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1. 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., Antoni, A. D., Simonazzi, G., Maccabruni, A., Francisci, D., Frisina, V., Liuzzi, G., Dalzero, S., Tamburrini, E., Di Lorenzo, F., Sterrantino, G., Meli, M., Campolmi, I., Vichi, F., Del Pin, B., Marocco, R., Mastroianni, C., S. Mercurio V., Zanaboni, D., Guaraldi, G., Nardini, G., Stentarelli, C., Beghetto, B., Antoni, A. M. D., Molinari, A., Crisalli, M. P., Donisi, A., Piepoli, M., Cerri, V., Zuccotti, G., Giacomet, V., Coletto, S., Di Nello, F., Madia, C., Placido, G., Milini, P., Savalli, F., Portelli, V., Sabbatini, F., Papalini, C., Bernini, L., Grossi, P., Rizzi, L., Bernardon, M., Maso, G., Rizzante, E., Belcaro, C., Meloni, A., Dedoni, M., Ortu, F., Piano, P., Citernesi, A., Bordonivicini, I., Luzi, K., Spinillo, A., Roccio, M., Vimercati, A., Crupano, F. M., Calabretti, D., Cervi, F., Margarito, E., Capretti, M. G., Marsico, C., Faldella, G., Martinelli, P., Agangi, A., Capone, A., Maruotti, G. M., Tibaldi, C., Trentini, L., Todros, T., Brambilla, T., Savasi, V., Personeni, C., Giaquinto, C., Fiscon, M., Rubino, E., Franceschetti, L., Badolato, R., Tiso, G. C., Genovese, O., Cafforio, C., Pinnetti, C., Casadei, A. M., Cavaliere, A. F., Cellini, M., Marconi, A. M., Sacchi, V., Ierardi, M., 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., Parazzini, F., Vella, S., Floridia, M., Masuelli, G., Ravizza, M., Tassis, B., Cetin, I., Sansone, M., Antoni, A. Degli, Simonazzi, G., Maccabruni, A., Francisci, D., Frisina, V., Liuzzi, G., Dalzero, S., Tamburrini, E., Di Lorenzo, F., Sterrantino, G., Meli, M., Campolmi, I., Vichi, F., Del Pin, B., Marocco, R., Mastroianni, C., S.Mercurio, V., Zanaboni, D., Guaraldi, G., Nardini, G., Stentarelli, C., Beghetto, B., Antoni, A.M. Degli, Molinari, A., Crisalli, M.P., Donisi, A., Piepoli, M., Cerri, V., Zuccotti, G., Giacomet, V., Coletto, S., Di Nello, F., Madia, C., Placido, G., Milini, P., Savalli, F., Portelli, V., Sabbatini, F., Papalini, C., Bernini, L., Grossi, P., Rizzi, L., Bernardon, M., Maso, G., Rizzante, E., Belcaro, C., Meloni, A., Dedoni, M., Ortu, F., Piano, P., Citernesi, A., BordoniVicini, I., Luzi, K., Spinillo, A., Roccio, M., Vimercati, A., Crupano, F.M., Calabretti, D., Cervi, F., Margarito, E., Capretti, M.G., Marsico, C., Faldella, G., Martinelli, P., Agangi, A., Capone, A., Maruotti, G.M., Tibaldi, C., Trentini, L., Todros, T., Brambilla, T., Savasi, V., Personeni, C., Giaquinto, C., Fiscon, M., Rubino, E., Franceschetti, L., Badolato, R., Tiso, G.C., Genovese, O., Cafforio, C., Pinnetti, C., Casadei, A.M., Cavaliere, A.F., Cellini, M., Marconi, A.M., Sacchi, V., Ierardi, M., 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., Parazzini, F., and Vella, S.

Subjects
Male, 0301 basic medicine, medicine.medical_treatment, HIV Infections, 0302 clinical medicine, Pregnancy, Pharmacology (medical), 030212 general & internal medicine, Pregnancy Complications, Infectious, Darunavir, medicine.diagnostic_test, Obstetrics, Pregnancy Outcome, virus diseases, Alanine Transaminase, Viral Load, Cholesterol, Treatment Outcome, Infectious Diseases, Premature birth, Gestation, Female, Drugs in pregnancy, medicine.drug, Adult, Microbiology (medical), medicine.medical_specialty, Drug-Related Side Effects and Adverse Reactions, Anti-HIV Agents, Atazanavir Sulfate, Settore MED/17 - MALATTIE INFETTIVE, 03 medical and health sciences, pharmacology, pharmacology (medical), infectious diseases, medicine, Humans, Caesarean section, Triglycerides, Pharmacology, business.industry, Infant, Newborn, Infant, Bilirubin, medicine.disease, 030112 virology, Atazanavir, azatanavir sulfate, Lipid profile, business
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

