A, .

Agangi, A.

Airoud, M.

Alberico, S.

Alberico, Salvatore

Amici, R.

Antoni, for the Italian Group on Surveillance on Antiretroviral Treatment in Pregnancya ￼Degli

Baroncelli, S.

Bassi, E.

Bernini, L.

Brambilla, T.

Bucceri, A.

Cafforio, C.

Capretti, M. G.

Casadei, A. M.

Castelli, P.

Cavaliere, A. F.

Cellini, M.

Cerioli, M. C.u.s.a.t.o. A.

Cerri, V.

Cervi, F.

Cetin, I.

Citernesi, A.

Contoli, M.

Crisalli, M. P.

Cuboni, C.

Dalzero, S.

Dalzero, Serena

Dedoni, M.

Donisi, A.

Donnini, S.

Fabiano, V.

Faldella, G.

Finelli, V.

Fiscon, M.

Floridia, Marco

Francisci, D.

Frisina, V.

Fundarò, C.

Galluzzo, C. M.

Gattinara, G. Castelli

Genovese, O.

Gerald, Giovanni

Giacomet, V.

Giaquinto, C.

Grossi, P.

Guerra, B.

Liuzzi, G.

Liuzzi, Giuseppina

Luzi, K.

Marconi, A. M.

Margarito, E.

Marsico, C.

Martinelli, P.

Maruotti, G. M.

Maso, G.

Massetti, P.

Masuelli, G.

Matrone, R.

Mattei, A.

Meloni, A.

Meloni, Alessandra

Miccolis,

Molinari, A.

Molinari, Anna Macaroni

Ortu, F.

Personeni, C.

Piano, P.

Piepoli, M.

Pinnetti, C.

Pinnetti, Carmela

Pirillo, M. F.

Pirro, A. De

Placido, G.

Polizzi, C.

Portelli, V.

Puccetti, C.

Ravizza, Marina

Rinaldi, R.

Rizzi, L.

Rizzi, Laura

Roccio, M.

Rubino, E.

Sabbatini, F.

Sacchi, V.

Sansone, M.

Savalli, F.

Savasi, V.

Scaravelli, G.

Soppelsa, G.

Spinillo, A.

Tamburrini, Enrica

Tibaldi, C.

Tibaldi, Cecilia

Todros, T.

Tozzi, V.

Trentini, L.

Vicini, I. Bordoni

Villani, M. F.l.o.r.i.d.i.a. P.

VIMERCATI, antonella

English

Zuccotti, G.

Vivarelli, A.

Fundarò, C.

