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RESEARCH QUESTION

In Europe, HIV infected women are advised not to breastfeed. However, recent viewpoints and guidelines show the movement towards a more tailored approach and shared-decision making with the patient about breastfeeding. It is unknown what the best treatment is for these women. Our pharmacokinetic studies will support an concrete advise for the preferred antiretroviral regimen for women living with HIV with the desire to breastfeed, with optimal protection for the child against HIV infection.

HYPOTHESIS

Define a preferred antiretroviral regimen for these breastfeeding women by performing pharmacokinetic studies.

STUDY DESIGN

Pharmacokinetic studies to investigate the transition into breastmilk from the most recent single tablet regimens (PK study) and preferred antiretroviral agents during pregnancy (Therapeutic drug monitoring TDM study). Survey administered by interviewers including questions on implementation of breastfeeding advice and quality of life questionnaires.

STUDY POPULATION

PK study: healthy women who have breastfed

TDM study: women with HIV who are breastfeeding or have breastfed

Survey: women living with HIV in the Netherlands.

INTERVENTION

PK study: single dose of antiretroviral medicine and blood and breastmilk collection.

TDM study: collection blood and breastmilk samples.

Survey: questionnaires.

OUTCOME MEASURES

PK + TDM study: transfer into breastmilk of doravirine, bictegravir, TAF, darunavir and raltegravir. Survey: implementation guidance and impression of quality of life

SAMPLE SIZE/DATA-ANALYSIS

PK study: 24 subjects, with a 30% CV% a sample size of 12 per drug will result in reliable PK parameters.

TDM study: samples from ~40 women mainly on darunavir or raltegravir (current drug women who are breastfeeding use).

Survey: 3800 women are living with HIV in the Netherlands, we will be able to contact around 1000 women, of whom we expect 10% to participate, resulting in 100 women.

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