test: 26.75; P < 0.00001). Multivariate analysis showed that baseline CD4 cell counts < 50 x 10/6 cells/l and AIDS at enrolment predicted failure; after adjusting for 3-month CD4 cell counts this marker was the only one independently associated with clinical failure (hazard risk 4.79; 95% confidence interval 1.40--16.47). The 3-month immunological response is a reliable predictor of long-term clinical outcome. (authors)

Published
1999

13. Virological response and retention in care according to time of starting ART in Italy: data from the Icona Foundation Study cohort

Author

D'Arminio Monforte, A., Tavelli, A., Cozzi-Lepri, A., Castagna, A., Passerini, S., Francisci, D., Saracino, A., Maggiolo, F., Lapadula, G., Girardi, E., Perno, C. F., Antinori, A., Andreoni, M., Castelli, F., Cauda, R., Di Perri, G., Galli, M., Iardino, R., Ippolito, G., Lazzarin, A., Marchetti, G. C., Rezza, G., Von Schloesser, F., Viale, P., Ceccherini-Silberstein, F., Lo Caputo, S., Mussini, C., Puoti, M., Bai, F., Balotta, C., Bandera, A., Bonora, S., Borderi, M., Calcagno, A., Capetti, A., Capobianchi, M. R., Cicalini, S., Cingolani, A., Cinque, P., De Luca, A., Di Biagio, A., Gianotti, N., Gori, A., Guaraldi, G., Lichtner, M., Madeddu, G., Marchetti, G., Monno, L., Nozza, S., Pinnetti, C., Quiros Roldan, E., Rossotti, R., Rusconi, S., Santoro, M. M., Sarmati, L., Fanti, I., Galli, L., Lorenzini, P., Rodano, A., Macchia, M., Carletti, F., Carrara, S., Di Caro, A., Graziano, S., Petroni, F., Prota, G., Truffa, S., Giacometti, A., Costantini, A., Barocci, V., Angarano, G., Milano, E., Suardi, C., Donati, V., Verucchi, G., Castelnuovo, F., Minardi, C., Menzaghi, B., Abeli, C., Cacopardo, B., Celesia, B., Vecchiet, J., Falasca, K., Pan, A., Lorenzotti, S., Sighinolfi, L., Segala, D., Blanc, P., Vichi, F., Cassola, G., Viscoli, C., Alessandrini, A., Bobbio, N., Mazzarello, G., Fondaco, L., Bonfanti, P., Molteni, C., Chiodera, A., Milini, P., Nunnari, G., Pellicano, G., Rizzardini, G., Cannizzo, E. S., Moioli, M. C., Piolini, R., Bernacchia, D., Salpietro, S., Tincati, C., Puzzolante, C., Migliorino, C., Sangiovanni, V., Borgia, G., Esposito, V., Di Flumeri, G., Gentile, I., Rizzo, V., Cattelan, A. M., Marinello, S., Cascio, A., Trizzino, M., Schiaroli, E., Parruti, G., Sozio, F., Magnani, G., Ursitti, M. A., Cristaudo, A., Vullo, V., Acinapura, R., Moschese, D., Capozzi, M., Mondi, A., Rivano Capparuccia, M., Iaiani, G., Latini, A., Gagliardini, R., Plazzi, M. M., De Girolamo, G., Vergori, A., Cecchetto, M., Viviani, F., De Vito, A., Rossetti, B., Montagnani, F., Franco, A., Fontana Del Vecchio, R., Di Giuli, C., Caramello, P., Orofino, G. C., Sciandra, M., Bassetti, M., Londero, A., Manfrin, V., Battagin, G., Starnini, G., Ialungo, A., D'Arminio Monforte, A., Tavelli, A., Cozzi-Lepri, A., Castagna, A., Passerini, S., Francisci, D., Saracino, A., Maggiolo, F., Lapadula, G., Girardi, E., Perno, C. F., Antinori, A., Andreoni, M., Castelli, F., Cauda, R., Di Perri, G., Galli, M., Iardino, R., Ippolito, G., Lazzarin, A., Marchetti, G. C., Rezza, G., Von Schloesser, F., Viale, P., Ceccherini-Silberstein, F., Lo Caputo, S., Mussini, C., Puoti, M., Bai, F., Balotta, C., Bandera, A., Bonora, S., Borderi, M., Calcagno, A., Capetti, A., Capobianchi, M. R., Cicalini, S., Cingolani, A., Cinque, P., De Luca, A., Di Biagio, A., Gianotti, N., Gori, A., Guaraldi, G., Lichtner, M., Madeddu, G., Marchetti, G., Monno, L., Nozza, S., Pinnetti, C., Quiros Roldan, E., Rossotti, R., Rusconi, S., Santoro, M. M., Sarmati, L., Fanti, I., Galli, L., Lorenzini, P., Rodano, A., Macchia, M., Carletti, F., Carrara, S., Di Caro, A., Graziano, S., Petroni, F., Prota, G., Truffa, S., Giacometti, A., Costantini, A., Barocci, V., Angarano, G., Milano, E., Suardi, C., Donati, V., Verucchi, G., Castelnuovo, F., Minardi, C., Menzaghi, B., Abeli, C., Cacopardo, B., Celesia, B., Vecchiet, J., Falasca, K., Pan, A., Lorenzotti, S., Sighinolfi, L., Segala, D., Blanc, P., Vichi, F., Cassola, G., Viscoli, C., Alessandrini, A., Bobbio, N., Mazzarello, G., Fondaco, L., Bonfanti, P., Molteni, C., Chiodera, A., Milini, P., Nunnari, G., Pellicano, G., Rizzardini, G., Cannizzo, E. S., Moioli, M. C., Piolini, R., Bernacchia, D., Salpietro, S., Tincati, C., Puzzolante, C., Migliorino, C., Sangiovanni, V., Borgia, G., Esposito, V., Di Flumeri, G., Gentile, I., Rizzo, V., Cattelan, A. M., Marinello, S., Cascio, A., Trizzino, M., Schiaroli, E., Parruti, G., Sozio, F., Magnani, G., Ursitti, M. A., Cristaudo, A., Vullo, V., Acinapura, R., Moschese, D., Capozzi, M., Mondi, A., Rivano Capparuccia, M., Iaiani, G., Latini, A., Gagliardini, R., Plazzi, M. M., De Girolamo, G., Vergori, A., Cecchetto, M., Viviani, F., De Vito, A., Rossetti, B., Montagnani, F., Franco, A., Fontana Del Vecchio, R., Di Giuli, C., Caramello, P., Orofino, G. C., Sciandra, M., Bassetti, M., Londero, A., Manfrin, V., Battagin, G., Starnini, G., Ialungo, A., A d'Arminio Monforte, A Antinori, M Andreoni, A Castagna, F Castelli, R Cauda, G Di Perri, M Galli, R Iardino, G Ippolito, A Lazzarin, G C Marchetti, G Rezza, F von Schloesser, F Ceccherini-Silberstein, A Cozzi-Lepri, E Girardi, S Lo Caputo, C Mussini, M Puoti, C F Perno, F Bai, C Balotta, A Bandera, S Bonora, M Borderi, A Calcagno, A Capetti, M R Capobianchi, S Cicalini, A Cingolani, P Cinque, , A Di Biagio, N Gianotti, A Gori, G