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1. Is HCV elimination among persons living with HIV feasible? Data from the NoCo study in the setting of the ICONA cohort

Author

D'Arminiomonforte, A, Tavelli, A, Rossotti, R, Gagliardini, R, Saracino, A, Locaputo, S, Sala, M, Quiros-Roldan, E, Mussini, C, Girardi, E, Cozzi-Lepri, A, Antinori, A, Puoti, M, d'ArminioMonforte A., Tavelli A., Rossotti R., Gagliardini R., Saracino A., LoCaputo S., Sala M., Quiros-Roldan E., Mussini C., Girardi E., Cozzi-Lepri A., Antinori A., Puoti M., D'Arminiomonforte, A, Tavelli, A, Rossotti, R, Gagliardini, R, Saracino, A, Locaputo, S, Sala, M, Quiros-Roldan, E, Mussini, C, Girardi, E, Cozzi-Lepri, A, Antinori, A, Puoti, M, d'ArminioMonforte A., Tavelli A., Rossotti R., Gagliardini R., Saracino A., LoCaputo S., Sala M., Quiros-Roldan E., Mussini C., Girardi E., Cozzi-Lepri A., Antinori A., and Puoti M.

Abstract

Background and Aims: Whether the HCV test-and-treat strategy impacted on the rate of new HCV infections among PLWH in Italy is unknown. Methods: Prospective study of PLWH in the ICONA network. At baseline, PLWH were tested for HCV-Ab; HCV-RNA (if HCV-Ab positive) and, if positive, treated with DAA. SVR12 indicated eradication. Seroconversions and re-infections were evaluated yearly in HCV-Ab neg and HCV-RNA neg at first screening. We estimated the following: HCV seroconversions, incidence of HCV reinfections, and access to DAA and SVR12 rates tighter with factors associated with each outcome. Data were analysed by Cox regression, Poisson regression and logistic regression models. Results: Sixteen thousand seven hundred and forty-three PLWH were included; 27.3% HCV-Ab positive; of these, 39.3% HCV-RNA positive. HCV seroconversion incidence:.48/100 PYFU (95% CI:.36–.65); re-infections incidence: 1.40/100 PYFU (95% CI:.91–2.04). The risk factor for HCV re-infection was young age: aIRR 1.85, 95% CI: 1.17–2.95) per 10 years younger. 86.4% of HCV viremic in follow-up started DAA. PWID vs. heterosexuals (aHR.75, 95% CI.62–.90), HIV-RNA >50 copies/mL (aHR.70, 95% CI.56–.87), HCV genotype other than G1, G2, G3, G4 or with multiple/missing HCV genotype and post-COVID-19 calendar periods were associated with lower DAA access. 922/965 (95.5%) PLWH achieved SVR12. We estimated 72% reduction of chance to achieve SVR12 in PLWH with a CD4 count <200/mm3 (vs. CD4 ≥200/mm3 aOR.18, 95% CI:.07–.46). 95.5% of DAA-treated individuals eradicated HCV, but they represent only 53.2% of HCV viremic PLWH and 66.4% of those in follow-up. HCV-RNA positivity by year decreased from 41.7% in 2017 to 11.7% in 2022. Conclusions: The screening-and-treat campaign implemented in Italy, even if only partially effective, resulted in a dramatic drop in HCV circulation in our cohort.

Published
2023

2. Biochemical and inflammatory modifications after switching to dual antiretroviral therapy in HIV-infected patients in Italy: A multicenter retrospective cohort study from 2007 to 2015

Author

Quiros-Roldan, E, Magro, P, Raffetti, E, Izzo, I, Borghetti, A, Lombardi, F, Saracino, A, Maggiolo, F, Castelli, F, Carosi, G, Paraninfo, G, Torti, C, Cauda, R, Di Giambenedetto, S, Fabbiani, M, Colafigli, M, Scalzini, A, Castelnuovo, F, El Hamad, I, Mazzotta, F, Locaputo, S, Marino, N, Pierotti, P, Di Pietro, M, Ble, C, Vichi, F, Sighinolfi, L, Angarano, G, Ladisa, N, Monno, L, Maggi, P, Pan, A, Costarelli, S, Gori, A, Lapadula, G, Puoti, M, Viale, P, Colangeli, V, Borderi, M, Quiros-Roldan E., Magro P., Raffetti E., Izzo I., Borghetti A., Lombardi F., Saracino A., Maggiolo F., Castelli F., Carosi G., Paraninfo G. E., Torti C., Cauda R., Di Giambenedetto S., Fabbiani M., Colafigli M., Scalzini A., Castelnuovo F., El Hamad I., Mazzotta F., Locaputo S., Marino N., Pierotti P., Di Pietro M., Ble C., Vichi F., Sighinolfi L., Angarano G., Ladisa N., Monno L., Maggi P., Pan A., Costarelli S., Gori A., Lapadula G., Puoti M., Viale P., Colangeli V., Borderi M., Quiros-Roldan, E, Magro, P, Raffetti, E, Izzo, I, Borghetti, A, Lombardi, F, Saracino, A, Maggiolo, F, Castelli, F, Carosi, G, Paraninfo, G, Torti, C, Cauda, R, Di Giambenedetto, S, Fabbiani, M, Colafigli, M, Scalzini, A, Castelnuovo, F, El Hamad, I, Mazzotta, F, Locaputo, S, Marino, N, Pierotti, P, Di Pietro, M, Ble, C, Vichi, F, Sighinolfi, L, Angarano, G, Ladisa, N, Monno, L, Maggi, P, Pan, A, Costarelli, S, Gori, A, Lapadula, G, Puoti, M, Viale, P, Colangeli, V, Borderi, M, Quiros-Roldan E., Magro P., Raffetti E., Izzo I., Borghetti A., Lombardi F., Saracino A., Maggiolo F., Castelli F., Carosi G., Paraninfo G. E., Torti C., Cauda R., Di Giambenedetto S., Fabbiani M., Colafigli M., Scalzini A., Castelnuovo F., El Hamad I., Mazzotta F., Locaputo S., Marino N., Pierotti P., Di Pietro M., Ble C., Vichi F., Sighinolfi L., Angarano G., Ladisa N., Monno L., Maggi P., Pan A., Costarelli S., Gori A., Lapadula G., Puoti M., Viale P., Colangeli V., and Borderi M.