Archivio istituzionale della ricerca - Università di Bari

1 J A N U A R YCorrespondenceIs “Option B+” Also BeingAdopted in Pregnant Womenin High-Income Countries?Temporal Trends From aNational Study in ItalyTO THE EDITOR—The World Health Orga-nization currently recommends lifelongcontinuation of antiretroviral therapy(ART) after delivery (“Option B+”) asan option for human immunodeficiencyvirus (HIV)-infected women startingcombination ART in pregnancy [1].This approach is therefore increasinglybeing implemented in African countrieswith high HIV disease burden [2–4] andevaluated in economic studies [5, 6].The advantages of this strategy includeease of implementation, no need for CD4and HIV RNA testing, possibility to initi-ate immediately treatment, potential bet-ter retention in care, and reduced risk ofsexual HIV transmission to uninfectedmale partners [7].It is not known to which extent a sim-ilar approach is being adopted in high-income countries, where, despite a lowerHIV disease burden and fewer economicconstraints, some of the benefits may bethe same. To explore this issue, we useddata from the Italian National Programon Surveillance on Antiretroviral Treat-ment in Pregnancy [8], a national obser-vational study of pregnant women withHIV established in 2001, where therapeu-tic decisions are taken by the individualphysicians. We considered all pregnan-cies ending in live births among antire-troviral-naive women with no indicationto ART for their own health (defined bysymptomatic HIV disease or CD4 count<350 cells/µL), who started treatment inpregnancy by 32 weeks of gestation andhad available information on treatmentstatus after delivery.Quantitative data were compared byMann–Whitney U test and the temporaltrends were analyzed using the χ2 testfor trend. P values <.05 were consideredsignificant. All analyses were performedusing SPSS software, version 22.0 (IBM,Somers, New York). Ethics approval wasobtained on 28 September 2001 from theEthics Committee of the I.N.M.I. LazzaroSpallanzani in Rome (reference delibera-tion number 578).Overall, between 2002 and 2012, 263pregnancies met the above eligibility cri-teria. In most of them (159/263 [60.5%]),ART was continued after delivery, eitherunchanged (150/159 [94.3%]) or withchanges (9/159 [5.7%]). The proportionof women continuing treatment afterdelivery increased significantly over theFigure 1. Temporal trends in continuation of treatment after delivery, 2002–2012. Continued with changes (1 or more changes): switch from zidovudine +lamivudine (3TC) to tenofovir (TDF) + emtricitabine (FTC), 5; switch between different protease inhibitors, 3; intensification (3TC or TDF added), 3; switchfrom nevirapine- or lopinavir/ritonavir-based regimens to TDF + FTC + efavirenz, 2.CORRESPONDENCE • CID 2015:60 (1 January) • 159 at Istituto Superiore di Sanita on December 12, 2014http://cid.oxfordjournals.org/Downloaded from period considered, from 43.2% in 2002 to70.0% in 2012 (P < .001; Figure 1). Suchchanges were not accompanied by sig-nificant temporal changes in other condi-tions that could have affected the decisionto maintain treatment, such as presenceof an HIV-uninfected partner (overallproportion 2002–2012: 57.6%; P for tem-poral trend = .808), hepatitis virus B or C(overall proportion: 8.4% and 13.5%,respectively; P = .721 and .483, respec-tively), or CD4 between 350 cells/µLand 500 cells/µL (overall proportion:50.3; P = .823).Follow-up data on CD4 count andHIV RNA copy number were availablefor 118 and 114 women, respectively, at1 year after delivery and for 77 and 74women, respectively, at 2 years after de-livery. One year after delivery, medianCD4 counts were similar in the 2 groups(continuers: 672/µL [interquartile range{IQR}, 504–840]; discontinuers: 646/µL[IQR, 508–825], P = .895), but medianHIV RNA copy number was higher indiscontinuers (3100/mL [IQR, 170–17 370]) than in continuers (49/mL[IQR, 40–1207], P < .001). At 2 years,the discontinuers had significantly