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1. Premature ovarian senescence and a high miscarriage rate impair fertility in women with HCV

Author

Karampatou, Aimilia, Han, Xue, Kondili, Loreta A., Taliani, Gloria, Ciancio, Alessia, Morisco, Filomena, Critelli, Rosina Maria, Baraldi, Enrica, Bernabucci, Veronica, Troshina, Giulia, Guarino, Maria, Tagliavini, Simonetta, D'Ambrosio, Federica, Bristot, Laura, Turco, Laura, Rosato, Stefano, Vella, Stefano, Trenti, Tommaso, Neri, Isabella, La Marca, Antonio, Manthena, Shivaji, Goldstein, Andrea S., Bruno, Savino, Bao, Yanjun, Gonzalez, Yuri Sanchez, Villa, Erica, Craxì, A., Petta, S., Calvaruso, V., Brunetto, M., Coco, B., Chessa, L., Pasetto, M. C., Bigliotti, E., Tamburrini, F., Montalto, G., Capitano, A. R., Ieluzzi, D., Fattovich, G., Zignego, A. L., Monti, M., Gragnani, L., Zuin, M., Finati, E., Giorgini, A., Angarano, G., Milella, M., Federico, A., Alessandro, F., Dallio, M., Mazzella, G., Lazzarini, G., Di Fine, M., Russo, F. P., Zanetto, A., Castelli, F., Zaltron, S., Raimondo, G., Filomia, R., Puoti, M., Danieli, E., Strazzabosco, M., Gemma, M., Angelico, M., De Leonardis, F., Gori, A., Cappelletti, E., Bruno, R., Cima, S., Coppola, C., Amoruso, D. C., Andreone, P., Simonetti, G., Gaeta, G. B., Brancaccio, G., Toniutto, P., Dissegna, D., Mondelli, M., Ludovisi, S., Persico, M., Masarone, M., Torti, C., Strazzulla, A., Rosina, F., Framarin, L., Weimer, L. E., Quaranta, M. G., Falzano, L., Mallano, A., Karampatou, A., Han, X., Kondili, L., Taliani, G., Ciancio, A., Morisco, F., Critelli, R., Baraldi, E., Bernabucci, V., Troshina, G., Guarino, M., Tagliavini, S., D'Ambrosio, F., Bristot, L., Turco, L., Rosato, S., Vella, S., Trenti, T., Neri, I., La Marca, A., Manthena, S., Goldstein, A., Bruno, S., Bao, Y., Gonzalez, Y., Villa, E., Craxi, A., Petta, S., Calvaruso, V., Karampatou, A, Han, X, Kondili, L, Taliani, G, Ciancio, A, Morisco, F, Critelli, R, Baraldi, E, Bernabucci, V, Troshina, G, Guarino, M, Tagliavini, S, D'Ambrosio, F, Bristot, L, Turco, L, Rosato, S, Vella, S, Trenti, T, Neri, I, La Marca, A, Manthena, S, Goldstein, A, Bruno, S, Bao, Y, Gonzalez, Y, Villa, E, Craxi, A, Petta, S, Calvaruso, V, Brunetto, M, Coco, B, Chessa, L, Pasetto, M, Bigliotti, E, Tamburrini, F, Montalto, G, Capitano, A, Ieluzzi, D, Fattovich, G, Zignego, A, Monti, M, Gragnani, L, Zuin, M, Finati, E, Giorgini, A, Angarano, G, Milella, M, Alessandro, F, Dallio, M, Mazzella, G, Lazzarini, G, Di Fine, M, Russo, F, Zanetto, A, Castelli, F, Zaltron, S, Raimondo, G, Filomia, R, Puoti, M, Danieli, E, Strazzabosco, M, Gemma, M, Angelico, M, De Leonardis, F, Gori, A, Cappelletti, E, Bruno, R, Cima, S, Coppola, C, Amoruso, D, Andreone, P, Simonetti, G, Gaeta, G, Brancaccio, G, Toniutto, P, Dissegna, D, Mondelli, M, Ludovisi, S, Persico, M, Masarone, M, Torti, C, Strazzulla, A, Rosina, F, Framarin, L, Weimer, L, Quaranta, M, Falzano, L, Mallano, A, Karampatou, Aimilia, Han, Xue, Kondili, Loreta A., Taliani, Gloria, Ciancio, Alessia, Morisco, Filomena, Critelli, Rosina Maria, Baraldi, Enrica, Bernabucci, Veronica, Troshina, Giulia, Guarino, Maria, Tagliavini, Simonetta, D'Ambrosio, Federica, Bristot, Laura, Turco, Laura, Rosato, Stefano, Vella, Stefano, Trenti, Tommaso, Neri, Isabella, La Marca, Antonio, Manthena, Shivaji, Goldstein, Andrea S., Bruno, Savino, Bao, Yanjun, Gonzalez, Yuri Sanchez, Villa, Erica, Craxì, A., Brunetto, M., Coco, B., Chessa, L., Pasetto, M. C., Bigliotti, E., Tamburrini, F., Montalto, G., Capitano, A. R., Ieluzzi, D., Fattovich, G., Zignego, A. L., Monti, M., Gragnani, L., Zuin, M., Finati, E., Giorgini, A., Angarano, G., Milella, M., Alessandro, F., Dallio, M., Mazzella, G., Lazzarini, G., Di Fine, M., Russo, F. P., Zanetto, A., Castelli, F., Zaltron, S., Raimondo, G., Filomia, R., Puoti, M., Danieli, E., Strazzabosco, M., Gemma, M., Angelico, M., De Leonardis, F., Gori, A., Cappelletti, E., Bruno, R., Cima, S., Coppola, C., Amoruso, D. C., Andreone, P., Simonetti, G., Gaeta, G. B., Brancaccio, G., Toniutto, P., Dissegna, D., Mondelli, M., Ludovisi, S., Persico, M., Masarone, M., Torti, C., Strazzulla, A., Rosina, F., Framarin, L., Weimer, L. E., Quaranta, M. G., Falzano, L., Mallano, A., Pasetto, M.C., Capitano, A.R., Zignego, A.L., Russo, F.P., Amoruso, D.C., Gaeta, G.B., Weimer, L.E., Quaranta, M.G., Craxã¬, A., and Federico, A.

