• Dosage of Ledipasvir and sofosbuvir in details
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Dosage of Ledipasvir and sofosbuvir in details

Ledipasvir and sofosbuvir Dosage

Generic name: Ledipasvir (Ledipasvir and Sofosbuvir (Ledipasvir and sofosbuvir)) 90mg, Sofosbuvir (Ledipasvir and sofosbuvir) 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 Ledipasvir and sofosbuvir 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 Ledipasvir and sofosbuvir 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.

Table 1 Recommended Treatment Regimen and Duration for Ledipasvir and sofosbuvir in Patients with Genotype 1, 4, 5 or 6 HCV

​	Patient Population	Treatment Regimen and Duration
* Ledipasvir and sofosbuvir for 8 weeks can be considered in treatment-naïve genotype 1 patients without cirrhosis who have pre-treatment HCV RNA less than 6 million IU/mL. † Treatment-experienced patients include those who have failed a peginterferon alfa + ribavirin based regimen with or without an HCV protease inhibitor. ‡ Ledipasvir and sofosbuvir+ribavirin for 12 weeks can be considered in treatment-experienced genotype 1 patients with cirrhosis who are eligible for ribavirin. See footnote ¶ for ribavirin dosage recommendations. § In patients with decompensated cirrhosis, the starting dosage of ribavirin is 600 mg and can be titrated up to 1000 mg for patients <75 kg and 1200 mg for those ≥75 kg in two divided doses with food. If the starting dosage of ribavirin is not well tolerated, the dosage should be reduced as clinically indicated based on hemoglobin levels. ¶ The daily dosage of ribavirin is weight-based (1000 mg for patients <75 kg and 1200 mg for those ≥75 kg) administered orally in two divided doses with food.
​Genotype 1	Treatment-naïve without cirrhosis or with compensated cirrhosis (Child-Pugh A)	Ledipasvir and sofosbuvir 12 weeks*
	Treatment-experienced† without cirrhosis	Ledipasvir and sofosbuvir 12 weeks
	Treatment-experienced† with compensated cirrhosis (Child-Pugh A)	Ledipasvir and sofosbuvir 24 weeks‡
	Treatment-naïve and treatment-experienced† with decompensated cirrhosis (Child-Pugh B or C)	Ledipasvir and sofosbuvir + ribavirin§ 12 weeks
​Genotype 1 or 4	Treatment-naïve and treatment-experienced† liver transplant recipients without cirrhosis, or with compensated cirrhosis (Child-Pugh A)	Ledipasvir and sofosbuvir + ribavirin¶ 12 weeks
​Genotype 4, 5 or 6	Treatment-naïve and treatment-experienced†, without cirrhosis or with compensated cirrhosis (Child-Pugh A)	Ledipasvir and sofosbuvir 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 (Ledipasvir and sofosbuvir) metabolite.

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Consumer resources

• Ledipasvir and sofosbuvir
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Professional resources

• Ledipasvir and sofosbuvir (AHFS Monograph)
• Ledipasvir and sofosbuvir (FDA)

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• Hepatitis C

What other drugs will affect Ledipasvir and sofosbuvir?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Ledipasvir (Ledipasvir and Sofosbuvir (Ledipasvir and sofosbuvir)) and Sofosbuvir (Ledipasvir and sofosbuvir), especially:

• Atripla (efavirenz, emtricitabine, and tenofovir);

• digoxin (digitalis);

• other drugs to treat hepatitis C, such as simeprevir (Olysio) or Sofosbuvir (Ledipasvir and sofosbuvir) (Sovaldi);

• ritonavir (Norvir) when used with tipranavir (Aptivus);

• rosuvastatin (Crestor);

• tenofovir when used in combination with atazanavir, darunavir, lopinavir, or ritonavir;

• Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir);

• seizure medicine--carbamazepine, oxcarbazepine, phenobarbital, phenytoin;

• stomach acid reducers--cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), ranitidine (Zantac), and others; or

• tuberculosis medicine--rifabutin, rifampin, rifapentine.

This list is not complete. Other drugs may interact with Ledipasvir (Ledipasvir and Sofosbuvir (Ledipasvir and sofosbuvir)) and Sofosbuvir (Ledipasvir and sofosbuvir), including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Ledipasvir and sofosbuvir interactions

Potential For Drug Interaction

As Ledipasvir and sofosbuvir contains Ledipasvir (Ledipasvir and Sofosbuvir (Ledipasvir and sofosbuvir)) and Sofosbuvir (Ledipasvir and sofosbuvir), any interactions that have been identified with these agents individually may occur with Ledipasvir and sofosbuvir.

After oral administration of Ledipasvir and sofosbuvir, Sofosbuvir (Ledipasvir and sofosbuvir) is rapidly absorbed and subject to extensive first-pass hepatic extraction. In clinical pharmacology studies, both Sofosbuvir (Ledipasvir and sofosbuvir) and the inactive metabolite GS-331007 were monitored for purposes of pharmacokinetic analyses. Ledipasvir (Ledipasvir and Sofosbuvir (Ledipasvir and sofosbuvir)) 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 (Ledipasvir and Sofosbuvir (Ledipasvir and sofosbuvir)) and Sofosbuvir (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 (Ledipasvir and Sofosbuvir (Ledipasvir and sofosbuvir)) and Sofosbuvir (Ledipasvir and sofosbuvir) plasma concentrations, leading to reduced therapeutic effect of Ledipasvir and sofosbuvir, and the use with P-gp inducers is not recommended with Ledipasvir and sofosbuvir.

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 Ledipasvir and sofosbuvir, the components of Ledipasvir and sofosbuvir (Ledipasvir (Ledipasvir and Sofosbuvir (Ledipasvir and sofosbuvir)) and Sofosbuvir (Ledipasvir and sofosbuvir)) as individual agents, or are predicted drug interactions that may occur with Ledipasvir and sofosbuvir.

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 Ledipasvir and sofosbuvir

Based on drug interaction studies conducted with the components of Ledipasvir and sofosbuvir (Ledipasvir (Ledipasvir and Sofosbuvir (Ledipasvir and sofosbuvir)) or Sofosbuvir (Ledipasvir and sofosbuvir)) or Ledipasvir and sofosbuvir, no clinically significant drug interactions have been either observed or are expected when Ledipasvir and sofosbuvir 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 Ledipasvir and sofosbuvir with certain HIV antiretroviral regimens.

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References

1. 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).
2. 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).
3. MeSH. "Antiviral Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology