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1. Weight Gain during Pregnancy in Women with HIV Receiving Different Antiretroviral Regimens

Author

Floridia, M., Masuelli, G., Tassis, B., Franceschetti, L., Savasi, V. M., Spinillo, A., Tamburrini, E., Guaraldi, G., Dalzero, S., Sansone, M., Chiodo, A., Degli Antoni, A. M., Pinnetti, C., Liuzzi, G., Ravizza, M., Di Lorenzo, F., Sterrantino, G., Meli, M., Campolmi, I., Vichi, F., Del Pin, B., Marocco, R., Mastroianni, C., Mercurio, V. S., Zanaboni, D., Nardini, G., Stentarelli, C., Beghetto, B., Molinari, A., Crisalli, M. P., Donisi, A., Ruggieri, A., Piepoli, M., Cerri, V., Zuccotti, G., Giacomet, V., Paradiso, L., Forlanini, F., Longoni, E., Placido, G., Milini, P., Savalli, F., Portelli, V., Sabbatini, F., Francisci, D., Papalini, C., Bernini, L., Grossi, P., Rizzi, L., Maso, G., Bernardon, M., Bussolaro, S., della Pieta, I., Sorz, A., Meloni, A., Dedoni, M., Ortu, F., Piano, P., Citernesi, A., Vicini, I. B., Luzi, K., Roccio, M., Vimercati, A., Calabretti, D., Gigante, S., 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., Cardellicchio, E., Giaquinto, C., Fiscon, M., Rubino, E., Badolato, R., Forleo, M. A., Ruggiero, M., Genovese, O., Cafforio, C., Casadei, A. M., Cavaliere, A. F., Cellini, M., Marconi, A. M., Ierardi, M., Simonetti, S. C., Alfieri, N., Agrati, S., Polizzi, C., Mattei, A., Pirillo, M. F., Amici, R., Galluzzo, C. M., Donnini, S., Baroncelli, S., Cerioli, A., de Martino, M., Parazzini, F., and Vella, S.

Subjects
medicine.medical_specialty, Multivariate analysis, Anti-HIV Agents, Integrase inhibitor, HIV Infections, Overweight, Weight Gain, Cohort Studies, Pregnancy, Internal medicine, medicine, Humans, Pharmacology (medical), Settore MED/38 - Pediatria Generale e Specialistica, Pharmacology, business.industry, Weight change, Odds ratio, medicine.disease, Obesity, Infectious Diseases, Reverse Transcriptase Inhibitors, Female, medicine.symptom, business, Weight gain
Abstract

Background No published studies have evaluated in pregnant women with HIV weight gain with different antiretroviral drug classes. Methods Data from a national cohort study were used. We compared absolute weight gain and occurrence of excessive weight gain in women with HIV who received during pregnancy integrase inhibitors (INSTI), protease inhibitors (PI), or non-nucleoside reverse transcriptase inhibitors (NNRTI). Excessive weight gain was defined according to the Institute of Medicine recommendations. Possible predictors of weight gain were assessed using univariate and multivariate analyses. Results Among 273 cases (PI: 191, NNRTI: 43, INSTI: 39), the mean weight increase was 11.3 kg, and 25.4% of the mothers had an excessive weight increase. No significant differences were found among the three treatment groups for absolute weight increase, occurrence of excessive weight gain, infant birthweight, and other pregnancy and laboratory outcomes. The comparisons of individual drugs, although based on a limited number of cases, suggested no major differences. A significant positive correlation was found between weight gain and CD4+ T-cell increase during pregnancy. In multivariate analyses, drug class and nucleoside backbone were not associated with absolute or excessive weight increase. Excessive weight increase was significantly associated with week of delivery (adjusted odds ratio: 1.74, 95% CI 1.15, 2.63), obesity (5.21, 95% CI 1.85, 14.64), overweight (7.95, 95% CI 3.26, 19.39), recent substance use (5.96, 95% CI 1.13, 31.40) and fasting 2nd trimester hyperglycaemia (3.94, 95% CI 1.14, 13.65). Conclusions No significant differences in absolute weight change or occurrence of excessive weight gain were found among women with HIV who received during pregnancy different classes of antiretroviral drugs.

