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

2013; Oxford University Press; Volume: 69; Issue: 5 Linguagem: Inglês

10.1093/jac/dkt497

1460-2091

Marco Floridia, M. 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, Marco Floridia, M. Ravizza, Enrica Tamburrini, M. Ravizza, Enrica Tamburrini, Flor Marlene Luna Victoria Mori, P Ortolani, Ernesto Renato Dalle Nogare, Francesco Di Lorenzo, Gaetana Sterrantino, Massimo Meli, S. Polemi, J. Nocentini, Massimo Baldini, G. Montorzi, Marcello Mazzetti, Pier Giorgio Rogasi, Beatrice Borchi, Francesca Vichi, B. Del Pin, Elena Pinter, E. Anzalone, R. Marocco, Claudio Maria Mastroianni, V. S. Mercurio, A. Carocci, Elisabetta Grilli, Anna Maccabruni, Marco Zaramella, B Mariani, G. Natalini Raponi, Giovanni Guaraldi, Giulia Nardini, Chiara Stentarelli, Barbara Beghetto, Anna Maria Degli Antoni, A. Molinari, M Crisalli, Alessandra Donisi, Massimo Piepoli, V. Cerri, Gian Vincenzo Zuccotti, Vania Giacomet, Valentina Fabiano, G. Placido, A Vivarelli, P. Castelli, F. Savalli, V. Portelli, Francesca Sabbatini, Daniela Francisci, Luigi F. Bernini, Paolo Grossi, Laura Rizzi, Salvatore Alberico, Gianpaolo Maso, M. Airoud, G. Soppelsa, Alessandra Meloni, M. Dedoni, C. Cuboni, Francesco Perna, P Piano, A. Citernesi, I. Vicini, Kety Luzi, Arsenio Spinillo, Marianna Roccio, Antonella Vimercati, A. Miccolis, Emma Bassi, B. Guerra, Francesca Cervi, Chiara Puccetti, Paola Murano, M. Contoli, Maria Grazia Capretti, Concetta Marsico, Giacomo Faldella, Matilde Sansone, Pasquale Martinelli, A. Agangi, Cecilia Tibaldi, L. Trentini, Tullia Todros, Giulia Masuelli, Valentina Frisina, Irene Cetin, Tatiana Brambilla, Valeria Savasi, C. Personeni, Carlo Giaquinto, Marta Fiscon, Rita Rinaldi, Elena C. Rubino, A. Bucceri, R. Matrone, Giulia Scaravelli, C. Fundarò, Orazio Genovese, C. Cafforio, Carmela Pinnetti, Giuseppina Liuzzi, Valerio Tozzi, Anna Paola Massetti, A. M. Casadei, Anna Franca Cavaliere, Vincent N. Finelli, Monica Cellini, Guido Castelli Gattinara, Anna Maria Marconi, Serena Dalzero, V. Sacchi, Antonella De Pirro, C. Polizzi, Adriana Mattei, Maria Franca Pirillo, Roberta Amici, Clementina Maria Galluzzo, S. Donnini, Silvia Baroncelli, Marco Floridia, Mario Regazzi, P. Villani, Maria Cusato, Andrea Cerioli, Matteo Martino, P Mastroiacovo, Mauro Moroni, Fabio Parazzini, Enrica Tamburrini, Stefano Vella, Pasquale Martinelli, M. Ravizza,

Pregnancy and Medication Impact

Atazanavir and lopinavir represent the main HIV protease inhibitors recommended in pregnancy, but comparative data in pregnant women are limited.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.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).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.