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1. Amniocentesis and chorionic villus sampling in HIV-infected pregnant women: a multicentre case series

Author

Floridia M, Masuelli G, Meloni A, Cetin I, Tamburrini E, Cavaliere AF, Dalzero S, Sansone M, Alberico S, Guerra B, Spinillo A, Chiadò Fiorio Tin M, Ravizza M, Mori F, Ortolani P, Dalle Nogare ER, 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 VS, Carocci A, Grilli E, Maccabruni A, Zaramella M, Mariani B, Natalini Raponi G, Guaraldi G, Nardini G, Stentarelli C, Beghetto B, Degli Antoni AM, Molinari A, Crisalli MP, 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, Maso G, Airoud M, Soppelsa G, Dedoni M, Cuboni C, Ortu F, Piano P, Citernesi A, Bordoni Vicini I, Luzi K, Roccio M, Vimercati A, Miccolis A, De Gennaro A, Cervi F, Simonazzi G, Margarito E, Capretti MG, Marsico C, Faldella G, Martinelli P, Agangi A, Capone A, Maruotti GM, Tibaldi C, Trentini L, Todros T, Frisina V, 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 AM, Cellini M, Castelli Gattinara G, Marconi AM, Sacchi V, Ierardi M, Polizzi C, Mattei A, Pirillo MF, Amici R, Galluzzo CM, Donnini S, Baroncelli S, Villani P, Cusato M, Cerioli A, De Martino M, Mastroiacovo P, Parazzini F, Vella S., Floridia M, Masuelli G, Meloni A, Cetin I, Tamburrini E, Cavaliere AF, Dalzero S, Sansone M, Alberico S, Guerra B, Spinillo A, Chiadò Fiorio Tin M, Ravizza M, and Mori F, Ortolani P, Dalle Nogare ER, 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 VS, Carocci A, Grilli E, Maccabruni A, Zaramella M, Mariani B, Natalini Raponi G, Guaraldi G, Nardini G, Stentarelli C, Beghetto B, Degli Antoni AM, Molinari A, Crisalli MP, 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, Maso G, Airoud M, Soppelsa G, Dedoni M, Cuboni C, Ortu F, Piano P, Citernesi A, Bordoni Vicini I, Luzi K, Roccio M, Vimercati A, Miccolis A, De Gennaro A, Cervi F, Simonazzi G, Margarito E, Capretti MG, Marsico C, Faldella G, Martinelli P, Agangi A, Capone A, Maruotti GM, Tibaldi C, Trentini L, Todros T, Frisina V, 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 AM, Cellini M, Castelli Gattinara G, Marconi AM, Sacchi V, Ierardi M, Polizzi C, Mattei A, Pirillo MF, Amici R, Galluzzo CM, Donnini S, Baroncelli S, Villani P, Cusato M, Cerioli A, De Martino M, Mastroiacovo P, Parazzini F, Vella S.

Subjects
Infectious Disease Transmission, Prenatal diagnosis, HIV Infections, 0302 clinical medicine, Birth defect, Pregnancy, Odds Ratio, Vertical, Medicine, 030212 general & internal medicine, Pregnancy Complications, Infectious, education.field_of_study, Amniocentesi, 030219 obstetrics & reproductive medicine, medicine.diagnostic_test, Obstetrics, Infectious, Obstetrics and Gynecology, Amniocentesis, birth defects, chorionic villus sampling, HIV, invasive testing, mother-to child HIV transmission, pregnancy, prenatal diagnosis, Birth defects, Chorionic villus sampling, Invasive testing, Mother-to child HIV transmission, Anti-Retroviral Agents, Chorionic Villi Sampling, Female, Adult, medicine.medical_specialty, Prenatal diagnosi, Population, Settore MED/17 - MALATTIE INFETTIVE, 03 medical and health sciences, Humans, education, Fetal Death, Analysis of Variance, Chi-Square Distribution, business.industry, Infectious Disease Transmission, Vertical, Odds ratio, medicine.disease, Confidence interval, Pregnancy Complications, business, Chi-squared distribution
Abstract