Published
2021

2. CD4/CD8 ratio in pregnant women with HIV and its association with pregnancy outcome: data from a national study in Italy

Author

Floridia, M., Pinnetti, C., Masuelli, G., Spinillo, A., Savasi, V. M., Liuzzi, G., Degli Antoni, A. M., Sansone, M., Guaraldi, G., Dalzero, S., Maso, G., Francisci, D., Sterrantino, G., Ravizza, M., Tamburrini, E., Di Lorenzo, F., Meli, M., Campolmi, I., Vichi, F., Del Pin, B., Marocco, R., Mastroianni, C., Mercurio, V. S., Zanaboni, D., Nardini, G., Stentarelli, C., Beghetto, B., Molinari, A., Crisalli, M. P., Donisi, A., Ruggieri, A., Piepoli, M., Cerri, V., Zuccotti, G., Giacomet, V., Paradiso, L., Forlanini, F., Longoni, E., Placido, G., Milini, P., Savalli, F., Sabbatini, F., Papalini, C., Bernini, L., Grossi, P., Rizzi, L., Portelli, V., Bernardon, M., Bussolaro, S., Della Pieta, I., Sorz, A., Meloni, A., Chiodo, A., Dedoni, M., Ortu, F., Piano, P., Citernesi, A., Bordoni Vicini, I., Luzi, K., Roccio, M., Vimercati, A., Calabretti, D., Gigante, S., 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., Savasi, V., Cardellicchio, E., Giaquinto, C., Fiscon, M., Rubino, E., Franceschetti, L., Badolato, R., Forleo, M. A., Tassis, B., Ruggiero, M., Genovese, O., Cafforio, C., Casadei, A. M., Cavaliere, A. F., Cellini, M., Marconi, A. M., Ierardi, M., Simonetti, S. C., Alfieri, N., Agrati, S., Polizzi, C., Mattei, A., Pirillo, M. F., Amici, R., Galluzzo, C. M., Donnini, S., Baroncelli, S., Cerioli, A., De Martino, M., Parazzini, F., Vella, S., Floridia M., Pinnetti C., Masuelli G., Spinillo A., Savasi V.M., Liuzzi G., Degli Antoni A.M., Sansone M., Guaraldi G., Dalzero S., Maso G., Francisci D., Sterrantino G., Ravizza M., Tamburrini E., Di Lorenzo F., Meli M., Campolmi I., Vichi F., Del Pin B., Marocco R., Mastroianni C., Mercurio V.S., Zanaboni D., Nardini G., Stentarelli C., Beghetto B., Molinari A., Crisalli M.P., Donisi A., Ruggieri A., Piepoli M., Cerri V., Zuccotti G., Giacomet V., Paradiso L., Forlanini F., Longoni E., Placido G., Milini P., Savalli F., Sabbatini F., Papalini C., Bernini L., Grossi P., Rizzi L., Portelli V., Bernardon M., Bussolaro S., Della Pieta I., Sorz A., Meloni A., Chiodo A., Dedoni M., Ortu F., Piano P., Citernesi A., Bordoni Vicini I., Luzi K., Roccio M., Vimercati A., Calabretti D., Gigante S., 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., Savasi V., Cardellicchio E., Giaquinto C., Fiscon M., Rubino E., Franceschetti L., Badolato R., Forleo M.A., Tassis B., Ruggiero M., Genovese O., Cafforio C., Casadei A.M., Cavaliere A.F., Cellini M., Marconi A.M., Ierardi M., Simonetti S.C., Alfieri N., Agrati S., Polizzi C., Mattei A., Pirillo M.F., Amici R., Galluzzo C.M., Donnini S., Baroncelli S., Cerioli A., De Martino M., Parazzini F., and Vella S.

Subjects
0301 basic medicine, Microbiology (medical), medicine.medical_specialty, Multivariate analysis, 030106 microbiology, CD4-CD8 Ratio, Human immunodeficiency virus (HIV), HIV Infections, CD8-Positive T-Lymphocytes, medicine.disease_cause, 03 medical and health sciences, 0302 clinical medicine, CD4/CD8 ratio, Pregnancy, CD4, CD8, HIV suppression, Preterm delivery, Female, Humans, Infant, Newborn, Pregnancy Outcome, Pregnant Women, Viral Load, Pregnancy Complications, Infectious, medicine, 030212 general & internal medicine, business.industry, Obstetrics, Infectious, Infant, General Medicine, Newborn, medicine.disease, Pregnancy Complications, Infectious Diseases, Increased risk, National study, Outcome data, business
Abstract

