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1. Pillars of long-term antiretroviral therapy success

Author

Taramasso, L, Andreoni, M, Antinori, A, Bandera, A, Bonfanti, P, Bonora, S, Borderi, M, Castagna, A, Cattelan, A, Celesia, B, Cicalini, S, Cingolani, A, Cossarizza, A, Arminio Monforte, A, Ettorre, G, Di Biagio, A, Di Giambenedetto, S, Perri, G, Esposito, V, Focà, E, Gervasoni, C, Gori, A, Gianotti, N, Guaraldi, G, Gulminetti, R, Caputo, S, Madeddu, G, Maggi, P, Marandola, G, Marchetti, G, Mastroianni, C, Mussini, C, Perno, C, Rizzardini, G, Rusconi, S, Santoro, M, Sarmati, L, Zazzi, M, Maggiolo, F, Taramasso, Lucia, Andreoni, Massimo, Antinori, Andrea, Bandera, Alessandra, Bonfanti, Paolo, Bonora, Stefano, Borderi, Marco, Castagna, Antonella, Cattelan, Anna Maria, Celesia, Benedetto Maurizio, Cicalini, Stefania, Cingolani, Antonella, Cossarizza, Andrea, Arminio Monforte, Antonella d', Ettorre, Gabriella d', Di Biagio, Antonio, Di Giambenedetto, Simona, Perri, Giovanni Di, Esposito, Vincenzo, Focà, Emanuele, Gervasoni, Cristina, Gori, Andrea, Gianotti, Nicola, Guaraldi, Giovanni, Gulminetti, Roberto, Caputo, Sergio Lo, Madeddu, Giordano, Maggi, Paolo, Marandola, Giorgio, Marchetti, Giulia Carla, Mastroianni, Claudio Maria, Mussini, Cristina, Perno, Carlo Federico, Rizzardini, Giuliano, Rusconi, Stefano, Santoro, Maria, Sarmati, Loredana, Zazzi, Maurizio, Maggiolo, Franco, Taramasso, L, Andreoni, M, Antinori, A, Bandera, A, Bonfanti, P, Bonora, S, Borderi, M, Castagna, A, Cattelan, A, Celesia, B, Cicalini, S, Cingolani, A, Cossarizza, A, Arminio Monforte, A, Ettorre, G, Di Biagio, A, Di Giambenedetto, S, Perri, G, Esposito, V, Focà, E, Gervasoni, C, Gori, A, Gianotti, N, Guaraldi, G, Gulminetti, R, Caputo, S, Madeddu, G, Maggi, P, Marandola, G, Marchetti, G, Mastroianni, C, Mussini, C, Perno, C, Rizzardini, G, Rusconi, S, Santoro, M, Sarmati, L, Zazzi, M, Maggiolo, F, Taramasso, Lucia, Andreoni, Massimo, Antinori, Andrea, Bandera, Alessandra, Bonfanti, Paolo, Bonora, Stefano, Borderi, Marco, Castagna, Antonella, Cattelan, Anna Maria, Celesia, Benedetto Maurizio, Cicalini, Stefania, Cingolani, Antonella, Cossarizza, Andrea, Arminio Monforte, Antonella d', Ettorre, Gabriella d', Di Biagio, Antonio, Di Giambenedetto, Simona, Perri, Giovanni Di, Esposito, Vincenzo, Focà, Emanuele, Gervasoni, Cristina, Gori, Andrea, Gianotti, Nicola, Guaraldi, Giovanni, Gulminetti, Roberto, Caputo, Sergio Lo, Madeddu, Giordano, Maggi, Paolo, Marandola, Giorgio, Marchetti, Giulia Carla, Mastroianni, Claudio Maria, Mussini, Cristina, Perno, Carlo Federico, Rizzardini, Giuliano, Rusconi, Stefano, Santoro, Maria, Sarmati, Loredana, Zazzi, Maurizio, and Maggiolo, Franco

