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

摘要

Abstract Objectives Malawi's Option B+ universal antiretroviral therapy (ART) program for pregnant and breastfeeding women does not include routine laboratory monitoring. We report safety outcomes of pregnant women who initiated ART through Option B+. Methods We analysed 12‐month 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?≥?2 laboratory toxicity, grade?≥?3 adverse events (AEs), viral suppression (1000 copies/mL), birth outcomes and infant HIV infections are reported. Results At ART initiation, participants ( n ?=?299) had a median age of 26?years (IQR 22–30), median CD4 count of 352?cells/μl (IQR 231–520) and 94% were in WHO Stage 1. We noted 76 incident DAIDS Grade?≥?2 laboratory results among 58 women, most commonly elevated liver function tests ( n ?=?30 events) and low haemoglobin ( n ?=?27). No women had elevated creatinine. Clinical AEs ( n ?=?45) 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??1000?copies/ml (90%). 8% of pregnancies resulted in preterm birth, 9% were low birthweight (2500?g), and 2% resulted in infant HIV infection at 6?weeks post‐delivery. Conclusion Most women remained on ART and were virally suppressed 12?months after starting Option B+. Few infants contracted HIV perinatally. While some women experienced adverse laboratory events, clinical symptom monitoring is likely reasonable.