Abstract

Background: Triple-drug regimens are the gold standard for HIV therapy. Nucleos(t)ide reverse transcriptase inhibitors (NRTIs) reducing regimens are used to decrease drugs toxicity, exposure and costs. Aim of our study was to evaluate trends of biochemical and inflammatory indices in patients switching to dual therapy (DT). Methods: We included patients that a) switched to a DT from 2007 to 2015 from a tenofovir/abacavir-based triple regimen b) previously maintained a triple and c) subsequently a dual regimen for 12 months with virological suppression. We retrieved data measured at 5 points (at the switch, 6 and 12 months before and after switch). We used platelet-to-lymphocyte ratio (PLR), neutrophil-to-lymphocyte ratio (NLR) and CD4/CD8 ratio as inflammatory indices. We assessed temporal trends of viro-immunological, biochemical and inflammatory parameters. Results: Overall, 364 and 65 patients switched from a tenofovir- and an abacavir-triple regimen, respectively. In the tenofovir-reducing group, creatinine clearance and lipids raised after the switch. There was a significant increase in both CD4+ cells and CD4/CD8. CD8+ cells rose after the switch, while opposite trend was found for PLR. In the abacavir-reducing group total lipids showed a decrease during the first 6 months after the switch and then stabilized. An increase of CD4+ and a decrease of CD8+ cells was observed during the study period, although not statistically significant. While CD4/CD8 remained stable after simplification, PLR decreased significantly after 6 months, then returning to baseline. CD8+ cells increased in the tenofovir-reducing group despite a viro-immunological response. Intriguingly, PLR decreased, maintaining this trend for 12 and 6 months after tenofovir and abacavir interruption respectively. Conclusions: Increased PLR has been linked to hypercholesterolemia and metabolic-syndrome, while high CD8+ cells count to increased risk of non-AIDS-related events regardless of CD4 T-cell re

Published
2018

3. Biochemical and inflammatory modifications after switching to dual antiretroviral therapy in HIV-infected patients in Italy: A multicenter retrospective cohort study from 2007 to 2015

Author

Quiros-Roldan, E., Magro, P., Raffetti, E., Izzo, I., Borghetti, Alberto, Lombardi, Francesca, Saracino, A., Maggiolo, F., Castelli, F., Carosi, Giulia, Paraninfo, G. E., Torti, Carlo, Cauda, Roberto, Di Giambenedetto, Simona, Fabbiani, M., Colafigli, Manuela, Scalzini, A., Castelnuovo, F., El Hamad, I., Mazzotta, F., Locaputo, S., Marino, N., Pierotti, P., Di Pietro, Maria Luisa, Ble, C., Vichi, F., Sighinolfi, L., Angarano, G., Ladisa, N., Monno, L., Maggi, P., Pan, A., Costarelli, S., Gori, A., Lapadula, G., Puoti, M., Viale, P., Colangeli, V., Borderi, M., Quiros-Roldan, E, Magro, P, Raffetti, E, Izzo, I, Borghetti, A, Lombardi, F, Saracino, A, Maggiolo, F, Castelli, F, Carosi, G, Paraninfo, G, Torti, C, Cauda, R, Di Giambenedetto, S, Fabbiani, M, Colafigli, M, Scalzini, A, Castelnuovo, F, El Hamad, I, Mazzotta, F, Locaputo, S, Marino, N, Pierotti, P, Di Pietro, M, Ble, C, Vichi, F, Sighinolfi, L, Angarano, G, Ladisa, N, Monno, L, Maggi, P, Pan, A, Costarelli, S, Gori, A, Lapadula, G, Puoti, M, Viale, P, Colangeli, V, Borderi, M, Blè, C, and Border, M

Subjects
0301 basic medicine, Male, HIV Infections, Gastroenterology, Cohort Studies, 0302 clinical medicine, Abacavir, Antiretroviral Therapy, Highly Active, 030212 general & internal medicine, Darunavir, virus diseases, Switch, Middle Aged, Antiretroviral therapy, Infectious Diseases, Treatment Outcome, Italy, Reverse Transcriptase Inhibitors, Female, medicine.symptom, medicine.drug, Research Article, Adult, medicine.medical_specialty, Anti-HIV Agents, Dual-therapy, HIV, Inflammation, Atazanavir Sulfate, CD4-CD8 Ratio, Renal function, Settore MED/17 - MALATTIE INFETTIVE, lcsh:Infectious and parasitic diseases, 03 medical and health sciences, Immune system, Internal medicine, medicine, Humans, lcsh:RC109-216, Tenofovir, Retrospective Studies, business.industry, Retrospective cohort study, Reverse transcriptase, Dideoxynucleosides, Regimen, 030104 developmental biology, business, CD8
Abstract

Background Triple-drug regimens are the gold standard for HIV therapy. Nucleos(t)ide reverse transcriptase inhibitors (NRTIs) reducing regimens are used to decrease drugs toxicity, exposure and costs. Aim of our study was to evaluate trends of biochemical and inflammatory indices in patients switching to dual therapy (DT). Methods We included patients that a) switched to a DT from 2007 to 2015 from a tenofovir/abacavir-based triple regimen b) previously maintained a triple and c) subsequently a dual regimen for 12 months with virological suppression. We retrieved data measured at 5 points (at the switch, 6 and 12 months before and after switch). We used platelet-to-lymphocyte ratio (PLR), neutrophil-to-lymphocyte ratio (NLR) and CD4/CD8 ratio as inflammatory indices. We assessed temporal trends of viro-immunological, biochemical and inflammatory parameters. Results Overall, 364 and 65 patients switched from a tenofovir- and an abacavir-triple regimen, respectively. In the tenofovir-reducing group, creatinine clearance and lipids raised after the switch. There was a significant increase in both CD4+ cells and CD4/CD8. CD8+ cells rose after the switch, while opposite trend was found for PLR. In the abacavir-reducing group total lipids showed a decrease during the first 6 months after the switch and then stabilized. An increase of CD4+ and a decrease of CD8+ cells was observed during the study period, although not statistically significant. While CD4/CD8 remained stable after simplification, PLR decreased significantly after 6 months, then returning to baseline. CD8+ cells increased in the tenofovir-reducing group despite a viro-immunological response. Intriguingly, PLR decreased, maintaining this trend for 12 and 6 months after tenofovir and abacavir interruption respectively. Conclusions Increased PLR has been linked to hypercholesterolemia and metabolic-syndrome, while high CD8+ cells count to increased risk of non-AIDS-related events regardless of CD4 T-cell recovery and to virological failure. Whether these findings may have clinical implications, and which role DT plays on the immune system and on inflammation should be further investigated.

