Abstract
Doravirine is a non-nucleoside reverse transcriptase inhibitor for treatment of human immunodeficiency virus type 1 (HIV-1) infection. A population pharmacokinetic (PK) model for treatment-naive participants in doravirine clinical studies was updated with data from switch participants in the DRIVE-SHIFT trial and used to estimate individual post hoc PK parameter values and evaluate the efficacy exposure-response relationship. The results support the 100-mg dose for people living with HIV switching to a doravirine-based regimen (This study has been registered at ClinicalTrials.gov under ClinicalTrials registration no. NCT02397096.).
Highlights
Doravirine is a non-nucleoside reverse transcriptase inhibitor for treatment of human immunodeficiency virus type 1 (HIV-1) infection
DOR/3TC/tenofovir disoproxil fumarate (TDF) is approved for the treatment of HIV-1 infection in adults who have not received prior ARV treatment or who are virologically suppressed on a stable ARV regimen that can be appropriately replaced by DOR/3TC/TDF [4]
The primary endpoint in DRIVE-SHIFT was the proportion of participants with an HIV-1 RNA level of Ͻ50 copies/ml (U.S Food and Drug Administration [FDA] snapshot approach), with the primary comparison between ISG at week 48 and DSG at week 24
Summary
Doravirine is a non-nucleoside reverse transcriptase inhibitor for treatment of human immunodeficiency virus type 1 (HIV-1) infection. The main objectives of the current analysis were to evaluate the consistency of DOR pharmacokinetics (PK) in the ISG population with that of the treatment-naive population described previously [9] and to evaluate the exposure-response relationship between different quantiles of DOR exposure and the primary endpoint in ISG participants to further inform on the efficacy and appropriateness of a switch to a DOR-based regimen.
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