Objectives To assess in pregnant women with HIV the rates of amniocentesis and chorionic villus sampling (CVS), and the outcomes associated with such procedures. Design Observational study. Data from the Italian National Program on Surveillance on Antiretroviral Treatment in Pregnancy were used. Setting University and hospital clinics. Population Pregnant women with HIV. Methods Temporal trends were analysed by analysis of variance and by the Chi-square test for trend. Quantitative variables were compared by Student's t-test and categorical data by the Chi-square test, with odds ratios and 95% confidence intervals calculated. Main outcome measures Rate of invasive testing, intrauterine death, HIV transmission. Results Between 2001 and 2015, among 2065 pregnancies in women with HIV, 113 (5.5%) had invasive tests performed. The procedures were conducted under antiretroviral treatment in 99 cases (87.6%), with a significant increase over time in the proportion of tests performed under highly active antiretroviral therapy (HAART) (100% in 2011–2015). Three intrauterine deaths were observed (2.6%), and 14 pregnancies were terminated because of fetal anomalies. Among 96 live newborns, eight had no information available on HIV status. Among the remaining 88 cases with either amniocentesis (n = 75), CVS (n = 12), or both (n = 1), two HIV transmissions occurred (2.3%). No HIV transmission occurred among the women who were on HAART at the time of invasive testing, and none after 2005. Conclusions The findings reinforce the assumption that invasive prenatal testing does not increase the risk of HIV vertical transmission among pregnant women under suppressive antiretroviral treatment. Tweetable abstract No HIV transmission occurred among women who underwent amniocentesis or CVS under effective anti-HIV regimens.

Published
2016

2. Atazanavir and lopinavir profile in pregnant women with HIV: tolerability, activity and pregnancy outcomes in an observational national study

Author

Floridia, M., Ravizza, M., Masuelli, G., Giacomet, V., Martinelli, P., Degli Antoni, A., Spinillo, A., Fiscon, M., Francisci, D., Liuzzi, G., Pinnetti, C., Marconi, A. M., Tamburrini, E., 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, Giovanni, Nardini, Giulia, Stentarelli, Chiara, Beghetto, Barbara, Degli Antoni, A. M., Molinari, A., Crisalli, M. P., Donisi, A., Piepoli, M., Cerri, V., Zuccotti, G., Fabiano, V., Placido, G., Vivarelli, A., Castelli, P., Savalli, F., Portelli, V., Sabbatini, F., 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., Roccio, M., Vimercati, A., Miccolis, A., Bassi, E., Guerra, B., Cervi, F., Puccetti, C., Murano, P., Contoli, M., Capretti, M. G., Marsico, C., Faldella, G., Sansone, M., Agangi, A., Tibaldi, C., Trentini, L., Todros, T., Frisina, V., Cetin, I., Brambilla, T., Savasi, V., Personeni, C., Giaquinto, C., Rinaldi, R., Rubino, E., Bucceri, A., Matrone, R., Scaravelli, G., Fundaro, C., Genovese, O., Cafforio, C., Tozzi, V., Massetti, P., Casadei, A. M., Cavaliere, A. F., Finelli, V., Cellini, M., Castelli Gattinara, G., Dalzero, S., Sacchi, V., De Pirro, A., Polizzi, C., Mattei, A., Pirillo, M. F., Amici, R., Galluzzo, C. M., Donnini, S., Baroncelli, S., Regazzi, M., Villani, P., Cusato, M., Cerioli, A., De Martino, M., Mastroiacovo, P., Moroni, M., Parazzini, F., Vella, S., Floridia, M, Ravizza, M, Masuelli, G, Giacomet, V, Martinelli, Pasquale, Degli Antoni, A, Spinillo, A, Fiscon, M, Francisci, D, Liuzzi, G, Pinnetti, C, Marconi, Am, Tamburrini, E, on behalf of The Italian Group on Surveillance on Antiretroviral Treatment in, Pregnancy, Floridia, M1, Italian Group on Surveillance on Antiretroviral Treatment in, P. r. e. g. n. a. n. c. y., Marco Floridia, Marina Ravizza, Giulia Masuelli, Vania Giacomet, Pasquale Martinelli, Anna Degli Antoni, Arsenio Spinillo, Marta Fiscon, Daniela Francisci, Giuseppina Liuzzi, Carmela Pinnetti, Anna Maria Marconi, Enrica Tamburrini, on behalf of The Italian Group on Surveillance on Antiretroviral Treatment in Pregnancy [.., Capretti, M.G., Marsico, C., Faldella, G., and ].

