BACKGROUND: Current Kenya National Anti-retroviral (ARV) Guidelines and World Health
Organization (WHO) Guidelines recommend first-line therapy of tenofovir disoproxil fumarate
(TDF), lamivudine (3TC) and dolutegravir (DTG) for adult people living with HIV (PLHIV). This
regimen has limitations, particularly for the aging PLHIV who are more likely to have
pre-existing comorbidities and higher risk of developing comorbidities, including osteopenia,
osteoporosis, and renal insufficiency. Abacavir, the preferred alternative nucleoside reverse
transcriptase inhibitor (NRTI) in Kenya, is associated with increased cardiovascular risk
that also limits its use in elderly populations. B/F/TAF is highly efficacious, well
tolerated, co-formulated in a small pill, and does not have the same bone, renal or
cardiovascular risks associated with currently recommended regimens in Kenya. We are not
aware of any clinical trial to date that has been fully powered to compare ARV regimens for
the increasing population of elderly PLHIV.
BROAD OBJECTIVE: We will compare the efficacy, safety, and impact on bone mineral density of
switching to B/F/TAF to that of remaining on current ARV regimen in a population of elderly
patients (60 years old or greater) with no prior confirmed treatment failure in Kenya.