The draft reports were shared with the respective sponsor companies before publication. The addition of instructions for use ifu for the oral pellets to update the prescribing informations pi dosage and adminstration. The median terminal halflife of sofosbuvir following administration of ledipasvirsofosbuvir is 0. Harvoni ledipasvirsofosbuvir expanded orphan indication, new. On august 28, 2019, the fda approved gileads harvoni. Real world analysis of ledipasvirsofosbuvir harvoni. Ledipasvir is a drug for the treatment of hepatitis c that was developed by gilead sciences.
Safety pooled safety data for ledipasvirsofosbuvir is available from the three phase 3 clinical trials. Coadministered drug dose of drug dose of ledipasvirsofosbuvir effect on drug levels effect on ledipasvirsofosbuvir levels potential clinical effects. In addition, ledipasvirsofosbuvir is indicated for the treatment of hepatitis c in persons coinfected with hiv. The aim of this study was to evaluate the treatment outcome of ledipasvirsofosbuvir ldvsof for patients with chronic hepatitis c virus genotype 2 infection. Extensively metabolized in liver to form the pharmacologically active nucleoside analog triphosphate gs461203. Ledipasvirsofosbuvir is approved for the treatment of chronic hepatitis c virus hcv genotype 1 infections in adults. Harvoni ledipasvir and sofosbuvir tablet, film coated harvoni ledipasvir and sofosbuvir pellet gilead sciences, inchighlights of prescribing information these highlights do not include all the information needed to use harvoni safely and effectively. Hepatitis c treatment factsheet harvoni sofosbuvir.
Oncedaily ledipasvirsofosbuvir with or without ribavirin for 12 or 24 weeks was highly effective in previously untreated patients with hcv genotype 1 infection. Svrs did not differ in patients receiving ledipasvirsofosbuvir with or without ribavirin. What drugs, substances, or supplements interact with harvoni. The ledipasvirsofosbuvir combination is a daa agent that interferes with hcv replication and can be used to treat patients without pegifn or ribavirin. Ledipasvirsofosbuvir has limited potential for clinically significant drug interactions with most antiretroviral agents. Whether and in which patients their improved efficacy justifies their increased cost is unclear. Ledipasvir and sofosbuvir for 12 weeks for hepatitis c. The recommended dosage of harvoni is one tablet taken orally once daily with or without food. After completing phase iii clinical trials, on february 10, 2014 gilead filed for u. The median terminal halflife of ledipasvir in healthy volunteers following administration of ledipasvirsofosbuvir in the fasted state is 47 hours. Ledipasvirsofosbuvir generic brand hicl gcn exception. Overall, strenuous efforts made on the antihcv drug development are paying off with the development of four daas including boceprevir, telaprevir, sofosbuvir, and ledipasvir. Harvoni is a twodrug fixeddose combination product that contains 90 mg of ledipasvir and 400 mg of sofosbuvir in a single tablet. The ledipasvirsofosbuvir combination is a directacting antiviral agent that interferes with hcv replication and can be.
If you miss a dose, take the missed dose as soon as you remember the same day. Therapynaive genotype 1 patients without cirrhosis. Seven of those patients came from the 12week ledipasvirsofosbuvir arm and four came from the 12week ledipasvir. Ledipasvir and sofosbuvir is a combination medicine used to treat chronic hepatitis c in adults and children who are at least 3 years old. Ledipasvirsofosbuvir is a preferred regimen for initial treatment and retreatment of patients with genotypes 1, 4, 5, or 6 chronic hepatitis c infection. Ledipasvir and sofosbuvir for untreated hcv genotype 1. Ledipasvir 90 mg with sofosbuvir 400 mg qdledipasvir auc, cmin, cmax all v 34% sofosbuvir. Ledipasvirsofosbuvir generic brand hicl gcn exceptionother ledipasvir sofo sbuvir harvoni 41457 this drug requires a written request for prior authorization. Efficacy and safety of ledipasvirsofosbuvir with and without. Sofosbuvir for 12 weeks in children 3 to aasld journals. Ribavirin must be administered with food, and if tolerated, the dose may be increased as follows.
