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64. Portal vein thrombosis relevance on liver cirrhosis: Italian Venous Thrombotic Events Registry

Author

Violi, F, Corazza, R, Caldwell, S, Perticone, F, Gatta, A, Angelico, M, Farcomeni, A, Masotti, M, Napoleone, L, Vestri, A, Raparelli, V, Basili, S, Palasciano, G, D'Alitto, F, Palmieri, V, Santovito, D, Di Michele, D, Croce, G, Sacerdoti, D, Brocco, S, Fasolato, S, Cecchetto, L, Bombonato, G, Bertoni, M, Restuccia, R, Andreozzi, P, Liguori, L, Caroleo, B, Perticone, M, Staltari, O, Manfredini, R, De Giorgi, A, Averna, M, Giammanco, A, Granito, A, Pettinari, I, Marinelli, S, Bolondi, L, Falsetti, L, Salvi, A, Durante-Mangoni, E, Cesaro, F, Farinaro, V, Ragone, E, Morana, I, Andriulli, A, Ippolito, A, Iacobellis, A, Niro, G, Merla, A, Raimondo, G, Maimone, S, Cacciola, I, Varvara, D, Drenaggi, D, Staffolani, S, Picardi, A, Vespasiani-Gentilucci, U, Galati, G, Gallo, P, Davi, G, Schiavone, C, Santilli, F, Tana, C, Licata, A, Soresi, M, Bianchi, B, Carderi, I, Pinto, A, Tuttolomondo, A, Ferrari, G, Gresele, P, Fierro, T, Morelli, O, Laffi, G, Romanelli, R, Arena, U, Cristina, S, Gasbarrini, A, Gargovich, M, Zocco, Z, Riccardi, L, Ainora, M, Capeci, W, Martino, M, Lorenzo, N, Cavallo, M, Frugiuele, P, Greco, A, Pietrangelo, A, Ventura, P, Cuoghi, C, Marcacci, M, Serviddio, G, Vendemiale, G, Villani, R, Gargano, R, Vidili, G, Di Cesare, V, Masala, M, Delitala, G, Invernizzi, P, Di Minno, G, Tufano, A, Purrello, F, Privitera, G, Forgione, A, Curigliano, V, Senzolo, M, Rodriguez-Castro, K, Giannelli, G, Serra, C, Neri, S, Pignataro, P, Rizzetto, M, Debernardi, V, Svegliati, B, Bergamaschi, G, Costanzo, F, Angelico, F, Del Ben, M, Polimeni, L, Talerico, G, Proietti, M, Romiti, G, Ruscio, E, Toriello, F, Violi F., Corazza R. G., Caldwell S. H., Perticone F., Gatta A., Angelico M., Farcomeni A., Masotti M., Napoleone L., Vestri A., Raparelli V., Basili S., Palasciano G., D'Alitto F., Palmieri V. O., Santovito D., Di Michele D., Croce G., Sacerdoti D., Brocco S., Fasolato S., Cecchetto L., Bombonato G., Bertoni M., Restuccia R., Andreozzi P., Liguori L. M., Caroleo B., Perticone M., Staltari O., Manfredini R., De Giorgi A., Averna M., Giammanco A., Granito A., Pettinari I., Marinelli S., Bolondi L., Falsetti L., Salvi A., Durante-Mangoni E., Cesaro F., Farinaro V., Ragone E., Morana I., Andriulli A., Ippolito A., Iacobellis A., Niro G., Merla A., Raimondo G., Maimone S., Cacciola I., Varvara D., Drenaggi D., Staffolani S., Picardi A., Vespasiani-Gentilucci U., Galati G., Gallo P., Davi G., Schiavone C., Santilli F., Tana C., Licata A., Soresi M., Bianchi B. G., Carderi I., Pinto A., Tuttolomondo A., Ferrari G., Gresele P., Fierro T., Morelli O., Laffi G., Romanelli R. G., Arena U., Cristina S., Gasbarrini A., Gargovich M., Zocco Z. M., Riccardi L., Ainora M. E., Capeci W., Martino M. G., Lorenzo N., Cavallo M., Frugiuele P., Greco A., Pietrangelo A., Ventura P., Cuoghi C., Marcacci M., Serviddio G., Vendemiale G., Villani R., Gargano R., Vidili G., Di Cesare V., Masala M., Delitala G., Invernizzi P., Di Minno G., Tufano A., Purrello F., Privitera G., Forgione A., Curigliano V., Senzolo M., Rodriguez-Castro K. -I., Giannelli G., Serra C., Neri S., Pignataro P., Rizzetto M., Debernardi V. W., Svegliati B. G., Bergamaschi G., Costanzo F., Angelico F., Del Ben M., Polimeni L., Talerico G., Proietti M., Romiti G. F., Ruscio E., Toriello F., Violi, F, Corazza, R, Caldwell, S, Perticone, F, Gatta, A, Angelico, M, Farcomeni, A, Masotti, M, Napoleone, L, Vestri, A, Raparelli, V, Basili, S, Palasciano, G, D'Alitto, F, Palmieri, V, Santovito, D, Di Michele, D, Croce, G, Sacerdoti, D, Brocco, S, Fasolato, S, Cecchetto, L, Bombonato, G, Bertoni, M, Restuccia, R, Andreozzi, P, Liguori, L, Caroleo, B, Perticone, M, Staltari, O, Manfredini, R, De Giorgi, A, Averna, M, Giammanco, A, Granito, A, Pettinari, I, Marinelli, S, Bolondi, L, Falsetti, L, Salvi, A, Durante-Mangoni, E, Cesaro, F, Farinaro, V, Ragone, E, Morana, I, Andriulli, A, Ippolito, A, Iacobellis, A, Niro, G, Merla, A, Raimondo, G, Maimone, S, Cacciola, I, Varvara, D, Drenaggi, D, Staffolani, S, Picardi, A, Vespasiani-Gentilucci, U, Galati, G, Gallo, P, Davi, G, Schiavone, C, Santilli, F, Tana, C, Licata, A, Soresi, M, Bianchi, B, Carderi, I, Pinto, A, Tuttolomondo, A, Ferrari, G, Gresele, P, Fierro, T, Morelli, O, Laffi, G, Romanelli, R, Arena, U, Cristina, S, Gasbarrini, A, Gargovich, M, Zocco, Z, Riccardi, L, Ainora, M, Capeci, W, Martino, M, Lorenzo, N, Cavallo, M, Frugiuele, P, Greco, A, Pietrangelo, A, Ventura, P, Cuoghi, C, Marcacci, M, Serviddio, G, Vendemiale, G, Villani, R, Gargano, R, Vidili, G, Di Cesare, V, Masala, M, Delitala, G, Invernizzi, P, Di Minno, G, Tufano, A, Purrello, F, Privitera, G, Forgione, A, Curigliano, V, Senzolo, M, Rodriguez-Castro, K, Giannelli, G, Serra, C, Neri, S, Pignataro, P, Rizzetto, M, Debernardi, V, Svegliati, B, Bergamaschi, G, Costanzo, F, Angelico, F, Del Ben, M, Polimeni, L, Talerico, G, Proietti, M, Romiti, G, Ruscio, E, Toriello, F, Violi F., Corazza R. G., Caldwell S. H., Perticone F., Gatta A., Angelico M., Farcomeni A., Masotti M., Napoleone L., Vestri A., Raparelli V., Basili S., Palasciano G., D'Alitto F., Palmieri V. O., Santovito D., Di Michele D., Croce G., Sacerdoti D., Brocco S., Fasolato S., Cecchetto L., Bombonato G., Bertoni M., Restuccia R., Andreozzi P., Liguori L. M., Caroleo B., Perticone M., Staltari O., Manfredini R., De Giorgi A., Averna M., Giammanco A., Granito A., Pettinari I., Marinelli S., Bolondi L., Falsetti L., Salvi A., Durante-Mangoni E., Cesaro F., Farinaro V., Ragone E., Morana I., Andriulli A., Ippolito A., Iacobellis A., Niro G., Merla A., Raimondo G., Maimone S., Cacciola I., Varvara D., Drenaggi D., Staffolani S., Picardi A., Vespasiani-Gentilucci U., Galati G., Gallo P., Davi G., Schiavone C., Santilli F., Tana C., Licata A., Soresi M., Bianchi B. G., Carderi I., Pinto A., Tuttolomondo A., Ferrari G., Gresele P., Fierro T., Morelli O., Laffi G., Romanelli R. G., Arena U., Cristina S., Gasbarrini A., Gargovich M., Zocco Z. M., Riccardi L., Ainora M. E., Capeci W., Martino M. G., Lorenzo N., Cavallo M., Frugiuele P., Greco A., Pietrangelo A., Ventura P., Cuoghi C., Marcacci M., Serviddio G., Vendemiale G., Villani R., Gargano R., Vidili G., Di Cesare V., Masala M., Delitala G., Invernizzi P., Di Minno G., Tufano A., Purrello F., Privitera G., Forgione A., Curigliano V., Senzolo M., Rodriguez-Castro K. -I., Giannelli G., Serra C., Neri S., Pignataro P., Rizzetto M., Debernardi V. W., Svegliati B. G., Bergamaschi G., Costanzo F., Angelico F., Del Ben M., Polimeni L., Talerico G., Proietti M., Romiti G. F., Ruscio E., and Toriello F.