Abstract

Background: Meeting the challenge of antiretroviral therapy (ART) whose efficacy can last a lifetime requires continuous updating of the virological, pharmacological, and quality of life outcomes to be pursued and a continuous review of literature data on the efficacy and tolerability of new drugs and therapeutic strategies. Methods: With the aim of identifying open questions and answers about the current controversies in modern ART, we adapted the Design Thinking methodology to the needs of the design phase of a scientific article, involving a team of experts in HIV care. Results: Five main pillars of treatment success were discussed: sustained virologic suppression over time; immunological recovery; pharmacological attributes; long-term tolerability and safety of ART; and people's satisfaction and quality of life. The definition of the outcomes to be achieved in each thematic area and the tools to achieve them were reviewed and discussed. Conclusions: Long-term treatment success should be intended as a combination of HIV-RNA suppression, immune recovery, and high quality of life. To achieve this, the regimen should be well-tolerated, with high potency, genetic barrier, and forgiveness, and should be tailored by a person-centered perspective, based on individual needs, preferences, and therapeutic history.

Published
2023

2. Long-term exposure to combination antiretroviral therapy and risk of death from specific causes: no evidence for any previously unidentified increased risk due to antiretroviral therapy

Author

Kowalska, Justyna D., Joanne Reekie, Amanda Mocroft, Peter Reiss, Bruno Ledergerber, Jose Gatell, Arminio Monforte, Antonella D., Andrew Phillips, Lundgren, Jens D., Ole Kirk, EuroSIDA Study Group, Matti Ristola, Amsterdam institute for Infection and Immunity, Amsterdam Public Health, Global Health, Kowalska, Justyna D., Reekie, Joanne, Mocroft, Amanda, Reiss, Peter, Ledergerber, Bruno, Gatell, Jose, D'arminio Monforte, Antonella, Phillips, Andrew, Lundgren, Jens D., Kirk, Ole, Eurosida Study, Group, Castagna, Antonella, University of Zurich, and Kowalska, J D

Subjects
Male, Time Factors, Comorbidity, non-AIDS event, 10234 Clinic for Infectious Diseases, cause of death, 0302 clinical medicine, immune system diseases, Risk Factors, Antiretroviral Therapy, Highly Active, Cause of Death, Immunology and Allergy, 030212 general & internal medicine, Prospective Studies, Prospective cohort study, Cause of death, 0303 health sciences, Smoking, virus diseases, Hepatitis C, Middle Aged, Viral Load, Hepatitis B, 3. Good health, AIDS, Infectious Diseases, Hypertension, symbols, 2723 Immunology and Allergy, Disease Progression, combination antiretroviral therapy, RNA, Viral, Drug Therapy, Combination, Female, Human, Cart, Adult, medicine.medical_specialty, Time Factor, Anti-HIV Agents, Immunology, 610 Medicine & health, Follow-Up Studie, 03 medical and health sciences, symbols.namesake, Pharmacotherapy, Internal medicine, adverse effect, mental disorders, medicine, Humans, Poisson regression, Adverse effect, 2403 Immunology, Acquired Immunodeficiency Syndrome, 030306 microbiology, business.industry, Risk Factor, HIV, Anti-HIV Agent, 2725 Infectious Diseases, medicine.disease, mortality, Confidence interval, CD4 Lymphocyte Count, Prospective Studie, nervous system, HIV-1, business, Follow-Up Studies
Abstract

