NDAORALTABLETPriority Review
Approved
Oct 2014
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
51
Data completeness
7/8 — Comprehensive
Priority Review
HARVONI (ledipasvir and sofosbuvir) by Gilead Sciences is p-glycoprotein inhibitors [moa]. Approved for hepatitis c virus ns5a inhibitor [epc]. First approved in 2014.
Drug data last refreshed 19h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HARVONI is an oral fixed-dose combination tablet containing ledipasvir (an NS5A inhibitor) and sofosbuvir, approved by the FDA on October 10, 2014. It is indicated for the treatment of chronic hepatitis C virus (HCV) infection. The combination works through dual mechanism inhibition of viral NS5A protein and nucleotide polymerase, directly targeting HCV replication. HARVONI represents a foundational direct-acting antiviral (DAA) regimen that transformed HCV treatment from interferon-based therapy to all-oral, interferon-free regimens.
$0.1BPart D
8.2 years to LOEMechanism of Action
P-Glycoprotein Inhibitors
Pharmacologic Class:
Hepatitis C Virus NS5A Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (51)
The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study
Started Jul 2020
87 enrolled
Hepatitis C, Chronic
Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks in Adults With Chronic HCV Infection and Compensated Cirrhosis
Started Oct 2019
37 enrolled
Hepatitis C Virus Infection
Ledipasvir/Sofosbuvir for Hepatitis B Virus Infection
Started Feb 2018
21 enrolled
Hepatitis B
Harvoni Treatment Porphyria Cutanea Tarda
Started Sep 2017
23 enrolled
Porphyria Cutanea TardaHepatitis C
Safety And Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Adults Who Participated in a Prior Gilead-Sponsored HCV Treatment Study
Started Apr 2017
31 enrolled
Hepatitis C Virus Infection
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.