Birth outcomes and HIV-free survival with Option B+ in Lesotho: Results from an observational prospective cohort study
Background: Combination antiretroviral
therapy (cART) reduces mother-to-child transmission of HIV and improves
maternal health. Since introduction of option B+, there are scant data on birth
outcomes of HIV-exposed compared to unexposed infants. We assessed birth
outcomes and six-week HIV free survival among HIV-exposed infants (HEI) and HIV-unexposed
infants (HUI).
Methods: 941 HIV-negative and 653 HIV-positive pregnant
women were enrolled in an observational cohort to evaluate effectiveness of
universal maternal cART (Option B+) rolled out within routine programs in 13
health facilities in Lesotho. Birth outcomes included infant birth weight (IBW),
maturity, congenital anomalies, and mortality. Infant HIV birth testing by DNA
PCR within two weeks of birth was introduced at study sites alongside routine
six-week testing. Data were
analysed to determine birth outcomes, HIV transmission, and HIV-free survival rates
at six weeks.
Results: : HIV-positive women
were older, 28.7 vs. 24.4 years (p<0.001) and presented for antenatal care earlier
at 23 weeks vs. 25.3 weeks gestation (p<0.001). Mean IBWs were similar: 3.0 kgs for HEIs vs 3.1
kgs for HUI. HEI were more likely to be premature, 8.3% vs. 4.0% (p=0.001).
Neither Age (median age: 26 vs
25) nor parity (median: 1 vs 1) was associated with prematurity. No differences in stillbirths or congenital
anomalies were noted. Six infants were HIV-infected by six weeks: cumulative HIV
transmission was 0.9% (N=4) at birth (95%CI: 0.25%-2.36%) and 1.03% (N=6)
(95%CI: 0.38%-2.23%) by six weeks. Infant mortality was 4.4% and 4.3% for HUI
and HEI respectively (p=0.93). The estimated six-week HIV free survival was 91.5%
[95%CI: 89.1% - 93.6%] for HEI. Survival for HUI was 94.1% [95% CI: 92.4% -
95.6%]. Excluding stillbirths, six-week HIV free survival for HEI was 95.2%
[95% CI: 93.2% - 96.8%] compared to survival rate of 97.5% [95% CI: 96.2% -
98.4%] among HUI (p=0.02).
Conclusions: A low HIV transmission rate by six weeks
was found among mother-infant pairs enrolled in a universal cART prevention of
mother-to-child transmission program, though there were higher rates of
prematurity; six-week survival among HIV-exposed infants was comparable to HIV-unexposed
infants. It will be important to explore if this trend continues
at 12 months and 24 months.
A. Tiam1,2, S. Kassaye3, R. Machekano1, V. Tukei4, M. Gill1, M. Mokone4, S. Mohale4, M. Letsie5, M. Tsietso6, I. Seipati7, J. Barisa4, A. Isavwa8, L. Guay1,9
1Elizabeth Glaser Pediatric AIDS Foundation, Research, Washington, United States, 2University of Bergen, Centre for International Health, Bergen, Norway, 3George Town University, Medicine and Infectious Disease, Washington, United States, 4Elizabeth Glaser Pediatric AIDS Foundation, Research, Maseru, Lesotho, 5Ministry of Health, Disease Control, Maseru, Lesotho, 6Ministry of Health, Laboratory Services, Maseru, Lesotho, 7Ministry of Health, Family Health, Maseru, Lesotho, 8Elizabeth Glaser Pediatric AIDS Foundation, SI & E, Maseru, Lesotho, 9George Washington University, Milken Institute School of Public Health, Washington, United States