Published
2017
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2. 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
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3. Vaginal delivery in women with HIV in Italy: results of 5 years of implementation of the national SIGO-HIV protocol

Author

Tibaldi, C., Masuelli, G., Sansone, M., Tassis, B., Cetin, I., Franceschetti, L., Spinillo, A., Simonazzi, G., Vimercati, A., Dalzero, S., Meloni, A., Bernardon, M., Frisina, V., Polizzi, C., Todros, T., Martinelli, P., Floridia, M., Ravizza, M., Trentini, L., Tiso, G., Brambilla, T., Savasi, V., Personeni, C., Zuccotti, G., Giacomet, V., Coletto, S., Di Nello, F., Madia, C., Forleo, M. A., Badolato, R., Roccio, M., Zanaboni, D., Sirico, A., Maruotti, G. M., Capone, A., Guerra, B., Cervi, F., Margarito, E., Capretti, M. G., Marsico, C., Faldella, G., Crupano, F. M., Calabretti, D., Ravizz, M., Marconi, A. M., Galiano, V., Ierardi, S. C. S. M., Chiodo, A., Ortu, F., Piano, P., Dedoni, I. M., Maso, G., Belcaro, C., Rizzante, E., Alberico, S., Citernesi, A., Vicini, I. B., Luzi, K., Tibaldi C, Masuelli G, Sansone M, Tassis B, Cetin I, Franceschetti L, Spinillo A, Simonazzi G, Vimercati A, Dalzero S, Meloni A, Bernardon M, Frisina V, Polizzi C, Todros T, Martinelli P, Floridia M, Ravizza M, and for SIGO-HIV Study Group.

Subjects
0301 basic medicine, Microbiology (medical), Adult, medicine.medical_specialty, 030106 microbiology, Human immunodeficiency virus (HIV), HIV Infections, medicine.disease_cause, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Pregnancy, medicine, Humans, 030212 general & internal medicine, Young adult, Hiv transmission, Delivery complications, Vaginal delivery, business.industry, Obstetrics, Cesarean Section, HIV, Mode of delivery, Delivery, Obstetric, Female, Italy, Viral Load, Obstetric, General Medicine, medicine.disease, Infectious Diseases, Delivery complication, business, Viral load, Delivery
Abstract

PURPOSE: To evaluate the maternal and neonatal safety of vaginal delivery in women with HIV following the implementation of a national protocol in Italy. METHODS: Vaginal delivery was offered to all eligible women who presented antenatally at twelve participating clinical sites. Data collection and definition of outcomes followed the procedures of the National Program on Surveillance on Antiretroviral Treatment in Pregnancy. Pregnancy outcomes were compared according to the mode of delivery, classified as vaginal, elective cesarean (ECS) and non-elective cesarean section (NECS). RESULTS: Among 580 women who delivered between January 2012 and September 2017, 142 (24.5%) had a vaginal delivery, 323 (55.7%) had an ECS and 115 (19.8%) had an NECS. The proportion of vaginal deliveries increased significantly over time, from 18.9% in 2012 to 35.3% in 2017 (p

Published
2019

4. Abacavir/Lamivudine and Tenofovir/Emtricitabine in Pregnant Women with Hiv: Laboratory and Clinical Outcomes in an Observational National Study

Author

Floridia, M., Pinnetti, C., Ravizza, M., Masuelli, G., Personeni, C., Sansone, M., Antoni, A. D., Guaraldi, G., Spinillo, A., Tassis, B., Dalzero, S., Liuzzi, G., Tamburrini, E., Di Lorenzo, F., Sterrantino, G., Meli, M., Campolmi, I., Vichi, F., Del Pin, B., Marocco, R., Mastroianni, C., Mercurio, V. S., Maccabruni, A., Zaramella, M., Mariani, B., 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., Milini, P., Savalli, F., Portelli, V., Sabbatini, F., Francisci, D., Papalini, C., Bernini, L., Grossi, P., Rizzi, L., Bernardon, M., Maso, G., Rizzante, E., Belcaro, C., Meloni, A., Dedoni, M., Ortu, F., Piano, P., Citernesi, A., Vicini, I. B., Luzi, K., Roccio, M., Vimercati, A., Miccolis, A., De Gennaro, A., Guerra, B., Cervi, F., Simonazzi, G., Margarito, E., Capretti, M. G., Marsico, C., Faldella, G., Martinelli, P., Agangi, A., Capone, A., Maruotti, G. M., Tibaldi, C., Trentini, L., Todros, T., Frisina, V., Cetin, I., Brambilla, T., Savasi, V., Giaquinto, C., Fiscon, M., Rubino, E., Franceschetti, L., Badolato, R., Tiso, G. C., Genovese, O., Cafforio, C., Casadei, A. M., Cavaliere, A. F., Cellini, M., Marconi, A. M., Sacchi, V., Ierardi, M., Polizzi, C., Mattei, A., Pirillo, M. F., Amici, R., Galluzzo, C. M., Donnini, S., and Baroncelli, S.