fewerCD4 cells (578/µL [IQR, 454–674] vs686/µL [IQR, 530–1005], P = .010) andsignificantly higher HIV RNA levels(3191 copies/mL [IQR, 157–32 434] vs49 copies/mL [IQR, 40–599], P < .001).No clinical progression of HIV diseasewas observed in the 2 groups.Our study, based on a national sam-ple from a high-income country, showsthat an increasing proportion of HIV-infected pregnant women with no per-sonal indication to treatment are main-tained on ART after delivery, suggestingthat this approach is being considered fa-vorably also in high-income countries.Future studies based on a long-term fol-low-up evaluation will have to assessthe clinical benefits of this approach, tak-ing into account levels of retention incare, which are likely to represent a criti-cal factor for the effectiveness of thisapproach [9].NotesAcknowledgments. We thank Cosimo Polizziand Alessandra Mattei of the Istituto Superiore diSanità in Rome, Italy, for providing technical sec-retarial assistance for this study.Disclaimer. The corresponding author hadfull access to all the data in the study and takesresponsibility for the integrity of the data andthe accuracy of the data analysis.Financial support. This work was supportedby public research grants (reference numberH85E08000200005) from the Italian MedicinesAgency.Potential conflicts of interest. All authors:No reported conflicts.All authors have submitted the ICMJE Formfor Disclosure of Potential Conflicts of Interest.Conflicts that the editors consider relevant to thecontent of the manuscript have been disclosed.Marco Floridia,1 Giovanni Guaraldi,2Marina Ravizza,3 Cecilia Tibaldi,4Carmela Pinnetti,5 Anna Maccabruni,6Atim Molinari,7 Giuseppina Liuzzi,5Salvatore Alberico,8 Alessandra Meloni,9Laura Rizzi,10 Serena Dalzero,3 andEnrica Tamburrini11; for the Italian Group onSurveillance on Antiretroviral Treatment inPregnancya1Department of Therapeutic Research and MedicinesEvaluation, Istituto Superiore di Sanità, Rome,2Department of Medical and Surgical Sciences forChildren & Adults, University of Modena and ReggioEmilia, 3Department of Obstetrics and Gynaecology,DMSD San Paolo Hospital Medical School, Universityof Milan, 4Department of Obstetrics and Neonatology,Città della Salute e della Scienza Hospital, andUniversiy of Turin, 5I.N.M.I. Lazzaro Spallanzani, Rome,6Infectious Diseases, University of Pavia, IRCCSPoliclinico San Matteo, 7Department of InfectiousDiseases and Hepatology, Azienda Ospedaliera diParma, 8Institute for Maternal and Child Health, IRCCSBurlo Garofolo, Trieste, 9Division of Gynaecology andObstetrics, S. Giovanni di Dio Hospital and Universityof Cagliari, 10Infectious and Tropical Diseases Unit,General Hospital, Varese, and 11Department ofInfectious Diseases, Catholic University, Rome, ItalyReferences1. World Health Organization. Consolidatedguidelines on the use of antiretroviral drugsfor treating and preventing HIV infection.Recommendations for a public health ap-proach. Geneva, Switzerland: WHO, 2013.Available at: http://www.who.int/hiv/pub/guidelines/arv2013/download/en/. Accessed24 July 2014.2. World Health Organization. Programmaticupdate: use of antiretroviral drugs for treatingpregnant women and preventing HIV infec-tion in infants: executive summary, April2012. Geneva, Switzerland: WHO, 2012.Available at: http://www.who.int/hiv/PMTCT_update.pdf. Accessed 24 July 2014.3. Fasawe O, Avila C, Shaffer N, et al. Cost-effectiveness analysis of Option B+ for HIVprevention and treatment of mothers and chil-dren in Malawi. PLoS One 2013; 8:e57778.4. World Health Organization. Implementationof Option B+ for prevention of mother-to-child transmission of HIV: the Malawi experi-ence. Brazzaville, Republic of the Congo:WHO Regional Office for Africa, 2014. Avail-able at: http://www.emtct-iatt.org/wp-content/uploads/2014/05/Report-of-the-Documentation-of-Implementation-of-Option-0B+for-PMTCT-in-Malawi.pdf. Accessed 24 July2014.5. Gopalappa C, Stover J, Shaffer N, Mahy M.The costs and benefits