Subjects
Pyridines, Pyridine, HIV Infections, Triglyceride, Lopinavir, Liver Function Tests, Pregnancy, HIV Infection, Pharmacology (medical), Viral, Pregnancy Complications, Infectious, triglycerides, pre-term delivery, medicine.diagnostic_test, Liver Function Test, Obstetrics, Medicine (all), Pregnancy Outcome, Infectious, virus diseases, HIV, pregnancy, RNA, Lipid, Viral Load, Lipids, Infectious Diseases, Tolerability, Oligopeptide, Population study, RNA, Viral, Female, medicine.symptom, bilirubin, Viral load, Oligopeptides, Human, medicine.drug, Microbiology (medical), Adult, medicine.medical_specialty, HIV RNA, Anti-HIV Agents, Atazanavir Sulfate, Infectious Disease, Bilirubin, Cholesterol, Pre-term delivery, Triglycerides, Pharmacology, cholesterol, Settore MED/17 - MALATTIE INFETTIVE, medicine, Humans, business.industry, Anti-HIV Agent, medicine.disease, Atazanavir, CD4 Lymphocyte Count, Pregnancy Complications, Immunology, Pregnancy Complications, Infectiou, business, Liver function tests, Weight gain
Abstract

BACKGROUND: Atazanavir and lopinavir represent the main HIV protease inhibitors recommended in pregnancy, but comparative data in pregnant women are limited. METHODS: Women from a national observational study, exposed in pregnancy to either atazanavir or lopinavir, were compared for glucose and lipid profiles, liver function tests, CD4 count, HIV RNA and main pregnancy outcomes. Statistical methods included univariate and multivariable analyses. RESULTS: The study population included 428 pregnancies (lopinavir, 322; atazanavir, 106). The lopinavir group was characterized by higher rates of HIV diagnosis in pregnancy and treatment indication for maternal health, lower CD4 counts, higher HIV RNA levels, less frequent antiretroviral treatment at conception and shorter duration of drug exposure during pregnancy. No differences in pregnancy outcomes, glucose metabolism and weight gain were observed. The two groups also showed in a multivariable analysis similar odds for detectable HIV RNA in the third trimester (adjusted OR 0.85, 95% CI 0.35-2.10, P = 0.730). Total lipid levels were significantly higher in the lopinavir group (median values in the third trimester 239 versus 221 mg/dL for total cholesterol and 226 versus 181 mg/dL for triglycerides; P < 0.001 for both comparisons) and bilirubin levels were significantly higher in the atazanavir group (1.53 versus 0.46 mg/dL, P < 0.001). CONCLUSIONS: In this observational study atazanavir and lopinavir showed similar safety and activity in pregnancy, with no differences in the main pregnancy outcomes. Atazanavir use was associated with a better lipid profile and with higher bilirubin levels. Overall, the study findings confirm that these two HIV protease inhibitors represent equally valid alternative options.

Published
2014

3. Body Mass Index and Weight Gain in Pregnant Women With HIV: A National Study in Italy

Author

Floridia, M., Ravizza, M., Masuelli, G., Dalzero, S., Pinnetti, C., Cetin, I., Meloni, A., Spinillo, A., Rubino, E., Francisci, D., Tamburrini, E., 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., Pinter, E., Anzalone, E., Marocco, R., Mastroianni, Claudio Maria, Mercurio, V. S., Carocci, A., Grilli, E., Maccabruni, A., Zaramella, M., Mariani, B., Natalini Raponi, G., Guaraldi, G., Luzi, K., Nardini, G., Stentarelli, C., Degli Antoni, A. M., Molinari, A., Crisalli, M. P., Donisi, A., Piepoli, M., Cerri, V., Zuccotti, G., Giacomet, V., Fabiano, V., Placido, G., Vivarelli, A., Castelli, P., Savalli, F., Portelli, V., Sabbatini, F., Bernini, L., Alberico, S., Maso, G., Tropea, M., Dedoni, M., Cuboni, C., Ortu, F., Piano, P., Citernesi, A., Vicini, I., Roccio, M., Vimercati, A., Miccolis, A., Bassi, E., Guerra, B., Cervi, F., Puccetti, C., Murano, P., Contoli, M., Capretti, M. G., Marsico, C., Faldella, G., Sansone, M., Martinelli, P., Agangi, A., Tibaldi, C., Trentini, L., Todros, T., Garetto, S., Brambilla, T., Savasi, V., Crepaldi, A., Giaquinto, C., Fiscon, M., Rinaldi, R., Bucceri, A., Matrone, R., Scaravelli, G., Fundaro, C., Genovese, O., Cafforio, C., Liuzzi, G., Tozzi, V., Massetti, Anna Paola, Anceschi, M., Casadei, A. M., Cavaliere, A. F., Finelli, V., Cellini, M., Castelli Gattinara, G., Marconi, A. M., Sacchi, V., De Pirro, A., Polizzi, C., Mattei, A., Pirillo, M. F., Amici, R., Galluzzo, C. M., Donnini, S., Baroncelli, S., Villani, P., Cusato, M., Cerioli, A., De Martino, M., Mastroiacovo, P., Moroni, M., Parazzini, F., Vella, S., Floridia, M, Ravizza, M, Masuelli, G, Dalzero, S, Pinnetti, C, Cetin, I, Meloni, A, Spinillo, A, Rubino, E, Francisci, D, Tamburrini, E, Italian Group on Surveillance on Antiretroviral Treatment in, Pregnancy, Martinelli, Pasquale, Floridia M, Ravizza M, Masuelli G, Dalzero S, Pinnetti C, Cetin I, Meloni A, Spinillo A, Rubino E, Francisci D, Tamburrini E, Faldella G, Guerra B, and for the Italian Group on Surveillance on Antiretroviral Treatment in Pregnancy