Guaraldi, G Lapadula, M Lichtner, G Madeddu, F Maggiolo, L Monno, S Nozza, C Pinnetti, E Quiros Roldan, R Rossotti, S Rusconi, M M Santoro, A Saracino, L Sarmati, I Fanti, L Galli, P Lorenzini, A Rodano', M Macchia, A Tavelli, F Carletti, S Carrara, A Di Caro, S Graziano, F Petroni, G Prota, S Truffa, A Giacometti, A Costantini, V Barocci, G Angarano, E Milano, C Suardi, V Donati, G Verucchi, F Castelnuovo, C Minardi, B Menzaghi, C Abeli, B Cacopardo, B Celesia, J Vecchiet, K Falasca, A Pan, S Lorenzotti, L Sighinolfi, D Segala, P Blanc, F Vichi, G Cassola, C Viscoli, A Alessandrini, N Bobbio, G Mazzarello, L Fondaco, P Bonfanti, C Molteni, A Chiodera, P Milini, G Nunnari, G Pellicanò, G Rizzardini, E S Cannizzo, M C Moioli, R Piolini, D Bernacchia, S Salpietro, C Tincati, C Puzzolante, C Migliorino, V Sangiovanni, G Borgia, V Esposito, G Di Flumeri, I Gentile, V Rizzo, A M Cattelan, S Marinello, A Cascio, M Trizzino, D Francisci, E Schiaroli, G Parruti, F Sozio, G Magnani, M A Ursitti, A Cristaudo, V Vullo, R Acinapura, D Moschese, M Capozzi, A Mondi, M Rivano Capparuccia, G Iaiani, A Latini, R Gagliardini, M M Plazzi, G De Girolamo, A Vergori, M Cecchetto, F Viviani, A De Vito, B Rossetti, F Montagnani, A Franco, R Fontana Del Vecchio, C Di Giuli, P Caramello, G C Orofino, M Sciandra, M Bassetti, A Londero, V Manfrin, G Battagin, G Starnini, A Ialungo, D'Arminio Monforte, A, Tavelli, A, Cozzi-Lepri, A, Castagna, A, Passerini, S, Francisci, D, Saracino, A, Maggiolo, F, Lapadula, G, Girardi, E, Perno, C, Antinori, A, Andreoni, M, Castelli, F, Cauda, R, Di Perri, G, Galli, M, Iardino, R, Ippolito, G, Lazzarin, A, Marchetti, G, Rezza, G, Von Schloesser, F, Viale, P, Ceccherini-Silberstein, F, Lo Caputo, S, Mussini, C, Puoti, M, Bai, F, Balotta, C, Bandera, A, Bonora, S, Borderi, M, Calcagno, A, Capetti, A, Capobianchi, M, Cicalini, S, Cingolani, A, Cinque, P, De Luca, A, Di Biagio, A, Gianotti, N, Gori, A, Guaraldi, G, Lichtner, M, Madeddu, G, Monno, L, Nozza, S, Pinnetti, C, Quiros Roldan, E, Rossotti, R, Rusconi, S, Santoro, M, Sarmati, L, Fanti, I, Galli, L, Lorenzini, P, Rodano, A, Macchia, M, Carletti, F, Carrara, S, Di Caro, A, Graziano, S, Petroni, F, Prota, G, Truffa, S, Giacometti, A, Costantini, A, Barocci, V, Angarano, G, Milano, E, Suardi, C, Donati, V, Verucchi, G, Castelnuovo, F, Minardi, C, Menzaghi, B, Abeli, C, Cacopardo, B, Celesia, B, Vecchiet, J, Falasca, K, Pan, A, Lorenzotti, S, Sighinolfi, L, Segala, D, Blanc, P, Vichi, F, Cassola, G, Viscoli, C, Alessandrini, A, Bobbio, N, Mazzarello, G, Fondaco, L, Bonfanti, P, Molteni, C, Chiodera, A, Milini, P, Nunnari, G, Pellicano, G, Rizzardini, G, Cannizzo, E, Moioli, M, Piolini, R, Bernacchia, D, Salpietro, S, Tincati, C, Puzzolante, C, Migliorino, C, Sangiovanni, V, Borgia, G, Esposito, V, Di Flumeri, G, Gentile, I, Rizzo, V, Cattelan, A, Marinello, S, Cascio, A, Trizzino, M, Schiaroli, E, Parruti, G, Sozio, F, Magnani, G, Ursitti, M, Cristaudo, A, Vullo, V, Acinapura, R, Moschese, D, Capozzi, M, Mondi, A, Rivano Capparuccia, M, Iaiani, G, Latini, A, Gagliardini, R, Plazzi, M, De Girolamo, G, Vergori, A, Cecchetto, M, Viviani, F, De Vito, A, Rossetti, B, Montagnani, F, Franco, A, Fontana Del Vecchio, R, Di Giuli, C, Caramello, P, Orofino, G, Sciandra, M, Bassetti, M, Londero, A, Manfrin, V, Battagin, G, Starnini, G, Ialungo, A, D'Arminio Monforte A., Tavelli A., Cozzi-Lepri A., Castagna A., Passerini S., Francisci D., Saracino A., Maggiolo F., Lapadula G., Girardi E., Perno C.F., Antinori A., Andreoni M., Castelli F., Cauda R., Di Perri G., Galli M., Iardino R., Ippolito G., Lazzarin A., Marchetti G.C., Rezza G., Von Schloesser F., Viale P., Ceccherini-Silberstein F., Lo Caputo S., Mussini C., Puoti M., Bai F., Balotta C., Bandera A., Bonora S., Borderi M., Calcagno A., Capetti A., Capobianchi M.R., Cicalini S., Cingolani A., Cinque P., De Luca A., Di Biagio A., Gianotti N., Gori A., Guaraldi G., Lichtner M., Madeddu G., Marchetti G., Monno L., Nozza S., Pinnetti C., Quiros Roldan E., Rossotti R., Rusconi S., Santoro M.M., Sarmati L., Fanti I., Galli L., Lorenzini P., Rodano A., MacChia M., Carletti F., Carrara S., Di Caro A., Graziano S., Petroni F., Prota G., Truffa S., Giacometti A., Costantini A., Barocci V., Angarano G., Milano E., Suardi C., Donati V., Verucchi G., Castelnuovo F., Minardi C., Menzaghi B., Abeli C., Cacopardo B., Celesia B., Vecchiet J., Falasca K., Pan A., Lorenzotti S., Sighinolfi L., Segala D., Blanc P., Vichi F., Cassola G., Viscoli C., Alessandrini A., Bobbio N., Mazzarello G., Fondaco L., Bonfanti P., Molteni C., Chiodera A., Milini P., Nunnari G., Pellicano G., Rizzardini G., Cannizzo E.S., Moioli M.C., Piolini R., Bernacchia D., Salpietro S., Tincati C., Puzzolante C., Migliorino C., Sangiovanni V., Borgia G., Esposito V., Di Flumeri G., Gentile I., Rizzo V., Cattelan A.M., Marinello S., Cascio A., Trizzino M., Schiaroli E., Parruti G., Sozio F., Magnani G., Ursitti M.A., Cristaudo A., Vullo V., Acinapura R., Moschese D., Capozzi M., Mondi A., Rivano Capparuccia M., Iaiani G., Latini A., Gagliardini R., Plazzi M.M., De Girolamo G., Vergori A., Cecchetto M., Viviani F., De Vito A., Rossetti B., Montagnani F., Franco A., Fontana Del Vecchio R., Di Giuli C., Caramello P., Orofino G.C., Sciandra M., Bassetti M., Londero A., Manfrin V., Battagin G., Starnini G., and Ialungo A.

