Outcomes of Children Born to Pregnant Women With Drug-resistant Tuberculosis Treated With Novel Drugs in Khayelitsha, South Africa: A Report of Five Patients

Abstract

This brief report presents a series of 5 pregnant women treated for rifampicin-resistant tuberculosis with the novel drugs bedaquiline, delamanid, and linezolid as part of an optimized backbone regimen and reviews the outcomes of the children born to them. Although the case series is small, all children had excellent birth outcomes suggesting pregnant women should not be denied access to novel therapies for RR-TB.

A review of the safety of linezolid during pregnancy, a potential alternative syphilis treatment

“…Of the 13 included studies, 6 were animal studies and 7 were human studies. The search performed on PubMed and Embase returned 8 studies (1 animal and 7 human studies)., [24][25][26][27][28][29][30]31 The review performed on the publicly available FDA New Drug Application 021130 Pfizer (Zyvox-linezolid) 2000 to 2021 included 5 animal studies. [19][20][21][22][23] We summarized the linezolid dosage, duration of treatment, disease of interest, sample size, and animal, fetal, and maternal toxicities to assess the safety of linezolid treatment during pregnancy (Table 1).…”

Pregnancy and Birth Outcomes in Patients With Multidrug-Resistant Tuberculosis Treated With Regimens That Include New and Repurposed Drugs

“…A South African study that compared outcomes in pregnant women who did and did not receive bedaquiline found that fetal exposure to bedaquiline in utero was associated with low birthweight (<2500 g), with no other significant differences in infant, pregnancy, or maternal treatment outcomes [ 14 ]. Another small case study from South Africa found successful maternal treatment outcomes and excellent birth outcomes in children born to pregnant women who were receiving bedaquiline, delamanid, and linezolid [ 21 ]. In light of this evidence, in their most recent update to treatment guidelines, WHO now recommends a 9-month, all-oral regimen that includes linezolid, instead of ethionamide, for pregnant women with MDR/RR-TB without documented FQ resistance [ 5 ].…”

Uso de bedaquilina durante el embarazo en una paciente con TB-MDR. Primer reporte de caso en México

“…This evidence gap could also be supplemented by developing and using registries of pregnant women with DR-TB treated with these drugs. 10…”