Background: In April 2012, Rwanda started to implement a policy to initiate HIV-positive pregnant women on lifelong antiretroviral treatment (ART) (‘Option B+’). In April 2013, EGPAF and the Ministry of Health began the Kigali Antiretroviral and Breastfeeding Assessment for the Elimination of HIV (Kabeho) Study. The study will determine 18 and 24 month HIV-free survival of a cohort of HIV-exposed children in the PMTCT program.
Methods: From April 2013-January 2014, 608 HIV-positive women on triple drug ART in the third trimester of pregnancy or within two weeks post-delivery were enrolled in the observational prospective cohort from 14 health facilities in Kigali. After providing written informed consent, women underwent enrollment, including HIV and ART-related history and adherence, and a blood draw for viral load (VL) testing by RNA-PCR (Roche).
Results: The median time women knew their HIV-positive status was 38.0 months (IQR 4.7–83.5). The most common ARV regimen (56.6%, 344/608) was TDF/3TC/EFV. Overall, 35.2% (n=214) of women reported taking another regimen previously; 21.5% (n=130) due to PMTCT during an earlier pregnancy. At enrollment, women were on ART for a median of 13.4 months (IQR 2.96–48.8); median time on current ART was 9.2 months (IQR 2.3-34.8). The adherence rate based on a 3-day ART recall was 90.9%. Side effects were reported in the past month by 17.5% (n=105) of women, with dizziness as most common (n=53).
Half of women (52.2%, 316/606) had undetectable VL. Figure 1 shows the distribution of VL by ART duration. Logistic regression using GEE (N=579) indicates women were more likely to have a detectable VL if they had no education (AOR=2.21, 95% CI: 1.31, 3.73), reported side effects in the past month (AOR=1.96, 95% CI: 1.37, 2.81), and had been on ART less than four months, when compared to those with ART exposure from 4-12 months (AOR=3.98, 95% CI: 2.11, 7.50), 12-24 months (AOR=6.04, 95% CI: 2.47, 14.76), and 24-36 months (AOR=5.57, 95% CI: 2.38, 13.05). VL slightly decreased beyond 36 months on ART (AOR=3.56, 95% CI: 1.69, 7.50).
Conclusions: High rates of ART adherence in the antenatal/peripartum period under Option B+ were reported. However, only half of women had undetectable VL at enrollment. Findings suggest longer ART duration may be needed for women in PMTCT to achieve viral suppression. Testing for ARV resistance is planned. Analysis of the cohort will incorporate specific regimen information, regimen changes, longitudinal VL, and adherence over time.
Figure 1. Distribution of viral loads stratified by time on ART.