Safety and Pharmacokinetics of Cabotegravir in Pregnant Women
Author Information
Author(s): Delany‐Moretlwe Sinead, Hanscom Brett, Guo Xu, Nkabiito Clemensia, Mandima Patricia, Nahirya Patricia Ntege, Mpendo Juliet, Bhondai‐Mhuri Muchaneta, Mgodi Nyaradzo, Berhanu Rebecca, Farrior Jennifer, Piwowar‐Manning Estelle, Ford Susan L., Hendrix Craig W., Rinehart Alex R., Rooney James F., Adeyeye Adeola, Landovitz Raphael J., Cohen Myron S., Hosseinipour Mina C., Marzinke Mark A., the HPTN 084 Study Team
Primary Institution: Wits RHI, University of the Witwatersrand
Hypothesis
What is the safety and pharmacokinetics of long-acting cabotegravir in pregnant women?
Conclusion
Cabotegravir concentrations were well tolerated in pregnant women, with no significant differences in pregnancy outcomes compared to those not receiving the drug.
Supporting Evidence
- 57 pregnancies were confirmed during the study.
- Most pregnancies resulted in live births (81%).
- No congenital anomalies were observed.
- Grade 2 or higher maternal adverse event incidence did not differ significantly between study arms.
- The apparent terminal half-life of cabotegravir was comparable between pregnant and non-pregnant women.
Takeaway
This study looked at how a medicine called cabotegravir affects pregnant women and found it to be safe without causing problems for the babies.
Methodology
Participants were randomized to receive either cabotegravir or a placebo, and pregnancy outcomes were monitored and compared.
Limitations
The study had a small sample size and was limited to specific regions in Africa.
Participant Demographics
Participants were mostly women aged 18-45 from sub-Saharan Africa, with a median age of 24 years.
Statistical Information
P-Value
p = 0.256
Confidence Interval
95% CI 1.1−1.9
Digital Object Identifier (DOI)
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