Purpose: To evaluate associations between CD4/CD8 ratio and pregnancy outcomes in women with HIV. Methods: We evaluated, in a national study of pregnant women with HIV receiving antiretroviral treatment (ART), values of CD4/CD8 ratio at entry in pregnancy, changes between first and third trimester, and possible associations with preterm delivery, low birthweight, and HIV-RNA < 50 copies/ml at third trimester in univariate and multivariate analyses. Results: Among 934 women, 536 (57.4%) were already on ART at conception. CD4/CD8 ratio (baseline value 0.570) increased significantly between the first and third trimesters, particularly in women who started ART in pregnancy (+ 0.163, vs. + 0.036 in women already on treatment). The rate of CD4/CD8 ratio normalization, defined by achieving a ratio ≥ 1 at the third trimester, was 13.2%. In multivariable analyses, women who entered pregnancy with a CD4/CD8 ratio < 0.3, compared to women with ratio ≥ 1, were almost four-times less likely to have third-trimester HIV-RNA < 50 copies/ml (AOR 0.258, 95%CI 0.111–0.601), and more than twice as likely to have preterm delivery (AOR 2.379, 95%CI 1.082–5.232). For preterm delivery, also a baseline CD4/CD8 ratio between 0.3 and 0.45 was significantly associated with an increased risk (AOR: 3.415, 95%CI 1.690–6.900). Conclusion: We described for the first time independent associations of low CD4/CD8 ratio with preterm delivery and HIV-RNA suppression.

Published
2021

3. 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

4. Dynamics and phylogenetic relationships of HIV-1 transmitted drug resistance according to subtype in Italy over the years 2000-14

Author

Fabeni, L., Alteri, C., Di Carlo, D., Orchi, N., Carioti, L., Bertoli, A., Gori, C., Forbici, F., Continenza, F., Maffongelli, G., Pinnetti, C., Vergori, A., Mondi, A., Ammassari, A., Borghi, V., Giuliani, M., De Carli, G., Pittalis, S., Grisetti, S., Pennica, Alfredo, Mastroianni, Claudio Maria, Montella, F., Cristaudo, A., Mussini, C., Girardi, E., Andreoni, M., Antinori, A., Ceccherini silberstein, F., Perno, C. F., Santoro, M. M., Capobianchi, M. R., Navarra, A., Palummieri, A., Abbate, I., D'Arrigo, R., Fusco, F. M., Mariano, A., Nicastri, E., Nurra, G., Puro, V., Sampaolesi, A., Sciarrone, M. R., Scognamiglio, P., Selleri, M., Sias, C., Zaccarelli, M., Di Carlo, A., Vullo, Vincenzo, Falciano, Mario, Pennica, A., Errigo, F., Gattari, P., Spizzichino, L., Schito, S., Sarmati, L., Buonomini, A. R., Cerva, C., Mastroianni, C., Lichtner, Miriam, Mercurio, V. S., Anzalone, E., Pitorri, A., Caterini, A., and Aviani Barbacci, S.

Subjects
0301 basic medicine, Microbiology (medical), Adult, Male, medicine.medical_specialty, Genotype, Anti-HIV Agents, Population, Human immunodeficiency virus (HIV), HIV Infections, Drug resistance, Biology, Molecular Dynamics Simulation, medicine.disease_cause, law.invention, Men who have sex with men, 03 medical and health sciences, pharmacology, pharmacology (medical), infectious diseases, HIV Protease, law, Internal medicine, Epidemiology, Drug Resistance, Viral, medicine, Prevalence, Humans, Pharmacology (medical), education, Phylogeny, Pharmacology, education.field_of_study, Phylogenetic tree, Bayes Theorem, Middle Aged, Settore MED/07 - Microbiologia e Microbiologia Clinica, Virology, HIV Reverse Transcriptase, 030104 developmental biology, Transmission (mechanics), Infectious Diseases, Italy, HIV-1, Female
Abstract

Background Transmitted drug-resistance (TDR) remains a critical aspect for the management of HIV-1-infected individuals. Thus, studying the dynamics of TDR is crucial to optimize HIV care. Methods In total, 4323 HIV-1 protease/reverse-transcriptase sequences from drug-naive individuals diagnosed in north and central Italy between 2000 and 2014 were analysed. TDR was evaluated over time. Maximum-likelihood and Bayesian phylogenetic trees with bootstrap and Bayesian-probability supports defined transmission clusters. Results Most individuals were males (80.2%) and Italian (72.1%), with a median (IQR) age of 37 (30-45) years. MSM accounted for 42.2% of cases, followed by heterosexuals (36.4%). Non-B subtype infections accounted for 30.8% of the overall population and increased over time (

Published
2017

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. 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

8. The potential impact of routine testing of individuals with HIV indicator diseases in order to prevent late HIV diagnosis