Subjects
Anti-Mullerian hormone, Antiviral therapy, HBV, HCV, Sustained viral response, Hepatology, Infertility, medicine.medical_specialty, media_common.quotation_subject, Fertility, Anti-Müllerian hormone, Miscarriage, 03 medical and health sciences, 0302 clinical medicine, Medicine, Prospective cohort study, media_common, Gynecology, Anti-Müllerian hormone, Antiviral therapy, HBV, HCV, Sustained viral response, 030219 obstetrics & reproductive medicine, business.industry, Obstetrics, medicine.disease, Anti-Müllerian hormone, Gestational diabetes, Cohort, 030211 gastroenterology & hepatology, business, Live birth, Cell aging
Abstract

Background & Aims Premenopausal women who are HCV positive (HCV+) have failing ovarian function, which is likely to impact their fertility. Thus, we investigated the reproductive history, risk of infertility, and pregnancy outcomes in women of childbearing age who were HCV+. Methods Three different groups were studied: (1) Clinical cohort: 100 women who were HCV+ and also had chronic liver disease (CLD), age matched with 50 women who were HBV+ with CLD and with 100 healthy women; all women were consecutively observed in three gastroenterology units in hospitals in Italy; (2) 1,998 women who were HCV+ and enrolled in the Italian Platform for the Study of Viral Hepatitis Therapies (PITER); (3) 6,085 women, who were mono-infected with HCV, and 20,415 women, who were HCV−, from a large de-identified insurance database from the USA. Measurements: total fertility rate (TFR) defined as the average number of children that a woman would bear during her lifetime. To define the reproductive stage of each participant, levels of anti-Müllerian hormone (AMH) and 17β-estradiol were measured. Results Clinical cohort: women who were either HCV+ or HBV+ had similar CLD severity and age at first pregnancy. Based on a multivariate analysis, women who were HCV+ had a higher risk of miscarriage than those who were HBV+ (odds ratio [OR] 6,905; 95% CI 1.771–26.926). Among women who were HCV+, incidence of miscarriage was correlated with median AMH level (1.0 ng/ml). Achieving a sustained virologic response (SVR) after antiviral treatment reduced the risk of miscarriage (OR 0.255; 95% CI 0.090–0.723). In the PITER-HCV cohort, miscarriage occurred in 42.0% of women (44.6% had multiple miscarriages). TFR for women who were HCV+ and between 15 and 49 years of age was 0.7 vs. 1.37 of Italian population of the same age range. In the US cohort: compared with women who were HCV−, women who were HCV+ positive were significantly more likely to have infertility (OR 2.439; 95% CI 2.130–2.794), premature birth (OR 1.34; 95% CI 1.060–1.690), gestational diabetes (OR 1.24; 95% CI 1.020–1.510), and pre-eclampsia (OR 1.206; 95% CI 0.935–1.556), and were less likely to have a live birth (OR 0.754; 95% CI 0.622–0.913). Conclusions Ovarian senescence in women of childbearing age who are HCV+ is associated with a lower chance of live birth, greater risk of infertility, gestational diabetes, pre-eclampsia and