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