Abstract

Portal vein thrombosis may occur in cirrhosis; nevertheless, its prevalence, and predictors are still elusive. To investigate this issue, the Italian Society of Internal Medicine undertook the “Portal vein thrombosis Relevance On Liver cirrhosis: Italian Venous thrombotic Events Registry” (PRO-LIVER). This prospective multicenter study includes consecutive cirrhotic patients undergoing Doppler ultrasound examination of the portal area to evaluate the prevalence and incidence of portal vein thrombosis over a 2-year scheduled follow-up. Seven hundred and fifty-three (68 % men; 64 ± 12 years) patients were included in the present analysis. Fifty percent of the cases were cirrhotic outpatients. Viral (44 %) etiology was predominant. Around half of the patients had a mild-severity disease according to the Child–Pugh score; hepatocellular carcinoma was present in 20 %. The prevalence of ultrasound-detected portal vein thrombosis was 17 % (n = 126); it was asymptomatic in 43 % of the cases. Notably, more than half of the portal vein thrombosis patients (n = 81) were not treated with anticoagulant therapy. Logistic step-forward multivariate analysis demonstrated that previous portal vein thrombosis (p < 0.001), Child–Pugh Class B + C (p < 0.001), hepatocellular carcinoma (p = 0.01), previous upper gastrointestinal bleeding (p = 0.030) and older age (p = 0.012) were independently associated with portal vein thrombosis. Portal vein thrombosis is a frequent complication of cirrhosis, particularly in patients with moderate–severe liver failure. The apparent undertreatment of patients with portal vein thrombosis is a matter of concern and debate, which should be addressed by planning interventional trials especially with newer oral anticoagulants. Clinicaltrials.gov identifier NCT01470547.