miscarriage. Such risks could be positively influenced by successful HCV cure. Lay summary Most new cases of HCV infection are among people who inject drugs, many of whom are young women in their childbearing years. Women of reproductive age who are HCV+ display markers of ovarian senescence. This is associated with an increased burden in terms of infertility and adverse pregnancy outcomes, including stillbirth, miscarriage, fewer live births, and gestational diabetes. Early viral suppression with therapy is likely to mitigate these risks.

Published
2017

2. Corrigendum to 'Premature ovarian senescence and a high miscarriage rate impair fertility in women with HCV' [J Hepatol 68 (2018) 33–41](S0168827817322596)(10.1016/j.jhep.2017.08.019)

Author

Karampatou, A., Han, X., Kondili, L. A., Taliani, G., Ciancio, A., Morisco, F., Critelli, R. M., Baraldi, E., Bernabucci, V., Troshina, G., Guarino, M., Tagliavini, S., D'Ambrosio, F., Bristot, L., Turco, L., Rosato, S., Vella, S., Trenti, T., Neri, I., La Marca, A., Manthena, S., Goldstein, A. S., Bruno, S., Bao, Y., Gonzalez, Y. S., Villa, E., Craxi, A., Petta, S., Calvaruso, V., Brunetto, M., Coco, B., Chessa, L., Pasetto, M. C., Bigliotti, E., Tamburrini, F., Montalto, G., Capitano, A. R., Ieluzzi, D., Fattovich, G., Zignego, A. L., Monti, M., Gragnani, L., Zuin, M., Finati, E., Giorgini, A., Angarano, G., Milella, M., Alessandro, F., Dallio, M., Mazzella, G., Lazzarini, G., Di Fine, M., Russo, F. P., Zanetto, A., Castelli, F., Zaltron, S., Raimondo, G., Filomia, R., Puoti, M., Danieli, E., Strazzabosco, M., Gemma, M., Angelico, M., De Leonardis, F., Gori, A., Cappelletti, E., Bruno, R., Cima, S., Coppola, C., Amoruso, D. C., Andreone, P., Simonetti, G., Gaeta, G. B., Brancaccio, G., Toniutto, P., Dissegna, D., Mondelli, M., Ludovisi, S., Persico, M., Masarone, M., Torti, C., Strazzulla, A., Rosina, F., Framarin, L., Weimer, L. E., Quaranta, M. G., Falzano, L., Mallano, A., Karampatou A., Han X., Kondili L.A., Taliani G., Ciancio A., Morisco F., Critelli R.M., Baraldi E., Bernabucci V., Troshina G., Guarino M., Tagliavini S., D'Ambrosio F., Bristot L., Turco L., Rosato S., Vella S., Trenti T., Neri I., La Marca A., Manthena S., Goldstein A.S., Bruno S., Bao Y., Gonzalez Y.S., Villa E., Craxi A., Petta S., Calvaruso V., Brunetto M., Coco B., Chessa L., Pasetto M.C., Bigliotti E., Tamburrini F., Montalto G., Capitano A.R., Ieluzzi D., Fattovich G., Zignego A.L., Monti M., Gragnani L., Zuin M., Finati E., Giorgini A., Angarano G., Milella M., Alessandro F., Dallio M., Mazzella G., Lazzarini G., Di Fine M., Russo F.P., Zanetto A., Castelli F., Zaltron S., Raimondo G., Filomia R., Puoti M., Danieli E., Strazzabosco M., Gemma M., Angelico M., De Leonardis F., Gori A., Cappelletti E., Bruno R., Cima S., Coppola C., Amoruso D.C., Andreone P., Simonetti G., Gaeta G.B., Brancaccio G., Toniutto P., Dissegna D., Mondelli M., Ludovisi S., Persico M., Masarone M., Torti C., Strazzulla A., Rosina F., Framarin L., Weimer L.E., Quaranta M.G., Falzano L., and Mallano A.

