Ledvir are antiviral medications that prevent hepatitis C virus (HCV) cells from multiplying in your body.
Ledvir is a combination medicine used to treat hepatitis C in adults.
Ledvir may also be used for purposes not listed in this medication guide.
Ledvir indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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See also: Ledvir
Adult Patients:
Ledvir Tablets are indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) :
genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis
genotype 1 infection with decompensated cirrhosis, for use in combination with ribavirin
genotype 1 or 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhosis, for use in combination with ribavirin
Pediatric Patients:
Ledvir Tablets are indicated for the treatment of pediatric patients 12 years of age and older or weighing at least 35 kg with HCV genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis.
How should I use Ledvir?
Use Ledvir as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.
An extra patient leaflet is available with Ledvir. Talk to your pharmacist if you have questions about this information.
Take Ledvir by mouth with or without food.
Do not take an antacid that has aluminum or magnesium in it within 4 hours of Ledvir.
If you take cimetidine, dexlansoprazole, esomeprazole, famotidine, lansoprazole, nizatidine, omeprazole, pantoprazole, rabeprazole, or ranitidine, ask your doctor or pharmacist how to take it with Ledvir.
Ledvir works best if it is taken at the same time each day.
Continue to take Ledvir even if you feel well. Do not miss any doses.
If you miss a dose of Ledvir, take it as soon as you remember the same day and go back to your regular dosing schedule. Do not take more than 1 dose of Ledvir in the same day. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Ledvir.
Uses of Ledvir in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Use: Labeled Indications
Chronic hepatitis C: Treatment of chronic hepatitis C virus genotype 1, 4, 5, or 6 infection in adult and pediatric patients ≥3 years of age, without cirrhosis or with compensated cirrhosis; genotype 1 in adult patients with decompensated cirrhosis, in combination with ribavirin; and genotype 1 or 4 in adult liver transplant patients without cirrhosis or with compensated cirrhosis, in combination with ribavirin.
Off Label Uses
Chronic hepatitis C, genotype 1 or 4 (kidney transplant recipients)
Based on the AASLD/IDSA Recommendations for Testing, Managing, and Treating Hepatitis C guidelines, Ledvir is recommended and effective for treatment of hepatitis C virus genotype 1 or 4 infection in kidney transplant recipients without cirrhosis or with compensated cirrhosis. Hepatitis C treatment guidelines are constantly changing with the advent of new treatment therapies and information; consult current clinical practice guidelines for the most recent treatment recommendations.
Based on the AASLD/IDSA Recommendations for Testing, Managing, and Treating Hepatitis C guidelines, Ledvir, with or without concomitant ribavirin, is recommended and effective for treatment of hepatitis C virus genotype 4, 5, or 6 infection in patients with decompensated cirrhosis, including patients who have prior Sofosbuvir (Ledvir)-based treatment failure. Hepatitis C treatment guidelines are constantly changing with the advent of new treatment therapies and information; consult current clinical practice guidelines for the most recent treatment recommendations.
Chronic hepatitis C, genotype 5 or 6 (liver transplant recipients)
Based on the AASLD/IDSA Recommendations for Testing, Managing, and Treating Hepatitis C guidelines, Ledvir, with concomitant ribavirin, is recommended and effective for treatment of hepatitis C virus genotype 5 or 6 infection in liver transplant recipients with or without cirrhosis (including decompensated cirrhosis). Hepatitis C treatment guidelines are constantly changing with the advent of new treatment therapies and information; consult current clinical practice guidelines for the most recent treatment recommendations.
Ledvir description
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Ledvir is a 2-drug fixed-dose combination product containing Ledipasvir (Ledvir) 90 mg and Sofosbuvir (Ledvir) 400 mg in a single tablet, for oral administration.
Each tablet contains Ledipasvir (Ledvir) 90 mg and Sofosbuvir (Ledvir) 400 mg.
It also includes the following excipients: Colloidal silicon dioxide, copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. Film-Coating: FD&C yellow no. 6/sunset yellow FCF aluminum lake, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.
Ledispavir is a hepatitis C virus (HCV) nonstructural protein 5A (NS5A) inhibitor and Sofosbuvir (Ledvir) is a nucleotide analog inhibitor of HCV NS5B polymerase.
Ledipasvir (Ledvir) is methyl [(2S)-1-{(6S)-6-[5-(9,9-difluoro-7-{2-[(1R,3S,4S)-2-{(2S)-2-[(methoxycarbonyl)amino]3 methylbutanoyl}-2-azabicyclo(2.2.1)hept-3-yl)-1H-benzimidazol-6-yl}-9H-fluoren-2-yl)-1H-imidazol-2-yl]-5-azaspiro(2.4)hept-5-yl}-3-methyl-1-oxobutan-2-yl]carbamate. It has a molecular formula of C49H54F2N8O6 and a molecular weight of 889.
