Abacavir/lamivudine and tenofovir/emtricitabine in pregnant women with HIV: Laboratory and clinical outcomes in an observational national study

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.; Baroncelli, S.

doi:10.1097/QAI.0000000000001640

Background: 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. Methods: 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. Results: 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%, P < 0.001), and had lower CD4 counts (475/mm3 vs. 533/mm3, 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). Conclusions: 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.

Abacavir/lamivudine and tenofovir/emtricitabine in pregnant women with HIV: Laboratory and clinical outcomes in an observational national study / M. Floridia, C. Pinnetti, M. Ravizza, G. Masuelli, C. Personeni, M. Sansone, A.D. Antoni, G. Guaraldi, A. Spinillo, B. Tassis, S. Dalzero, G. Liuzzi, E. Tamburrini, F. Di Lorenzo, G. Sterrantino, M. Meli, I. Campolmi, F. Vichi, B. Del Pin, R. Marocco, C. Mastroianni, V.S. Mercurio, A. Maccabruni, M. Zaramella, B. Mariani, G. Nardini, C. Stentarelli, B. Beghetto, A.M. Degli Antoni, A. Molinari, M.P. Crisalli, A. Donisi, M. Piepoli, V. Cerri, G. Zuccotti, V. Giacomet, S. Coletto, F. Di Nello, C. Madia, G. Placido, P. Milini, F. Savalli, V. Portelli, F. Sabbatini, D. Francisci, C. Papalini, L. Bernini, P. Grossi, L. Rizzi, M. Bernardon, G. Maso, E. Rizzante, C. Belcaro, A. Meloni, M. Dedoni, F. Ortu, P. Piano, A. Citernesi, I.B. Vicini, K. Luzi, M. Roccio, A. Vimercati, A. Miccolis, A. De Gennaro, B. Guerra, F. Cervi, G. Simonazzi, E. Margarito, M.G. Capretti, C. Marsico, G. Faldella, P. Martinelli, A. Agangi, A. Capone, G.M. Maruotti, C. Tibaldi, L. Trentini, T. Todros, V. Frisina, I. Cetin, T. Brambilla, V. Savasi, C. Giaquinto, M. Fiscon, E. Rubino, L. Franceschetti, R. Badolato, G.C. Tiso, O. Genovese, C. Cafforio, A.M. Casadei, A.F. Cavaliere, M. Cellini, A.M. Marconi, V. Sacchi, M. Ierardi, C. Polizzi, A. Mattei, M.F. Pirillo, R. Amici, C.M. Galluzzo, S. Donnini, S. Baroncelli. - In: JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES. - ISSN 1525-4135. - 78:1(2018 May 01), pp. 99-104. [10.1097/QAI.0000000000001640]