Dolutegravir is an inhibitor of HIV integrase that is used (usually in combination with other antiretroviral drugs) to treat HIV infection.
An ongoing birth surveillance study is currently the only controlled study to assess rates of adverse pregnancy outcomes following in utero exposure to dolutegravir. In 2018 this study reported four cases of neural tube defects among 426 infants exposed to dolutegravir around the time of conception (rate of 0.94% compared to that of 0.12% in infants whose mothers took other HIV medication). While this signal is being evaluated the manufacturer of dolutegravir and the European Medicines Agency have recommended that use of dolutegravir should be avoided during pregnancy and in women seeking to become pregnant. A negative pregnancy test should be obtained before initiation of treatment, effective contraception should be used throughout, and if first trimester pregnancy is confirmed during treatment, the patient’s therapy should be switched unless there is no suitable alternative. In practice there may be some cases where the potential risks of first trimester dolutegravir treatment are considered to be outweighed by the benefit of continued HIV viral suppression. Discussion with the patient should occur in all such cases.
The birth surveillance study discussed above includes data from >1,700 women exposed to dolutegravir at any stage of pregnancy and provides no evidence of associations with other adverse outcomes including preterm delivery, small for gestational age, stillbirth, or neonatal death, although data are too limited to rule this out. Neurodevelopmental outcomes and rates of childhood cancer following gestational exposure to dolutegravir have not yet been assessed.
Women who have been exposed to dolutegravir around the time of fetal neural tube closure (usually up to 5 weeks’ gestation) should be offered additional fetal anomaly scans to screen for neural tube defects prior to their routine anomaly scan at 20 weeks gestation. Other risk factors which independently increase the risk of adverse pregnancy outcome may also be present in individual cases. Clinicians are reminded of the importance of consideration of such factors when performing case-specific risk assessments.
This is a summary of the full UKTIS monograph for health care professionals and should not be used in isolation. The full UKTIS monograph and access to any hyperlinked related documents is available to NHS health care professionals who are logged in.
If you have a patient with exposure to a drug or chemical and require assistance in making a patient-specific risk assessment, please telephone UKTIS on 0344 892 0909 to discuss the case with a teratology specialist.
If you would like to report a pregnancy to UKTIS please click here to download our pregnancy reporting form. Please encourage all women to complete an online reporting form.