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ASHM Report Back
Clinical posts from members and guests of the Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM) from various international medical and scientific conferences on HIV, AIDS, viral hepatitis, and sexual health.
DTG/TDF/FTC started in pregnancy is as safe as EFV/TDF/FTC in nationwide birth outcomes surveillance in Botswana
Presented as part of the mixed bag "Co-chair's Choice" session this study aimed to assess dolutegravir (DTG) in pregnancy. There are many benefits to DTG as treatment, highly effective, well tolerated, once daily with high barriers to resistance. However, despite being a drug with many desirable qualities, the lack of data in pregnancy have resulted in DTG not being recommended in pregnancy by the WHO. This study addresses some of the research shortfalls and compared pregnancy outcomes from patients who used EFV/TDF/FTC between August 2014 and August 2016 and those who used DTG/TDF/FTC from November 2016 to April 2017
Much of the groundwork for this study was laid out by the Tsempano study, which demonstrated that EFV/TDF/FTC was associated with lower rates of any adverse birth outcomes as well as lower rates of severe adverse birth outcomes compared with other ART regimens (NVP/TDF/FTC, NVP/ZDV/3TC, LPV/r/TDF/FTC, LPV/r/ZDV/3TC). A similar framework was adopted for the comparison of DTG/TDF/FTC with EFV/TDF/FTC in women who commence ART pregnancy.
Maternal demographics were well matched in both groups for age, employment, parity, gestational age at presentation, previous pregnancy losses and smoking and alcohol consumption. They were also well matched with regards to the gestational age at which ART was commenced as well as their CD4 counts.
Outcomes were startlingly similar as listed below:
Total and severe adverse birth outcomes 34% in the DTG/TDF/FTC group, with 11% being a severe adverse birth outcome.
Total and severe adverse birth outcomes 35% in the EFV/TDF/FTC group, with 11% being a severe adverse birth outcome.
Birth at less than 37 weeks gestation 18% and less than 32 weeks gestation 4% in the DTG/TDF/FTC group
Birth at less than 37 weeks gestation 19% and less than 32 weeks gestation 4% in the EFV/TDF/FTC group
19% small for gestational age and 6% very small for gestational age in the DTG/TDF/FTC group
19% small for gestational age and 7% very small for gestational age in the EFV/TDF/FTC group
2.1% stillbirth in the DTG/TDF/FTC group
2.3% stillbirth in the EFV/TDF/FTC group
1 major congenital abnormality in the form of skeletal dysplasia in the EFV/TDF/FTC group
This preliminary data suggests that DTG may well be considered safe in pregnancy at some point but further research is needed in the following areas:
Birth outcomes associated with exposure to DTG from conception
Combination with other backbones eg ABC/3TC
Maternal viral load at delivery