Published
2018

5. Exploratory analysis for the evaluation of estimated glomerular filtration rate, cholesterol and triglycerides after switching from tenofovir/emtricitabine plus atazanavir/ritonavir (ATV/r) to abacavir/lamivudine plus ATV/r in patients with preserved renal function

Author

Postorino, M, Quiros-Roldan, E, Maggiolo, F, di Giambenedetto, S, Ladisa, N, Lapadula, G, Lorenzotti, S, Sighinolfi, L, Castelnuovo, F, di Pietro, M, Gotti, D, Mazzini, N, Torti, C, Castelli, F, Carosi, G, Nasta, P, Paraninfo, G, Foca, E, Fabbiani, M, Colafigli, M, Scalzini, A, El Hamad, I, Mazzotta, F, Locaputo, S, Marino, N, Pierotti, P, Ble, C, Vichi, F, Angarano, G, Monno, L, Maggi, P, Pan, A, Costarelli, S, Gori, A, Puoti, M, Viale, P, Colangeli, V, Borderi, M, Postorino M. C., Quiros-Roldan E., Maggiolo F., di Giambenedetto S., Ladisa N., Lapadula G., Lorenzotti S., Sighinolfi L., Castelnuovo F., di Pietro M., Gotti D., Mazzini N., Torti C., Castelli F., Carosi G., Nasta P., Paraninfo G., Foca E., Fabbiani M., Colafigli M., Scalzini A., El Hamad I., Mazzotta F., Locaputo S., Marino N., Pierotti P., Ble C., Vichi F., Angarano G., Monno L., Maggi P., Pan A., Costarelli S., Gori A., Puoti M., Viale P., Colangeli V., Borderi M., Postorino, M, Quiros-Roldan, E, Maggiolo, F, di Giambenedetto, S, Ladisa, N, Lapadula, G, Lorenzotti, S, Sighinolfi, L, Castelnuovo, F, di Pietro, M, Gotti, D, Mazzini, N, Torti, C, Castelli, F, Carosi, G, Nasta, P, Paraninfo, G, Foca, E, Fabbiani, M, Colafigli, M, Scalzini, A, El Hamad, I, Mazzotta, F, Locaputo, S, Marino, N, Pierotti, P, Ble, C, Vichi, F, Angarano, G, Monno, L, Maggi, P, Pan, A, Costarelli, S, Gori, A, Puoti, M, Viale, P, Colangeli, V, Borderi, M, Postorino M. C., Quiros-Roldan E., Maggiolo F., di Giambenedetto S., Ladisa N., Lapadula G., Lorenzotti S., Sighinolfi L., Castelnuovo F., di Pietro M., Gotti D., Mazzini N., Torti C., Castelli F., Carosi G., Nasta P., Paraninfo G., Foca E., Fabbiani M., Colafigli M., Scalzini A., El Hamad I., Mazzotta F., Locaputo S., Marino N., Pierotti P., Ble C., Vichi F., Angarano G., Monno L., Maggi P., Pan A., Costarelli S., Gori A., Puoti M., Viale P., Colangeli V., and Borderi M.

Abstract

Background and Objectives: Renal toxicity due to tenofovir (TDF) has been largely described in patients with HIV infection. However, other antiretroviral drugs (such as atazanavir [ATV], especially when boosted by ritonavir, ATV/r) could perpetuate some degrees of renal impairment with or without TDF co-administration. Also, possible benefits of stopping TDF in patients without renal diseases is not well known. This study aimed at exploring evolution of renal function and lipid profile after switching from tenofovir/emtricitabine (TDF/FTC) to abacavir/lamivudine (ABC/3TC), maintaining the ATV/r component of the regimen. Methods: Patients in the Italian MASTER Cohort, who switched from TDF/FTC plus ATV/r to ABC/3TC plus ATV/r were included, provided that major renal diseases were not diagnosed before switching (i.e., baseline). Serum creatinine, estimated glomerular filtration rate (eGFR), total cholesterol, HDL and triglycerides were evaluated at baseline and at month 18 after switching. Results: 126 patients were selected (80% males). Patients were mostly Italians (92%). 79% had undetectable HIV-RNA and 44% were coinfected by HBV and/or HCV. Median age at switch was 47 years (IQR 43-55). A small but significant decrease in serum creatinine [from 1.06 mg/dl (SD: 0.3) to 0.94 mg/dl (SD: 0.2); p<0.001] with an improvement in eGFR [from 86.8 ml/min (SD: 33) to 96.4 ml/min (SD: 37); p<0.001] were observed in per protocol analysis at month 18. Also ITT analysis showed a decrease in mean serum creatinine [from 1.08 mg/dl (SD: 0.35) to 0.95 mg/dl (SD: 0.24); p<0.001] with an improvement in mean eGFR [from 86.9 ml/min/1.73m2 (SD: 24.11) to 95.8 ml/min/1.73m2 (SD: 19.99); p<0.001]. Total cholesterol increased [from 188 mg/dl (SD: 42) to 206 mg/dl (SD: 44); p<0.001] but also HDL increased as well [from 46 mg/dl (SD: 14) to 54 mg/dl (SD: 19); p=0.015]. An increase in triglycerides concentration was observed [from 162 mg/dl (SD: 144) to 214 mg/dl (SD: 109); p=0.0

Published
2016

6. Risk of Severe Non AIDS Events Is Increased among Patients Unable to Increase their CD4+ T-Cell Counts >200+/μl Despite Effective HAART