of Option B+ for theprevention of mother-to-child transmissionof HIV. AIDS 2014; 28(suppl 1):S5–14.6. O’Brien L, Shaffer N, Sangrujee N, AbimbolaTO. The incremental cost of switchingfrom Option B to Option B+ for the preven-tion of mother-to-child transmission ofHIV. Bull World Health Organ 2014; 92:162–70.7. Ishikawa N, Shimbo T, Miyano S, et al. Healthoutcomes and cost impact of the new WHO2013 guidelines on prevention of mother-to-child transmission of HIV in Zambia.PLoS One 2014; 9:e90991.8. Floridia M, RavizzaM, Tamburrini E, et al. Di-agnosis of HIV infection in pregnancy: datafrom a national cohort of pregnant womenwith HIV in Italy. Epidemiol Infect 2006;134:1120–7.9. Tenthani L, Haas AD, Tweya H, et al. Reten-tion in care under universal antiretroviraltherapy for HIV-infected pregnant and breast-feeding women (‘Option B+’) in Malawi.AIDS 2014; 28:589–98.APPENDIXThe Italian Group on Surveillance onAntiretroviral Treatment in Pregnancy.Project coordinators: M. Floridia, M.Ravizza, E. Tamburrini. Participants:M. Ravizza, E. Tamburrini, F. Mori,P. Ortolani, E. R. dalle Nogare, F. Di Lo-renzo, G. Sterrantino, M. Meli, S. Polemi,J. Nocentini, M. Baldini, G. Montorzi,M. Mazzetti, P. Rogasi, B. Borchi, F.Vichi, B. Del Pin, E. Pinter, E. Anzalone,R. Marocco, C. Mastroianni, V. S.Mercurio, A. Carocci, E. Grilli, A.Maccabruni, M. Zaramella, B. Mariani,G. Natalini Raponi, G. Guaraldi, G. Nar-dini, C. Stentarelli, B. Beghetto, A.M.160 • CID 2015:60 (1 January) • CORRESPONDENCE at Istituto Superiore di Sanita on December 12, 2014http://cid.oxfordjournals.org/Downloaded from Degli Antoni, A. Molinari, M. P. Crisalli,A. Donisi, M. Piepoli, V. Cerri, G.Zuccotti, V. Giacomet, V. Fabiano, G.Placido, A. Vivarelli, P. Castelli, F. Savalli,V. Portelli, F. Sabbatini, D. Francisci, L.Bernini, P. Grossi, L. Rizzi, S. Alberico,G. Maso, M. Airoud, G. Soppelsa, A.Meloni, M. Dedoni, C. Cuboni, F. Ortu,P. Piano, A. Citernesi, I. Bordoni Vicini,K. Luzi, A. Spinillo, M. Roccio, A.Vimercati, A. Miccolis, E. Bassi, B. Guerra,F. Cervi, C. Puccetti, E. Margarito,M. Contoli, M. G. Capretti, C. Marsico,G. Faldella, M. Sansone, P. Martinelli,A. Agangi, G. M. Maruotti, C. Tibaldi,L. Trentini, T. Todros, G. Masuelli, V.Frisina, I. Cetin, T. Brambilla, V. Savasi,C. Personeni, C. Giaquinto, M. Fiscon,R. Rinaldi, E. Rubino, A. Bucceri, R.Matrone, G. Scaravelli, C. Fundarò,O. Genovese, C. Cafforio, C. Pinnetti,G. Liuzzi, V. Tozzi, P. Massetti, A. M.Casadei, A. F. Cavaliere, V. Finelli, M.Cellini, G. Castelli Gattinara, A. M.Marconi, S. Dalzero, V. Sacchi, A. DePirro, C. Polizzi, A. Mattei, M. F. Pirillo,R. Amici, C. M. Galluzzo, S. Donnini,S. Baroncelli, M. Floridia. Pharmacoki-netics: P. Villani, M. Cusato. Advisoryboard: A. Cerioli, M. De Martino, P.Mastroiacovo, M. Moroni, F. Parazzini,E. Tamburrini, S. Vella. SIGO-HIVGroup National Coordinators: P.Martinelli, M. Ravizza.aThe members of the Italian Group on Surveillance on Antire-troviral Treatment in Pregnancy group of members are listed inthe Appendix.Correspondence: Marco Floridia, MD, Department of Thera-peutic Research and Medicines Evaluation, Istituto Superioredi Sanità, Viale Regina Elena 299, 00161 Rome, Italy (marco.floridia@iss.it).Clinical Infectious Diseases® 2015;60(1):159–61© The Author 2014. Published by Oxford University Presson behalf of the Infectious Diseases Society of America. Allrights reserved. For Permissions, please e-mail: journals.permissions@oup.com.DOI: 10.1093/cid/ciu736CORRESPONDENCE • CID 2015:60 (1 January) • 161 at Istituto Superiore di Sanita on December 12, 2014http://cid.oxfordjournals.org/Downloaded from 

Is "option B+" also being adopted in pregnant women in high-income countries? Temporal trends from a national study in Italy

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Is "option B+" also being adopted in pregnant women in high-income countries? Temporal trends from a national study in Italy

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