Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Atea Pharmaceuticals, Inc. | AVIR | 2 | PHASE3 | Bemnifosbuvir-Ruzasvir, Sofosbuvir-Velpatasvir |
| Abbott Laboratories | ABT | 2 | - | Undisclosed |
| AbbVie, Inc. | ABBV | 1 | - | Undisclosed |
Harvoni is used for Hepatitis C and Porphyria Cutanea Tarda. It is a small molecule drug being developed by Gilead Sciences, Inc. for these indications. Harvoni is currently in Phase 2 clinical development for these conditions.
Harvoni is a small molecule drug that targets the Hepatitis C virus. It is being studied for the treatment of Hepatitis C and related conditions such as Porphyria Cutanea Tarda and cryoglobulinemia.
Harvoni is developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The drug is currently in Phase 2 clinical development for Hepatitis C and Porphyria Cutanea Tarda.
Harvoni is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. Clinical trials for Harvoni are completed, with a total of 23 participants enrolled across two studies.
Harvoni has been studied in two completed Phase 2 clinical trials. NCT02825212 evaluated the efficacy of all-oral anti-viral therapy for symptomatic Hepatitis C virus infection-related cryoglobulinemia, enrolling 10 participants. NCT03118674 studied Harvoni treatment for Porphyria Cutanea Tarda, enrolling 23 participants.
Harvoni is a brand name for a combination of ledipasvir and sofosbuvir, which are direct-acting antiviral agents used to treat Hepatitis C. The drug is being studied for additional indications such as Porphyria Cutanea Tarda.