Drug-resistant tuberculosis treatment

Regarding bedaquiline exposure during pregnancy, the findings of the cohort study demonstrated 
no statistically significant differences in birth or pregnancy outcomes when comparing infants who 
had intrauterine bedaquiline exposure versus those who did not have this exposure (P=0.741 for 
birth outcomes and P=0.312 for pregnancy outcomes) (74). There were 45 live births (92% of total) 
in the bedaquiline exposed group versus 54 live births (90% of total) in the unexposed group. In 
addition, there were four fetal and neonatal deaths in the infants exposed to bedaquiline (8% of the 
total bedaquiline exposed group, with three stillbirths and one termination of pregnancy) and six 
fetal and neonatal deaths in the bedaquiline unexposed group (10% of the total unexposed group, 
comprising three stillbirths and three miscarriages) (74). The results of the study also demonstrated 
that treatment outcomes were favourable for pregnant women exposed to bedaquiline versus not 
exposed (71% versus 62%, respectively, P=0.349) (74). Pregnancy outcomes included live births and 
unfavourable pregnancy outcomes (fetal and neonatal deaths, preterm births <37 weeks and low 
birth weight <2500 g) and infant outcomes included weight gain and developmental milestones and 
the diagnosis of TB (74). Of all pregnancy and infant outcomes assessed, only low birth weight was 
associated with bedaquiline exposure in utero (45% versus 26%, P=0.034). The average weight in 
bedaquiline exposed infants was 2690 g versus 2900 g in infants not exposed to bedaquiline. However, 
it was not possible to conclusively ascribe this effect to bedaquiline, and more investigation is needed 
to explore this relationship (74). There were no significant differences in infant growth after birth: in a 
subanalysis of 86 babies followed up prospectively – 41 exposed to bedaquiline in utero and 45 not 
exposed – 88% of babies exposed to bedaquiline in utero had normal weight gain at 1 year of age 
versus 82% of babies not exposed (P=0.914) (74) .