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Drugs. 2018 Oct;78(15):1643-1650. doi: 10.1007/s40265-018-0993-4.

Doravirine: First Global Approval.

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1
Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.

Abstract

Doravirine is a new non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Merck & Co for the treatment of HIV-1 infection. The drug is approved in the USA both as a single-agent tablet (Pifeltro™) and as a fixed-dose combination tablet with the nucleos(t)ide reverse transcriptase inhibitors lamivudine and tenofovir disoproxil fumarate (Delstrigo™). Each formulation is indicated in the USA for treating HIV-1 infection in adults with no prior antiretroviral treatment, has received a positive opinion in the EU for treating HIV-1 infection in adults without resistance to NNRTIs or (in the case of the fixed-dose combination tablet) lamivudine or tenofovir, and is also under regulatory review for the treatment of HIV-1 infection in Canada. This article summarizes the milestones in the development of doravirine leading to this first approval for the treatment of HIV-1 infection in treatment-naïve adults.

PMID:
30341683
DOI:
10.1007/s40265-018-0993-4
[Indexed for MEDLINE]

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