Published
2016

91. Portal Vein Thrombosis Relevance on Liver Cirrhosis: Italian Venous Thrombotic Events Registry

Author

Violi F., Corazza R. G., Caldwell S. H., Perticone F., Gatta A., Angelico M., Farcomeni A., Masotti M., Napoleone L., Vestri A., Raparelli V., Basili S., Palasciano G., D'Alitto F., Palmieri V. O., Santovito D., Di Michele D., Croce G., Sacerdoti D., Brocco S., Fasolato S., Cecchetto L., Bombonato G., Bertoni M., Restuccia R., Andreozzi P., Liguori L. M., Caroleo B., Perticone M., Staltari O., Manfredini R., De Giorgi A., Averna M., Giammanco A., Granito A., Pettinari I., Marinelli S., Bolondi L., Falsetti L., Salvi A., Durante-Mangoni E., Cesaro F., Farinaro V., Ragone E., Morana I., Andriulli A., Ippolito A., Iacobellis A., Niro G., Merla A., Raimondo G., Maimone S., Cacciola I., Varvara D., Drenaggi D., Staffolani S., Picardi A., Vespasiani-Gentilucci U., Galati G., Gallo P., Davi G., Schiavone C., Santilli F., Tana C., Licata A., Soresi M., Bianchi B. G., Carderi I., Pinto A., Tuttolomondo A., Ferrari G., Gresele P., Fierro T., Morelli O., Laffi G., Romanelli R. G., Arena U., Cristina S., Gasbarrini A., Gargovich M., Zocco Z. M., Riccardi L., Ainora M. E., Capeci W., Martino M. G., Lorenzo N., Cavallo M., Frugiuele P., Greco A., Pietrangelo A., Ventura P., Cuoghi C., Marcacci M., Serviddio G., Vendemiale G., Villani R., Gargano R., Vidili G., Di Cesare V., Masala M., Delitala G., Invernizzi P., Di Minno G., Tufano A., Purrello F., Privitera G., Forgione A., Curigliano V., Senzolo M., Rodriguez-Castro K. -I., Giannelli G., Serra C., Neri S., Pignataro P., Rizzetto M., Debernardi V. W., Svegliati B. G., Bergamaschi G., Costanzo F., Angelico F., Del Ben M., Polimeni L., Talerico G., Proietti M., Romiti G. F., Ruscio E., Toriello F., Violi, F., Corazza, R. G., Caldwell, S. H., Perticone, F., Gatta, A., Angelico, M., Farcomeni, A., Masotti, M., Napoleone, L., Vestri, A., Raparelli, V., Basili, S., Palasciano, G., D'Alitto, F., Palmieri, V. O., Santovito, D., Croce, G., Sacerdoti, D., Brocco, S., Fasolato, S., Cecchetto, L., Bombonato, G., Restuccia, R., Andreozzi, P., Liguori, L. M., Perticone, M., Staltari, O., Manfredini, R., De Giorgi, A., Averna, M., Giammanco, A., Granito, A., Marinelli, S., Bolondi, L., Falsetti, L., Salvi, A., Durante-Mangoni, E., Cesaro, F., Farinaro, V., Ragone, E., Morana, I., Andriulli, A., Ippolito, A., Iacobellis, A., Niro, G., Merla, A., Raimondo, G., Maimone, S., Cacciola, I., Varvara, D., Drenaggi, D., Staffolani, S., Picardi, A., Vespasiani-Gentilucci, U., Galati, G., Gallo, P., Davi, G., Schiavone, C., Santilli, F., Tana, C., Licata, A., Soresi, M., Bianchi, B. G., Carderi, I., Pinto, A., Tuttolomondo, A., Ferrari, G., Gresele, P., Fierro, T., Morelli, O., Laffi, G., Romanelli, R. G., Arena, U., Cristina, S., Gasbarrini, A., Gargovich, M., Zocco, Z. M., Riccardi, L., Ainora, M. E., Capeci, W., Martino, M. G., Lorenzo, N., Cavallo, M., Frugiuele, P., Greco, A., Pietrangelo, A., Ventura, P., Cuoghi, C., Marcacci, M., Serviddio, G., Vendemiale, G., Villani, R., Gargano, R., Vidili, G., Di Cesare, V., Masala, M., Delitala, G., Invernizzi, P., Di Minno, G., Tufano, A., Purrello, F., Privitera, G., Forgione, A., Curigliano, V., Senzolo, M., Rodriguez-Castro, K. -I., Giannelli, G., Serra, C., Neri, S., Pignataro, P., Rizzetto, M., Debernardi, V. W., Svegliati, B. G., Bergamaschi, G., Costanzo, F., Angelico, F., Del Ben, M., Polimeni, L., Talerico, G., Proietti, M., Romiti, G. F., Ruscio, E., Toriello, F., Violi, F, Corazza, R, Caldwell, S, Perticone, F, Gatta, A, Angelico, M, Farcomeni, A, Masotti, M, Napoleone, L, Vestri, A, Raparelli, V, Basili, S, Palasciano, G, D'Alitto, F, Palmieri, V, Santovito, D, Di Michele, D, Croce, G, Sacerdoti, D, Brocco, S, Fasolato, S, Cecchetto, L, Bombonato, G, Bertoni, M, Restuccia, R, Andreozzi, P, Liguori, L, Caroleo, B, Perticone, M, Staltari, O, Manfredini, R, De Giorgi, A, Averna, M, Giammanco, A, Granito, A, Pettinari, I, Marinelli, S, Bolondi, L, Falsetti, L, Salvi, A, Durante-Mangoni, E, Cesaro, F, Farinaro, V, Ragone, E, Morana, I, Andriulli, A, Ippolito, A, Iacobellis, A, Niro, G, Merla, A, Raimondo, G, Maimone, S, Cacciola, I, Varvara, D, Drenaggi, D, Staffolani, S, Picardi, A, Vespasiani-Gentilucci, U, Galati, G, Gallo, P, Davi, G, Schiavone, C, Santilli, F, Tana, C, Licata, A, Soresi, M, Bianchi, B, Carderi, I, Pinto, A, Tuttolomondo, A, Ferrari, G, Gresele, P, Fierro, T, Morelli, O, Laffi, G, Romanelli, R, Arena, U, Cristina, S, Gasbarrini, A, Gargovich, M, Zocco, Z, Riccardi, L, Ainora, M, Capeci, W, Martino, M, Lorenzo, N, Cavallo, M, Frugiuele, P, Greco, A, Pietrangelo, A, Ventura, P, Cuoghi, C, Marcacci, M, Serviddio, G, Vendemiale, G, Villani, R, Gargano, R, Vidili, G, Di Cesare, V, Masala, M, Delitala, G, Invernizzi, P, Di Minno, G, Tufano, A, Purrello, F, Privitera, G, Forgione, A, Curigliano, V, Senzolo, M, Rodriguez-Castro, K, Giannelli, G, Serra, C, Neri, S, Pignataro, P, Rizzetto, M, Debernardi, V, Svegliati, B, Bergamaschi, G, Costanzo, F, Angelico, F, Del Ben, M, Polimeni, L, Talerico, G, Proietti, M, Romiti, G, Ruscio, E, Toriello, F, Violi F., Corazza R.G., Caldwell S.H., Perticone F., Gatta A., Angelico M., Farcomeni A., Masotti M., Napoleone L., Vestri A., Raparelli V., Basili S., Palasciano G., D'Alitto F., Palmieri V.O., Santovito D., Di Michele D., Croce G., Sacerdoti D., Brocco S., Fasolato S., Cecchetto L., Bombonato G., Bertoni M., Restuccia R., Andreozzi P., Liguori L.M., Caroleo B., Perticone M., Staltari O., Manfredini R., De Giorgi A., Averna M., Giammanco A., Granito A., Pettinari I., Marinelli S., Bolondi L., Falsetti L., Salvi A., Durante-Mangoni E., Cesaro F., Farinaro V., Ragone E., Morana I., Andriulli A., Ippolito A., Iacobellis A., Niro G., Merla A., Raimondo G., Maimone S., Cacciola I., Varvara D., Drenaggi D., Staffolani S., Picardi A., Vespasiani-Gentilucci U., Galati G., Gallo P., Davi G., Schiavone C., Santilli F., Tana C., Licata A., Soresi M., Bianchi B.G., Carderi I., Pinto A., Tuttolomondo A., Ferrari G., Gresele P., Fierro T., Morelli O., Laffi G., Romanelli R.G., Arena U., Cristina S., Gasbarrini A., Gargovich M., Zocco Z.M., Riccardi L., Ainora M.E., Capeci W., Martino M.G., Lorenzo N., Cavallo M., Frugiuele P., Greco A., Pietrangelo A., Ventura P., Cuoghi C., Marcacci M., Serviddio G., Vendemiale G., Villani R., Gargano R., Vidili G., Di Cesare V., Masala M., Delitala G., Invernizzi P., Di Minno G., Tufano A., Purrello F., Privitera G., Forgione A., Curigliano V., Senzolo M., Rodriguez-Castro K.-I., Giannelli G., Serra C., Neri S., Pignataro P., Rizzetto M., Debernardi V.W., Svegliati B.G., Bergamaschi G., Costanzo F., Angelico F., Del Ben M., Polimeni L., Talerico G., Proietti M., Romiti G.F., Ruscio E., and Toriello F.