Subjects
0301 basic medicine, diagnosis, hiv, communicable diseases, HIV Infections, Logistic regression, Virological response, Cohort Studies, 0302 clinical medicine, Retention in Care, Medicine, Pharmacology (medical), HIV Infection, 030212 general & internal medicine, Prospective cohort study, cd4 count determination procedure, drug, suppression, Viral Load, CD4 Lymphocyte Count, Humans, Italy, Anti-HIV Agents, virology, Infectious Diseases, blood hiv rna, Cohort, hiv, cd4 count determination procedure, communicable diseases, incomeitaly, diagnosis, virology, blood hiv rna, retention in care, incomeitaly, Viral load, HIV, ART, Cohort study, Human, Microbiology (medical), medicine.medical_specialty, antiretroviral therapy, Settore MED/17 - MALATTIE INFETTIVE, NO, 03 medical and health sciences, HIV viral load, Internal medicine, HIV, CD4, ART, Pharmacology, business.industry, double blind, Anti-HIV Agent, HIV viral load, antiretroviral therapy, double blind, initiation, suppression, infection, Retention in care, 030112 virology, infection, initiation, Observational study, Cohort Studie, business
Abstract

Objectives To describe: (i) factors associated with rapid and delayed ART initiation; (ii) rates of 12 week virological response; and (iii) virologically controlled retention in care by 1 year from ART initiation according to timing of start in a real-life setting. Methods All individuals in the Icona cohort diagnosed with HIV in 2016–17 who initiated ART were grouped according to the time between HIV diagnosis and ART initiation: Group 1, ≤7 days; Group 2, 8–14 days; Group 3, 15–30 days; Group 4, 31–120 days; and Group 5, >120 days. Multivariable logistic regression models were used to identify factors associated with: (i) the probability of rapid (Group 1) and very delayed (Group 5) ART initiation; (ii) the 12 week virological response (by a modified snapshot algorithm); and (iii) the probability of retention in care at 1 year (on ART with HIV-RNA Results A total of 1247 individuals were included [82 (6.6%) in Group 1, 115 (9.2%) in Group 2, 267 (21.4%) in Group 3, 641 (51.4%) in Group 4 and 142 (11.4%) in Group 5]. Main predictors of rapid ART start (Group 1) were low CD4 cell count and high HIV-RNA at first contact with the infectious diseases centre. There was no association between probability of virological response and timing of ART initiation. Overall, 90% of individuals remained on ART after 1 year, 91% with undetectable HIV-RNA. Participants of Italian nationality, those with higher CD4 cell count and lower HIV-RNA at ART initiation were more likely to be retained in care after 1 year. Conclusions In our high-income observational setting, we did not observe differences in the 1 year rate of virological response and retention in care according to timing of ART initiation.

Published
2020

14. Incidence and risk factors for liver enzyme elevation among naive HIV-1-infected patients receiving ART in the ICONA cohort

