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 infections.
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
Since Harvoni contains ledipasvir and sofosbuvir, any interaction with these drugs alone may occur.
After oral tablets, sofosbuvir is rapidly absorbed and undergoes extensive extraction of the liver for the first time. In clinical pharmacology studies, sofosbuvir and the inactive metabolite GS-331007 were monitored for pharmacokinetic analysis. Ledipasvir is an inhibitor of the drug transporter P-gp and breast cancer resistance protein (BCRP) and can increase intestinal absorption of the co-administered substrates of these transporters.
Ledipasvir and sofosbuvir are substrates for the drug transporters P-gp and BCRP, while GS-331007 is not. P-gp inducers (such as rifampicin or St. John's wort) reduce the plasma concentrations of ledipasvir and sofosbuvir, resulting in reduced therapeutic effects of Harvoni, and Harvoni is not recommended for use with P-gp inducers.
Sofosbuvir and Ledipasvir Tablets
|Strength||400mg And 90mg|