Implementation of Option B and a fixed-dose combination antiretroviral regimen for prevention of mother-to-child transmission of HIV in South Africa: A model of uptake and adherence to care

INTRODUCTION: Initiating and retaining pregnant women on antiretroviral therapy (ART) to prevent mother-to-child HIV transmission (PMTCT) remains a major challenge facing African HIV programs, particularly during the critical final months prior to delivery. In 2013, South Africa implemented its “Option B” PMTCT regimen (three-drug ART throughout pregnancy and breastfeeding, regardless of maternal CD4 count) and introduced once-daily fixed-dose combinations and lifelong ART. Currently, the uptake of Option B and its possible impact on adherence to PMTCT during the critical final months of pregnancy is unclear. MATERIALS AND METHODS: We prospectively collected visit data from a cohort of adult, HIV-infected, pregnant women between July 2013-August 2014 to estimate three models of adherence to PMTCT during the final 16 weeks immediately preceding delivery. Adherence was defined according to possession of antiretroviral drugs, which was inferred from clinic visit records under varying assumptions in each model. We describe uptake of the PMTCT regimen, gestational age at initiation, and model possible scenarios of adherence through delivery after the implementation of Option B. RESULTS: Among 138 women enrolled (median (IQR) age 28 years (24–32), median CD4 count 378 cells/mm(3)), median (IQR) gestational age at initiation was 22 weeks (16–26). Estimates of adherence during the final 16 weeks of pregnancy prior to delivery ranged from 75% (52–89%) under the best case scenario assumptions to 52% (30–75%) under the worst case scenario assumptions. Estimates of the proportion of women who would achieve 80% adherence to PMTCT were <50% across all models. CONCLUSIONS: Despite the switch to Option B and once-daily dosing, South African women continue to initiate PMTCT late in pregnancy, and estimations of regimen adherence, as modelled using PMTCT visit attendance data, is poor, with <50% of women reaching 80% adherence during final months of pregnancy across all models. Further guideline changes and interventions are needed to achieve vertical transmission goals. TRIAL REGISTRATION: ClinicalTrials.gov NCT01710397 South African National Clinical Trials Register DOH-27-0213-4177