Author

Taramasso, L., Lorenzini, P., Di Biagio, A., Lichtner, M., Marchetti, G., Rossotti, R., Lapadula, G., Cozzi-Lepri, A., Vichi, F., Antinori, A., Bonora, S., D'Arminio Monforte, A., ICONA Foundation Study Group:, A d'Arminio Monforte, Antinori, A, Andreoni, M, Castagna, A, Castelli, F, Cauda, R, G Di Perri, Galli, M, Iardino, R, Ippolito, G, Lazzarin, A, C Marchetti, G, Rezza, G, F von Schloesser, Viale, P, A d'Arminio Monforte, Ceccherini-Silberstein, F, Cozzi-Lepri, A, Girardi, E, S Lo Caputo, Mussini, C, Puoti, M, F Perno, C, Bai, F, Balotta, C, Bandera, A, Bonora, S, Borderi, M, Calcagno, A, Capetti, A, R Capobianchi, M, Cicalini, S, Cingolani, A, Cinque, P, A De Luca, A Di Biagio, Gianotti, N, Gori, A, Guaraldi, G, Lapadula, G, Lichtner, M, Madeddu, G, Maggiolo, F, Marchetti, G, Monno, L, Nozza, S, Pinnetti, C, QUIROS ROLDAN, Maria Eugenia, Rossotti, R, Rusconi, S, M Santoro, M, Saracino, A, Sarmati, L, Fanti, I, Galli, L, Lorenzini, P, Rodano', A, Macchia, M, Tavelli, A, Carletti, F, Carrara, S, A Di Caro, Graziano, S, Petroni, F, Prota, G, Truffa, S, Giacometti, A, Costantini, A, Barocci, V, Angarano, G, Milano, E, Suardi, C, Donati, V, Verucchi, G, Castelnuovo, F, Minardi, C, Menzaghi, B, Abeli, C, Cacopardo, B, Celesia, B, Vecchiet, J, Falasca, K, Pan, A, Lorenzotti, S, Sighinolfi, L, Segala, D, Blanc, P, Vichi, F, Cassola, G, Viscoli, C, Alessandrini, A, Bobbio, N, Mazzarello, G, Vita, S, Bonfanti, P, Molteni, C, Chiodera, A, Milini, P, Nunnari, G, Pellicanò, G, Rizzardini, G, S Cannizzo, E, C Moioli, M, Piolini, R, Bernacchia, D, Salpietro, S, Tincati, C, Puzzolante, C, Migliorino, C, Sangiovanni, V, Borgia, G, Esposito, V, F Di Martino, Gentile, I, Rizzo, V, M Cattelan, A, Marinello, S, Cascio, A, Trizzino, M, Baldelli, F, Schiaroli, E, Parruti, G, Sozio, F, Magnani, G, A Ursitti, M, Cristaudo, A, Vullo, V, Acinapura, R, Moschese, D, Capozzi, M, Mondi, A, M Rivano Capparuccia, Iaiani, G, Latini, A, Gagliardini, R, M Plazzi, M, Savinelli, S, Vergori, A, Cecchetto, M, Viviani, F, A De Vito, Rossetti, B, Montagnani, F, Franco, A, R Fontana Del Vecchio, Francisci, D, C Di Giuli, Caramello, P, C Orofino, G, Sciandra, M, Bassetti, M, Londero, A, Pellizzer, G, Manfrin, V, Starnini, G, Ialungo, A, Taramasso, L, Lorenzini, P, Di Biagio, A, Lichtner, M, Marchetti, G, Rossotti, R, Lapadula, G, Cozzi-Lepri, A, Vichi, F, Antinori, A, Bonora, S, D'Arminio Monforte, A, d'Arminio Monforte, A, Andreoni, M, Castagna, A, Castelli, F, Cauda, R, Di Perri, G, Galli, M, Iardino, R, Ippolito, G, Lazzarin, A, Marchetti, Gc, Rezza, G, von Schloesser, F, Viale, P, Ceccherini-Silberstein, F, Girardi, E, Lo Caputo, S, Mussini, C, Puoti, M, Perno, Cf, Bai, F, Balotta, C, Bandera, A, Borderi, M, Calcagno, A, Capetti, A, Capobianchi, Mr, Cicalini, S, Cingolani, A, Cinque, P, De Luca, A, Gianotti, N, Gori, A, Guaraldi, G, Madeddu, G, Maggiolo, F, Monno, L, Nozza, S, Pinnetti, C, Quiros Roldan, E, Rusconi, S, Santoro, Mm, Saracino, A, Sarmati, L, Fanti, I, Galli, L, Rodano', A, Macchia, M, Tavelli, A, Carletti, F, Carrara, S, Di Caro, A, Graziano, S, Petroni, F, Prota, G, Truffa, S, Giacometti, A, Costantini, A, Barocci, V, Angarano, G, Milano, E, Suardi, C, Donati, V, Verucchi, G, Castelnuovo, F, Minardi, C, Menzaghi, B, Abeli, C, Cacopardo, B, Celesia, B, Vecchiet, J, Falasca, K, Pan, A, Lorenzotti, S, Sighinolfi, L, Segala, D, Blanc, P, Cassola, G, Viscoli, C, Alessandrini, A, Bobbio, N, Mazzarello, G, Vita, S, Bonfanti, P, Molteni, C, Chiodera, A, Milini, P, Nunnari, G, Pellicanò, G, Rizzardini, G, Cannizzo, E, Moioli, Mc, Piolini, R, Bernacchia, D, Salpietro, S, Tincati, C, Puzzolante, C, Migliorino, C, Sangiovanni, V, Borgia, G, Esposito, V, Di Martino, F, Gentile, I, Rizzo, V, Cattelan, Am, Marinello, S, Cascio, A, Trizzino, M, Baldelli, F, Schiaroli, E, Parruti, G, Sozio, F, Magnani, G, Ursitti, Ma, Cristaudo, A, Vullo, V, Acinapura, R, Moschese, D, Capozzi, M, Mondi, A, Capparuccia, Mr, Iaiani, G, Latini, A, Gagliardini, R, Plazzi, Mm, Savinelli, S, Vergori, A, Cecchetto, M, Viviani, F, De Vito, A, Rossetti, B, Montagnani, F, Franco, A, Fontana Del Vecchio, R, Francisci, D, Di Giuli, C, Caramello, P, Orofino, Gc, Sciandra, M, Bassetti, M, Londero, A, Pellizzer, G, Manfrin, V, Starnini, G, Ialungo, A, Taramasso L., Lorenzini P., Di Biagio A., Lichtner M., Marchetti G., Rossotti R., Lapadula G., Cozzi-Lepri A., Vichi F., Antinori A., Bonora S., Cascio A., D'Arminio Monforte A., Cascio A. in ICONA Foundation Study Group., Taramasso, L., Lorenzini, P., Di Biagio, A., Lichtner, M., Marchetti, G., Rossotti, R., Lapadula, G., Cozzi-Lepri, A., Vichi, F., Antinori, A., Bonora, S., D'Arminio Monforte, A., Castagna, A., and A d'Arminio Monforte,i, M Andreoni, A Castagna, F Castelli, R Cauda, G Di Perri, M Galli, R Iardino, G Ippolito, A Lazzarin, G Rezza, F von Schloesser, F Ceccherini-Silberstein, E Girardi, S Lo Caputo, C Mussini, M Puoti, C F Perno, F Bai, C Balotta, A Bandera, M Borderi, A Calcagno, A Capetti, M R Capobianchi, S Cicalini, A Cingolani, P Cinque, A De Luca, E Girardi, N Gianotti, A Gori, G Guaraldi, G Madeddu, F Maggiolo, L Monno, S Nozza, C Pinnetti, E Quiros Roldan, S Rusconi, M M Santoro, A Saracino, L Sarmati, I Fanti, A Rodano', M Macchia, A Tavelli, F Carletti, S Carrara, A Di Caro, S Graziano, F Petroni, G Prota, S Truffa, A Giacometti, A Costantini, V Barocci, G Angarano, L Monno, E Milano, F Maggiolo, C Suardi, P Viale, V Donati, G Verucchi, F Castelnuovo, C Minardi, B Menzaghi, C Abeli, B Cacopardo, B Celesia, J Vecchiet, K Falasca, A Pan, S Lorenzotti, L Sighinolfi, D Segala, P Blanc, G Cassola, C Viscoli, A Alessandrini, N Bobbio, G Mazzarello, S Vita, P Bonfanti, C Molteni, A Chiodera, P Milini, G Nunnari, G Pellicanò, G Rizzardini, E S Cannizzo, M C Moioli, R Piolini, D Bernacchia, S Salpietro, C Tincati, C Puzzolante, C Migliorino, V Sangiovanni, G Borgia, V Esposito, F Di Martino, I Gentile, V Rizzo, A M Cattelan, S Marinello, A Cascio, M Trizzino, F Baldelli, E Schiaroli, G Parruti, F Sozio, G Magnani, M A Ursitti, A Cristaudo, V Vullo, R Acinapura, D Moschese, M Capozzi, A Mondi, M Rivano Capparuccia, G Iaiani, A Latini, R Gagliardini, M M Plazzi, S Savinelli, A Vergori, M Cecchetto, F Viviani, G Madeddu, A De Vito, B Rossetti, F Montagnani, A Franco, R Fontana Del Vecchio, D Francisci, C Di Giuli, P Caramello, G C Orofino, M Sciandra, M Bassetti, A Londero, G Pellizzer, V Manfrin, G Starnini, A Ialungo