Author

LAPADULA, GIUSEPPE, GORI, ANDREA, Chatenoud, L, Castelli, F, Di Giambenedetto, S, Fabbiani, M, Maggiolo, F, Focà, E, Ladisa, N, Sighinolfi, L, Di Pietro, M, Pan, A, Torti, C, Carosi, G, Quiros, E, Nasta, P, Paraninfo, G, Cauda, R, Colafigli, M, Scalzini, A, Castelnuovo, F, El Hamad, I, Mazzotta, F, Locaputo, S, Pierotti, P, Marino, N, Blè, C, Vichi, F, Angarano, G, Monno, L, Maggi, P, Costarelli, S, Puoti, M, Viale, P, Colangeli, V, Borderi, M., Lapadula, G, Chatenoud, L, Gori, A, Castelli, F, Di Giambenedetto, S, Fabbiani, M, Maggiolo, F, Focà, E, Ladisa, N, Sighinolfi, L, Di Pietro, M, Pan, A, Torti, C, Carosi, G, Quiros, E, Nasta, P, Paraninfo, G, Cauda, R, Colafigli, M, Scalzini, A, Castelnuovo, F, El Hamad, I, Mazzotta, F, Locaputo, S, Pierotti, P, Marino, N, Blè, C, Vichi, F, Angarano, G, Monno, L, Maggi, P, Costarelli, S, Puoti, M, Viale, P, Colangeli, V, Borderi, M, Lapadula, G., Chatenoud, L., Gori, A., Castelli, F., Di Giambenedetto, S., Fabbiani, M., Maggiolo, F., Foca, E., Ladisa, N., Sighinolfi, L., Di Pietro, M., Pan, A., Torti, C., Carosi, G., Quiros, E., Nasta, P., Paraninfo, G., Cauda, R., Colafigli, M., Scalzini, A., Castelnuovo, F., El Hamad, I., Mazzotta, F., Locaputo, S., Pierotti, P., Marino, N., Ble, C., Vichi, F., Angarano, G., Monno, L., Maggi, P., Costarelli, S., Puoti, M., Viale, P., Colangeli, V., and Borderi, M.

Subjects
Male, Comorbidity, medicine.disease_cause, Risk Factors, Neoplasms, Antiretroviral Therapy, Highly Active, Cardiovascular Disease, education.field_of_study, Multidisciplinary, Coinfection, Incidence (epidemiology), Liver Diseases, Liver Disease, Medicine (all), Hepatitis C, Middle Aged, Viral Load, Cardiovascular Diseases, Disease Progression, Medicine, Female, Viral load, Research Article, Human, Adult, medicine.medical_specialty, Science, Hepatitis C virus, Population, Antiretroviral Therapy, Settore MED/17 - MALATTIE INFETTIVE, Acquired immunodeficiency syndrome (AIDS), Internal medicine, medicine, Humans, Highly Active, education, Acquired Immunodeficiency Syndrome, Biochemistry, Genetics and Molecular Biology (all), business.industry, Risk Factor, medicine.disease, CD4 Lymphocyte Count, cd4, Agricultural and Biological Sciences (all), Immunology, Neoplasm, business
Abstract

Background: Immunological non-response (INR) despite virological suppression is associated with AIDS-defining events/death (ADE). Little is known about its association with serious non-AIDS-defining events (nADE). Methods Patients highly-active antiretroviral therapy (HAART) with 50. Results: 1221 patients were observed for a median of 3 (IQR: 1.3-6.1) years. Pre-HAART CD4+were 77/μl (IQR: 28-142) and 56% of patients had experienced an ADE. After 1 year, CD4+ increased to 286 (IQR: 197-387), but 26.1% of patients were INR. Thereafter, 86 nADE (30.2% malignancies, 27.9%infectious, 17.4%renal, 17.4Êrdiovascular, 7% hepatic) were observed, accounting for an incidence of 1.83 events (95%CI: 1.73-2.61) per 100 PYFU. After adjusting for measurable confounders, INR had a significantly greater risk of nADE (HR 1.65; 95%CI: 1.06-2.56). Older age (per year, HR 1.03; 95%CI: 1.01-1.05), hepatitis C co-infection (HR 2.09; 95%CI: 1.19-3.7), a history of previous nADE (HR 2.16; 95% CI: 1.06-4.4) and the occurrence of ADE during the follow-up (HR 2.2; 95%CI: 1.15-4.21) were other independent predictors of newly diagnosed nADE. Conclusions: Patients failing to restore CD4+ to >200 cells/μl run a greater risk of serious nADE, which is intertwined or predicted by AIDS progression. Improved management of this fragile population and innovative therapy able to induce immune-reconstitution are urgently needed. Also, our results strengthen the importance of earlier diagnosis and HAART introduction.

Published
2015

7. Exploratory analysis for the evaluation of estimated glomerular filtration rate, cholesterol and triglycerides after switching from tenofovir/emtricitabine plus atazanavir/ritonavir (ATV/r) to abacavir/lamivudine plus ATV/r in patients with preserved renal function

Author

Postorino, Maria Concetta, Quiros Roldan, Eugenia, Maggiolo, Franco, Di Giambenedetto, Simona, Ladisa, Nicoletta, Lapadula, Giuseppe, Lorenzotti, Silvia, Sighinolfi, Laura, Castelnuovo, Filippo, di Pietro, Massimo, Gotti, Daria, Mazzini, Nicola, Torti, Carlo, Castelli, F., Carosi, G., Nasta, P., Paraninfo, G., Focà, E., di Giambenedetto, R. Cauda S., Fabbiani, Massimiliano, Colafigli, Manuela, Scalzini, A., El Hamad, I., Mazzotta, F., Locaputo, S., Marino, N., Pierotti, P., Ble, C., Vichi, F., Angarano, G., Monno, L., Maggi, P., Pan, A., Costarelli, S., Gori, A., Lapadula, G., Puoti, M., Viale, P., Colangeli, V., Borderi, M., Postorino, M, Quiros-Roldan, E, Maggiolo, F, di Giambenedetto, S, Ladisa, N, Lapadula, G, Lorenzotti, S, Sighinolfi, L, Castelnuovo, F, di Pietro, M, Gotti, D, Mazzini, N, Torti, C, Castelli, F, Carosi, G, Nasta, P, Paraninfo, G, Foca, E, Fabbiani, M, Colafigli, M, Scalzini, A, El Hamad, I, Mazzotta, F, Locaputo, S, Marino, N, Pierotti, P, Ble, C, Vichi, F, Angarano, G, Monno, L, Maggi, P, Pan, A, Costarelli, S, Gori, A, Puoti, M, Viale, P, Colangeli, V, and Borderi, M