Subjects
0301 basic medicine, HIV Infections, Hemoglobins, 0302 clinical medicine, Abacavir, Anemia, Cholesterol, Emtricitabine, HIV-RNA, Lamivudine, Low birthweight, Pregnancy, Preterm delivery, Tenofovir, immune system diseases, Antiretroviral Therapy, Highly Active, Pharmacology (medical), 030212 general & internal medicine, Pregnancy Outcome, virus diseases, Lipoproteins, LDL, Drug Combinations, Infectious Diseases, Hypertension, RNA, Viral, Female, medicine.drug, Adult, medicine.medical_specialty, Anti-HIV Agents, Pregnancy Trimester, Third, 03 medical and health sciences, Internal medicine, medicine, Humans, AIDS-Associated Nephropathy, Cesarean Section, business.industry, Abacavir/Lamivudine, medicine.disease, 030112 virology, Dideoxynucleosides, CD4 Lymphocyte Count, Pregnancy Complications, HIV-1, Observational study, business
Abstract

Abacavir-lamivudine (ABC/3TC) and tenofovir-emtricitabine (TDF/FTC) represent in the guidelines of several countries, including Italy and United States, the preferred nucleoside/nucleotide backbones of antiretroviral regimens. We assessed their profile in pregnancy using data from a national observational study.Laboratory measures (CD4, HIV-RNA, lipid profile, glucose, hemoglobin, and alanine transferase) and pregnancy outcomes (preterm delivery, low birthweight, nonelective cesarean section, birthweight Z-score, congenital defects, HIV transmission, maternal weight gain, and pregnancy complications) were compared after prenatal exposure to ABC/3TC or TDF/FTC.The study evaluated 913 pregnancies (ABC/3TC: 252; TDF/FTC: 661). At entry in pregnancy, women on TDF/FTC were older (33.6 vs. 32.4 years, P = 0.005), less frequently on treatment (66.9% vs. 80.2%, P0.001), and had lower CD4 counts (475/mm vs. 533/mm, P = 0.003) and higher plasma HIV-RNA levels (2.48 vs. 2.22 log10 copies/mL, P = 0.003). Women on ABC/3TC had more commonly hypertension/nephropathy (5.2% vs. 2.0%, P = 0.013). No major differences were observed in the main pregnancy outcomes and in rates of undetectable HIV-RNA at third trimester. In a subgroup analysis that evaluated at third trimester only cases with regular 3-drug treatment during pregnancy, women on TDF/FTC had lower hemoglobin levels (median: 11.1 vs. 11.8 g/dL, P = 0.002) and women on ABC/3TC had higher levels of total cholesterol (median: 230 vs. 216 mg/dL, P = 0.023) and low-density lipoprotein-cholesterol (133 vs. 111 mg/dL, P = 0.030).In this study, use of TDF/FTC and ABC/3TC in pregnancy was associated with similar pregnancy outcomes and with some differences in laboratory measures that might guide physicians' prescriptions in mothers with hematologic or metabolic risk factors.

