Dosage of Ledivir in details
Ledivir Dosage
Generic name: Ledipasvir (Ledivir) 90mg, Sofosbuvir (Ledivir) 400mg
Dosage form: tablet, film coated
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Recommended Dosage
The recommended dosage of Ledivir is one tablet taken orally once daily with or without food.
Relapse rates are affected by baseline host and viral factors and differ between treatment durations for certain subgroups.
Table 1 shows the recommended Ledivir treatment regimen and duration based on patient population.
For patients with HCV/HIV-1 co-infection, follow the dosage recommendations in Table 1. Refer to Drug Interactions (7) for dosage recommendations for concomitant HIV-1 antiviral drugs.
| | Patient Population | Treatment Regimen and Duration |
|---|---|---|
| ||
| Genotype 1 | Treatment-naïve without cirrhosis or with compensated cirrhosis (Child-Pugh A) | Ledivir 12 weeks* |
| Treatment-experienced† without cirrhosis | Ledivir 12 weeks | |
| Treatment-experienced† with compensated cirrhosis (Child-Pugh A) | Ledivir 24 weeks‡ | |
| Treatment-naïve and treatment-experienced† with decompensated cirrhosis (Child-Pugh B or C) | Ledivir + ribavirin§ 12 weeks | |
| Genotype 1 or 4 | Treatment-naïve and treatment-experienced† liver transplant recipients without cirrhosis, or with compensated cirrhosis (Child-Pugh A) | Ledivir + ribavirin¶ 12 weeks |
| Genotype 4, 5 or 6 | Treatment-naïve and treatment-experienced†, without cirrhosis or with compensated cirrhosis (Child-Pugh A) | Ledivir 12 weeks |
For further information on ribavirin dosing and dosage modifications, refer to the ribavirin prescribing information.
Severe Renal Impairment and End Stage Renal Disease
No dosage recommendation can be given for patients with severe renal impairment (estimated Glomerular Filtration Rate [eGFR] less than 30 mL/min/1.73 m2) or with end stage renal disease (ESRD) due to higher exposures (up to 20-fold) of the predominant Sofosbuvir (Ledivir) metabolite.
More about Ledivir (Ledipasvir (Ledivir) / Sofosbuvir (Ledivir))
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What other drugs will affect Ledivir?
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Ledivir, especially:
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Atripla (efavirenz, emtricitabine, and tenofovir);
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digoxin (digitalis);
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other drugs to treat hepatitis C, such as simeprevir (Olysio) or Sofosbuvir (Ledivir) (Sovaldi);
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ritonavir (Norvir) when used with tipranavir (Aptivus);
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rosuvastatin (Crestor);
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tenofovir when used in combination with atazanavir, darunavir, lopinavir, or ritonavir;
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Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir);
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seizure medicine--carbamazepine, oxcarbazepine, phenobarbital, phenytoin;
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stomach acid reducers--cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), ranitidine (Zantac), and others; or
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tuberculosis medicine--rifabutin, rifampin, rifapentine.
This list is not complete. Other drugs may interact with Ledivir, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Ledivir interactions
Potential For Drug Interaction
As Ledivir contains Ledivir, any interactions that have been identified with these agents individually may occur with Ledivir.
After oral administration of Ledivir, Sofosbuvir (Ledivir) is rapidly absorbed and subject to extensive first-pass hepatic extraction. In clinical pharmacology studies, both Sofosbuvir (Ledivir) and the inactive metabolite GS-331007 were monitored for purposes of pharmacokinetic analyses. Ledipasvir (Ledivir) 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.
Ledivir 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 Ledivir plasma concentrations, leading to reduced therapeutic effect of Ledivir, and the use with P-gp inducers is not recommended with Ledivir.
Established And Potentially Significant Drug Interactions
Table 4 provides a listing of established or potentially clinically significant drug interactions. The drug interactions described are based on studies conducted with either Ledivir, the components of Ledivir (Ledivir) as individual agents, or are predicted drug interactions that may occur with Ledivir.
Table 4 : Potentially Significant Drug Interactions: Alteration in Dose or Regimen May Be Recommended Based on Drug Interaction Studies or Predicted Interaction These interactions have been studied in healthy adults.
Drugs Without Clinically Significant Interactions With Ledivir
Based on drug interaction studies conducted with the components of Ledivir (Ledipasvir (Ledivir) or Sofosbuvir (Ledivir)) or Ledivir, no clinically significant drug interactions have been either observed or are expected when Ledivir is used with the following drugs : abacavir, atazanavir/ritonavir, cyclosporine, darunavir/ritonavir, dolutegravir, efavirenz, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide, emtricitabine, lamivudine, methadone, oral contraceptives, pravastatin, raltegravir, rilpivirine, tacrolimus, or verapamil. See Table 4 for use of Ledivir with certain HIV antiretroviral regimens.
References
- DailyMed. "LEDIPASVIR; SOFOSBUVIR: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- FDA/SPL Indexing Data. "013TE6E4WV: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
- MeSH. "Antiviral Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Ledivir are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Ledivir. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported frequency of use
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Information checked by Dr. Sachin Kumar, MD Pharmacology