Subjects
Registrie, Liver Cirrhosis, Male, Cirrhosis, Hepatocellular carcinoma, 030204 cardiovascular system & hematology, Gastroenterology, 0302 clinical medicine, Esophageal varices, Prevalence, Medicine, Prospective Studies, Registries, Prospective cohort study, Multivariate Analysi, Venous Thrombosis, Portal Vein, Anticoagulants, Liver failure, Splanchnic venous thrombosis, Emergency Medicine, Internal Medicine, Middle Aged, Portal vein thrombosis, Venous thrombosis, Splanchnic venous thrombosis , Anticoagulants , Liver failure , Hepatocellular carcinoma , Esophageal varices, Italy, Liver, Female, 030211 gastroenterology & hepatology, medicine.symptom, Settore SECS-S/01 - Statistica, Human, medicine.medical_specialty, Liver Cirrhosi, Socio-culturale, Asymptomatic, 03 medical and health sciences, Anticoagulants, Esophageal varices, Hepatocellular carcinoma, Liver failure, Splanchnic venous thrombosis, Internal medicine, Humans, Aged, Hepatology, Esophageal varice, business.industry, Anticoagulant, Splanchnic venous thrombosi, medicine.disease, Surgery, Prospective Studie, Splanchnic venous thrombosis, Anticoagulants, Liver failure, Hepatocellular carcinoma, Esophageal varices, Multivariate Analysis, Upper gastrointestinal bleeding, Complication, business
Abstract

Portal vein thrombosis may occur in cirrhosis; nevertheless, its prevalence, and predictors are still elusive. To investigate this issue, the Italian Society of Internal Medicine undertook the “Portal vein thrombosis Relevance On Liver cirrhosis: Italian Venous thrombotic Events Registry” (PRO-LIVER). This prospective multicenter study includes consecutive cirrhotic patients undergoing Doppler ultrasound examination of the portal area to evaluate the prevalence and incidence of portal vein thrombosis over a 2-year scheduled follow-up. Seven hundred and fifty-three (68% men; 64±12years) patients were included in the present analysis. Fifty percent of the cases were cirrhotic outpatients. Viral (44%) etiology was predominant. Around half of the patients had a mild-severity disease according to the Child–Pugh score; hepatocellular carcinoma was present in 20%. The prevalence of ultrasound-detected portal vein thrombosis was 17% (n=126); it was asymptomatic in 43% of the cases. Notably, more than half of the portal vein thrombosis patients (n=81) were not treated with anticoagulant therapy. Logistic step-forward multivariate analysis demonstrated that previous portal vein thrombosis (p&nbsp

Published
2016
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92. Risk management of HBsAg or anti-HCV positive healthcare workers in hospital

Author

Mele, A., Ippolito, G., Craxì, A., Coppola, R.C., Petrosillo, N., Piazza, M., Puro, V., Rizzetto, M., Sagliocca, L., Taliani, G., Zanetti, A., Barni, M., Bianco, E., Bollero, E., Cargnel, A., Cattaneo, M., Chiaramonte, M., Conti, E., D'Amelio, R., De Stefano, D.M., Di Giulio, S., Franco, E., Gallo, G., Levrero, M., Mannella, E., Merli, S., Milazzo, F., Moiraghi, A., Polillo, R., Prati, D., Ragni, P., Sagnelli, E., Scognamiglio, P., Sommella, L., Stroffolini, T., Terrana, T., Tosolini, G., Vitiello, E., Zanesco, L., Ziparo, V., Maffei, C., Moro, M.L., Satolli, R., and Traversa, G.

Published
2001
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93. A Glossary of Zooarchaeological Methods

Author

Albarella, U., Rizzetto, M., and Albarella, U.

Abstract

This methodological glossary presents brief explanations of the main analytical methods employed by zooarchaeologists and makes reference to those chapters in the Handbook that provide examples of their applications. The aim is to provide non-expert readers with a basic understanding of how the evidence presented in this volume has been obtained. The limitations and biases of each type of analysis are also briefly outlined, as their acknowledgement represents an essential prerequisite to research on archaeological materials. The definitions always refer to zooarchaeological applications of the term, although many of them may be employed in other disciplines with similar or different meanings. Each term makes reference to the chapters where it is mentioned, with the exception of approaches that are invariably adopted (e.g. taxonomic identification, quantification).

