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1. Treatment with valacyclovir during pregnancy for prevention of congenital cytomegalovirus infection: a real-life multicenter Italian observational study

Author

Zammarchi, L, Tomasoni, L, Liuzzi, G, Simonazzi, G, Dionisi, C, Mazzarelli, L, Seidenari, A, Maruotti, G, Ornaghi, S, Castelli, F, Abbate, I, Bordi, L, Mazzotta, S, Fusco, P, Torti, C, Calò Carducci, F, Baccini, M, Modi, G, Galli, L, Lilleri, D, Furione, M, Zavattoni, M, Ricciardi, A, Arossa, A, Vimercati, A, Lovatti, S, Salomè, S, Raimondi, F, Sarno, L, Sforza, A, Fichera, A, Caforio, L, Trotta, M, Lazzarotto, T, Zammarchi L., Tomasoni L. R., Liuzzi G., Simonazzi G., Dionisi C., Mazzarelli L. L., Seidenari A., Maruotti G. M., Ornaghi S., Castelli F., Abbate I., Bordi L., Mazzotta S., Fusco P., Torti C., Calò Carducci F. I., Baccini M., Modi G., Galli L., Lilleri D., Furione M., Zavattoni M., Ricciardi A., Arossa A., Vimercati A., Lovatti S., Salomè S., Raimondi F., Sarno L., Sforza A., Fichera A., Caforio L., Trotta M., Lazzarotto T., Zammarchi, L, Tomasoni, L, Liuzzi, G, Simonazzi, G, Dionisi, C, Mazzarelli, L, Seidenari, A, Maruotti, G, Ornaghi, S, Castelli, F, Abbate, I, Bordi, L, Mazzotta, S, Fusco, P, Torti, C, Calò Carducci, F, Baccini, M, Modi, G, Galli, L, Lilleri, D, Furione, M, Zavattoni, M, Ricciardi, A, Arossa, A, Vimercati, A, Lovatti, S, Salomè, S, Raimondi, F, Sarno, L, Sforza, A, Fichera, A, Caforio, L, Trotta, M, Lazzarotto, T, Zammarchi L., Tomasoni L. R., Liuzzi G., Simonazzi G., Dionisi C., Mazzarelli L. L., Seidenari A., Maruotti G. M., Ornaghi S., Castelli F., Abbate I., Bordi L., Mazzotta S., Fusco P., Torti C., Calò Carducci F. I., Baccini M., Modi G., Galli L., Lilleri D., Furione M., Zavattoni M., Ricciardi A., Arossa A., Vimercati A., Lovatti S., Salomè S., Raimondi F., Sarno L., Sforza A., Fichera A., Caforio L., Trotta M., and Lazzarotto T.

Abstract

BACKGROUND: Valacyclovir is the only treatment demonstrated to be effective for the prevention of vertical transmission of cytomegalovirus within a clinical randomized, placebo-controlled trial and has been reimbursed by the Italian National Health System since December 2020. OBJECTIVE: This study reported the results of a real-life Italian multicenter observational study on cytomegalovirus infection in pregnancy evaluating the effect of the introduction of valacyclovir in the clinical practice for the prevention of vertical transmission of cytomegalovirus. STUDY DESIGN: The outcomes of women who received valacyclovir treatment and their fetuses or newborns were compared with those of a retrospective cohort observed between 2010 and 2020 who did not receive the antiviral treatment. The inclusion criterion was the diagnosis of cytomegalovirus primary infection occurring in the periconceptional period or up to 24 weeks of gestation. The primary outcome was the transmission by the time of amniocentesis. The secondary outcomes were termination of pregnancy, transmission at birth, symptomatic infection at birth, and a composite outcome (termination of pregnancy or transmission at birth). RESULTS: A total of 447 pregnant women from 10 centers were enrolled, 205 women treated with valacyclovir (called the valacyclovir group, including 1 twin pregnancy) and 242 women not treated with valacyclovir (called the no-valacyclovir group, including 2 twin pregnancies). Valacyclovir treatment was significantly associated with a reduction of the diagnosis of congenital cytomegalovirus infection by the time of amniocentesis (weighted odds ratio, 0.39; 90% confidence interval, 0.22–0.68; P=.005; relative reduction of 61%), termination of pregnancy (weighted odds ratio, 0.36; 90% confidence interval, 0.17–0.75; P=.0021; relative reduction of 64%), symptomatic congenital cytomegalovirus infection at birth (weighted odds ratio, 0.17; 90% confidence interval, 0.06–0.49; P=.006; relative re

Published
2023

2. Valacyclovir for prevention and treatment of fetal cmv infection: Inclusion in the law 648/96 list and launch of the italian multicentre observational prospective study “megal-itali”