Background: Despite the known substantial benefits of combination antiretroviral therapy (cART), cumulative adverse effects could still limit the overall long-term treatment benefit. Therefore we investigated changes in the rate of death with increasing exposure to cART. Methods: A total of 12 069 patients were followed from baseline, which was defined as the time of starting cART or enrolment into EuroSIDA whichever occurred later, until death or 6 months after last follow-up visit. Incidence rates of death were calculated per 1000 person-years of follow-up (PYFU) and stratified by time of exposure to cART (>= 3 antiretrovirals): less than 2, 2-3.99, 4-5.99, 6-7.99 and more than 8 years. Duration of cART exposure was the cumulative time actually receiving cART. Poisson regression models were fitted for each cause of death separately. Results: A total of 1297 patients died during 70 613 PYFU [incidence rate 18.3 per 1000 PYFU, 95% confidence interval (CI) 17.4-19.4], 413 due to AIDS (5.85, 95% CI 5.28-6.41) and 884 due to non-AIDS-related cause (12.5, 95% CI 11.7-13.3). After adjustment for confounding variables, including baseline CD4 cell count and HIV RNA, there was a significant decrease in the rate of all-cause and AIDS-related death between 2 and 3.99 years and longer exposure time. In the first 2 years on cART the risk of non-AIDS death was significantly lower, but no significant difference in the rate of non-AIDS-related deaths between 2 and 3.99 years and longer exposure to cART was observed. Conclusion: In conclusion, we found no evidence of an increased risk of both all-cause and non-AIDS-related deaths with long-term cumulative cART exposure. (C) 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins

Published
2012
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3. A comparison of the long-term durability of nevirapine, efavirenz and lopinavir in routine clinical practice in Europe: a EuroSIDA study

Author

Reekie, J1, Reiss, P, Ledergerber, B, Sedlacek, D, Parczewski, M, Gatell, J, Katlama, C, Fätkenheuer, G, Lundgren, Jd, Mocroft, A, Collaborators Losso M, EuroSIDA study g. r. o. u. p., Elias, C, Vetter, N, Zangerle, R, Karpov, I, Vassilenko, A, Mitsura, Vm, Suetnov, O, Clumeck, N, De Wit, S, Delforge, M, Colebunders, R, Vandekerckhove, L, Hadziosmanovic, V, Kostov, K, Begovac, J, Machala, L, Rozsypal, H, Nielsen, J, Kronborg, G, Benfield, T, Larsen, M, Gerstoft, J, Katzenstein, T, Hansen, Ab, Skinhøj, P, Pedersen, C, Larsen, Od, Oestergaard, L, Zilmer, K, Smidt, J, Ristola, M, Viard, Jp, Girard, Pm, Livrozet, Jm, Vanhems, P, Pradier, C, Dabis, F, Neau, D, Rockstroh, J, Schmidt, R, van Lunzen, J, Degen, O, Stellbrink, Hj, Staszewski, S, Bogner, J, Kosmidis, J, Gargalianos, P, Xylomenos, G, Perdios, J, Panos, G, Filandras, A, Karabatsaki, E, Sambatakou, H, Banhegyi, D, Mulcahy, F, Yust, I, Turner, D, Burke, M, Pollack, S, Hassoun, G, Maayan, S, Chiesi, A, Esposito, R, Mazeu, I, Mussini, C, Arici, C, Pristera, R, Mazzotta, F, Gabbuti, A, Vullo, Vincenzo, Lichtner, M, Chirianni, A, Montesarchio, E, Gargiulo, M, Antonucci, G, Iacomi, F, Narciso, P, Vlassi, C, Zaccarelli, M, Lazzarin, A, Finazzi, R, Galli, M, Ridolfo, A, Arminio Monforte A, D., Rozentale, B, Zeltina, I, Chaplinskas, S, Hemmer, R, Staub, T, Bruun, J, Maeland, A, Ormaasen, V, Knysz, B, Gasiorowski, J, Horban, A, Bakowska, E, Grzeszczuk, A, Flisiak, R, Boron Kaczmarska, A, Pynka, M, Beniowski, M, Mularska, E, Trocha, H, Jablonowska, E, Malolepsza, E, Wojcik, K, Antunes, F, Valadas, E, Mansinho, K, Maltez, F, Duiculescu, D, Rakhmanova, A, Vinogradova, E, Buzunova, S, Jevtovic, D, Mokrá, M, Staneková, D, Tomazic, J, González Lahoz, J, Soriano, V, Labarga, P, Medrano, J, Moreno, S, Clotet, B, Jou, A, Paredes, R, Tural, C, Puig, J, Bravo, I, Gatell, Jm, Miró, Jm, Domingo, P, Gutierrez, M, Mateo, G, Sambeat, Ma, Karlsson, A, Flamholc, L, Weber, R, Francioli, P, Cavassini, M, Hirschel, B, Boffi, E, Furrer, H, Battegay, M, Elzi, L, Kravchenko, E, Chentsova, N, Kutsyna, G, Servitskiy, S, Antoniak, S, Krasnov, M, Barton, S, Johnson, Am, Mercey, D, Phillips, A, Johnson, Ma, Murphy, M, Weber, J, Scullard, G, Fisher, M, Leen, C, Gazzard, B, Arminio Montforte A, D., Lundgren, J, Kirk, O, Friis Møller, N, Cozzi Lepri, A, Bannister, W, Ellefson, M, Borch, A, Podlekareva, D, Kjær, J, Peters, L, Reekie, J, and Kowalska, J.

