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