Published
2018

5. Pregnant with HIV before age 25: Data from a large national study in Italy, 2001-2016

Author

Floridia, M., Masuelli, G., Tamburrini, E., Cetin, I., Liuzzi, G., Martinelli, Paolo, Guaraldi, G., Spinillo, A., Vimercati, A., Maso, G., Pinnetti, C., Frisina, V., Dalzero, S., Ravizza, M., Di Lorenzo, F., Sterrantino, G., Meli, M., Campolmi, I., Vichi, F., Del Pin, B., Marocco, R., Mastroianni, C., Mercurio, V. S., Maccabruni, A., Zaramella, M., Mariani, Bianca, Nardini, G., Stentarelli, C., Beghetto, B., Antoni, A. M. Degli, Molinari, A., Crisalli, M. P., Donisi, A., Piepoli, M., Cerri, V., Zuccotti, G., Giacomet, V., Coletto, S., Di Nello, F., Madia, C., Placido, G., Milini, P., Savalli, F., Portelli, V., Sabbatini, F., Francisci, D., Angeli, G., Bernini, L., Grossi, P., Rizzi, L., Bernardon, M., Rizzante, E., Belcaro, C., Meloni, Antonio, Dedoni, M., Ortu, F., Piano, Pierluigi, Citernesi, A., Vicini, I. Bordoni, Luzi, K., Roccio, M., Miccolis, A., De Gennaro, A., Guerra, B., Cervi, Filippo, Simonazzi, G., Margarito, E., Capretti, M. G., Marsico, C., Faldella, G., Sansone, M., Agangi, A., Capone, A., Maruotti, G. M., Tibaldi, C., Trentini, L., Todros, T., Brambilla, T., Savasi, V., Personeni, C., Giaquinto, C., Fiscon, M., Rubino, E., Franceschetti, L., Tassis, B., Genovese, O., Cafforio, C., Casadei, A. M., Cavaliere, A. F., Cellini, Matteo, Marconi, A. M., Sacchi, V., Ierardi, M., Polizzi, C., Mattei, A., Pirillo, M. F., Amici, R., Galluzzo, C. M., Donnini, S., Baroncelli, S., Cerioli, A., DE MARTINO, MARIA CRISTINA, Parazzini, F., and Vella, S.

Subjects
Antiretroviral treatment, HIV diagnosis, HIV testing, pregnancy, women's health, medicine.medical_specialty, Pediatrics, Longitudinal study, Adolescent, Epidemiology, Short Report, HIV Infections, Cohort Studies, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Pregnancy, medicine, Odds Ratio, Humans, 030212 general & internal medicine, Young adult, 030219 obstetrics & reproductive medicine, business.industry, Odds ratio, medicine.disease, Female, Italy, Infectious Diseases, Confidence interval, Family planning, business, Cohort study
Abstract

SUMMARYYoung pregnant women with HIV may be at significant risk of unplanned pregnancy, lower treatment coverage, and other adverse pregnancy outcomes. In a large cohort of pregnant women with HIV in Italy, among 2979 pregnancies followed in 2001–2016, 9·0% were in women P< 0·001). Younger women had a lower rate of planned pregnancy (23·2%vs.37·7%, odds ratio (OR) 0·50, 95% confidence interval (CI) 0·36–0·69), were more frequently diagnosed with HIV in pregnancy (46·5%vs.20·9%, OR 3·29, 95% CI 2·54–4·25), and, if already diagnosed with HIV before pregnancy, were less frequently on antiretroviral treatment at conception (vs.99·3%), with no differences in rate of HIV viral suppression at third trimester and adverse pregnancy outcomes. The data show that young women represent a growing proportion of pregnant women with HIV, and are significantly more likely to have unplanned pregnancy, undiagnosed HIV infection, and lower treatment coverage at conception. During pregnancy, antiretroviral treatment, HIV suppression, and pregnancy outcomes are similar compared with older women. Earlier intervention strategies may provide additional benefits in the quality of care for women with HIV.

Published
2017

6. Rate, correlates and outcomes of repeat pregnancy in HIV-infected women

Author

Floridia, M., Tamburrini, E., Masuelli, G., Martinelli, P., Spinillo, A., Liuzzi, G., Vimercati, A., Alberico, S., Maccabruni, A., Pinnetti, C., Frisina, V., Dalzero, S., 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., Vichi, F., Del Pin, B., Pinter, E., Anzalone, E., Marocco, R., Mastroianni, C., Mercurio, V. S., Carocci, A., Grilli, E., 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., 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., Miccolis, A., De Gennaro, A., Guerra, B., Cervi, F., Simonazzi, G., Margarito, E., Capretti, M. G., Marsico, C., Faldella, G., Sansone, M., Agangi, A., Capone, A., Maruotti, M., Tibaldi, C., Trentini, L., Todros, T., Cetin, I., Brambilla, T., Savasi, V., Personeni, C., Giaquinto, C., Fiscon, M., Rubino, E., Bucceri, A., Matrone, R., Scaravelli, G., Genovese, O., Cafforio, C., Tozzi, V., Massetti, P., Casadei, A. M., Cavaliere, A. F., Cellini, M., Castelli Gattinara, G., Marconi, A. M., Sacchi, V., Ierardi, M., 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., Parazzini, F., Vella, S., Floridia, M, Tamburrini, E., Masuelli, G., Martinelli, P., Spinillo, A., Liuzzi, G., Vimercati, A., Alberico, S., Maccabruni, A., Pinnetti, C., Frisina, V., Dalzero, S., Ravizza, M. [, Faldella G., and ]