Subjects
Cyclopropanes, Male, Argentina, Drug Resistance, HIV Infections, HIV Protease Inhibitors, Pyrimidinones, Viral Load, Drug Administration Schedule, Lopinavir, Benzoxazines, Europe, Treatment Outcome, Alkynes, HIV-1, Humans, Reverse Transcriptase Inhibitors, Drug Therapy, Combination, Female, Nevirapine, Prospective Studies, Israel
Abstract

The durability of combination antiretroviral therapy (cART) regimens can be measured as time to discontinuation because of toxicity or treatment failure, development of clinical disease or serious long-term adverse events. The aim of this analysis was to compare the durability of nevirapine, efavirenz and lopinavir regimens based on these measures.Patients starting a nevirapine, efavirenz or lopinavir-based cART regimen for the first time after 1 January 2000 were included in the analysis. Follow-up started ≥ 3 months after initiation of treatment if viral load was500 HIV-1 RNA copies/mL. Durability was measured as discontinuation rate or development/worsening of clinical markers.A total of 603 patients (21%) started nevirapine-based cART, 1465 (51%) efavirenz, and 818 (28%) lopinavir. After adjustment there was no significant difference in the risk of discontinuation for any reason between the groups on nevirapine and efavirenz (P=0.43) or lopinavir (P=0.13). Compared with the nevirapine group, those on efavirenz had a 48% (P=0.0002) and those on lopinavir a 63% (P0.0001) lower risk of discontinuation because of treatment failure and a 31% (P=0.01) and 66% (P.0001) higher risk, respectively, of discontinuation because of toxicities or patient/physician choice. There were no significant differences in the incidence of non-AIDS-related events, worsening anaemia, severe weight loss, increased aspartate aminotransferase (AST)/alanine aminotransferase (ALT) levels or increased total cholesterol. Compared with patients on nevirapine, those on lopinavir had an 80% higher incidence of high-density lipoprotein (HDL) cholesterol decreasing below 0.9 mmol/L (P=0.003), but there was no significant difference in this variable between those on nevirapine and those on efavirenz (P=0.39).The long-term durability of nevirapine-based cART, based on risk of all-cause discontinuation and development of long-term adverse events, was comparable to that of efavirenz or lopinavir, in patients in routine clinical practice across Europe who initially tolerated and virologically responded to their regimen.

