Population Pharmacokinetic and Pharmacodynamic Analysis To Evaluate a Switch to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate in People Living with HIV-1

Author:

Vaddady Pavan1,Kandala Bhargava1,Yee Ka Lai1

Affiliation:

1. Merck & Co., Inc., Kenilworth, New Jersey, USA

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.

Funder

Merck Sharp & Dohme Corp.

Publisher

American Society for Microbiology

Subject

Infectious Diseases,Pharmacology (medical),Pharmacology

Reference11 articles.

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3. Merck Sharp & Dohme Corp. 2019. PIFELTRO (doravirine) prescribing information. Merck & Co, Inc, Whitehouse Station, NJ. https://www.merck.com/product/usa/pi_circulars/p/pifeltro/pifeltro_pi.pdf. Accessed 16 March 2020.

4. Merck Sharp & Dohme Corp. 2019. DELSTRIGO (doravirine/lamivudine/tenofovir disoproxil fumarate) prescribing information. Merck Sharp & Dohme Corp, Whitehouse Station, NJ. https://www.merck.com/product/usa/pi_circulars/d/delstrigo/delstrigo_pi.pdf. Accessed 16 March 2020.

5. Doravirine dose selection and 96-week safety and efficacy versus efavirenz in antiretroviral therapy-naive adults with HIV-1 infection in a Phase IIb trial

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