Published
2017

96. Impact of Safety-Related Dose Reductions or Discontinuations on Sustained Virologic Response in HCV-Infected Patients: Results from the GUARD-C Cohort

Author

GUARD C, Study Group, Hassanein, T, Bakalos, G, Ahlers, S, Shiffman, Ml, Tallarico, L, Reddy, Kr, Orlandini, A, Ferenci, P, Derbala, M, Coppola, C, Foster, Gr, Basho, J, Shabanaj, G, Harxhi, A, Debzi, N, Afredj, N, Guessab, N, Mahindad, N, Mahiou, H, Aissaoui, M, Al Qameesh, J, Al Ghandoor, Z, Assene, C, Bastens, B, Brixko, C, Cool, M, De Galocsy, C, Delwaide, J, George, C, Laukens, P, Lefebvre, V, Mulkay, Jp, Nevens, F, Servais, B, Van Vlierberghe, H, Horsmans, Y, Henrion, J, Sprengers, D, Michielsen, P, Bourgeois, S, Lasser, L, Langlet, P, Robaeys, G, Martinet, Jp, Warzee, P, Hoste, P, Reynaert, H, Juriens, I, Decaestecker, J, Van Der Meersch, F, Janssens, F, Ahmetagic, S, Verhaz, A, Bevanda, M, Calkic, L, Ibrahimpasic, N, Mesihovic, R, Mello, Ce, Ruiz, Fj, Martins Junior, E, Ferraz, Ml, Silva, G, Mendes, C, Lyra, A, Silva, Mh, Gomide, G, Fernandes, Jc, Pereira, P, Correa, Mc, Teixeira, R, Yousry, A, Hanno, A, Gabr, M, Omar, A, Esmat, G, Karatapanis, S, Nikolopoulou, V, Giannoulis, G, Manolakopoulos, S, Elefsiniotis, I, Drakoulis, C, Dimitroulopoulos, D, Kanatakis, S, Ketikoglou, I, Mimidis, K, Evgenidis, N, Akriviades, E, Vafiadi Zoubouli, I, Tsianos, E, Mela, M, Orfanou, E, Mousoulis, G, Karagiannis, I, Manesis, E, Varga, M, Nemesánszky, E, Fried, K, Schuller, J, Szalay, F, Lengyel, G, Tornai, I, Banyai, T, Lesch, M, Nagy, I, Gervain, J, Tusnadi, A, Schneider, F, Szentgyörgyi, L, Hunyady, B, Vincze, A, Tolvaj, G, Varkonyi, I, Makkai, E, Enyedi, J, Racz, I, Hausinger, P, Váczi, Z, Patai, Á, Ozsvár, Z, Lakner, L, Ribiczey, P, Bhalla, A, Somani, S, Luaia, R, Rao, P, Philip, M, Lawate, P, Nagral, A, Sood, A, Parikh, S, Merat, S, Nassiri Toosi, M, Alavian, Sm, Zali, Mr, Daryani, Ne, Drenaggi, D, Attili, Af, Bandiera, F, Bassi, P, Bellati, G, Bellantani, S, Brunetto, MAURIZIA ROSSANA, Bruno, S, Castelli, F, Castellacci, R, Cattelan, Am, Colombo, M, Craxi, A, D'Angelo, S, Colombo, S, Demelia, L, Di Perri, G, Di Giacomo, A, Ferrari, C, Francisci, D, Casinelli, K, Ganga, R, Costa, C, Mangia, A, Russo, Fp, Matarazzo, F, Mazzella, G, Mazzeo, M, Memoli, M, Montalbano, M, Montalto, G, Pieri, A, Passariello, N, Picciotto, A, Pietrangelo, A, Pirisi, M, Quirino, T, Raimondo, G, Rapaccini, Gl, Rizzardini, G, Rizzetto, M, Russello, M, Sabusco, G, Santantonio, T, Soardo, G, Amedea, A, Verucchi, G, Vinelli, F, Zignego, Al, Zuin, M, Ascione, A, Vinci, M, Pigozzi, Mg, Tundo, P, Saracco, Gm, Amoroso, P, Andreoni, M, Colletta, C, Erne, E, Megna, As, Biglino, A, Chiriaco, P, Foti, G, Spinzi, G, D'Amico, E, Paik, Sw, Ahn, Sh, Lee, Yn, Kim, Y, Yang, J, Han, Sy, Varghese, R, Al Gharabally, A, Askar, H, Sharara, A, Yaghi, C, Rached, Aa, Houmani, Z, Zaarour, F, Dohaibi, A, Ivanovski, L, Joksimovic, N, Abbas, Z, Memon, S, Mohsin, A, Masood, S, Hashmi, Z, Halota, W, Deron, Z, Mazur, W, Flisiak, R, Lipczynski, A, Musialik, J, Piekarska, A, Augustyniak, K, Baka Cwierz, B, Simon, K, Gietka, A, Berak, H, Sieklucki, J, Radowska, D, Szlauer, B, Piekos, T, Olszok, I, Jablkowski, M, Orszulak, G, Warakomska, I, Aleixo, Mj, Valente, C, Macedo, G, Sarmento Castro, R, Roxo, F, Faria, T, Mansinho, K, Velez, J, Ramos, Jp, Guerreiro, H, Alberto, S, Monteverde, C, Serejo, F, Peixe, P, Malhado, J, Curescu, M, Streinu Cercel, A, Caruntu, F, Livia, H, Preotescu, L, Arama, V, Ancuta, I, Gheorghe, L, Stanciu, C, Trifan, A, Acalovschi, M, Andreica, V, Pascu, O, Lencu, M, Sporea, I, Olteanu, D, Ionita Radu, F, Fierbinteanu Braticevici, C, Motoc, A, Silaghi, R, Musat, M, Coman, F, Stan, M, Cijevschi, C, Miftode, E, Delic, D, Jesic, R, Nozic, D, Svorcan, P, Fabri, M, Konstantinovic, L, Pelemis, M, Jankovic, G, Todorovic, Z, Nagorni, A, Kupcova, V, Skladany, L, Szantova, M, Krkoska, D, Jarcuska, P, Schreter, I, Oltman, M, Bocakova, J, Bunganic, I, Holoman, J, Giguere, A, Abdou, A. M., Basic (bio-) Medical Sciences, Gastroenterology, Laboratory of Molecullar and Cellular Therapy, Liver Cell Biology, Michielsen, Peter, GUARD-C Study Group, Graham R. Foster, Carmine Coppola, Moutaz Derbala, Peter Ferenci, Alessandra Orlandini, K. Rajender Reddy, Ludovico Tallarico, Mitchell L. Shiffman, Silke Ahler, Georgios Bakalo, Tarek Hassanein, GUARD-C Study Group: [.., Davide Drenaggi, Adolfo Francesco Attili, Franco Bandiera, Paolo Bassi, Giorgio Bellati, Stefano Bellantani, Maurizia Brunetto, Savino Bruno, Francesco Castelli, Roberto Castellacci, Anna Maria Cattelan, Massimo Colombo, Antonio Craxi, Salvatore D'angelo, Silvia Colombo, Luigi Demelia, Giovanni Di Perri, Antonio Di Giacomo, Carlo Ferrari, Daniela Francisci, Katia Casinelli, Roberto