Subjects
0301 basic medicine, Atazanavir, Cholesterol, eGFR, Highly active antiretroviral therapy, Nephrotoxicity, Tenofovir, Public Health, Environmental and Occupational Health, Infectious Diseases, Virology, medicine.medical_specialty, Urology, Renal function, Pharmacology, Emtricitabine, Settore MED/17 - MALATTIE INFETTIVE, Article, 03 medical and health sciences, chemistry.chemical_compound, Abacavir, medicine, Creatinine, business.industry, Highly Active Antiretroviral Therapy, Environmental and Occupational Health, Lamivudine, Abacavir/Lamivudine, 030112 virology, chemistry, Ritonavir, Public Health, business, medicine.drug
Abstract

Background and Objectives: Renal toxicity due to tenofovir (TDF) has been largely described in patients with HIV infection. However, other antiretroviral drugs (such as atazanavir [ATV], especially when boosted by ritonavir, ATV/r) could perpetuate some degrees of renal impairment with or without TDF co-administration. Also, possible benefits of stopping TDF in patients without renal diseases is not well known. This study aimed at exploring evolution of renal function and lipid profile after switching from tenofovir/emtricitabine (TDF/FTC) to abacavir/lamivudine (ABC/3TC), maintaining the ATV/r component of the regimen. Methods: Patients in the Italian MASTER Cohort, who switched from TDF/FTC plus ATV/r to ABC/3TC plus ATV/r were included, provided that major renal diseases were not diagnosed before switching (i.e., baseline). Serum creatinine, estimated glomerular filtration rate (eGFR), total cholesterol, HDL and triglycerides were evaluated at baseline and at month 18 after switching. Results: 126 patients were selected (80% males). Patients were mostly Italians (92%). 79% had undetectable HIV-RNA and 44% were coinfected by HBV and/or HCV. Median age at switch was 47 years (IQR 43-55). A small but significant decrease in serum creatinine [from 1.06 mg/dl (SD: 0.3) to 0.94 mg/dl (SD: 0.2); p

Published
2016

8. Use of efavirenz or atazanavir/ritonavir is associated with better clinical outcomes of HAART compared to other protease inhibitors: Routine evidence from the Italian MASTER Cohort

Author

Postorino, M, Prosperi, M, Quiros-Roldan, E, Maggiolo, F, Di Giambenedetto, S, Saracino, A, Costarelli, S, Lorenzotti, S, Sighinolfi, L, Di Pietro, M, Torti, C, Castelli, F, Carosi, G, Nasta, P, Paraninfo, G, Foca, E, Cauda, R, Fabbiani, M, Colafigli, M, Scalzini, A, Castelnuovo, F, Mazzotta, F, Locaputo, S, Marino, N, Pierotti, P, Ble, C, Vichi, F, Angarano, G, Ladisa, N, Monno, L, Maggi, P, Pan, A, Gori, A, Lapadula, G, Ospedale, S, Puoti, M, Viale, P, Colangeli, V, Borderi, M, Policlinico, S, Postorino M. C., Prosperi M., Quiros-Roldan E., Maggiolo F., Di Giambenedetto S., Saracino A., Costarelli S., Lorenzotti S., Sighinolfi L., Di Pietro M., Torti C., Castelli F., Carosi G., Nasta P., Paraninfo G., Foca E., Cauda R., Fabbiani M., Colafigli M., Scalzini A., Castelnuovo F., Mazzotta F., Locaputo S., Marino N., Pierotti P., Ble C., Vichi F., Angarano G., Ladisa N., Monno L., Maggi P., Pan A., Gori A., Lapadula G., Ospedale S., Puoti M., Viale P., Colangeli V., Borderi M., Policlinico S., Postorino, M, Prosperi, M, Quiros-Roldan, E, Maggiolo, F, Di Giambenedetto, S, Saracino, A, Costarelli, S, Lorenzotti, S, Sighinolfi, L, Di Pietro, M, Torti, C, Castelli, F, Carosi, G, Nasta, P, Paraninfo, G, Foca, E, Cauda, R, Fabbiani, M, Colafigli, M, Scalzini, A, Castelnuovo, F, Mazzotta, F, Locaputo, S, Marino, N, Pierotti, P, Ble, C, Vichi, F, Angarano, G, Ladisa, N, Monno, L, Maggi, P, Pan, A, Gori, A, Lapadula, G, Ospedale, S, Puoti, M, Viale, P, Colangeli, V, Borderi, M, Policlinico, S, Postorino M. C., Prosperi M., Quiros-Roldan E., Maggiolo F., Di Giambenedetto S., Saracino A., Costarelli S., Lorenzotti S., Sighinolfi L., Di Pietro M., Torti C., Castelli F., Carosi G., Nasta P., Paraninfo G., Foca E., Cauda R., Fabbiani M., Colafigli M., Scalzini A., Castelnuovo F., Mazzotta F., Locaputo S., Marino N., Pierotti P., Ble C., Vichi F., Angarano G., Ladisa N., Monno L., Maggi P., Pan A., Gori A., Lapadula G., Ospedale S., Puoti M., Viale P., Colangeli V., Borderi M., and Policlinico S.

Abstract

Randomized trials and observational cohorts reported higher rates of virological suppression after highly active antiretroviral therapy (HAART) including efavirenz (EFV), compared with boosted protease inhibitors (PIs). Correlations with immunological and clinical outcomes are unclear. Patients of the Italian MASTER cohort who started HAART from 2000 to 2010 were selected. Outstanding outcome (composite outcome for success (COS)) was introduced. We evaluated predictors of COS (no AIDS plus CD4+ count >500/mm3 plus HIV-RNA <500 copies/mL) and of eight single outcomes either at month 6 or at year 3. Multivariable logistic regression was conducted. There were 6259 patients selected. Patients on EFV (43%) were younger, had greater CD4+ count, presented with AIDS less frequently, and more were Italians. At year 3, 90% of patients had HIV RNA <500 copies/mL, but only 41.4% were prescribed EFV, vs. 34.1% prescribed boosted PIs achieved COS (p <0.0001). At multivariable analysis, patients on lopinavir/ritonavir had an odds ratio of 0.70 for COS at year 3 (p <0.0001). Foreign origin and positive hepatitis C virus-Ab were independently associated with worse outcome (OR 0.54, p <0.0001 and OR 0.70, p 0.01, respectively). Patients on boosted PIs developed AIDS more frequently either at month 6 (13.8% vs. 7.6%, p <0.0001) or at year 3 (17.1% vs. 13.8%, p <0.0001). At year 3, deaths of patients starting EFV were 3%, vs. 5% on boosted PIs (p 0.008). In this study, naïve patients on EFV performed better than those on boosted PIs after adjustment for imbalances at baseline. Even when virological control is achieved, COS is relatively rare. Hepatitis C virus-positive patients and those of foreign origin are at risk of not obtaining COS.