Subjects
Microbiology (medical), medicine.medical_specialty, antiretroviral therapy, MEDLINE, Human immunodeficiency virus (HIV), HIV Infections, body mass index, medicine.disease_cause, Settore MED/17 - MALATTIE INFETTIVE, Body Mass Index, BMI, weight gain, HIV-1, Pregnancy, Medicine, Humans, HIV infection, pregnancy, Pregnancy Complications, Infectious, business.industry, Obstetrics, Cesarean Section, Infectious, Pregnancy Outcome, HIV, medicine.disease, Pregnancy Complications, Infectious Diseases, Italy, National study, Female, medicine.symptom, business, Weight gain, Body mass index
Abstract

Although most of the women (69.4%) had a normal BMI at start of pregnancy, only 37% had an adequate weight gain during pregnancy. Inadequate body weight gain was more common (44.8%) than excessive weight gain (18.2%), but 40% of overweight women and 50% of obese women had an excessive weight gain in pregnancy, with about 9% of the women in these categories gaining >18 kg during pregnancy (Table 1). Only 1.9% of the women had a vaginal delivery; elective and nonelective cesarean deliveries accounted for 81.3% and 16.7% of deliveries, respectively. Compared to underweight/normal women, overweight/obese women had similar occurrences of preterm delivery (23.4% vs 22.7%, P = .871), significantly lower rates of low birthweight (14.2% vs 24.2%, P = .007) and nonelective cesarean deliveries (11.7% vs 18.3%, P = .042), and a significantly higher occurrence of fasting plasma glucose >92 mg/dL at 20–28 weeks (12.1% vs 6.6%, P = .027), hypertension during pregnancy (6.4% vs 2.7%, P = .019), and gestational age–adjusted birthweight >90th percentile (15.5% vs 5.0%, P < .001). Complications of delivery, major birth defects, and HIV transmission were similar between the 2 groups (7.3% vs 7.6%, P = .881; 2.6% vs 3.5%, P = .589; and 0.8% vs 0.5%, P = .661, respectively). An inadequate weight gain during pregnancy was associated with an increased risk of nonelective cesarean delivery (OR, 1.589 [95% CI, 1.077–2.346], P = .020). Excessive weight gain during pregnancy was not associated with either hypertension (OR, 1.364 [95% CI, .537–3.465], P = .514) or 20–28 week glucose level of >92 mg/dL (OR, 0.841 [95% CI, .399–1.772], P = .648), but was significantly associated with birthweight >90th percentile (OR, 2.271 [95% CI, 1.229–4.195], P = .009), and appeared to be protective against low birthweight (OR, 0.544 [95% CI, .323–.918], P = .023) and birthweight