Subjects
0301 basic medicine, Male, Integrase inhibitor, Hepatitis B Surface Antigen, HIV Infections, 0302 clinical medicine, Risk Factors, hivh epatitis c rna surface antigens follow-up homosexuality integrase inhibitors hepatitis b virus hepatitis b virus measurement hiv infections hepatotoxicity hepatitis c virus coinfection nucleoside reverse transcriptase inhibitors non-nucleoside reverse transcriptase inhibitors cox proportional hazards models baseline value liver enzyme raltegravir, Pharmacology (medical), HIV Infection, 030212 general & internal medicine, Prospective Studies, Prospective cohort study, Coinfection, Incidence (epidemiology), Liver Disease, Incidence, Liver Diseases, virus diseases, Hepatitis C, Middle Aged, Reverse Transcriptase Inhibitor, Infectious Diseases, Cohort, Population study, Regression Analysis, Reverse Transcriptase Inhibitors, Female, medicine.drug, Human, Microbiology (medical), Adult, medicine.medical_specialty, Anti-HIV Agents, Regression Analysi, NO, 03 medical and health sciences, Internal medicine, medicine, Humans, HIV Integrase Inhibitors, HIV Protease Inhibitor, Pharmacology, Hepatitis B Surface Antigens, business.industry, Anti-HIV Agent, HIV, ART, HIV Protease Inhibitors, medicine.disease, Raltegravir, 030112 virology, HIV Integrase Inhibitor, Prospective Studie, HIV-1, business, Adult, Anti-HIV Agents, Coinfection, Female, Hepatitis B Surface Antigens, Hepatitis C, HIV Infections, HIV Integrase Inhibitors, HIV Protease Inhibitors, HIV-1, Humans, Incidence, Liver Diseases, Male, Middle Aged, Prospective Studies, Regression Analysis, Reverse Transcriptase Inhibitors, Risk Factors
Abstract

ObjectivesTo evaluate the incidence and risk factors for liver enzyme elevations (LEE) in patients initiating first-line ART in the ICONA prospective observational cohort, between June 2009 and December 2017.Patients and methodsIn total, 6575 ART-naive patients were selected, initiating two NRTIs with the third drug being a boosted PI (n=2436; 37.0%), an NNRTI (n=2384; 36.3%) or an integrase strand transfer inhibitor (INSTI) (n=1755; 26.7%). HBV surface antigen and HCV RNA were detected in 3.9% and 5.8% of the study population. Inverse probability weighted Cox regression analysis was used to calculate the HRs, according to first-line regimen, for LEE, defined as ALT or AST increases of ≥2.5× upper limit of normal (ULN) for patients with normal baseline values or ≥2.5× baseline for patients with higher baseline values.ResultsOne hundred and eighty-three LEE occurred over 20722 patient-years of follow-up. After adjusting for the main confounders, the risk of LEE halved with INSTIs compared with NNRTIs (HR 0.46, 95% CI 0.25–0.86), with a significant reduction in the raltegravir group (HR 0.11, 95% CI 0.02–0.84 using the NNRTI class as reference). HRs for LEE were significantly higher in subjects with HBV or HCV coinfection, in patients with poorly controlled HIV infection and in those who acquired HIV through homosexual transmission.ConclusionsIn our study, INSTI use almost halved the risk of LEE compared with other regimens. This finding could be particularly important for choosing ART in patients with risk factors for liver toxicity such as HCV and HBV coinfections.

Published
2019

15. 96-week results of a dual therapy with darunavir/ritonavir plus rilpivirine once a day vs triple therapy in patients with suppressed viraemia: virological success and non-HIV related morbidity evaluation.

Author

Di Cristo V, Adorni F, Maserati R, Annovazzi Lodi M, Bruno G, Maggi P, Volpe A, Vitiello P, Abeli C, Bonora S, Ferrara M, Cossu MV, Oreni ML, Colella E, and Rusconi S

Subjects
Adult, Drug Administration Schedule, Female, HIV Infections mortality, HIV Infections virology, HIV-1 drug effects, HIV-1 genetics, HIV-1 physiology, Humans, Italy, Male, Middle Aged, Treatment Outcome, Viral Load drug effects, Viremia mortality, Viremia virology, Anti-HIV Agents administration & dosage, Darunavir administration & dosage, Drug Therapy, Combination, HIV Infections drug therapy, Rilpivirine administration & dosage, Ritonavir administration & dosage, Viremia drug therapy
Abstract

Antiretroviral therapies have been tested with the goal of maintaining virological suppression with a particular attention in limiting drug-related toxicity. With this aim we designed the DUAL study: a randomized, open-label, multicenter, 96 weeks-long pilot exploratory study in virologically suppressed HIV-1+ patients with the aim of evaluating the immunovirological success and the impact on non-HIV related morbidity of switching to a dual therapy with darunavir-ritonavir (DRV/r) and rilpivirine (RPV). We recruited patients who received a PI/r-containing HAART for ≥6 months, HIV-RNA < 50 cp/mL for ≥3 months, eGFR > 60 mL/min/1,73m2, without DRV or RPV RAMs. We randomized patients in arm A: RPV + DRV/r QD or arm B: ongoing triple therapy. The primary endpoint has been defined as the percentage of patients with HIV-RNA < 50 cp/mL at week 48 (ITT). VACS index, Framingham CVD risk (FRS) and urinary RBP (uRBP) were calculated. We used Chi-square or Fisher statistics for categorical variables and Mann-Whitney U for continuous ones. Forty-one patients were enrolled (22 in arm A, 14 in arm B, plus 5 screening failures): 30 patients reached 96 weeks: 100% had HIV-RNA < 50 cp/mL in arm A versus 91.7% in arm B. Similar changes were observed in median CD4/mL between baseline and week 96 (+59 versus  - 31, p: n.s.). Thirty-one in arm A and 23 in arm B adverse events took place, whereas only 1 was serious (arm A: turbinate hypertrophy, unrelated to HAART). Among the 6 discontinuations (3 in A, 3 in B), only 1 was related to adverse event (arm A: G3 depression, insomnia, weakness). VACS index, median FRS and median uRBP values did not vary from baseline to week 96. At 96-weeks all patients switched to a QD 2-drug regimen based on DRV/r + RPV maintained HIV-RNA suppression, but a single patient who showed a virological failure at week 4. CD4 counts increased overtime without significant differences between the two arms. The novel dual regimen was well tolerated with the same amount of discontinuation as the control arm. VACS index, FRS and uRBP did not differ between arms at week 96.

Published
2020
Full Text
View/download PDF

16. Maraviroc as intensification strategy in HIV-1 positive patients with deficient immunological response: an Italian randomized clinical trial.