Published
2010

4. Factors associated with specific causes of death amongst HIV-positive individuals in the D:A:D study: Erratum

Author

Nina Friis-Møller, Rodolphe Thiébaut, CA Sabin, Rainer Weber, Ole Kirk, CJ Smith, Peter Reiss, Jens D Lundgren, Sadr, W., El, Christian Pradier, Matthew Law, Signe Westring Worm, Arminio Monforte, A., d', and AN Phillips

Subjects
Infectious Diseases, business.industry, Immunology, Human immunodeficiency virus (HIV), Immunology and Allergy, Medicine, business, medicine.disease_cause
Published
2011
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5. The clinical benefits of antiretroviral therapy in severely immunocompromised HIV-1-infected patients with and without complete viral suppression

Author

Amanda Mocroft, Bannister, Wendy P., Ole Kirk, Kowalska, Justyna D., Peter Reiss, Arminio-Monforte, Antonella D., Jose Gatell, Martin Fisher, Hanna Trocha, Aza Rakhmanova, Lundgren, Jens D., The EuroSIDA Study in EuroCOORD, Matti Ristola, Mocroft, Amanda, Bannister, Wendy P., Kirk, Ole, Kowalska, Justyna D., Reiss, Peter, D'arminio monforte, Antonella, Gatell, Jose, Fisher, Martin, Trocha, Hanna, Rakhmanova, Aza, Lundgren, Jens D, Eurosida In, Eurocoord, Castagna, Antonella, Amsterdam institute for Infection and Immunity, Amsterdam Public Health, and Global Health

Subjects
Male, medicine.medical_treatment, Rate ratio, 0302 clinical medicine, Risk Factors, Pharmacology (medical), 030212 general & internal medicine, Poisson Distribution, Prospective Studies, Prospective cohort study, Acquired Immunodeficiency Syndrome/ drug therapy/immunology, Adult, CD4 Lymphocyte Count, Drug Evaluation, Drug Therapy, Combination/methods, Female, Follow-Up Studies, HIV Protease Inhibitors/ therapeutic use, HIV-1/immunology/pathogenicity, Humans, Immunocompromised Host, Incidence, Middle Aged, Reverse Transcriptase Inhibitors/ therapeutic use, Viral Load, Viremia/virology, 0303 health sciences, Incidence (epidemiology), Immunosuppression, Reverse Transcriptase Inhibitor, 3. Good health, Infectious Diseases, symbols, Reverse Transcriptase Inhibitors, Drug Therapy, Combination, Viral load, Human, Cart, medicine.medical_specialty, Follow-Up Studie, 03 medical and health sciences, symbols.namesake, Acquired immunodeficiency syndrome (AIDS), Internal medicine, medicine, Poisson regression, Viremia, HIV Protease Inhibitor, Pharmacology, Acquired Immunodeficiency Syndrome, 030306 microbiology, business.industry, Risk Factor, HIV Protease Inhibitors, medicine.disease, Prospective Studie, Immunology, HIV-1, business
Abstract

Background The aim of this study was to determine whether there is a protective effect of combination anti-retroviral therapy (cART) on the development of clinical events in patients with ongoing severe immunosuppression. Methods A total of 3,780 patients from the EuroSIDA study under follow-up after 2001 with a current CD4+ T-cell count ≤200 cells/mm3 were stratified into five groups: group 1, viral load (VL)Results There were 428 AIDS/non-AIDS events during 3,780 person-years of follow-up. Compared with group 1, those in group 2 had a similar incidence of AIDS/ non-AIDS events (incidence rate ratio [IRR] 1.04; 95% CI 0.79–1.36). Groups 3, 4 and 5 had significantly higher incidence rates of AIDS/non-AIDS events compared with group 1; incidence rates increased from group 3 (IRR 1.78; 95% CI 1.25–2.55) to group 5 (IRR 2.36; 95% CI 1.66–3.40), demonstrating the increased incidence of AIDS/non-AIDS events associated with increasing viraemia. After adjustment, the use of cART was associated with a 40% reduction in the incidence of AIDS/non-AIDS events in patients with VL 50–99,999 copies/ml (IRR 0.59; 95% CI 0.41–0.85) and in those with a VL>100,000 copies/ml (IRR 0.66; 95% CI 0.44–1.00). Similar relationships were seen for non-AIDS events and AIDS events when considered separately. Conclusions In patients with ongoing severe immuno-suppression, cART was associated with significant clinical benefits in patients with suboptimal virological control or virological failure.

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