Published
2013

4. Birth defects in a national cohort of pregnant women with HIV infection in Italy, 2001-2011

Author

Floridia, M., Mastroiacovo, P., Tamburrini, E., Tibaldi, C., Todros, T., Crepaldi, A., Sansone, M., Fiscon, M., Liuzzi, G., Guerra, B., Vimercati, A., Vichi, F., Vicini, I., Pinnetti, C., Marconi, A. M., Ravizza, M., 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., 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., Luzi, K., Nardini, G., Stentarelli, C., Degli Antoni, A. M., Molinari, A., Crisalli, M. P., Donisi, A., Piepoli, M., Cerri, V., Zuccotti, G., Giacomet, V., Fabiano, V., Coletto, S., Placido, G., Vivarelli, A., Castelli, P., Savalli, F., Portelli, V., Sabbatini, F., Francisci, D., Bernini, L., Alberico, S., Maso, G., Tropea, M., Meloni, A., Dedoni, M., Cuboni, C., Ortu, F., Piano, P., Citernesi, A., Spinillo, A., Roccio, M., Miccolis, A., Bassi, E., Cervi, F., Puccetti, C., Murano, P., Contoli, M., Capretti, M. G., Marsico, C., Faldella, G., Martinelli, P., Agangi, A., Trentini, L., Masuelli, G., Garetto, S., Cetin, I., Brambilla, T., Savasi, V., Giaquinto, C., Rinaldi, R., Rubino, E., Bucceri, A., Matrone, R., Scaravelli, G., Fundaro, C., Genovese, O., Cafforio, C., Tozzi, V., Massetti, P., Anceschi, M., Casadei, A. M., Cavaliere, A. F., Finelli, V., Cellini, M., Castelli Gattinara, G., Dalzero, S., Sacchi, V., De Pirro, A., Polizzi, C., Mattei, A., Pirillo, M. F., Amici, R., Galluzzo, C. M., Donnini, S., Baroncelli, S., Regazzi, M., Villani, P., Cusato, M., Cerioli, A., De Martino, M., Moroni, M., Parazzini, F., Vella, S., Floridia, M, Mastroiacovo, P, Tamburrini, E, Tibaldi, C, Todros, T, Crepaldi, A, Sansone, M, Fiscon, M, Liuzzi, G, Guerra, B, Vimercati, A, Vichi, F, Vicini, I, Pinnetti, C, Marconi, A, Ravizza, M, Martinelli, Pasquale, and The Italian Group on Surveillance on Antiretroviral Treatment in, Pregnancy

Subjects
Male, HIV Infections, transcriptase inhibitors, Cohort Studies, chemistry.chemical_compound, Pregnancy, Prevalence, Birth Weight, Young adult, Pregnancy Complications, Infectious, education.field_of_study, Obstetrics, Coinfection, Antiretroviral therapy, birth defects, efavirenz, HIV, non-nucleoside reverse transcriptase inhibitors, nucleoside reverse transcriptase inhibitors, pregnancy, protease inhibitors, women, Obstetrics and Gynecology, Abnormalities, Drug-Induced, Middle Aged, Italy, Maternal Exposure, Reverse Transcriptase Inhibitors, Female, Cohort study, Adult, medicine.medical_specialty, Efavirenz, Adolescent, Anti-HIV Agents, Birth weight, Population, Antiretroviral Therapy, Birth defects, HIV-1, Young Adult, Hepatitis B, Chronic, medicine, Humans, education, business.industry, Infant, Newborn, Odds ratio, Hepatitis C, Chronic, medicine.disease, Infectious Disease Transmission, Vertical, Surgery, Pregnancy Trimester, First, chemistry, business
Abstract

Objective We used data from a national study of pregnant women with HIV to evaluate the prevalence of congenital abnormalities in newborns from women with HIV infection. Design Observational study. Setting University and hospital clinics. Population Pregnant women with HIV exposed to antiretroviral treatment at any time during pregnancy. Methods The total prevalence of birth defects was assessed on live births, stillbirths, and elective terminations for fetal anomaly. The associations between potentially predictive variables and the occurrence of birth defects were expressed as odds ratios (ORs) with 95% confidence intervals (95% CIs) for exposed versus unexposed cases, calculated in univariate and multivariate logistic regression analyses. Main outcome measures Birth defects, defined according to the Antiretroviral Pregnancy Registry criteria. Results A total of 1257 pregnancies with exposure at any time to antiretroviral therapy were evaluated. Forty-two cases with major defects were observed. The total prevalence was 3.2% (95% CI 1.9–4.5) for exposure to any antiretroviral drug during the first trimester (23 cases with defects) and 3.4% (95% CI 1.9–4.9) for no antiretroviral exposure during the first trimester (19 cases). No associations were found between major birth defects and first-trimester exposure to any antiretroviral treatment (OR 0.94, 95% CI 0.51–1.75), main drug classes (nucleoside reverse transcriptase inhibitors, OR 0.95, 95% CI 0.51–1.76; non-nucleoside reverse transcriptase inhibitors, OR 1.20, 95% CI 0.56–2.55; protease inhibitors, OR 0.92, 95% CI 0.43–1.95), and individual drugs, including efavirenz (prevalence for efavirenz, 2.5%). Conclusions This study adds further support to the assumption that first-trimester exposure to antiretroviral treatment does not increase the risk of congenital abnormalities.

Published
2013

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