Published
2015

9. Use of efavirenz or atazanavir/ritonavir is associated with better clinical outcomes of HAART compared to other protease inhibitors: routine evidence from the Italian MASTER Cohort

Author

Postorino, M. C, Prosperi, M., QUIROS ROLDAN, Maria Eugenia, Maggiolo, F., Di Giambenedetto, S., Saracino, A., Costarelli, S., Lorenzotti, S., Sighinolfi, L., Di Pietro, M., Torti, Carlo, Castelli, Francesco, Carosi, Giampiero, Nasta, Paola, Paraninfo, G., Foca', Emanuele, Torti, C., Cauda, R., Fabbiani, M., Colafigli, M., Scalzini, Alfredo, Castelnuovo, F., Mazzotta, F., Locaputo, S., Marino, N., Pierotti, P., Ble, C., Vichi, F., Angarano, G., Ladisa, N., Monno, L., Maggi, Paolo, Pan, A., Gori, A., Lapadula, G., Ospedale, S., Puoti, M., Viale, P., Colangeli, V., Borderi, M., Policlinico, S., Postorino, M. C., Prosperi, M., Quiros-Roldan, E., Maggiolo, F., Di Giambenedetto, S., Saracino, A., Costarelli, S., Lorenzotti, S., Sighinolfi, L., Di Pietro, M., Torti, C., Castelli, F., Carosi, G., Nasta, P., Paraninfo, G., Foca, E., Cauda, R., Fabbiani, M., Colafigli, M., Scalzini, A., Castelnuovo, F., Mazzotta, F., Locaputo, S., Marino, N., Pierotti, P., Ble, C., Vichi, F., Angarano, G., Ladisa, N., Monno, L., Maggi, P., Pan, A., Gori, A., Lapadula, G., Ospedale, S., Puoti, M., Viale, P., Colangeli, V., Borderi, M., and Policlinico, S.

Subjects
Cyclopropanes, Male, AIDS event, HIV Infections, Cohort Studies, chemistry.chemical_compound, Antiretroviral Therapy, Highly Active, HIV Infection, Viral, immunological response, ritonavir-boosted protease inhibitors, composite outcome, virus diseases, Lopinavir, General Medicine, Hepatitis C, Middle Aged, Viral Load, non-nucleoside reverse transcriptase inhibitors, Death, Ritonavir-boosted protease inhibitor, Treatment Outcome, Infectious Diseases, Anti-Retroviral Agents, Italy, Alkynes, Cohort, RNA, Viral, Female, Viral load, Human, medicine.drug, Cohort study, Benzoxazine, Adult, Microbiology (medical), medicine.medical_specialty, Efavirenz, Atazanavir Sulfate, virological response, Antiretroviral Therapy, Non-nucleoside reverse transcriptase inhibitor, AIDS events, Composite outcome, Deaths, First-line therapy, Immunological response, Non-nucleoside reverse transcriptase inhibitors, Ritonavir-boosted protease inhibitors, Virological response, Benzoxazines, CD4 Lymphocyte Count, Humans, Ritonavir, Settore MED/17 - MALATTIE INFETTIVE, first-line therapy, Internal medicine, medicine, Highly Active, business.industry, Odds ratio, medicine.disease, deaths, chemistry, Immunology, RNA, Anti-Retroviral Agent, Cohort Studie, business
Abstract

Randomized trials and observational cohorts reported higher rates of virological suppression after highly active antiretroviral therapy (HAART) including efavirenz (EFV), compared with boosted protease inhibitors (PIs). Correlations with immunological and clinical outcomes are unclear. Patients of the Italian MASTER cohort who started HAART from 2000 to 2010 were selected. Outstanding outcome (composite outcome for success (COS)) was introduced. We evaluated predictors of COS (no AIDS plus CD4+ count >500/mm3 plus HIV-RNA

Published
2015

17. [Retinal lesions in HIV seropositive patients]

Author

BALACCO GABRIELI, Corrado, Angarano, G., Moramarco, Antonietta, Locaputo, S., Rasi, V., and Pacella, Elena

Subjects
Adult, Male, Acquired Immunodeficiency Syndrome, Retinal Hemorrhage, Retinal Vessels, human immunodeficiency virus infection, Middle Aged, retina vasculitis, retinopathy, Chorioretinitis, Retinal Diseases, Ischemia, HIV Seropositivity, Humans, Female, Follow-Up Studies
Abstract

118 patients with HIV infection underwent complete ophthalmologic examination to detect the presence of any eye pathology. The study was intended to show a correlation between such pathology and the total CD4 + lymphocyte count considered to be indicative of the immunologic status. The most frequently encountered lesions were cotton-wool patches, vascular congestion, hemorrhages, chorioretinitis, segmental vasculitis and optic disc pallar. Almost all the patients with ocular manifestations, also had a CD4 + count of less than 200/mm3 which suggest that ocular lesions are of bad prognostic significance even in asymptomatic patients.

Published
1989

19. Ocular manifestations in HIV-seropositive patients

Author

Balacco Gabrieli, C., Angarano, G., Antonietta MORAMARCO, Locaputo, S., and Castellano, L.

Subjects
Adult, CD4-Positive T-Lymphocytes, Male, Acquired Immunodeficiency Syndrome, Adolescent, Eye Diseases, Fundus Oculi, eye disease, fluorescence angiography, aids related complex, human immunodeficiency virus infection, Middle Aged, Leukocyte Count, AIDS-Related Complex, HIV Seropositivity, Humans, Female, Fluorescein Angiography
Abstract

A total of 153 patients with human immunodeficiency virus (HIV) infection underwent complete ophthalmologic examinations for the presence of any eye pathology. We wanted to show a correlation between such pathology and total CD4+ lymphocyte count, believed to be an indicator of immunologic status. The most frequently encountered lesions were cotton-wool patches, vascular congestion, hemorrhages, chorioretinitis, segmental vasculitis, and pallid papilla. Almost all of the patients with ocular anomalies also had a CD4+ count of less than 200 cells/mm3 suggesting that ocular lesions have a negative prognostic significance even in asymptomatic patients who present with a severe impairment of their immune system.