Subjects
0301 basic medicine, Adult, medicine.medical_specialty, HIV RNA, Anti-HIV Agents, birth weight, HIV, pregnancy, preterm delivery, Health Policy, Infectious Diseases, Pharmacology (medical), Birth weight, Emigrants and Immigrants, HIV Infections, Settore MED/17 - MALATTIE INFETTIVE, Pregnancy, Preterm delivery, CD4 Lymphocyte Count, Female, HIV-1, Humans, Premature Birth, Viral Load, Infant, Low Birth Weight, 03 medical and health sciences, medicine, Obstetrics, business.industry, Low Birth Weight, Infant, Odds ratio, medicine.disease, 030112 virology, Confidence interval, Pregnancy rate, Low birth weight, Premature birth, medicine.symptom, business, Viral load
Abstract

Objectives The aim of the study was to assess the rate, determinants, and outcomes of repeat pregnancies in women with HIV infection. Methods Data from a national study of pregnant women with HIV infection were used. Main outcomes were preterm delivery, low birth weight, CD4 cell count and HIV plasma viral load. Results The rate of repeat pregnancy among 3007 women was 16.2%. Women with a repeat pregnancy were on average younger than those with a single pregnancy (median age 30 vs. 33 years, respectively), more recently diagnosed with HIV infection (median time since diagnosis 25 vs. 51 months, respectively), and more frequently of foreign origin [odds ratio (OR) 1.36; 95% confidence interval (CI) 1.10–1.68], diagnosed with HIV infection in the current pregnancy (OR: 1.69; 95% CI: 1.35–2.11), and at their first pregnancy (OR: 1.33; 95% CI: 1.06–1.66). In women with sequential pregnancies, compared with the first pregnancy, several outcomes showed a significant improvement in the second pregnancy, with a higher rate of antiretroviral treatment at conception (39.0 vs. 65.4%, respectively), better median maternal weight at the start of pregnancy (60 vs. 61 kg, respectively), a higher rate of end-of-pregnancy undetectable HIV RNA (60.7 vs. 71.6%, respectively), a higher median birth weight (2815 vs. 2885 g, respectively), lower rates of preterm delivery (23.0 vs. 17.7%, respectively) and of low birth weight (23.4 vs. 15.4%, respectively), and a higher median CD4 cell count (+47 cells/μL), with almost no clinical progression to Centers for Disease Control and Prevention stage C (CDC-C) HIV disease (0.3%). The second pregnancy was significantly more likely to end in voluntary termination than the first pregnancy (11.4 vs. 6.1%, respectively). Conclusions Younger and foreign women were more likely to have a repeat pregnancy; in women with sequential pregnancies, the second pregnancy was characterized by a significant improvement in several outcomes, suggesting that women with HIV infection who desire multiple children may proceed safely and confidently with subsequent pregnancies.

Published
2016

7. Good prenatal detection rate of major birth defects in HIV-infected pregnant women in Italy

Author

Floridia, M, Mastroiacovo, P., Ravizza, M., Todros, T., Chiadò Fiorio Tin, M., Marconi, A. M., Cetin, I., Maruotti, G. M., Liuzzi, G., Pinnetti, C., Degli Antoni, A., Spinillo, A., Guerra, B., Tamburrini, E., Floridia, 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., 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, Daniela, 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., De Gennaro, A., Cervi, F., Puccetti, C., Margarito, E., Contoli, M., Capretti, M. G., Marsico, C., Faldella, G., Sansone, M., Martinelli, P., Agangi, A., Capone, A., Tibaldi, C., Trentini, L., Masuelli, G., Frisina, V., Brambilla, T., Savasi, V., Personeni, C., Giaquinto, C., Fiscon, M., Rinaldi, R., Rubino, E., Bucceri, A., Matrone, R., Scaravelli, G., Fundarò, 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., Ierardi, M., 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., Parazzini, F., and Vella, S.

Subjects
Adult, Infectious, Obstetrics and Gynecology, HIV Infections, Congenital Abnormalities, Pregnancy Complications, Italy, Pregnancy, Humans, Female, Pregnancy Complications, Infectious, Genetics (clinical)
Published
2015

8. 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

9. 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

10. 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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