Author

Rusconi S, Vitiello P, Adorni F, Colella E, Focà E, Capetti A, Meraviglia P, Abeli C, Bonora S, D'Annunzio M, Di Biagio A, Di Pietro M, Butini L, Orofino G, Colafigli M, d'Ettorre G, Francisci D, Parruti G, Soria A, Buonomini AR, Tommasi C, Mosti S, Bai F, Di Nardo Stuppino S, Morosi M, Montano M, Tau P, Merlini E, and Marchetti G

Subjects
Adult, Biomarkers blood, CD4 Lymphocyte Count, CD4-Positive T-Lymphocytes drug effects, CD4-Positive T-Lymphocytes immunology, CD4-Positive T-Lymphocytes virology, CD8-Positive T-Lymphocytes drug effects, CD8-Positive T-Lymphocytes immunology, CD8-Positive T-Lymphocytes virology, Female, HIV Infections immunology, HIV Infections pathology, HIV Infections virology, HIV-1 drug effects, HIV-1 physiology, Humans, Interleukin-7 blood, Ki-67 Antigen blood, Male, Maraviroc, Middle Aged, RNA, Viral blood, Treatment Outcome, Viral Load drug effects, Anti-HIV Agents therapeutic use, Antiretroviral Therapy, Highly Active, Cyclohexanes therapeutic use, HIV Infections drug therapy, Immunocompromised Host, RNA, Viral antagonists & inhibitors, Triazoles therapeutic use
Abstract

Background: Immunological non-responders (INRs) lacked CD4 increase despite HIV-viremia suppression on HAART and had an increased risk of disease progression. We assessed immune reconstitution profile upon intensification with maraviroc in INRs., Methods: We designed a multi-centric, randomized, parallel, open label, phase 4 superiority trial. We enrolled 97 patients on HAART with CD4+<200/µL and/or CD4+ recovery ≤ 25% and HIV-RNA<50 cp/mL. Patients were randomized 1:1 to HAART+maraviroc or continued HAART. CD4+ and CD8+ CD45+RA/RO, Ki67 expression and plasma IL-7 were quantified at W0, W12 and W48., Results: By W48 both groups displayed a CD4 increase without a significant inter-group difference. A statistically significant change in CD8 favored patients in arm HAART+maraviroc versus HAART at W12 (p=.009) and W48 (p=.025). The CD4>200/µL and CD4>200/µL + CD4 gain ≥ 25% end-points were not satisfied at W12 (p=.24 and p=.619) nor at W48 (p=.076 and p=.236). Patients continuing HAART displayed no major changes in parameters of T-cell homeostasis and activation. Maraviroc-receiving patients experienced a significant rise in circulating IL-7 by W48 (p=.01), and a trend in temporary reduction in activated HLA-DR+CD38+CD4+ by W12 (p=.06) that was not maintained at W48., Conclusions: Maraviroc intensification in INRs did not have a significant advantage in reconstituting CD4 T-cell pool, but did substantially expand CD8. It resulted in a low rate of treatment discontinuations., Trial Registration: ClinicalTrials.gov NCT00884858 http://clinicaltrials.gov/show/NCT00884858.

Published
2013
Full Text
View/download PDF

17. Rate of CD4+ cell count increase over periods of viral load suppression: relationship with the number of previous virological failures.

Author

Trotta MP, Cozzi-Lepri A, Ammassari A, Vecchiet J, Cassola G, Caramello P, Vullo V, Soscia F, Chiodera A, Ladisa N, Abeli C, Cauda R, Buonuomi AR, Antinori A, and d'Arminio Monforte A

Subjects
Adult, Aged, CD4 Lymphocyte Count, Female, HIV Infections drug therapy, Humans, Male, Middle Aged, Treatment Failure, Anti-HIV Agents therapeutic use, Antiretroviral Therapy, Highly Active methods, HIV Infections immunology, HIV Infections virology, Viral Load
Abstract

Background: Although the kinetics of CD4(+) cell counts have been extensively studied in antiretroviral-naive HIV-infected patients, data on individuals who have failed combination antiretroviral therapy (cART) are lacking., Methods: This analysis was based on the ICONA Foundation Study. Subjects with > or = 1 episode of viral suppression after starting first-line cART were included (n = 3537). Following a viral rebound, patients who achieved another episode of viral suppression could reenter the analysis. The percentage of patients with an increase in CD4(+) cell count >300 cells/mm(3) was estimated using Kaplan-Meier techniques; the rate of CD4(+) cell count increase per year was estimated using a multivariable, multilevel linear model with fixed effects of intercept and slope. Multivariable models were also fitted to include several covariates., Results: The median time to reach a CD4(+) cell count increase >300 cells/mm(3) from baseline was significantly associated with the number of failed regimens: 34 months, 41 months, 51 months, and 45 months in subjects without evidence of previous virological failure, or 1, 2, or > or = 3 previous virologically failed regimens, respectively (P < .001, by log-rank test). The annual estimated increases in CD4(+) cell count were 36 cells/mm(3) (95% confidence interval [CI], 34-38 cells/mm(3)), 28 cells/mm(3) (95% CI, 11-21 cells/mm(3)), 31 cells/mm(3) (95% CI, 26-36 cells/mm(3)), and 26 cells/mm(3) (95% CI, 18-33 cells/mm(3)), respectively. Differences in the annual CD4(+) cell count increase were observed between specific antiretrovirals., Conclusions: Subjects with > or = 1 virological failure took a longer time to reach a CD4(+) cell count >300 cell/mm(3) and had a slower annual increase than those without virological failure. Efforts should be made to optimize first-line cART, because this represents the best chance of achieving an effective CD4(+) response.

Published
2010
Full Text
View/download PDF

18. Efficacy and safety of boosted and unboosted atazanavir-containing antiretroviral regimens in real life: results from a multicentre cohort study.

Author

Giuntini R, Martinelli C, Ricci E, Vichi F, Gianelli E, Madeddu G, Abeli C, Palvarini L, Penco G, Marconi P, Grosso C, Pellicano G, Bonfanti P, and Quirino T

Subjects
Adenine analogs & derivatives, Adenine therapeutic use, Adult, Anti-HIV Agents adverse effects, Antiretroviral Therapy, Highly Active methods, Atazanavir Sulfate, CD4 Lymphocyte Count, Cohort Studies, Drug Administration Schedule, Drug Interactions, Female, HIV Protease Inhibitors adverse effects, Humans, Kaplan-Meier Estimate, Male, Oligopeptides adverse effects, Organophosphonates therapeutic use, Pyridines adverse effects, Reverse Transcriptase Inhibitors therapeutic use, Ritonavir adverse effects, Tenofovir, Treatment Outcome, Viral Load, Anti-HIV Agents therapeutic use, HIV Infections drug therapy, HIV Protease Inhibitors therapeutic use, Oligopeptides therapeutic use, Pyridines therapeutic use, Ritonavir therapeutic use
Abstract

Background: Atazanavir (ATV) has demonstrated high efficacy and safety in both treatment-naïve and treatment-experienced patients. Some comparative data are available on the durability of ritonavir-boosted (ATV/r) and unboosted formulations, but there are no data on clinicians' motivations for choosing one or another in everyday practice. The aim of this study was to evaluate the long-term efficacy of boosted and unboosted ATV in a cohort of treatment-experienced patients., Methods: All patients included in the study were enrolled in an observational cohort within the Surveillance Cohort Long-Term Toxicity Antiretrovirals (SCOLTA) Project. Data on CD4 cell count, HIV viral load, metabolic parameters and adverse events of grade 3-4 are collected through an on-line system every six months. The duration of treatment with ATV was evaluated using the Kaplan-Meier curve and boosted and unboosted regimens were compared using the log-rank test., Results: A total of 509 patients starting ATV as a component of their antiretroviral therapy were enrolled in the SCOLTA Project at the time of the study. Boosted ATV was received by 379 patients (74.5%) while 130 (25.5%) were treated with the unboosted formulation. The last therapeutic regimen did not influence the choice of ATV formulation. The mean observational time was 23.9 months. At the end of follow-up, 58.5% of patients on unboosted ATV and 58.1% of patients on ATV/r continued the treatment and no statistically significant differences were observed for ATV durability between the formulations or among the single causes of therapy interruption., Conclusions: Our results suggest that, in unselected clinical settings, ATV-containing antiretroviral therapy is durable and safe in both its formulations.