Author

Scognamiglio, Paola, Chiaradia, Giacomina, De Carli, Gabriella, Giuliani, Massimo, Mastroianni, Claudio Maria, Aviani Barbacci, Stefano, Buonomini, Anna R., Grisetti, Susanna, Sampaolesi, Alessandro, Corpolongo, Angela, Orchi, Nicoletta, Puro, Vincenzo, Ippolito, Giuseppe, Girardi, Enrico, Girardi, E., Orchi, N., Angeletti, C., Balzano, R., Elia, P., Navarra, A., Nurra, G., Palummieri, A., Alba, L., Ammassari, A., Antinori, A., Baldini, F., Bellagamba, R., Bevilacqua, N., Boumis, E., Capobianchi, M. R., Cerilli, S., Chinello, P., Corpolongo, A., D'Arrigo, R., De Carli, G., Null, D'Offizig, Forbici, F., Fusco, F. M., Galati, V., Ghirga, P., Giancola, L., Gori, C., Grisetti, S., Lauria, F. N., Liuzzi, G., Marconi, P., Mariano, A., Narciso, P., Nicastri, E., Noto, P., Palmieri, A. F., Perno, C. F., Petrosillo, N., Pisapia, R., Pittalis, S., Puro, V., Sampaolesi, A., Scognamiglio, P., Sciarrone, M. R., Selleri, M., Sias, C., Topino, S., Tozzi, V., Vincenzi, L., Visco Comandini, U., Vlassi, C., Zaccarelli, M., Zaniratti, S., Vullo, Vincenzo, Falciano, Mario, Andreoni, M., Sarmati, L., Buonomini, A. R., Di Carlo, A., Giuliani, M., Brancatella, R., Maggi, T., Errico, F., De Filippis, A., Di Bacco, R., Schito, S., Gattari, P., Spizzichino, L., Francesconi, M., Pace, G., Gallo, I., Anzalone, E., Tacconi, L., Mercurio, V. S., Lichtner, Miriam, Natalini Raponi, G., Pitorri, A., Caterini, A., and Aviani Barbacci, S.

Subjects
Adult, Male, Pediatrics, medicine.medical_specialty, Delayed Diagnosis, Tuberculosis, Adolescent, HIV Infections, Disease, HIV testing, Indicator diseases, Late diagnosis, Sexually transmitted infections, Aged, Aged, 80 and over, CD4 Lymphocyte Count, Diagnostic Tests, Routine, Female, Humans, Italy, Middle Aged, Retrospective Studies, Risk Factors, Young Adult, Infectious Diseases, Medical microbiology, Diagnostic Tests, 80 and over, Medicine, Routine, Young adult, business.industry, virus diseases, Seborrhoeic dermatitis, Retrospective cohort study, medicine.disease, Settore MED/17, Surgery, Population study, business, Viral hepatitis, Research Article
Abstract

Background The aim of our work was to evaluate the potential impact of the European policy of testing for HIV all individuals presenting with an indicator disease, to prevent late diagnosis of HIV. We report on a retrospective analysis among individuals diagnosed with HIV to assess whether a history of certain diseases prior to HIV diagnosis was associated with the chance of presenting late for care, and to estimate the proportion of individuals presenting late who could have been diagnosed earlier if tested when the indicator disease was diagnosed. Methods We studied a large cohort of individuals newly diagnosed with HIV infection in 13 counselling and testing sites in the Lazio Region, Italy (01/01/2004-30/04/2009). Considered indicator diseases were: viral hepatitis infection (HBV/HCV), sexually transmitted infections, seborrhoeic dermatitis and tuberculosis. Logistic regression analysis was performed to estimate association of occurrence of at least one indicator disease with late HIV diagnosis. Results In our analysis, the prevalence of late HIV diagnosis was 51.3% (890/1735). Individuals reporting at least one indicator disease before HIV diagnosis (29% of the study population) had a lower risk of late diagnosis (OR = 0.7; 95%CI: 0.5-0.8) compared to those who did not report a previous indicator disease. 52/890 (5.8%) late presenters were probably already infected at the time the indicator disease was diagnosed, a median of 22.6 months before HIV diagnosis. Conclusions Our data suggest that testing for HIV following diagnosis of an indicator disease significantly decreases the probability of late HIV diagnosis. Moreover, for 5.5% of late HIV presenters, diagnosis could have been anticipated if they had been tested when an HIV indicator disease was diagnosed. However, this strategy for enhancing early HIV diagnosis needs to be complemented by client-centred interventions that aim to increase awareness in people who do not perceive themselves as being at risk for HIV.

Published
2013
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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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