Doravirine Dose Optimisation in Pregnancy

A randomised, open label, controlled PK standard of care vs doravirine plus 2 nucleoside reverse transcriptase inhibitors backbone in pregnant women initiating combination antiretroviral therapy in the second trimester of pregnancy.

Inclusion Criteria:Women ≥ 18 years oldAbility to give informed consent prior to participationWilling and able to comply with all study requirementsHIV positivePregnant (initiating cART ≥ 12 weeks and < 26 weeks gestation)Intention to breastfeed postpartumExclusion Criteria:Received any cART in preceding 6 monthsChronic hepatitis B (HBV) infection with clinical evidence of transaminitisElevations in serum levels of alanine aminotransferase (ALT) > 5 times the upper limit of normal (ULN) or ALT > 3xULN and bilirubin >2xULN (with > 35 % direct bilirubin)Previous documented failure of an NNRTI-containing cART regimenPrevious history of hypersensitivity to any ARVConcomitant medication which are inducers of SoC and DOR metabolism (e.g. rifampicin, anti-epileptic agents, rifabutin, St John's Wort, mitotane, enzalutamide, lumacaftor). Contraindicated medications can be found on Liverpool Drug Interactions website (hiv-druginteractions.org)Participants with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption cannot take DOR as the tablet contains lactose monohydrateClinical depression or clinical judgment suggests increased risk of suicidality