Doravirine exposure and HIV-1 suppression after switching from an efavirenz-based regimen to doravirine/lamivudine/tenofovir disoproxil fumarate

Wayne Greaves; Hong Wan; Ka Lai Yee; Bhargava Kandala; Pavan Vaddady; Carey Hwang

doi:10.1128/AAC.01298-19

Doravirine exposure and HIV-1 suppression after switching from an efavirenz-based regimen to doravirine/lamivudine/tenofovir disoproxil fumarate

Antimicrob Agents Chemother. 2019 Sep 9;63(12):e01298-19. doi: 10.1128/AAC.01298-19. Epub 2019 Sep 23.

Authors

Wayne Greaves¹, Hong Wan², Ka Lai Yee³, Bhargava Kandala³, Pavan Vaddady³, Carey Hwang⁴

Affiliations

¹ Global Clinical Development Infectious Diseases, Merck & Co., Inc., Kenilworth NJ, USA wayne.greaves@merck.com.
² Biostatistics and Research Decision Sciences, Merck & Co., Inc., Kenilworth NJ, USA.
³ Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck & Co., Inc., Kenilworth NJ, USA.
⁴ Global Clinical Development Infectious Diseases, Merck & Co., Inc., Kenilworth NJ, USA.

Abstract

Doravirine is a non-nucleoside reverse transcriptase inhibitor approved for the treatment of HIV-1. In a phase 1 trial, doravirine exposure was transiently decreased when treatment was started immediately after stopping efavirenz. In a post-hoc subgroup analysis of participants who switched from an efavirenz-based regimen to doravirine/lamivudine/tenofovir disoproxil fumarate in the phase 3 DRIVE-SHIFT trial, doravirine plasma levels at week 4 were similar to non-induced levels, and HIV-1 suppression was maintained at weeks 24 and 48.