Susan Jacob, PharmD

Nominated From: University of Washington

Research Site: Kenya

Research Area: HIV/AIDS

Primary Mentor: Alison Roxby

Research Project


Dolutegravir Use in Women and Adolescent Girls of Childbearing Age in Nairobi, Kenya


In May 2018, news broke that dolutegravir (DTG), a first line anti-retroviral agent, may cause serious birth defects in infants if taken at the time of conception. This birth defect is caused by incompletely formed neural tube, which forms the foundation of the spinal cord, brain and bone and tissues that surround it. This potential safety issue was brought to light by an unplanned interim analysis of an ongoing surveillance study in Botswana. This same study found no significant difference in birth outcomes between DTG and efavirenz based treatments in women who started treatment during pregnancy. In response to this, the WHO, the US Food and Drug Administration and the European Medicines Agency issued warnings about the use of DTG by women at the time of conception. In August 2018, the Kenya Ministry of Health (MOH) issued new guidelines stating DTG is not recommended for women and adolescent girls of childbearing potential; however, they may choose to remain on DTG based regimen if they are on effective contraception.
This situation provides a unique window of time to gather baseline data on patient’s experience of switching from DTG to an alternate regimen as DTG has been available as first line preferred agent in Kenya since 2017. Currently there is very little data on switching back to alternate regimens as DTG is generally well tolerated and has a low resistance profile.
This project will be conducted at the Comprehensive Care Clinic (CCC) in Kenyatta National Hospital (KNH) in Nairobi Kenya. This clinic cares for about 200 HIV-infected adults daily and more than 9000 patients each year.
The overarching goal of the project is to determine the total number of patients prescribed DTG at the CCC clinic in the last 2 years and to further elucidate the proportion of women and adolescent girls of child bearing age who are currently on DTG. We will also assess patient experience of switching to non-DTG regimen with respect to adverse events and patient tolerance.


Research Significance

Provide relevant, timely data on patient experience of switching from DTG to alternate regimen



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