Ganga, Chiara Costa, Alessandra Mangia, Francesco Paolo Russo, Filippo Matarazzo, Giuseppe Mazzella, Maurizio Mazzeo, Massimo Memoli, Marzia Montalbano, Giuseppe Montalto, Alessandro Pieri, Nicola Passariello, Antonio Picciotto, Antonello Pietrangelo, Mario Pirisi, Tiziana Quirino, Giovanni Raimondo, Gian Ludovico Rapaccini, Giuliano Rizzardini, Mario Rizzetto, Maurizio Russello, Giuseppe Sabusco, Teresa Santantonio, Giorgio Soardo, Alessandri Amedea, Gabriella Verucchi, Francesco Vinelli, Anna Linda Zignego, Massimo Zuin, Antonio Ascione, Maria Vinci, Maria Graziella Pigozzi, Paolo Tundo, Giorgio Maria Saracco, Pietro Amoroso, Massimo Andreoni, Cosimo Colletta, Elke Erne, Angelo Salomone Megna, Alberto Biglino, Piergiorgio Chiriaco, Giuseppe Foti, Giancarlo Spinzi, Emilio D'amico, …], Foster G.R., Coppola C., Derbala M., Ferenci P., Orlandini A., Reddy K.R., Tallarico L., Shiffman M.L., Ahlers S., Bakalos G., Hassanein T., Basho J., Shabanaj G., Harxhi A., Debzi N., Afredj N., Guessab N., Mahindad N., Mahiou H., Aissaoui M., Al Qameesh J., Al Ghandoor Z., Assene C., Bastens B., Brixko C., Cool M., De Galocsy C., Delwaide J., George C., Laukens P., Lefebvre V., Mulkay J.-P., Nevens F., Servais B., Van Vlierberghe H., Horsmans Y., Henrion J., Sprengers D., Michielsen P., Bourgeois S., Lasser L., Langlet P., Robaeys G., Martinet J.-P., Warzee P., Hoste P., Reynaert H., Juriens I., Decaestecker J., Van Der Meersch F., Janssens F., Ahmetagic S., Verhaz A., Bevanda M., Calkic L., Ibrahimpasic N., Mesihovic R., Mello C.E., Ruiz F.J., Junior E.M., Ferraz M.L., Silva G., Mendes C., Lyra A., Silva M.H., Gomide G., Fernandes J.C., Pereira P., Correa M.C., Teixeira R., Yousry A., Hanno A., Gabr M., Omar A., Esmat G., Karatapanis S., Nikolopoulou V., Giannoulis G., Manolakopoulos S., Elefsiniotis I., Drakoulis C., Dimitroulopoulos D., Kanatakis S., Ketikoglou I., Mimidis K., Evgenidis N., Akriviades E., Vafiadi-Zoubouli I., Tsianos E., Mela M., Orfanou E., Mousoulis G., Karagiannis I., Manesis E., Varga M., Nemesanszky E., Fried K., Schuller J., Szalay F., Lengyel G., Tornai I., Banyai T., Lesch M., Nagy I., Gervain J., Tusnadi A., Schneider F., Szentgyorgyi L., Hunyady B., Vincze A., Tolvaj G., Varkonyi I., Makkai E., Enyedi J., Racz I., Hausinger P., Vaczi Z., Patai A., Ozsvar Z., Lakner L., Ribiczey P., Bhalla A., Somani S., Luaia R., Rao P., Philip M., Lawate P., Nagral A., Sood A., Parikh S., Merat S., Nassiri-Toosi M., Alavian S.-M., Zali M.R., Daryani N.E., Drenaggi D., Attili A.F., Bandiera F., Bassi P., Bellati G., Bellantani S., Brunetto M., Bruno S., Castelli F., Castellacci R., Cattelan A.M., Colombo M., Craxi A., D'angelo S., Colombo S., Demelia L., Di Perri G., Di Giacomo A., Ferrari C., Francisci D., Casinelli K., Ganga R., Costa C., Mangia A., Russo F.P., Matarazzo F., Mazzella G., Mazzeo M., Memoli M., Montalbano M., Montalto G., Pieri A., Passariello N., Picciotto A., Pietrangelo A., Pirisi M., Quirino T., Raimondo G., Rapaccini G.L., Rizzardini G., Rizzetto M., Russello M., Sabusco G., Santantonio T., Soardo G., Amedea A., Verucchi G., Vinelli F., Zignego A.L., Zuin M., Ascione A., Vinci M., Pigozzi M.G., Tundo P., Saracco G.M., Amoroso P., Andreoni M., Colletta C., Erne E., Megna A.S., Biglino A., Chiriaco P., Foti G., Spinzi G., D'amico E., Paik S.W., Ahn S.-H., Lee Y.N., Kim Y., Yang J., Han S.Y., Varghese R., Al Gharabally A., Askar H., Sharara A., Yaghi C., Abou Rached A., Houmani Z., Zaarour F., Dohaibi A., Ivanovski L., Joksimovic N., Abbas Z., Memon S., Mohsin A., Masood S., Hashmi Z., Halota W., Deron Z., Mazur W., Flisiak R., Lipczynski A., Musialik J., Piekarska A., Augustyniak K., Baka-Cwierz B., Simon K., Gietka A., Berak H., Sieklucki J., Radowska D., Szlauer B., Piekos T., Olszok I., Jablkowski M., Orszulak G., Warakomska I., Aleixo M.J., Valente C., Macedo G., Sarmento-Castro R., Roxo F., Faria T., Mansinho K., Velez J., Ramos J.P., Guerreiro H., Alberto S., Monteverde C., Serejo F., Peixe P., Malhado J., Curescu M., Streinu-Cercel A., Caruntu F., Livia H., Preotescu L., Arama V., Ancuta I., Gheorghe L., Stanciu C., Trifan A., Acalovschi M., Andreica V., Pascu O., Lencu M., Sporea I., Olteanu D., Ionita-Radu F., Fierbinteanu-Braticevici C., Motoc A., Silaghi R., Musat M., Coman F., Stan M., Cijevschi C., Miftode E., Delic D., Jesic R., Nozic D., Svorcan P., Fabri M., Konstantinovic L., Pelemis M., Jankovic G., Todorovic Z., Nagorni A., Kupcova V., Skladany L., Szantova M., Krkoska D., Jarcuska P., Schreter I., Oltman M., Bocakova J., Bunganic I., Holoman J., Giguere A., Abdou A.M.S., UCL - SSS/IREC-Institut de recherche expérimentale et clinique, UCL - SSS/IREC/GAEN-Pôle d'Hépato-gastro-entérologie, and UCL - (SLuc) Service de gastro-entérologie

