Pifeltro FDA Approval History
Last updated by Judith Stewart, BPharm on June 30, 2022.
FDA Approved: Yes (First approved August 30, 2018)
Brand name: Pifeltro
Generic name: doravirine
Dosage form: Tablets
Company: Merck
Treatment for: HIV Infection
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 adults and pediatric patients weighing at least 35 kg:
- 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.
- Pifeltro works as an antiviral by binding to HIV-1 reverse transcriptase to prevent HIV from multiplying in the body.
- Pifeltro tablets are taken orally once daily with or without food.
- Common adverse reactions include nausea, dizziness, headache, fatigue, diarrhea, abdominal pain, and abnormal dreams.
Development timeline for Pifeltro
Further information
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