Subjects
Hepatology, Hepatitis B, EASL guidelines, Treatment, Interferon, Entecavir, Tenofovir, TAF, HBsAg, Hepatocellular carcinoma, HBV DNA, HBV reactivation, Mother to child transmission, EASL guideline
Abstract

It has come to our attention that the PITER framework investigator, Alessandro Federico, was incorrectly listed as F. Alessandro in the original manuscript. Please note that the correct name of this author is Alessandro Federico (2nd University of Naples). The correct list of PITER investigators is in the footnote below.

Published
2018

3. Pegylated interferon α plus ribavirin for the treatment of chronic hepatitis C: A multicentre independent study supported by the Italian Drug Agency

Author

Rosina, Floriano, Tosti, Maria Elena, Borghesio, Elisabetta, Masocco, Maria, Mele, Alfonso, Coppola, Carmine, Milella, Michele, Borgia, Guglielmo, Andreone, Pietro, Koch, Maurizio, Zignego, Anna Linda, Romano, Mario, Carrara, Maurizio, Almasio, Piero Luigi, Azzola, Emilio, Nardone, Gerardo, Benedetti, Antonio, Carosi, Giampiero, Mazzotta, Francesco, Sagnelli, Evangelista, Rizzetto, Mario, Mascolo, M. C., Cursaro, C., Scuteri, A., Crespi, C., Gianstefani, A., Ranieri, J., Monti, M., Corti, G., Blanc, P. L., Baragli, F., Bellentani, S., Gasbarrini, A., Pompili, M., Mecenate, F., Picardi, A., Vespasiani, U., Nosotti, Null, Null, A. Picardi, Ricci, G. L., Paffetti, A., Mastropietro, C., Moretti, A., Spagnolo, A. L., Puoti, C., Bellis, L., Regazzetti, A., Maffezzini, E., Pietrangelo, A., Abbati, G., Borghi, A., Sardini, C., Raimondo, G., Scribano, L., Martines, D., Svegliati Baroni, G., Faraci, G., Schi anchi, S., Fornaciari, G., Massari, M., Fabris, P., Bertin, T., Salvagnini, M., Madonia, S., Calì, A., Civitavecchia, G., Pirisi, M., Smirne, C., Andreoletti, M., Morisco, F., Caporaso, N., Gentile, I., Brancaccio, G., Gaeta, G. B., Liberti, A., Iannece, M. D., Rocco, A., Federico, A., Loguercio, C., Riegler, G., Esposito, P., Fargion, S., Fatta, E., Masutti, F., Bonaventura, M. E., Autolitano, A., Russello, M., Bellia, A., Toniutto, P., Bitetto, D., Pasulo, L., Lucà, M. G., Grattagliano, I., Palasciano, G., Romagno, D., Giannelli, G., Napoli, N., Plattella, M. S., Cassano, P., Gobbo, G., Monti, V., Raspanti, A., Cuccorese, Null, Colombo, A. E., Mandelli, G., Spinzi, G. C., Floridia, Null, Messina, V., Bonfante, S., Bellissima, P., Toti, M., Vecchiet, J., Falasca, K., Portelli, V., Stefano, G. De, Pietromatera, G., Viganò, P., Re, T., Andreoni, M., Null, G. Raineri, Grossi, P. A., Caputo, S., Cassola, G., Feasi, M., Biagio, A. Di, Nicolini, LAURA