MedicalResearch.com Interview with:
Claudia Syueping Crowell, MD
Lead author of the study
Assistant professor of pediatrics
University of Washington and
Seattle Children’s Hospital
MedicalResearch.com: What is the background for this study? What are the main findings?
- This research was conducted as part of the SMARTT (Surveillance Monitoring for ART Toxicities) study, which is an observational cohort study of HIV exposed uninfected children with the overall aim of studying the long-term safety of fetal and infant exposure to prophylactic antiretroviral (ARV) therapy.
- This particular analysis was conducted in response to prior studies that showed an increased risk of seizures and other neurologic conditions in children who were exposed to ARVs in utero.
- The aim of our study was to determine if in utero exposure to any particular ARV is associated with the diagnosis of neurologic conditions later in infancy and childhood.
- In our cohort of 3747 HIV-exposed uninfected children we found 237 children who had neurologic conditions, 16 of whom were exposed to efavirenz in utero and 4 of whom were exposed to dolutegravir in utero.
- The most common neurologic diagnoses were microcephaly, febrile seizures, non-febrile seizures and eye related disorders.
- When comparing various antiretroviral medications, we found that children of women whose ART regimen included efavirenz were more likely to be diagnosed with a neurologic condition than children of women whose ART regimen did not include efavirenz (9.6% vs. 6.2%). This translated to a 60% higher risk of being diagnosed with a neurologic condition in the efavirenz exposed group after controlling for other risk factors.
- We also found a suggestion of an association between in utero dolutegravir exposure and later diagnosis of a neurologic condition but the number of children exposed to dolutegravir was small (number of exposed children = 94).
MedicalResearch.com: What should readers take away from your report?
- We still have not confidently determined what is the best ART regimen in pregnancy and, therefore, need to continue to carefully weigh efficacy and safety issues.
- Adverse effects from in utero exposures may not be evident immediately after birth; therefore, it is important to follow children who have been exposed to ARVs in utero long-term to determine what is the safest antiretroviral regimen for use in pregnancy.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
- This was a single study and further study in other cohorts with more exposure to some of the newer ARV medications needs to be conducted to see if our findings can be replicated.
- Additionally, we need to follow our cohort further to determine the clinical implications of the neurologic conditions seen in our study.
- Continued close study of ARV safety in pregnancy is imperative and it is important that we include long-term follow-up of exposed children so that we do not miss potential long-term adverse effects of in utero ARV exposure.
ID week 2018 abstract discussing:
Children of women whose HIV ART regimen included efavirenz were 60 percent more likely to develop a neurological condition
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