Subjects
Genetics and Molecular Biology (all), Male, Chronic Hepatitis, Hepacivirus, Ribavirin/adverse effects, Asthenia/chemically induced, Polyethylene Glycol, Biochemistry, Polyethylene Glycols, Body Mass Index, Chronic Liver Disease, 0302 clinical medicine, Neutropenia/chemically induced, Interferon-alpha/adverse effects, Medicine, Chronic, lcsh:Science, Liver Diseases, virus diseases, Antiviral Agents/adverse effects, Cohort, Science & Technology - Other Topics, 030211 gastroenterology & hepatology, Drug Therapy, Combination, Cohort study, Human, medicine.medical_specialty, Alpha interferon, Gastroenterology and Hepatology, Antiviral Agents, Microbiology, Dose-Response Relationship, 03 medical and health sciences, Pharmacotherapy, Hepatitis C, Chronic/drug therapy, Dose Prediction Methods, Drug Therapy, Anemia/chemically induced, Humans, Hemoglobin, Aged, Medicine and health sciences, Biochemistry, Genetics and Molecular Biology (all), Hepaciviru, Science & Technology, Dose-Response Relationship, Drug, Flaviviruses, lcsh:R, Organisms, Biology and Life Sciences, Proteins, medicine.disease, digestive system diseases, chemistry, Agricultural and Biological Sciences (all), Withholding Treatment, Asthenia, Immunology, Proportional Hazards Model, lcsh:Q, Human medicine, RNA viruses, Physiology, lcsh:Medicine, Peginterferon-alfa, Polyethylene Glycols/adverse effects, Adult, Anemia, Cohort Studies, Female, Hepatitis C, Chronic, Host-Pathogen Interactions, Interferon-alpha, Middle Aged, Neutropenia, Outcome Assessment (Health Care), Proportional Hazards Models, RNA, Viral, Recombinant Proteins, Ribavirin, Medicine (all), chemistry.chemical_compound, Outcome Assessment, Health Care, Medicine and Health Sciences, 030212 general & internal medicine, Viral, Pathology and laboratory medicine, Multidisciplinary, biology, Hepatitis C virus, Pharmaceutics, Hepatitis C, Hematology, Recombinant Protein, Outcome Assessment (Health Care)/methods, Medical microbiology, Host-Pathogen Interaction, Multidisciplinary Sciences, Physiological Parameters, Research Design, Combination, Viruses, Drug, Pathogens, Host-Pathogen Interactions/drug effects, Research Article, Clinical Research Design, Research and Analysis Methods, Internal medicine, Recombinant Proteins/adverse effects, RNA, Viral/blood, Antiviral Agent, business.industry, Body Weight, Hepacivirus/drug effects, Viral pathogens, biology.organism_classification, Hepatitis viruses, Microbial pathogens, RNA, Adverse Events, Cohort Studie, business
Abstract

Background: Despite the introduction of direct-acting antiviral agents for chronic hepatitis C virus (HCV) infection, peginterferon alfa/ribavirin remains relevant in many resource-constrained settings. The non-randomized GUARD-C cohort investigated baseline predictors of safety-related dose reductions or discontinuations (sr-RD) and their impact on sustained virologic response (SVR) in patients receiving peginterferon alfa/ribavirin in routine practice. Methods: A total of 3181 HCV-mono-infected treatment-naive patients were assigned to 24 or 48 weeks of peginterferon alfa/ribavirin by their physician. Patients were categorized by time-to-first sr-RD (Week 4/12). Detailed analyses of the impact of sr-RD on SVR24 (HCV RNA

Published
2015

97. Undetectable HCV-RNA at treatment-week 8 results in high-sustained virological response in HCV G1 treatment-experienced patients with advanced liver disease: The International Italian/Spanish Boceprevir/Peginterferon/Ribavirin Name Patients Program

