Pifeltro FDA Approval History
Pifeltro (doravirine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for the treatment of HIV-1 infection.
Pifeltro is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients:
- with no prior antiretroviral treatment history, OR
- to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine.
Development Timeline for Pifeltro
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