24. A randomized controlled trial to evaluate antiretroviral salvage therapy guided by rules-based or phenotype-driven HIV-1 genotypic drug-resistance interpretation with or without concentration-controlled intervention: the Resistance and Dosage Adapted Regimens (RADAR) study

Author

Francesco Mazzotta, Paolo Maggi, Filippo Castelnuovo, Carlo Torti, Francesca Moretti, Sergio Lo Caputo, Carmine Tinelli, Valeria Micheli, Nicoletta Ladisa, Anna Orani, Mario Regazzi, Andrea Patroni, Andrea Antinori, Eugenia Quiros-Roldan, Giampiero Carosi, Simona Di Giambenedetto, Paola Villani, Andrea De Luca, Torti, C, Quiros-Roldan, E, Regazzi, M, De Luca, A, Mazzotta, F, Antinori, A, Ladisa, N, Micheli, V, Orani, A, Patroni, A, Villani, P, Locaputo, S, Moretti, F, Di Giambenedetto, S, Castelnuovo, F, Maggi, P, Tinelli, C, and Carosi, G.

Subjects
Adult, Male, Microbiology (medical), medicine.medical_specialty, Genotype, Anti-HIV Agents, Salvage therapy, HIV Infections, Drug resistance, law.invention, Randomized controlled trial, law, Internal medicine, Drug Resistance, Viral, medicine, Humans, Trough Concentration, Sida, Salvage Therapy, biology, Reverse-transcriptase inhibitor, business.industry, Middle Aged, biology.organism_classification, Surgery, Regimen, Phenotype, Infectious Diseases, HIV-1, Female, Ritonavir, business, medicine.drug
Abstract

Background. It is not well defined whether concentration-controlled intervention (CCI) and rules-based human immunodeficiency virus (HIV) type 1 genotype drug-resistance interpretation (GI) or virtual phenotype drug-resistance interpretation (VPI) may improve the outcome of HIV salvage therapy. Methods. In a prospective, randomized, controlled trial, patients were randomized (on a factorial basis) to change treatment after either GI or VPI, and they then were further randomized to the control arm (no CCI) or the CCI arm. Protease inhibitor (PI) and nonnucleoside reverse-transcriptase inhibitor (NNRTI) trough concentration (C trough ) values were determined at weeks 1, 4, 12, and 24 of the study. Results. Among 230 patients, virological benefit (defined by an HIV RNA load of

Published
2005

25. Selection of antiretroviral therapy guided by genotypic or phenotypic resistance testing: an open-label, randomized, multicenter study (PhenGen).

Author

Saracino A, Monno L, Locaputo S, Torti C, Scudeller L, Ladisa N, Antinori A, Sighinolfi L, Chirianni A, Mazzotta F, Carosi G, and Angarano G

Subjects
Adult, Anti-HIV Agents therapeutic use, Female, Genotype, HIV Infections drug therapy, HIV Infections virology, HIV-1 genetics, Humans, Male, Microbial Sensitivity Tests methods, Middle Aged, Phenotype, Reverse Transcriptase Inhibitors therapeutic use, Treatment Failure, Anti-HIV Agents pharmacology, Drug Resistance, Viral genetics, HIV-1 drug effects, Reverse Transcriptase Inhibitors pharmacology
Abstract

The phenotype/genotype (PhenGen) open-label, randomized, multicenter study evaluated the genotype/virtual phenotype (vPt) and real phenotype (rPt) for choosing a new highly active antiretroviral therapy regimen at failure. Patients with a plasma viral load (pVL) between 2000 and 200,000 copies/mL and a CD4 cell count >200/microL, failing > or =2 regimens (<6 drugs), were randomized for vPt or rPt. Three hundred three patients were enrolled: 111 and 108 patients received a new treatment in the vPt and rPt arms, respectively. The 2 groups were comparable for baseline patient characteristics and treatment history. The new therapy was in agreement with expert advice in 58.5% of cases. After 6 months, no statistical differences were found in the mean absolute change from baseline CD4 cells (+55 and +46 cells/muL; P = 0.7), mean pVL log decrease (-1.35 and -1.37; P = 0.8), or proportion of patients with a pVL <400 copies/mL (54.8% in vPt arm and 52.6% in rPt arm; P = 0.9). At multivariate analysis, variables independently associated with failure of the new regimen were: pVL at baseline (odds ratio [OR] = 1.81; P < 0.021), number of nucleoside reverse transcriptase inhibitor-associated mutations (OR = 1.21; P = 0.001), number of protease mutations (OR = 1.15; P < 0.001), and recycling of indinavir (OR = 4.63; P = 0.019). Patients' adherence to the prescribed regimen (OR = 0.23; P < 0.001), number of active drugs in the new regimen (OR = 0.55; P = 0.001), and adherence to expert advice (OR = 0.37; P < 0.001) predicted virologic response. The vPt is as predictive of treatment outcome as the rPT. Use of expert advice significantly improved the response to therapy.

Published
2004
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26. Plasminogen directs the pleiotropic effects of uPA in liver injury and repair.

Author

Currier AR, Sabla G, Locaputo S, Melin-Aldana H, Degen JL, and Bezerra JA

Subjects
Animals, Blotting, Northern, Carbon Tetrachloride Poisoning pathology, Cell Division drug effects, Chemical and Drug Induced Liver Injury genetics, Chemical and Drug Induced Liver Injury pathology, Hepatocytes drug effects, Indicators and Reagents, Liver pathology, Mice, Mice, Knockout, Mice, Transgenic, Microscopy, Electron, Mutation genetics, Reverse Transcriptase Polymerase Chain Reaction, Transgenes, Liver Diseases genetics, Liver Diseases pathology, Liver Regeneration physiology, Plasminogen genetics, Plasminogen physiology, Plasminogen Activators genetics, Plasminogen Activators physiology, Urokinase-Type Plasminogen Activator genetics, Urokinase-Type Plasminogen Activator physiology
Abstract

The urokinase-type plasminogen activator (uPA) plays a central role in liver repair. Nevertheless, the hepatic overexpression of uPA results in panlobular injury and neonatal mortality. Here, we define the molecular mechanisms of liver injury and explore whether uPA can regulate liver repair independently of plasminogen. To address the hypothesis that the liver injury in transgenic mice results from the intracellular activation of plasminogen by transgene-derived uPA (uPAT), we generated mice that overexpress uPAT and lack functional plasminogen (uPAT-Plg(-)). In these mice, loss of plasminogen abolished the hepatocyte-specific injury and prevented the formation of regenerative nodules displayed by uPAT littermates. Despite the increased expression of hepatic uPA, livers of uPAT-Plg(-) mice were unable to clear necrotic cells and restore normal lobular organization after an acute injury. Notably, high levels of circulating uPA in uPAT-Plg(-) mice did not prevent the long-term extrahepatic abnormalities previously associated with plasminogen deficiency. These data demonstrate that plasminogen directs the hepatocyte injury induced by uPAT and mediates the reparative properties of uPA in the liver.

