Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication Ledipasvir and sofosbuvir is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) [see Dosage and Administration (2.2 and 2.3) and Clinical Studies (14) ]: genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis genotype 1 infection with decompensated cirrhosis, for use in combination with ribavirin genotype 1 or 4… FDA label
Harvoni · 2 trials · 3 indications
Resolution of active PCT, defined as normalization of plasma porphyrins (less than 0.9 mcg/dL) by 7 months after start of therapy
Number of participants who attain SVR, ie, cleared HCV
Response to medication in patients with MC categorized as either complete response (100% response) vs partial response (50% response).
| Arm | Type | Description |
|---|---|---|
| Harvoni | EXPERIMENTAL | 1 tablet per day, oral, taken with or without food. 8 weeks for patients without cirrhosis, not previously treated with HCV GT1 and HCV rNA \< 6 million IU/mL; 12 weeks for patients without cirrhosis; 24 weeks for patients with compensated cirrhosis |
| Participant with Symptomatic Hepatitis C Virus Infection-Related Cryoglobulinemia | EXPERIMENTAL | Participants treated with either Harvoni or Epclusa * Harvoni 90mg/400 mg FDC once daily. Subjects will take 1 tablet daily with or without food. * Epclusa 400mg/100mg 400mg/100mg FDC once daily |
| Name | Type | Description |
|---|---|---|
| Harvoni | DRUG | One capsule of Harvoni/ ledipasvir, 90 mg + sofosbuvir, 400 mg administered daily for 8, 12, or 24 weeks |
| Epclusa | DRUG | once daily for 12 weeks (naïve subjects, non-cirrhotic treatment experienced or treatment experienced subjects with compensated cirrhosis) for genotype 1-6 subjects. |
Inclusion Criteria 1. Willing and able to give informed consent 2. ≥18 years of age 3. Symptoms and signs consistent with PCT and well documented biochemical diagnosis (urinary total porphyrin excretion \> 500 mcg/g Creatinine with HPLC pattern typical of PCT-predominance of 8- and 7-carboxyl porph...
Top 1 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Atea Pharmaceuticals, Inc. | AVIR | 2 | PHASE3 | Bemnifosbuvir-Ruzasvir |
Harvoni is a small molecule antiviral drug developed by Gilead Sciences, Inc. (ticker: GILD) for the treatment of Hepatitis C and Porphyria Cutanea Tarda. It is an oral therapy that has been studied in clinical trials for these infectious disease indications.
Harvoni is used for the treatment of Hepatitis C, a viral infection of the liver. It has also been studied in patients with Hepatitis C who have symptomatic cryoglobulinemia, a condition that can be associated with the infection.
Harvoni is made by Gilead Sciences, Inc., which trades under the ticker symbol GILD. Gilead is the developer responsible for the clinical development of Harvoni.
Harvoni has been studied in Phase 2 clinical trials. It is an investigational therapy and has not been approved by the FDA for the indications studied in these trials.
Harvoni has been evaluated in completed Phase 2 trials, including NCT03118674, which studied Harvoni treatment for Porphyria Cutanea Tarda in 23 participants, and NCT02825212, which assessed all-oral antiviral therapy for Hepatitis C virus infection-related cryoglobulinemia in 10 participants.
Harvoni is a specific fixed-dose combination antiviral medication developed by Gilead Sciences. It is distinct from other Hepatitis C therapies and should not be confused with them.