Harvoni Trade Information
|Minimum Order Quantity||1.00||Unit of Measure||Piece/Pieces|
|Payment Terms||Cash Advance (CA), Paypal, Others||Supply Ability||On Order Per Week|
|Delivery Time||7-15 Days||Sample Policy||Within a certain price range free samples are available|
|Packaging Details||Carton Boxes Packaging||Main Export Market(s)||Asia, Australia, Central America, North America, South America, Eastern Europe, Western Europe, Africa|
|Main Domestic Market||All India||Certifications||Certified Products.|
|Export Countries Details:||Countries: Russsia, Ukrain, Korea, Ajbakistan, Romania, Kajistan, Poland, USA, India, Philipines & China|
Prices of Harvoni Tablets Distributors, Traders, Exporters & Suppliers
Harvoni is a fixed-dose combination tablet containing ledipasvir and sofosbuvir for oral administration. Ledipasvir is an HCV NS5A inhibitor and sofosbuvir is a nucleotide analog inhibitor of HCV NS5B polymerase.
Doses & Administration
Each tablet contains 90 mg ledipasvir and 400 mg sofosbuvir. Tablets include the following inactive ingredients: colloidal silicon dioxide, copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. These tablets are film-coated with a coating material containing the following inactive ingredients: FD&C yellow #6/sunset yellow FCF aluminum lake, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.
It is indicated with or without ribavirin for the treatment of patients with chronic hepatitis C virus (HCV) genotype 1, 4, 5, or 6 infection.
If Harvoni is administered with ribavirin, refer to the prescribing information for ribavirin for a description of ribavirin-associated adverse reactions. The safety assessment was based on pooled data from three randomized, open-label Phase 3 clinical trials (ION-3, ION-1 and ION-2) of subjects with genotype 1 HCV with compensated liver disease (with and without cirrhosis) including 215, 539, and 326 subjects who received once daily by mouth for 8, 12 and 24 weeks, respectively.
The proportion of subjects who permanently discontinued treatment due to adverse events was 0%, less than 1%, and 1% for subjects receiving these tablets for 8, 12, and 24 weeks, respectively.
The most common adverse reactions (at least 10%) were fatigue and headache in subjects treated with 8, 12, or 24 weeks of Harvoni.
Potential For Drug Interaction
As Harvoni contains ledipasvir and sofosbuvir, any interactions that have been identified with these agents individually may occur with tablets.
After oral administration of tablets, sofosbuvir is rapidly absorbed and subject to extensive first-pass hepatic extraction. In clinical pharmacology studies, both sofosbuvir and the inactive metabolite GS-331007 were monitored for purposes of pharmacokinetic analyses. Ledipasvir is an inhibitor of the drug transporters P-gp and breast cancer resistance protein (BCRP) and may increase intestinal absorption of coadministered substrates for these transporters.
Ledipasvir and sofosbuvir are substrates of drug transporters P-gp and BCRP while GS-331007 is not. P-gp inducers (e.g., rifampin or St. John’s wort) may decrease ledipasvir and sofosbuvir plasma concentrations, leading to reduced therapeutic effect of Harvoni, and the use with P-gp inducers is not recommended with Harvoni.