2 of 12

Background (1/2)

Novel, 2^nd generation integrase strand transfer inhibitor

Less toxicity
Less resistance
Better viral load suppression

WHO 2018:DTG as preferred choice for first line treatment of HIV
Change of policy & guidelines for HIV programs

Tsepamo study, Botswana

Increased risk of neural tube defects (NTDs)
May 2018: 1 NTD per 100 births
April 2020: 2 NTDs per 1000 births

3 of 12

Background (2/2)

Ghana rolled out DTG for the first time in 2019 adopting WHO caution in its guidelines
Research on DTG commissioned to assess treatment outcomes in 2020
This sub-study assessed DTG safety among pregnant women in the cohort of women initiated on DTG in Ghana, a country with folic acid fortification of food.

WHO caution in 2018:

use Efavirenz (EFV) instead in pregnancy women in 1^st trimester
Effective contraception for non-pregnant women on DTG

WHO updated recommendations on DTG to include pregnant women in 2019 after more evidence of less risk

4 of 12

METHODS (1/4)

Study design:

Prospective observational study
Facility-based (multicenter)
Sub-study

(Sept 2020 to Aug 2022)

Study site

Study population

Figure 1: Study regions in Ghana, 2022

5 of 12

Methods (2/4)

Patient selection:
Non-pregnant women in the cohort initiated on DTG were eligible
They were to notify clinicians of desire to get pregnant for DTG change to EFV as per national HIV treatment guidelines in 2019.
All non-pregnant women in the cohort who were identified to be ≥8 weeks pregnant whilst on DTG without pre-notification of clinicians were included in study and followed up

6 of 12

Methods (3/4)

Primary outcome was presence of neural tube defects (NTDs) in babies at birth

Neural tube defects are defined as a group of birth defects in which an opening in the spine or cranium remains from early in human development.

Data was also collected on the following:

Mode of delivery
Birthweight of babies (normal 2.5 kg -< 4.0 kg; low <2.5kg; macrosomia ≥4.0kg)
Apgar scores (1-10) at 5 minutes

Normal: Score ≥ 7
Anormal: Score <7

7 of 12

Methods (4/4)

Data Analysis and Ethics:

Frequencies and means were calculated for continuous variables and proportions for categorical variables
Incidence rate (IR) were estimated with 95% confidence intervals in STATA

Obtained ethical approval from the Ethics Review Committees of Ghana Health Service and Korle Bu Teaching Hospital
Written inform consent obtained from participants

8 of 12

Results (1/2)

9 of 12

Results (2/2)

Mean age of women was 34 ± 5.0 years
All had HIV-1 except for one with HIV 1&2 dual infection
For babies:
Ninety-seven percent (34/35) had normal birth weight
Mean birthweight was 3.2 ± 0.4 kg.
All Apgar scores were normal
Mean Apgar score was 8.1 ± 1.1.

36 women on DTG throughout pregnancy

34 (94.4%) LB

1 (2.8%) MSB

1 (2.8%) miscarriage

26 (74%) via *SVD

9 (26%) via CS

LB: Live births; MSB: Mascerated still birth; SVD: Spontaneous vaginal delivery; ^CS: Caesarean section

Figure 2: Pregnancy and NTD outcomes among women on DTG, Ghana, 2022

LB: Live births; MSB: Mascerated still birth; SVD: Spontaneous vaginal delivery; ^CS: Caesarean section

Figure 2: Pregnancy and NTD outcomes among women on DTG, Ghana, 2022

No NTDs detected among all deliveries

10 of 12

Conclusion

There were no NTDs in children born to women with dolutegravir exposure within eight weeks of conception in our study.
Despite the small sample size being a limitation, we can report that dolutegravir is safe to use in pregnancy.

1 of 12