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We report safety outcomes of pregnant women who initiated ART through Option B+.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We analysed 12\u2010month data from an observational cohort study on Option B+ among women newly initiating tenofovir\/lamivudine\/efavirenz (TDF\/3TC\/EFV) at a government antenatal clinic in Lilongwe, Malawi. Proportions of women engaged in care, incidence of DAIDS grade\u00a0\u2265\u00a02 laboratory toxicity, grade\u00a0\u2265\u00a03 adverse events (AEs), viral suppression (&lt;1000 copies\/mL), birth outcomes and infant HIV infections are reported.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>At ART initiation, participants (<jats:italic>n<\/jats:italic>\u00a0=\u00a0299) had a median age of 26\u00a0years (IQR 22\u201330), median CD4 count of 352\u00a0cells\/\u03bcl (IQR 231\u2013520) and 94% were in WHO Stage 1. We noted 76 incident DAIDS Grade\u00a0\u2265\u00a02 laboratory results among 58 women, most commonly elevated liver function tests (<jats:italic>n<\/jats:italic>\u00a0=\u00a030 events) and low haemoglobin (<jats:italic>n<\/jats:italic>\u00a0=\u00a027). No women had elevated creatinine. Clinical AEs (<jats:italic>n<\/jats:italic>\u00a0=\u00a045) were predominantly infectious diseases and Grade 3. Five participants (2%) discontinued TDF\/3TC\/EFV due to virologic failure (3) or toxicity (2). Twelve months after ART initiation, most women were engaged in care (89%) and had HIV RNA\u00a0&lt;\u00a01000\u00a0copies\/ml (90%). 8% of pregnancies resulted in preterm birth, 9% were low birthweight (&lt;2500\u00a0g), and 2% resulted in infant HIV infection at 6\u00a0weeks post\u2010delivery.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Most women remained on ART and were virally suppressed 12\u00a0months after starting Option B+. Few infants contracted HIV perinatally. While some women experienced adverse laboratory events, clinical symptom monitoring is likely reasonable.<\/jats:p><\/jats:sec>","DOI":"10.1111\/tmi.13296","type":"journal-article","created":{"date-parts":[[2019,8,5]],"date-time":"2019-08-05T11:43:27Z","timestamp":1565005407000},"page":"1221-1228","update-policy":"http:\/\/dx.doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Safety and efficacy of Option B+ ART in Malawi: few severe maternal toxicity events or infant HIV infections among pregnant women initiating tenofovir\/lamivudine\/efavirenz"],"prefix":"10.1111","volume":"24","author":[{"given":"Bryna J.","family":"Harrington","sequence":"first","affiliation":[{"name":"Department of Epidemiology The University of North Carolina at Chapel Hill Chapel Hill NC USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bethany L.","family":"DiPrete","sequence":"additional","affiliation":[{"name":"Department of Epidemiology The University of North Carolina at Chapel Hill Chapel Hill NC USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Allan N.","family":"Jumbe","sequence":"additional","affiliation":[{"name":"UNC Project\u2010Malawi Kamuzu Central Hospital Lilongwe Malawi"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"McNeil","family":"Ngongondo","sequence":"additional","affiliation":[{"name":"UNC Project\u2010Malawi Kamuzu Central Hospital Lilongwe Malawi"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laura","family":"Limarzi","sequence":"additional","affiliation":[{"name":"UNC Project\u2010Malawi Kamuzu Central Hospital Lilongwe Malawi"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shaphil D.","family":"Wallie","sequence":"additional","affiliation":[{"name":"UNC Project\u2010Malawi Kamuzu Central Hospital Lilongwe Malawi"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maganizo B.","family":"Chagomerana","sequence":"additional","affiliation":[{"name":"UNC Project\u2010Malawi Kamuzu Central Hospital Lilongwe Malawi"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mina C.","family":"Hosseinipour","sequence":"additional","affiliation":[{"name":"UNC Project\u2010Malawi Kamuzu Central Hospital Lilongwe Malawi"},{"name":"Department of Medicine The University of North Carolina at Chapel Hill Chapel Hill NC USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"the S4 Study Team","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2019,8,19]]},"reference":[{"key":"e_1_2_6_2_1","unstructured":"ChimbwandiraF MhangoE MakombeS MidianiD MwansamboC NjalaJet al.Impact of an Innovative Approach to Prevent Mother\u2010to\u2010Child Transmission of HIV \u2014 Malawi July 2011\u2013September 2012;2013. 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