Author

Zammarchi, L, Lazzarotto, T, Di Tommaso, M, Tomasoni, L, Pasquini, L, Galli, L, Simonazzi, G, Castelli, F, Borchi, B, Campolmi, I, Ornaghi, S, Bartoloni, A, Andreoni, M, Pagano, I, Petraglia, S, Ramenghi, L, Clerici, P, Tavio, M, Trotta, M, Zammarchi L., Lazzarotto T., Di Tommaso M., Tomasoni L., Pasquini L., Galli L., Simonazzi G., Castelli F., Borchi B., Campolmi I., Ornaghi S., Bartoloni A., Andreoni M., Pagano I., Petraglia S., Ramenghi L., Clerici P., Tavio M., Trotta M., Zammarchi, L, Lazzarotto, T, Di Tommaso, M, Tomasoni, L, Pasquini, L, Galli, L, Simonazzi, G, Castelli, F, Borchi, B, Campolmi, I, Ornaghi, S, Bartoloni, A, Andreoni, M, Pagano, I, Petraglia, S, Ramenghi, L, Clerici, P, Tavio, M, Trotta, M, Zammarchi L., Lazzarotto T., Di Tommaso M., Tomasoni L., Pasquini L., Galli L., Simonazzi G., Castelli F., Borchi B., Campolmi I., Ornaghi S., Bartoloni A., Andreoni M., Pagano I., Petraglia S., Ramenghi L., Clerici P., Tavio M., and Trotta M.

Published
2021

3. Atazanavir and darunavir in pregnant women with HIV: evaluation of laboratory and clinical outcomes from an observational national study

Author

Floridia, M, Masuelli, G, Ravizza, M, Tassis, B, Cetin, I, Sansone, M, Degli Antoni, A, Simonazzi, G, Maccabruni, A, Francisci, D, Frisina, V, Liuzzi, G, Dalzero, S, Tamburrini, Enrica, Tamburrini, E (ORCID:0000-0003-4930-426X), Floridia, M, Masuelli, G, Ravizza, M, Tassis, B, Cetin, I, Sansone, M, Degli Antoni, A, Simonazzi, G, Maccabruni, A, Francisci, D, Frisina, V, Liuzzi, G, Dalzero, S, Tamburrini, Enrica, and Tamburrini, E (ORCID:0000-0003-4930-426X)

Abstract

Background: Atazanavir and darunavir represent the main HIV PIs recommended in pregnancy, but comparative data in pregnant women are limited. We assessed the safety and activity profile of these two drugs in pregnancy using data from a national observational study.Methods: Women with atazanavir or darunavir exposure in pregnancy were evaluated for laboratory measures and main pregnancy outcomes (e.g. preterm delivery, low birthweight, non-elective caesarean section and neonatal gestational age-adjusted birthweight Z-score).Results: Final analysis included 500 pregnancies with either atazanavir (n = 409) or darunavir (n = 91) exposure. No differences in pregnancy outcomes, weight gain in pregnancy, drug discontinuations, undetectable HIV-RNA, haemoglobin, ALT, total cholesterol, HDL cholesterol and LDL cholesterol were observed between the two groups. At third trimester, exposure to darunavir was associated with higher levels of plasma triglycerides (median 235.5 versus 179 mg/dL; P = 0.032) and a higher total cholesterol/HDL cholesterol ratio (median 4.03 versus 3.27; P = 0.028) and exposure to atazanavir was associated with higher levels of plasma bilirubin (1.54 versus 0.32 mg/dL; P < 0.001).Conclusions: In this observational study, the two main HIV PIs currently recommended by perinatal guidelines showed similar safety and activity in pregnancy, with no evidence of differences between the two drugs in terms of main pregnancy outcomes. Based on the minor differences observed in laboratory measures, prescribing physicians might prefer either drug in some particular situations where the different impacts of treatment on lipid profile and bilirubin may have clinical relevance.