Published
2010
Full Text
View/download PDF

19. Observational study on HIV-infected subjects failing HAART receiving tenofovir plus didanosine as NRTI backbone.

Author

Bongiovanni M, Gianotti N, Chiesa E, Nasta P, Cicconi P, Capetti A, di Biagio A, Matti A, Tirelli V, Marconi P, de Luca A, Mussini C, Gatti F, Zaccarelli M, Abeli C, Torti C, Antinori A, Castagna A, and d'Arminio Monforte A

Subjects
Adenine administration & dosage, Adenine therapeutic use, Adult, Anti-HIV Agents administration & dosage, CD4 Lymphocyte Count, DNA, Viral genetics, Didanosine administration & dosage, Drug Resistance, Viral, Drug Therapy, Combination, Female, HIV-1 genetics, HIV-1 isolation & purification, Humans, Male, Middle Aged, Mutation, Organophosphonates administration & dosage, Retrospective Studies, Reverse Transcriptase Inhibitors administration & dosage, Sequence Analysis, DNA, Tenofovir, Treatment Outcome, Adenine analogs & derivatives, Anti-HIV Agents therapeutic use, Antiretroviral Therapy, Highly Active, Didanosine therapeutic use, HIV Infections drug therapy, HIV Infections immunology, Organophosphonates therapeutic use, Reverse Transcriptase Inhibitors therapeutic use
Abstract

We evaluated the efficacy of tenofovir (TDF) - and didanosine (ddI)-containing backbones in HIV-infected experienced subjects. We included in the study 245 subjects who started a TDF/ddI-containing HAART with HIV-RNA > 3 log(10) cp/ml and an available genotypic resistance test at baseline. At baseline, median CD4 counts and HIV-RNA were 278 cell/mmc and 4.32 log(10) cp/ml, respectively. Seventy-four subjects (30.2%) discontinued TDF and/or ddI, 23 of them for drug-related toxicities or intolerance. One-hundred and twenty-six (51.4%) subjects achieved virologic success (HIV-RNA < 50 copies/ml in two consecutive determinations) in a median time of 6.1 months; higher HIV-RNA levels (HR: 0.66, 95% CI: 0.54- 0.79, p < 0.001 for each additional log(10) copies/ml), and the total number of mutations either for PI and NNRTI at baseline (HR: 0.87, 95% CI: 0.81-0.92, p < 0.001 for each additional mutation) were both predictors of virologic success. M184V was marginally associated with virologic success (HR: 1.34, 95% CI: 0.94-1.90, p = 0.10 vs no M184V), whilst the number of TAMs was not associated. One-hundred-thirty-three (54.3%) subjects achieved immunologic success (increase of > or = 100 cells/mm(3) from baseline) in a median time of 7.5 months; immunologic success was associated with HIV-RNA levels at baseline (HR: 0.91, 95% CI: 0.79-0.98, p = 0.04 for each additional log(10) copies/ml), the total number of mutations either for PI or NNRTI (HR: 0.91, 95% CI: 0.85-0.98, p = 0.01 for each additional mutation) and CD4 count at baseline (HR: 1.11, 95% CI: 1.00-1.23, p = 0.05 for each additional 100 cells/mm(3)). Results obtained by the on-treatment analyses were comparable. In our study, HAART containing TDF/ddI seem associated with a virologic and immunologic response, when such regimens are chosen according to a genotypic resistance test.

Published
2007
Full Text
View/download PDF

20. Outcome of a second-line protease inhibitor-containing regimen in patients failing or intolerant of a first highly active antiretroviral therapy.

Author

Bini T, Testa L, Chiesa E, Adorni F, Abeli C, Castelnuovo B, Melzi S, Sollima S, Bongiovanni M, and d'Arminio Monforte A

Subjects
Acquired Immunodeficiency Syndrome immunology, Adult, CD4 Lymphocyte Count, Drug Therapy, Combination, Female, Follow-Up Studies, HIV Seropositivity immunology, Humans, Male, RNA, Viral blood, Time Factors, Treatment Failure, Treatment Outcome, Acquired Immunodeficiency Syndrome drug therapy, Anti-HIV Agents therapeutic use, HIV Protease Inhibitors therapeutic use, HIV Seropositivity drug therapy, Nelfinavir therapeutic use, Ritonavir therapeutic use, Saquinavir therapeutic use
Abstract

The outcome of second-line protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) was investigated in 263 patients who were failed by (n = 148) or intolerant of (n = 115) a first HAART regimen. The endpoints were virologic failure (decline in HIV RNA < 1 log10 copies/ml after > or = 2 months) and discontinuation due to intolerance/toxicity. During a median follow-up of 483 days (33-1087 days), 154 patients (59%) discontinued the second regimen, 86 (33%) because of intolerance/toxicity; another 135 patients (51.3%) showed virologic failure. Independent factors associated with virologic failure (Cox's model) were 7 to 12 months of first HAART (hazard ratio [HR] 1.70 versus < or = 6 months: 95% confidence interval [CI], 1.08-2.70) and gender (HR 1.58 males versus females: 95% CI, 1.04-2.30); the negatively associated factors were advanced age (HR 0.61 > 34 years versus < or = 34 years: 95% CI, 0.42-0.88), a saquinavir-containing first HAART (HR 0.57 versus indinavir: 95% CI, 0.34-0.93) and change due to intolerance/toxicity (HR 0.58 versus failure: 95% CI, 0.35-0.98). The independent variables predictive of discontinuation due to intolerance/toxicity were the reason for switching (HR 1.79 intolerance versus failure: 95% CI, 1.02-3.16) and the first protease inhibitor (PI) regimen (HR 0.42 ritonavir versus indinavir: 95% CI, 0.22-0.80). Given that patients who are failed by a first regimen are at high risk of having rescue therapy fail as well, second-line regimens including therapies directed by testing of drug resistance patterns of clinical viral isolates are warranted. Patients experiencing toxicity due to a first PI-containing regimen are at risk of toxicity to other PIs and should be addressed to PI-sparing HAART.