Johns wort may decrease ledipasvir and sofosbuvir plasma concentrations, leading to reduced therapeutic effect of harvoni, and the use with pgp inducers is not recommended with harvoni see. Patient information harvoni harvoenee ledipasvir and. Harvoni is a fixeddose combination of ledipasvir, a hepatitis c virus. Side effects of harvoni ledipasvir and sofosbuvir tablets. The ledipasvir and sofosbuvir fixeddose combination tablet was initially approved for use. Ledipasvir with sofosbuvir is recommended as an option for treating adults with chronic hepatitis c infection. Crossresistance between sofosbuvir, ledipasvir, and ribavirin has not been identified.
Ledipasvir and sofosbuvir for hcv in patients coinfected. Harvoni ledipasvirsofosbuvir dose, indications, adverse. Ledipasvir sofosbuvir dosage guide with precautions. It was approved in europe in november 2014 for treatment of adults with genotype 1 or 4 chronic.
Ledipasvir and sofosbuvir is sometimes given in combination with another medicine called ribavirin ledipasvir and sofosbuvir treats specific genotypes of hepatitis c, and only in certain people. Ledipasvirsofosbuvir with or without ribavirin achieved svrs in the range of 9499%. Therapyexperienced patients have failed a peginterferon alfa with or without ribavirinbased regimen with or without an hcv protease inhibitor. Ledipasvirsofosbuvir harvoni treatment hepatitis c online. It is a combination pill containing sofosbuvir sold separately as sovaldi plus ledipasvir. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic hcv. Ledipasvirsofosbuvir for 8 weeks can be considered in those who have pretreatment hcv rna less than 6 million international unitsml. Efficacy and safety of ledipasvirsofosbuvir with and without ribavirin in patients with chronic hepatitis c virus genotype 1 infection.
To view the entire topic, please sign in or purchase a subscription. Dose does not exceed ledipasvirsofosbuvir 90 mg400 mg 1 tablet per day. If you take harvoni with ribavirin, you should also read the medication guide for ribavirin. Eleven of 440 patients had a virological relapse after the end of treatment. Sofosbuvir and ledipasvir, which have recently been approved for treatment of chronic hepatitis c virus hcv infection, are more efficacious and safer than the old standard of care osoc but are substantially more expensive.
Hcv ns5a inhibitor, and sofosbuvir, an hcv nucleotide analog. Ledipasvir and sofosbuvir are substrates of drug transporters pgp and bcrp while gs331007 is not. The use of harvoni for the treatment of chronic hepatitis c virus infection in patients with severe renal impairment including patients with end stage renal disease on. Ledipasvir is a potent inhibitor of hcv nonstructural protein 5a ns5a, a viral phosphoprotein that plays an important but poorly understood role in viral replication, assembly, and secretion. This medication is a combination of ledipasvir and sofosbuvir and is used to treat chronic longlasting hepatitis c, a viral infection of the liver.
Ledipasvirsofosbuvir july 12, 2018 ion1 pdf ion1 pptx. Costeffectiveness of hcv treatment with sofosbuvir and. If a member had at least 56 days eight or more weeks of therapy they were considered a completer. Variation assessment report as adopted by the chmp with all information of a commercially confidential nature deleted. Harvoni is a fixeddose combination of ledipasvir, a hepatitis c virus hcv ns5a inhibitor, and sofosbuvir, an hcv nucleotide analog ns5b polymerase inhibitor, and is indicated for the treatment of chronic hepatitis c virus hcv in adults and pediatric patients 3 years of age and older. Ledipasvir with sofosbuvir drug bnf content published. These prior approval supplemental new drug applications provide for the following. Harvoni combines the ns5a inhibitor ledipasvir with the nucleotide. The combination of sofosvubir and ledipasvir can be administered without regard to food. It is a combination pill containing sofosbuvir sold separately as. Ci, 95100% for 24 weeks of ledipasvir sofosbuvir, and 99% 95% ci, 95100% for 24 weeks of ledipasvirsofosbuvir plus ribavirin.163 1598 1517 1499 915 665 30 405 836 676 314 383 584 211 1034 98 95 46 744 288 658 1378 1568 543 588 215 76 73 1238 1500 1479 1144 760 1119 546 332 231 304 77 131 280 532 393