Background. According to World Health Organization (WHO), experimental studies performed in rats and rabbits have revealed no evidence of harmful side effects of bedaquiline to the fetus. WHO points out that, given the lack of adequate and controlled studies on the effects of bedaquiline on the fetus in pregnant women, and the fact that drug data regarding teratogenicity are limited to nonclinical animal data, this drug may be used when an effective treatment regimen cannot otherwise be provided. However, WHO recommends thorough registering treatment, pregnancy, and postpartum bedaquiline-related outcomes to provide data on appropriate dosing for multidrug-resistant tuberculosis (MDR-TB) treatment during pregnancy and postpartum. However, in the modern literature, there are no data about attributable to bedaquiline adverse events in MDR-TB/HIV co-infected pregnant women and their fetus as well as during the postpartum period.
Objective. To update the literature data with the clinical features of pregnancy and postpartum period in a MDR-TB/HIV co-infected patient receiving a bedaquiline-containing regimen as antimycobacterial therapy in the third trimester based on an example from own clinical experience.
Methods. We report the clinical case of pregnancy course in the MDR-TB/HIV co-infected woman treated with the bedaquiline-containing regimen as antimycobacterial therapy in the third trimester.
Results. In the clinical case presented, the patient demonstrated an initial poor adherence to treatment for both MDR-TB and HIV infection resulting in tuberculous process and HIV rapid progression. Since the patient refused the option of undergoing the therapeutic abortion prior to 22 gestational weeks as the pregnancy was intended, the antimycobacterial therapy regimen was modified by bedaquiline inclusion at 30 weeks’ gestation (the third trimester) for the maternal and neonatal mortality prevention. However, there was no sputum smear conversion on the antimycobacterial therapy regimen including bedaquiline, the patient presented with the signs of endogenous intoxication and nephropathy. Relatedly, neonatal transabdominal ultrasound revealed intrauterine growth retardation, worsening fetoplacental insufficiency (reverse flow) and intrauterine dystrophy. There was abundant placental calcification. Taking into account breech presentation, II degree intrauterine growth retardation, III degree fetoplacental insufficiency (reverse flow), oligohydramnios, fetal distress syndrome and bilateral pyelectasis, the patient was transferred to the Perinatal Centre for planned caesarean section at the 32nd week of gestation. The premature female infant was declared dead some hours later. In the postpartum period, the patient continued the initiated bedaquilinebased antimycobacterial therapy and antiretroviral therapy. However, positive clinical-radiological dynamics and sputum smear conversion have not been achieved.
Conclusions. The clinical case presented confirms the literature data that the features of pregnancy and postpartum period in patients with MDR-TB/HIV co-infection are characterized by such complications development as preterm delivery, early neonatal mortality, intrauterine growth retardation, distress syndrome, etc.
Clinical course of pregnancy and postpartum in a multidrug-resistant tuberculosis/HIV co-infected patient receiving bedaquiline-containing regimen as antimycobacterial therapy