In 2017, the Infectious Disease Institute (IDI) introduced dolutegravir (DTG)-based regimens in its Kampala clinic in Uganda. In May 2018, the WHO and international regulators released warnings on a possible increased risk of neural tube defects in infants born to women taking DTG at the time of conception. In response, IDI implemented a process to inform and support women already on DTG to make informed treatment choices.
A clinic response plan was developed in the first week following the alert and clinic staff were trained on safety guidance. All women <55 years on DTG were identified from the clinic database and contacted by phone for earlier appointments. From May-June, group counselling sessions (<15 women/ group) were held. Non-menopausal and non-surgically sterilized women were referred for urine pregnancy testing, evaluation of pregnancy intentions in next 12 months and effective family planning was offered (preferably condoms plus implants, IUDs, depo-provera or pills). Pregnancies were confirmed by ultrasound and obstetrician review. Women intending to conceive were offered efavirenz (EFV)-based regimens. Women that chose to remain on DTG without effective family planning signed a declaration of informed choice. We used modified Poisson regression to determine factors associated with switching off DTG.
9% (692/7963) were identified to be on DTG and 95% (658/692) were reviewed by September 2018. 22% (146/658) were menopausal or surgically sterilized. 510 women were of reproductive potential with median age (IQR); 37 (30 – 42) and mean duration (SD) on DTG of 4.26 months (1.63). 5% (23/510) were HCG positive and all initial ultrasound reports revealed no deformities. 21% (108/510) had intentions to conceive and opted to be switched off DTG with 90% (97/108) switched to EFV. 79% (402/510) opted to stay on DTG. However only, 40% (160/402) chose effective contraceptives methods and 60% (242/402) opted for condoms only/no contraceptive method. Factors associated with switching off DTG were younger age (Prevalence Ratio (PR) 0.96 [95% CI: 0.94, 0.99, p=0.002]) and not using effective contraception (PR 0.04 [95% CI: 0.01,0.15, p<0.001]).
A rapid well-coordinated response ensured prompt communication of the DTG safety warning. Women made informed decisions with most opting to stay on DTG however effective contraception uptake was low. While a patient-centered approach was feasible in this clinic, ongoing monitoring for DTG pregnancy exposures is needed.