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EPIC

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Evaluation of Pharmacokinetic drug-drug Interactions between hormonal Contraceptives and doravirine-containing ART among women living with HIV in South Africa (EPIC).

Rationale

While DOR-containing antiretroviral therapy (ART) has been studied in two large clinical trials, the representation of women, especially African women, has been disproportionately low at only 16-17% and 6-10%, respectively. Given that women of reproductive age in Africa are heavily impacted during epidemics, it’s crucial to conduct trials specifically focusing on African women’s outcomes. Adding to this urgency is the lack of data on potential drug-drug interactions (DDIs) between DOR and common hormonal contraceptives used in Africa’s public family planning clinics.

Our study aims to fill this gap by examining potential DDIs between DOR and commonly used contraceptive methods among women living with HIV in an African context. This includes short-acting (e.g., oral contraceptive pills/combined oral contraceptives), intermediate (e.g., injectables), and long-acting (e.g., implants or intrauterine devices) methods. We’ve excluded daily oral contraceptives from the study, as previous research found no significant bidirectional DDIs between DOR and a common combined oral contraceptive containing ethinyl estradiol and levonorgestrel.

The EPIC study focuses on intermediate- and long-acting contraceptive methods, which may have different pharmacokinetic profiles than daily oral drugs and could be more susceptible to potential DDIs with DOR. Participants will have the choice to select their contraceptive method group, and those already on EFV- or DTG-containing ART who wish to switch to DOR-containing ART will be included in the DOR groups (Groups 1-4), while those preferring to remain on DTG will form the DTG group.

Investigators

  • Wits RHI
  • Prof. Thesla Palanee-Phillips (Co-Principal Investigator)
  • Dr. Nkosiphile Ndlovu (Co-Principal Investigator)

Latest Update

April 2024

For more details about EPIC please email rhicomms@wrhi.ac.za

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