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

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

doi:10.1093/jac/dkt497

Cited by 14 publications

(12 citation statements)

References 28 publications

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“…This is the second study to compare pregnancy outcomes between women receiving ATV/r and those receiving LPV/r during pregnancy. The first, by Floridia et al ., also produced results consistent with ATV/r and LPV/r having similar safety and activity in pregnancy [26]. The two ART regimens were equally successful in preventing MTCT, with a transmission rate of 0.5%, consistent with national data from the UK and Ireland reported by the National Study of HIV in Pregnancy and Childhood [27].…”

Section: Discussionsupporting

confidence: 78%

Lopinavir and atazanavir in pregnancy: comparable infant outcomes, virological efficacies and preterm delivery rates

et al. 2015

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Section: Discussionsupporting

confidence: 78%

Lopinavir and atazanavir in pregnancy: comparable infant outcomes, virological efficacies and preterm delivery rates

et al. 2015

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“…Our findings do suggest, however, that atazanavir may be a useful option to consider amongst women intolerant of other regimens. This is in line with the findings of a recently published observational analysis which suggests that atazanavir-based therapy is comparable to lopinavir-based therapy in terms of safety and efficacy [ 18 ].…”

Section: Discussionsupporting

confidence: 90%

Antenatal Atazanavir: A Retrospective Analysis of Pregnancies Exposed to Atazanavir

Samuel

Bradshaw

Perry

et al. 2014

Infectious Diseases in Obstetrics and Gynecology

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Introduction. There are few data regarding the tolerability, safety, or efficacy of antenatal atazanavir. We report our clinical experience of atazanavir use in pregnancy. Methods. A retrospective medical records review of atazanavir-exposed pregnancies in 12 London centres between 2004 and 2010. Results. There were 145 pregnancies in 135 women: 89 conceived whilst taking atazanavir-based combination antiretroviral therapy (cART), “preconception” atazanavir exposure; 27 started atazanavir-based cART as “first-line” during the pregnancy; and 29 “switched” to an atazanavir-based regimen from another cART regimen during pregnancy. Gastrointestinal intolerance requiring atazanavir cessation occurred in five pregnancies. Self-limiting, new-onset transaminitis was most common in first-line use, occurring in 11.0%. Atazanavir was commenced in five switch pregnancies in the presence of transaminitis, two of which discontinued atazanavir with persistent transaminitis. HIV-VL < 50 copies/mL was achieved in 89.3% preconception, 56.5% first-line, and 72.0% switch exposures. Singleton preterm delivery (<37 weeks) occurred in 11.7% preconception, 9.1% first-line, and 7.7% switch exposures. Four infants required phototherapy. There was one mother-to-child transmission in a poorly adherent woman. Conclusions. These data suggest that atazanavir is well tolerated and can be safely prescribed as a component of combination antiretroviral therapy in pregnancy.

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“…This finding was supported by studies included in this review that compared PI use to other ART regimens [26, 28, 30]. The highest serum lipid concentrations found in this review were derived from studies that used first generation PI-based ART regimens [27, 29, 30, 33, 37, 40, 42], while the lower values did not use PIs, or used second generation PIs [27, 30, 31]. …”

Section: Discussionsupporting

confidence: 74%

“…No additional articles were identified through reference checking. Four studies using the same patient database were identified, [24–27] of which the two most recent studies were used [26, 27]. After analysing the full-texts, 17 articles were included in this review.…”

Section: Resultsmentioning

confidence: 99%

The association between HIV (treatment), pregnancy serum lipid concentrations and pregnancy outcomes: a systematic review

et al. 2017

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BackgroundObserved adverse effects of antiretroviral therapy (ART) on the lipid profile could be of significance in pregnancy. This systematic review aims to summarize studies that investigated the association between HIV, ART and serum lipids during pregnancy and adverse pregnancy outcomes.MethodsA systematic search was conducted in five electronic databases to obtain articles that measured serum lipid concentrations or the incidence of dyslipidaemia in HIV-infected pregnant women. Included articles were assessed for quality according to the Cochrane Risk of Bias Tool. The extracted data was analysed through descriptive analysis.ResultsOf the 1264 articles screened, 17 articles were included in this review; eleven reported the incidence of dyslipidaemia, and twelve on maternal serum lipid concentrations under the influence of HIV-infection and ART. No articles reported pregnancy outcomes in relation to serum lipids. Articles were of acceptable quality, but heterogenic in methods and study design. Lipid levels in HIV-infected women increased 1.5–3 fold over the trimesters of pregnancy, and remained within the physiological reference range. The percentage of women with dyslipidaemia was variable between the studies [0–88.9%] and highest in the groups on first generation protease inhibitors and for women on ART at conception.ConclusionThis systematic review observed physiologic concentrations of serum lipids for HIV-infected women receiving ART during pregnancy. Serum lipids were increased in users of first generation protease inhibitors and for those on treatment at conception. There was no information available about pregnancy outcomes. Future studies are needed which include HIV-uninfected control groups, control for potential confounders, and overcome limitations associated with included studies.Electronic supplementary materialThe online version of this article (doi:10.1186/s12879-017-2581-8) contains supplementary material, which is available to authorized users.

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

Cited by 14 publications

References 28 publications

Lopinavir and atazanavir in pregnancy: comparable infant outcomes, virological efficacies and preterm delivery rates

Lopinavir and atazanavir in pregnancy: comparable infant outcomes, virological efficacies and preterm delivery rates

Antenatal Atazanavir: A Retrospective Analysis of Pregnancies Exposed to Atazanavir

The association between HIV (treatment), pregnancy serum lipid concentrations and pregnancy outcomes: a systematic review

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