Published
2018

4. Pregnancy outcomes and cytomegalovirus DNAaemia in HIV-infected pregnant women with CMV

Author

Ravizza, M., Tamburrini, Enrica, Mori, F., Ortolani, P., dalle Nogare, E. R., Di Lorenzo, F., Sterrantino, G., Meli, M., Polemi, S., Nocentini, J., Baldini, M., Montorzi, G., Mazzetti, M., Rogasi, P., Borchi, B., Vichi, F., Del Pin, B., Pinter, E., Anzalone, E., Marocco, R., Mastroianni, C., Mercurio, V. S., Carocci, A., Grilli, E., Maccabruni, A., Zaramella, M., Mariani, B., Natalini Raponi, G., Guaraldi, G., Nardini, G., Stentarelli, C., Beghetto, B., Degli Antoni, A. M., Molinari, A., Crisalli, M. P., Donisi, A., Piepoli, M., Cerri, V., Zuccotti, G., Giacomet, V., Coletto, S., Di Nello, F., Madia, C., Placido, G., Vivarelli, A., Castelli, P., Savalli, F., Portelli, V., Sabbatini, F., Francisci, D., Bernini, L., Grossi, P., Rizzi, L., Alberico, S., Maso, G., Airoud, M., Soppelsa, G., Meloni, A., Dedoni, M., Cuboni, C., Ortu, F., Piano, P., Citernesi, A., Bordoni Vicini, I., Luzi, K., Spinillo, A., Roccio, M., Vimercati, A., Miccolis, A., De Gennaro, A., Guerra, B., Cervi, F., Simonazzi, G., Margarito, E., Capretti, M. G., Marsico, C., Faldella, G., Sansone, M., Martinelli, P., Agangi, A., Capone, A., Maruotti, G. M., Tibaldi, C., Trentini, L., Todros, T., Masuelli, G., Frisina, V., Cetin, I., Brambilla, T., Savasi, V., Personeni, C., Giaquinto, C., Fiscon, M., Rubino, E., Bucceri, A., Matrone, R., Scaravelli, G., Genovese, O., Cafforio, C., Pinnetti, C., Liuzzi, G., Tozzi, V., Massetti, P., Casadei, A. M., Cavaliere, Anna Franca, Cellini, M., Castelli Gattinara, G., Marconi, A. M., Dalzero, S., Sacchi, V., Ierardi, M., Polizzi, C., Mattei, A., Pirillo, M. F., Amici, R., Galluzzo, C. M., Donnini, S., Baroncelli, S., Floridia, M., Villani, P., Cusato, M., Cerioli, A., De Martino, M., Mastroiacovo, P., Parazzini, F., Vella, S., Tamburrini, Enrica (ORCID:0000-0003-4930-426X), Ravizza, M., Tamburrini, Enrica, Mori, F., Ortolani, P., dalle Nogare, E. R., Di Lorenzo, F., Sterrantino, G., Meli, M., Polemi, S., Nocentini, J., Baldini, M., Montorzi, G., Mazzetti, M., Rogasi, P., Borchi, B., Vichi, F., Del Pin, B., Pinter, E., Anzalone, E., Marocco, R., Mastroianni, C., Mercurio, V. S., Carocci, A., Grilli, E., Maccabruni, A., Zaramella, M., Mariani, B., Natalini Raponi, G., Guaraldi, G., Nardini, G., Stentarelli, C., Beghetto, B., Degli Antoni, A. M., Molinari, A., Crisalli, M. P., Donisi, A., Piepoli, M., Cerri, V., Zuccotti, G., Giacomet, V., Coletto, S., Di Nello, F., Madia, C., Placido, G., Vivarelli, A., Castelli, P., Savalli, F., Portelli, V., Sabbatini, F., Francisci, D., Bernini, L., Grossi, P., Rizzi, L., Alberico, S., Maso, G., Airoud, M., Soppelsa, G., Meloni, A., Dedoni, M., Cuboni, C., Ortu, F., Piano, P., Citernesi, A., Bordoni Vicini, I., Luzi, K., Spinillo, A., Roccio, M., Vimercati, A., Miccolis, A., De Gennaro, A., Guerra, B., Cervi, F., Simonazzi, G., Margarito, E., Capretti, M. G., Marsico, C., Faldella, G., Sansone, M., Martinelli, P., Agangi, A., Capone, A., Maruotti, G. M., Tibaldi, C., Trentini, L., Todros, T., Masuelli, G., Frisina, V., Cetin, I., Brambilla, T., Savasi, V., Personeni, C., Giaquinto, C., Fiscon, M., Rubino, E., Bucceri, A., Matrone, R., Scaravelli, G., Genovese, O., Cafforio, C., Pinnetti, C., Liuzzi, G., Tozzi, V., Massetti, P., Casadei, A. M., Cavaliere, Anna Franca, Cellini, M., Castelli Gattinara, G., Marconi, A. M., Dalzero, S., Sacchi, V., Ierardi, M., Polizzi, C., Mattei, A., Pirillo, M. F., Amici, R., Galluzzo, C. M., Donnini, S., Baroncelli, S., Floridia, M., Villani, P., Cusato, M., Cerioli, A., De Martino, M., Mastroiacovo, P., Parazzini, F., Vella, S., and Tamburrini, Enrica (ORCID:0000-0003-4930-426X)

Abstract

not available

Published
2016

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