AMBRA, Giannini, EDOARDO GIOVANNI, Corbo, M., Foti, G., Kunkar, A., Caterini, L., Migliorini, D., Chiodera, A., Calleri, G., Spezia, C., Framarin, L., Null, M. Berrutti, Ciancio, A., Baiguera, C., Puoti, M., Vento, S., Contini, C., Boccia, S., Casiraghi, M. A., Simone, L., Tacconi, D., Caremani, M., Almi, P., Chimenti, M., Cosco, Null, Messeri, D., Esperti, F. C., Lomonaco, L., Pazzi, P., Fornari, F., Comparato, G., Casetti, T., Foschi, F. G., Samori, A., Ferretti, E., Marin, R., Campo, N., Testa, R., Rizzo, S., Rosina, F, Tosti, ME, Borghesio, E, Masocco, M, Mele, A, Coppola, C, Milella, M, Borgia, G, Andreone, P, Koch, M, Zignego, AL, Romano, M, Carrara, M, Almasio, PL, Azzola, E, Nardone, G, Benedetti, A, Carosi, G, Mazzotta, F, Sagnelli, E, Rizzetto, M, Rosina, F., Tosti, M. E., Borghesio, E., Masocco, M., Mele, A., Coppola, C., Milella, M., Borgia, Guglielmo, Andreone, P., Koch, M., Zignego, A. L., Romano, M., Carrara, M., Almasio, P. L., Azzola, E., Nardone, GERARDO ANTONIO PIO, Benedetti, A., Carosi, G., Mazzotta, F., Sagnelli, E., Rizzetto, M., Aifa, Aisf, Simit, Aigo, Sige, Gentile, Ivan, Morisco, Filomena, Et, Al, Floriano Rosina, Maria Elena Tosti, Elisabetta Borghesio, Maria Masocco, Alfonso Mele, Carmine Coppola, Michele Milella, Guglielmo Borgia, Pietro Andreone, Maurizio Koch, Anna Linda Zignego, Mario Romano, Maurizio Carrara, Piero Luigi Almasio, Emilio Azzola, Gerardo Nardone, Antonio Benedetti, Giampiero Carosi, Francesco Mazzotta, Evangelista Sagnelli, and Mario Rizzetto

Subjects
Registrie, Male, Cirrhosis, medicine.disease_cause, Polyethylene Glycol, Gastroenterology, Polyethylene Glycols, chemistry.chemical_compound, Hepatitis Viruses, Hepatitis Viruse, Prospective Studies, Viral, Registries, Chronic, Prospective cohort study, Drug Carrier, Drug Carriers, Settore MED/12 - Gastroenterologia, Medicine (all), Recombinant Protein, Middle Aged, Hepatitis C, Recombinant Proteins, Treatment Outcome, Italy, Combination, RNA, Viral, Population study, Drug Therapy, Combination, Female, Human, medicine.medical_specialty, Genotype, Hepatitis C virus, Alpha interferon, Ribavirin, Sustained virological response (SVR), Treatment, Antiviral Agents, Follow-Up Studie, Hepatology, Drug Therapy, Internal medicine, medicine, Humans, Antiviral Agent, business.industry, Interferon-alpha, HCV therapy, Hepatitis C, Chronic, medicine.disease, Clinical trial, Prospective Studie, chemistry, Immunology, RNA, Follow-Up Studies, business
Abstract