Published
2003
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27. Zonal regulation of gene expression during liver regeneration of urokinase transgenic mice.

Author

Locaputo S, Carrick TL, and Bezerra JA

Subjects
Animals, Apoptosis, Blotting, Northern, Cell Division, Growth Inhibitors genetics, Growth Inhibitors metabolism, Growth Substances metabolism, In Situ Nick-End Labeling, Liver cytology, Liver metabolism, Liver pathology, Mice, Mice, Transgenic, Plasminogen Activators metabolism, RNA, Messenger metabolism, Urokinase-Type Plasminogen Activator metabolism, Gene Expression Regulation, Growth Substances genetics, Liver enzymology, Liver Regeneration genetics, Plasminogen Activators genetics, Urokinase-Type Plasminogen Activator genetics
Abstract

Liver gene transcription plays a fundamental role in the hepatic reparative response to injury. However, little is known about the functional relationship of gene expression between diseased and regenerative compartments following a liver injury. To address the hypothesis that the control of gene expression and the cellular proliferative response are specific to diseased and regenerative liver compartments independently, we assessed the expression of liver growth modulators, hepatocyte proliferation, and apoptosis in transgenic livers overexpressing the urokinase-type plasminogen activator (uPA). uPA livers have regenerative nodules that are visually distinct from the surrounding diseased compartments. Northern analyses using RNA from microdissected regenerative and diseased compartments showed that, among the known liver growth factors studied, there was a selective increase in the expression of hepatocyte growth factor (HGF) in diseased compartments above the levels seen in regenerative compartments and in livers of nontransgenic littermates. Despite the high level of HGF mRNA in diseased compartments, hepatocyte proliferation was low. In contrast, in regenerative compartments, where HGF mRNA was low, hepatocyte proliferation was abundant. For growth inhibitors, mRNA expression for transforming growth factor beta1 (TGF-beta1), p53, and activin A was increased in diseased compartments, where hepatocytes displayed apoptosis. These findings define a zone-specific regulation of gene expression in injured livers and point to an important role of the diseased microenvironment in the fate of hepatocytes during the regenerative process.

Published
1999
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28. Possible significance of antibodies to Legionella pneumophila in HIV-1 infected patients with acute respiratory illness.

Author

Del Prete R, Mosca A, Locaputo S, Federico M, Angarano G, and Miragliotta G

Subjects
Humans, Pneumonia, Pneumocystis, AIDS-Related Opportunistic Infections immunology, Antibodies, Bacterial blood, HIV-1, Legionella pneumophila immunology, Legionnaires' Disease immunology
Abstract

Eighty-six serum samples from 52 HIV-1 infected patients with complicating pneumonia illness were assayed for the presence of antibodies to Legionella pneumophila. In 25 of these patients Pneumocystic carinii has been previously diagnosed. Among all patients investigated only 4 had antibodies to L. pneumophila of significant titer of 128. In one patient L. pneumophila was demonstrated coexisting with P. carinii. Despite of a small proportion of patients with a significant titer of antibodies against L. pneumophila, the presence of this microorganism should be carefully investigated in AIDS patients with complicating pneumonia especially when the aetiological diagnosis is not defined; the reason is to improve the therapeutic treatment.

Published
1994

29. Ocular manifestations in HIV-seropositive patients.

Author

Balacco Gabrieli C, Angarano G, Moramarco A, LoCaputo S, and Castellano L

Subjects
AIDS-Related Complex complications, AIDS-Related Complex immunology, Acquired Immunodeficiency Syndrome complications, Acquired Immunodeficiency Syndrome immunology, Adolescent, Adult, CD4-Positive T-Lymphocytes immunology, Eye Diseases immunology, Female, Fluorescein Angiography, Fundus Oculi, HIV Seropositivity immunology, Humans, Leukocyte Count, Male, Middle Aged, Eye Diseases complications, HIV Seropositivity complications
Abstract

A total of 153 patients with human immunodeficiency virus (HIV) infection underwent complete ophthalmologic examinations for the presence of any eye pathology. We wanted to show a correlation between such pathology and total CD4+ lymphocyte count, believed to be an indicator of immunologic status. The most frequently encountered lesions were cotton-wool patches, vascular congestion, hemorrhages, chorioretinitis, segmental vasculitis, and pallid papilla. Almost all of the patients with ocular anomalies also had a CD4+ count of less than 200 cells/mm3 suggesting that ocular lesions have a negative prognostic significance even in asymptomatic patients who present with a severe impairment of their immune system.

Published
1990

30. [Retinal lesions in HIV seropositive patients].

Author

Gabrieli CB, Angarano G, Moramarco A, Locaputo S, Rasi V, and Pacella E

Subjects
Acquired Immunodeficiency Syndrome complications, Acquired Immunodeficiency Syndrome immunology, Adult, Chorioretinitis etiology, Female, Follow-Up Studies, HIV Seropositivity immunology, Humans, Ischemia etiology, Male, Middle Aged, Retinal Hemorrhage etiology, Retinal Vessels physiopathology, HIV Seropositivity complications, Retinal Diseases etiology
Abstract

118 patients with HIV infection underwent complete ophthalmologic examination to detect the presence of any eye pathology. The study was intended to show a correlation between such pathology and the total CD4 + lymphocyte count considered to be indicative of the immunologic status. The most frequently encountered lesions were cotton-wool patches, vascular congestion, hemorrhages, chorioretinitis, segmental vasculitis and optic disc pallar. Almost all the patients with ocular manifestations, also had a CD4 + count of less than 200/mm3 which suggest that ocular lesions are of bad prognostic significance even in asymptomatic patients.

Published
1989

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