Author

Bruno, S, Bollani, S., Zignego, A. L., Pascasio, J. M., Magni, C., Ciancio, A., Caremani, M., Mangia, A., Marenco, S., Piovesan, S., Chemello, L., Babudieri, S., Moretti, A., Gea, F., Colletta, C., Perez Alvarez, R., Forns, X., Larrubia, J. R., Arenas, J., Crespo, J., Calvaruso, V., Ceccherini Silberstein, F., Maisonneuve, P., Craxì, A., Calleja, J. L., Di Marco, V., Monti, M., Rizzardini, G., Landonio, S., Rizzetto, M., Lapini, L. E., Piazzolla, V., Picciotto, A., Alberti, A., Cavaletto, L., Koch, M., Massari, M., Muratori, L., Cipriano, V., Montineri, A., Iacobello, C., Fangazio, S., Pirisi, M., Colombo, A., Bellati, G., Mazzotta, F., Pierotti, P., Traverso, A., Serviddio, G., Russello, M., Santantonio, T., Drenaggi, D., Marchionne, E., Zuin, M., Delliponti, M., Farina, F., Andreone, P., Scuteri, A., Galli, M., Giannini, EDOARDO GIOVANNI, Nerli, A., Carbonai, S., Coppola, N., Montalbano, M., Portelli, V., Di Biagio, A., Nicolini, LAURA AMBRA, Mastroianni, C., Madonia, S., Licata, A., Montalto, G., Giannitrapani, L., Mondelli, M., Pellicelli, A., Toniutto, P., Borgia, G., Gentile, I., De Luca, M., Di Costanzo, G. G., Corti, G., Sousa, M., Delgado, M. B., De La Revilla, J., Navarro, J. M., Barcena, R., Romero Gomez, M., Fernandez Rodriguez, C. M., Narvaez, I., Erdozain, J. C., Molina, E., Fernandez, I., Cuenca, B., Planas, R., Garcia Samaniego, J., Ladero, J. M., Gonzalez, J. M., Serra, M. A., Castellote, I., Sola, R., Anton, T., Ryan, I., Gonzalez, F., Martinez, E., Portu, J., Bruno, S, Bollani, S., Zignego, A.L., Pascasio, J.M., Magni, C., Ciancio, A., Caremani, M., Mangia, A., Marenco, S., Piovesan, S., Chemello, L., Babudieri, S., Moretti, A., Gea, F., Colletta, C., Perez-Alvarez, R., Forns, X., Larrubia, J.R., Arenas, J., Crespo, J., Calvaruso, V., Ceccherini Silberstein, F., Maisonneuve, P., Craxì, A., Calleja, J.L., Di Marco, V., Monti, M., Rizzardini, G., Landonio, S., Rizzetto, M., Lapini, L.E., Piazzolla, V., Picciotto, A., Alberti, A., Cavaletto, L., Koch, M., Massari, M., Muratori, L., Cipriano, V., Montineri, A., Iacobello, C., Fangazio, S., Pirisi, M., Colombo, A., Bellati, G., Mazzotta, F., Pierotti, P., Traverso, A., Serviddio, G., Russello, M., Santantonio, T., Drenaggi, D., Marchionne, E., Zuin, M., Delliponti, M., Farina, F., Andreone, P., Scuteri, A., Galli, M., Giannini, E.G., Nerli, A., Carbonai, S., Coppola, N., Montalbano, M., Portelli, V., Di Biagio, A., Nicolini, L.A., Mastroianni, C., Madonia, S., Licata, A., Montalto, G., Giannitrapani, L., Mondelli, M., Pellicelli, A., Toniutto, P., Borgia, G., Gentile, I., De Luca, M., Di Costanzo, G.G., Corti, G., Sousa, M., Delgado, M.B., De La Revilla, J., Navarro, J.M., Barcena, R., Romero-Gomez, M., Fernandez-Rodriguez, C.M., Narvaez, I., Erdozain, J.C., Molina, E., Fernandez, I., Cuenca, B., Planas, R., Garcia-Samaniego, J., Ladero, J.M., Gonzalez, J.M., Serra, M.A., Castellote, I., Sola, R., Anton, T., Ryan, I., Gonzalez, F., Martinez, E., Portu, J., Bollani, S, Zignego, A. L, Pascasio, J. M, Magni, C, Ciancio, A, Caremani, M, Mangia, A, Marenco, S, Piovesan, S, Chemello, L, Gentile, Ivan, Borgia, Guglielmo, Et, A, Babudieri, S, Moretti, A, Gea, F, Colletta, C, Perez Alvarez, R, Forns, X, Larrubia, J. R, Arenas, J, Crespo, J, Calvaruso, V, Ceccherini Silberstein, F, Maisonneuve, P, Craxì, A, Calleja, J. L., Bruno, S., Zignego, A., Pascasio, J., Larrubia, J., Calleja, J., Lapini, L., Giannini, E., Nicolini, L., Di Costanzo, G., Delgado, M., Navarro, J., Fernandez-Rodriguez, C., Erdozain, J., Ladero, J., Gonzalez, J., and Serra, M.

Subjects
Male, Settore MED/09 - Medicina Interna, boceprevir, cirrhosis, first-generation protease inhibitors, hepatitis C, IFN-based therapy, Adult, Aged, Antiviral Agents, Drug Therapy, Combination, Female, Hepacivirus, Hepatitis C, Chronic, Humans, Interferon-alpha, Italy, Middle Aged, Proline, RNA, Viral, Ribavirin, Spain, Treatment Outcome, Viral Load, Hepatology, Infectious Diseases, Virology, Medicine (all), Gastroenterology, first-generation protease inhibitor, chemistry.chemical_compound, Liver disease, Medicine, Viral, Chronic, Settore MED/12 - Gastroenterologia, Drug Therapy, Combination, Hepatitis C, RNA, virus diseases, Settore MED/07 - Microbiologia e Microbiologia Clinica, HCV, Viral load, Human, medicine.medical_specialty, Alpha interferon, Infectious Disease, Internal medicine, Boceprevir, hepatitis c, adult, aged, antiviral agents, drug therapy, combination, female, hepacivirus, hepatitis c, chronic, humans, interferon-alpha, italy, male, middle aged, proline, RNA, viral, ribavirin, spain, treatment outcome, viral load, hepatology, infectious diseases, virology, Decompensation, Adverse effect, Antiviral Agent, Hepaciviru, business.industry, medicine.disease, digestive system diseases, chemistry, Immunology, business, cirrhosi
Abstract

In many countries, first-generation protease inhibitors (PIs)/peginterferon/ribavirin (P/R) still represent the only treatment option for HCV-infected patients. Subjects with advanced disease and previous failure to P/R urgently need therapy, but they are under-represented in clinical trials. All treatment-experienced F3/4 Metavir patients who received boceprevir (BOC)+P/R in the Italian-Spanish Name Patient Program have been included in this study. Multivariate logistic regression analysis (MLR) was used to identify baseline and on-treatment predictors of SVR and adverse events (AEs). Four hundred and sixteen patients, mean age 57.7 (range 25-78 years), 70% males, 69.5% (289/416) F4, 14% (41/289) Child-Pugh class A6, 24% (70/289) with varices and 42% (173/416) prior null responders to P/R, were analysed. Overall, SVR rate (all 381 patients who received one dose of BOC) was 49%, (58% in F3, 45% in F4, 61% in relapsers, 51% in partial, 38% in null responders, and 72% in subjects with undetectable HCV-RNA at treatment-week (TW)8. Among patients with TW8 HCV-RNA ≥ 1000 IU/L, SVR was 8% (negative predictive value = 92%). Death occurred in 3 (0.8%) patients, while decompensation and infections were observed in 2.9% and 11%, respectively. At MLR, SVR predictors were TW4 HCV-RNA ≥ 1log10 -decline from baseline, undetectable TW8 HCV-RNA, prior relapse, albumin levels ≥3.5 g/dL and platelet counts ≥100 000/μL. Metavir F4, Child-Pugh A6, albumin, platelets, age and female gender were associated with serious and haematological AEs. Among treatment-experienced patients with advanced liver disease eligible for IFN-based therapy, TW8 HCV-RNA characterised the subset with either high or poor likelihood of achieving SVR. Using TW8 HCV-RNA as a futility rule, BOC/P/R appears to have a favourable benefit-risk profile.

Published
2015

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