Published
2000
Full Text
View/download PDF

21. CD4 cell counts at the third month of HAART may predict clinical failure.

Author

d'Arminio Monforte A, Testori V, Adorni F, Castelnuovo B, Bini T, Testa L, Moscatelli G, Chiesa E, Rusconi S, Abeli C, Sollima S, Musicco M, Meroni L, Galli M, and Moroni M

Subjects
AIDS-Related Opportunistic Infections immunology, Acquired Immunodeficiency Syndrome complications, Adult, Aged, Drug Therapy, Combination, Female, HIV isolation & purification, HIV Infections immunology, HIV Infections mortality, HIV Infections virology, Humans, Male, Middle Aged, Prognosis, Time Factors, Treatment Failure, Viral Load, Anti-HIV Agents therapeutic use, CD4 Lymphocyte Count, HIV Infections drug therapy
Abstract

Objective: To evaluate the influence of immunological and virological markers on clinical outcome in patients receiving their first highly active antiretroviral therapy (HAART) regimen., Design and Methods: Observational study of 585 patients initiating HAART in a clinical setting. Clinical failure was defined as the occurrence of new or recurrent AIDS-defining events or death, and was analysed by means of intention-to-treat, univariate and multivariate analyses. An adjusted Cox regression model was used to evaluate the effect of 3-month CD4 cell counts on clinical outcome., Results: Clinical failure occurred in 55 patients (9.4%) during a median follow-up of 483 days (range 33-1334 days): 45 new AIDS-defining events (ADEs) in 38, ADE recurrence in six, and death in 11. Twenty-four of the 45 new ADEs (53.4%) occurred during the first 3 months of HAART, and 11 of 45 (24.4%) in the presence of CD4 cell counts > 200 x 10(6) cells/l. The mean (median, range) CD4 counts were 144 x 10(6) cells/l (128, 4-529) in patients with and 322 x 10(6) cells/l (288, 14-1162) in patients without clinical failure (P < 0.0001). Moreover, the proportion of patients with mean CD4 cell counts < 200 x 10(6) cells/l was higher in those experiencing subsequent clinical failure (X2 test: 26.75; P < 0.00001). Multivariate analysis showed that baseline CD4 cell counts < 50 x 10(6) cells/l and AIDS at enrolment predicted failure; after adjusting for 3-month CD4 cell counts, this marker was the only one independently associated with clinical failure (hazard risk, 4.79; 95% confidence interval, 1.40-16.47)., Conclusions: The 3-month immunological response is a reliable predictor of long-term clinical outcome.

Published
1999
Full Text
View/download PDF

22. BK virus renal infection in a patient with the acquired immunodeficiency syndrome.

Author

Nebuloni M, Tosoni A, Boldorini R, Monga G, Carsana L, Bonetto S, Abeli C, Caldarelli R, Vago L, and Costanzi G

Subjects
Adult, Biopsy, DNA, Viral metabolism, Fluorescent Antibody Technique, Humans, Immunohistochemistry, Kidney Diseases metabolism, Kidney Diseases pathology, Male, Microscopy, Immunoelectron, Papillomavirus Infections complications, Renal Insufficiency pathology, Renal Insufficiency virology, Tumor Virus Infections complications, Acquired Immunodeficiency Syndrome complications, BK Virus isolation & purification, Kidney Diseases virology, Papillomavirus Infections diagnosis, Tumor Virus Infections diagnosis
Abstract

Background: We describe herein a patient with the acquired immunodeficiency syndrome and renal failure due to biopsy-proven BK virus (BKV) infection. Three months after the diagnosis of the renal viral infection, his condition remained unchanged. Although BKV has previously been shown to be associated with ureteral stenosis and renal damage in renal transplant patients, to our knowledge, the literature contains only 3 cases describing the presence of BKV lesions in the kidneys of immunosuppressed patients who had not undergone transplantation., Methods: The presence of BKV infection was demonstrated by means of histology, immunohistochemistry with polyclonal anti-SV40 antibody, immunoelectron microscopy, polymerase chain reaction, and enzymatic cleavage with BamHI., Results: Histologic examination revealed interstitial inflammatory infiltrates and tubules with enlarged and eosinophilic nuclei., Conclusions: The high frequency of latent BKV infection and its reactivation during immunosuppression suggest that the possibility of its involvement in renal damage should be considered in immunocompromised patients.

Published
1999
Full Text
View/download PDF

23. Clinical outcome and predictive factors of failure of highly active antiretroviral therapy in antiretroviral-experienced patients in advanced stages of HIV-1 infection.

Author

d'Arminio Monforte A, Testa L, Adorni F, Chiesa E, Bini T, Moscatelli GC, Abeli C, Rusconi S, Sollima S, Balotta C, Musicco M, Galli M, and Moroni M

Subjects
Adult, CD4 Lymphocyte Count, Cohort Studies, Drug Therapy, Combination, Female, HIV Infections immunology, Humans, Male, Observation, RNA, Viral blood, Treatment Failure, Anti-HIV Agents therapeutic use, HIV Infections drug therapy, HIV Protease Inhibitors therapeutic use, HIV-1, Indinavir therapeutic use, Ritonavir therapeutic use, Saquinavir therapeutic use
Abstract

Objective: To verify the effectiveness of highly active antiretroviral therapy (HAART) and to identify any factors predictive of clinical outcome in a clinical setting., Design: Observational study., Methods: Treatment failure (i.e., the occurrence of new or recurrent AIDS-defining events, death or any definitive discontinuation) and the course of CD4+ cell counts and HIV RNA copies were evaluated in 250 heavily pretreated HIV-infected patients starting HAART [153 with indinavir (IDV), 55 with ritonavir (RTV), 43 with saquinavir (SQV)]. Univariate and multivariate analyses were performed to identify predictors of worse outcome., Results: During a median follow-up of 8 months, 75 patients (30%) had treatment failure because of the occurrence of an AIDS-defining event or death (n = 24), inefficacy (n = 24), or severe intolerance (n = 27). Twenty new and six recurrent AIDS-defining events, and nine deaths occurred (six out of 20 AIDS-defining events and two out of nine deaths within 1 month of treatment). CD4+ counts were above 200 x 10(6)/l at AIDS diagnosis in only two patients. None of the SQV patients, 12 (7.8%) of the IDV patients, and 15 (27.3%) of the RTV-treated patients were considered non-compliant. The SQV-containing regimens independently correlated with treatment failure (relative risk, 2.46; 95% confidence interval, 1.20-5.03; versus IDV). Low compliance partially determined outcome in RTV-treated patients; both severe immunodepression and AIDS at baseline were predictive of treatment failure. There was a 10-fold increase in CD4+ cell counts in the patients treated with IDV and RTV; the best virological outcome occurred in IDV-treated patients, with 68.4% of patients showing undetectable HIV RNA copies after 6 months., Conclusions: HAART was effective in 70% of patients; low compliance and previous AIDS diagnosis represented predictive factors of therapy failure.

Published
1998
Full Text
View/download PDF

Catalog

Books, media, physical & digital resources
See catalog results