HTB

No additional neural tube defects with preconception dolutegravir: data from three birth outcome cohorts

Polly Clayden, HIV i-Base

Three posters presented at Glasgow HIV 2018 showed data from analyses of dolutegravir (DTG) use in pregnancy from Canada, Frankfurt and Eastern/Central Europe. [1, 2, 3]

Although none of these reports found further neural tube defects (NTDs), after the possible risk found in Botswana, [4] numbers are small, so at best these findings are faintly reassuring.       

Canadian Perinatal HIV Surveillance Program

The Canadian Perinatal HIV Surveillance Program (CPHSP) found no NTDs among 80 infants exposed to DTG in the first trimester.

The CPHSP is an active surveillance system which collects information on HIV positive women’s pregnancies. From 2007 to 2017, there were 2,591 infants born to women in the CPHSP, of which 2,423 had data available on congenital anomalies and ART in pregnancy.

There were three neural tube defects reported in this cohort: 2/1311 exposed to ART at conception (0.15%). None were among the 80 infants with first trimester DTG exposure, including 69 exposed at the time of conception. The rate of NTDs in infants who were unexposed to ART in the first trimester was 1/690 (0.14%).

But there was a 3-fold higher rate of congenital anomalies (10.7%) in 28 infants with first trimester elvitegravir exposure.

The Frankfurt HIV Cohort

All women of the Frankfurt HIV Cohort who became pregnant and delivered between January 2008 and June 2018 were included in this retrospective study.

There were 274 pregnancies resulting in 281 infants. Fifty-two women (19%) received an integrase inhibitor: 48 raltegravir (RAL) and only four DTG (three of the four were switched to RAL during pregnancy week 4, 15 and 18). There were no NTDs among infants exposed to DTG.

Eastern and Central European Network Group

The Eastern and Central European Network Group collected epidemiological data on DTG use from 20 countries. Six countries provided detailed information on DTG exposure in pregnancy: Czech Republic, Finland, Greece, Poland, Slovakia and Turkey. Follow-up was to 31 May 2018.

In this cohort, 28 women took DTG in pregnancy; 24 started before conception. Although the report introduced the topic in the background information, the results did not include NTDs – so it is probably safe to assume that the investigators found none.

References

Unless stated otherwise, references are the the programme and abstract from the Glasgow 2018 conference. These are available online as a supplement to the Journal of the IAS.
https://onlinelibrary.wiley.com/toc/17582652/2018/21/S8

  1. Money D et al. An analysis of congenital anomalies in pregnant women living with HIV in Canada: no signal for neural tube defects in women exposed to dolutegravir. HIV Glasgow. 
28–31 October 2018. Glasgow, UK. Poster abstract P001.
  2. Weisman D et al. Use of integrase inhibitors in HIV-positive pregnant women: data from the Frankfurt HIV Cohort
. HIV Glasgow. 
28–31 October 2018. Glasgow, UK. Poster abstract P002.
  3. Kowalska J et al. Exposure to dolutegravir in pregnant HIV-positive women in Central and Eastern Europe and neighbouring countries: data from the ECEE Network Group. 
 HIV Glasgow. 
28–31 October 2018. Glasgow, UK. Poster abstract P004.
  4. Clayden P. Potential safety signal for dolutegravir from the time of conception. HTB. 21 May 2018.
    http://i-base.info/htb/34133

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