a b s t r a c t Background: Data on the efficacy of Peg-interferon/ribavirin therapy for chronic hepatitis C are mostly derived from treatment of selected patients enrolled in clinical trials. This study aimed to assess the effectiveness of Peg-interferon/ribavirin therapy in “real world” chronic hepatitis C patients in Italy. Methods: Independent observational multicentre study including consecutive patients receiving Peginterferon/ribavirin in the 18 months before (retrospective phase) and after (prospective phase) the start of the study. Results: 4176 patients were eligible. The final study population consisted of 2051 patients in the retrospective and 2073 in the prospective phase. Sustained virological response was achieved by 1036 patients (50.5%) during the retrospective phase: 325 were genotypes 1/4 (34.1%) and 684 were genotypes 2/3 (67.2%) and by 800 patients (38.6%) during the prospective phase: 300 were genotypes 1/4 (28.4%) and 473 were genotypes 2/3 (51.5%). During multivariate analysis genotypes 2/3 were significantly associated with higher sustained virological response rates; cirrhosis and -glutamil-transpeptidase >2 times the normal limit were associated with poorer response. Conclusions: The response to Peg-interferon/ribavirin therapy in “real world” clinical practice is distinctly lower than in registration trials. The difference in response rates was more pronounced among easy-totreat than among difficult-to-treat hepatitis C virus genotypes.

Published
2014

4. Steatosis in patients with HCV chronic liver disease: Baseline results from patients enrolled in the PITER cohort study

Author

L. Falzano, D. Ieluzzi, L. Nicolini, M.C. Pasetto, V. Rizzo, A. Orlandini, Cappelletti Mattia, B. Stagno, M. Borghi, M. Dallio, F.P. Russo, A. Rocco, M. Massella, L. Cavalletto, V. Donati, M. Milella, Alessia Ciancio, O. Patti, A. Mallano, D. Drenaggi, S. Petta, M.G. Faraci, P. Colombato, F. D’Aversa, Maria Giovanna Quaranta, A. Giammario, T. Tieghi, M. Margotti, S. Camera, Giulia Morsica, S. Zaltron, Mario Masarone, F. Giancotti, A. Iannone, L.E. Weimer, L. Giubilei, P. Blanc, L. Valenti, Loreta A. Kondili, L. Framarin, E.M. Erne, S. Rosato, C. Cerva, Ivan Gentile, M. Gonzo, F. Tamburrini, E. Danieli, M. Vinci, S. Storato, S. Pellicano, R. Filomia, A.R. Capitano, R. Corsini, Laura Staiano, Weimer, L. E., Falzano, L., Mallano, A., Quaranta, M. G., Massella, M., Rosato, S., Colombato, P., Giubilei, L., Ciancio, A., Iannone, A., Filomia, R., Orlandini, A., Petta, S., Tamburrini, F., Blanc, P., D’Aversa, F., Pasetto, M. C., Erne, E. M., Ieluzzi, D., Storato, S., Margotti, M., Vinci, M., Russo, F. P., Patti, O., Rizzo, V., Giammario, A., Gentile, Ivan, Donati, V., Staiano, L., Masarone, M., Cavalletto, L., Gonzo, M., Giancotti, F., Danieli, E., Corsini, R., Faraci, M. G., Valenti, L., Cappelletti, M., Camera, S., Pellicano, S., Stagno, B., Tieghi, T., Milella, M., Dallio, M., Rocco, A., Borghi, M., Drenaggi, D., Zaltron, S., Morsica, G., Framarin, L., Capitano, A. R., Cerva, C., Nicolini, L., and Kondili, L.

Subjects
medicine.medical_specialty, Hepatology, business.industry, Internal medicine, Gastroenterology, medicine, In patient, Steatosis, Chronic liver disease, medicine.disease, Baseline (configuration management), business, Cohort study
Published
2015

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