Ledipasvir (Ledvir) is practically insoluble (<0.1 mg/mL) across the pH range of 3-7.5 and is slightly soluble below pH 2.3 (1.1 mg/mL).
Sofosbuvir (Ledvir) is (S)-Isopropyl 2-((S)-(((2R,3R,4R,5R)-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl)methoxy (phenoxy)phosphorylamino)propanoate. It has a molecular formula of C22H29FN3O9P and a molecular weight of 529.45.
Sofosbuvir (Ledvir) is a white to off-white crystalline solid with a solubility of ≥2 mg/mL across the pH range of 2-7.7 at 37°C and is slightly soluble in water.
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Recommended Dosage
The recommended dosage of Ledvir 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 Ledvir 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 Ledvir in Patients with Genotype 1, 4, 5 or 6 HCV
Patient Population
Treatment Regimen and Duration
*
Ledvir 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.
‡
Ledvir+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)
Ledvir 12 weeks*
Treatment-experienced† without cirrhosis
Ledvir 12 weeks
Treatment-experienced† with compensated cirrhosis (Child-Pugh A)
Ledvir 24 weeks‡
Treatment-naïve and treatment-experienced† with decompensated cirrhosis (Child-Pugh B or C)
Ledvir + ribavirin§ 12 weeks
Genotype 1 or 4
Treatment-naïve and treatment-experienced† liver transplant recipients without cirrhosis, or with compensated cirrhosis (Child-Pugh A)
Ledvir + ribavirin¶ 12 weeks
Genotype 4, 5 or 6
Treatment-naïve and treatment-experienced†, without cirrhosis or with compensated cirrhosis (Child-Pugh A)
Ledvir 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 (Ledvir) metabolite.
More about Ledvir (Ledipasvir (Ledvir) / Sofosbuvir (Ledvir))
As Ledvir contains Ledvir, any interactions that have been identified with these agents individually may occur with Ledvir.
After oral administration of Ledvir, Sofosbuvir (Ledvir) is rapidly absorbed and subject to extensive first-pass hepatic extraction. In clinical pharmacology studies, both Sofosbuvir (Ledvir) and the inactive metabolite GS-331007 were monitored for purposes of pharmacokinetic analyses. Ledipasvir (Ledvir) 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.
Ledvir 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 Ledvir plasma concentrations, leading to reduced therapeutic effect of Ledvir, and the use with P-gp inducers is not recommended with Ledvir.
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 Ledvir, the components of Ledvir (Ledvir) as individual agents, or are predicted drug interactions that may occur with Ledvir.
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 Ledvir
Based on drug interaction studies conducted with the components of Ledvir (Ledipasvir (Ledvir) or Sofosbuvir (Ledvir)) or Ledvir, no clinically significant drug interactions have been either observed or are expected when Ledvir 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 Ledvir with certain HIV antiretroviral regimens.
The following serious adverse reactions are described below and elsewhere in labeling:
Serious Symptomatic Bradycardia When Coadministered with Amiodarone.
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
If Ledvir is administered with ribavirin, refer to the prescribing information for ribavirin for a description of ribavirin-associated adverse reactions.
The safety assessment of Ledvir 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 Ledvir 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 Ledvir 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 Ledvir.
Table 2 lists adverse reactions (adverse events assessed as causally related by the investigator, all grades) observed in at least 5% of subjects receiving 8, 12, or 24 weeks treatment with Ledvir in clinical trials. The majority of adverse reactions presented in Table 2 occurred at severity of grade 1. The side-by-side tabulation is to simplify presentation; direct comparison across trials should not be made due to differing trial designs.
Table 2 : Adverse Reactions (All Grades) Reported in ≥ 5% of Subjects Receiving 8, 12, or 24 Weeks of Treatment with Ledvir
Ledvir 8 weeks
N=215
Ledvir 12 weeks
N=539
Ledvir 24 weeks
N=326
Fatigue
16%
13%
18%
Headache
11%
14%
17%
Nausea
6%
7%
9%
Diarrhea
4%
3%
7%
Insomnia
3%
5%
6%
The safety assessment of Ledvir was also based on pooled data from three open-label trials (Study 1119, ION-4 and ELECTRON-2) in 118 subjects with chronic HCV genotype 4, 5 or 6 infection with compensated liver disease (with or without cirrhosis). The subjects received Ledvir once daily by mouth for 12 weeks. The safety profile in subjects with chronic HCV genotype 4, 5 or 6 infection with compensated liver disease was similar to that observed in subjects with chronic HCV genotype 1 infection with compensated liver disease. The most common adverse reactions occurring in at least 10% of subjects were asthenia (18%), headache (14%) and fatigue (10%).
Adverse Reactions In Subjects With Cirrhosis
The safety assessment of Ledvir with or without ribavirin was based on a randomized, double-blind and placebo-controlled trial in treatment-experienced genotype 1 subjects with compensated cirrhosis and was compared to placebo in the SIRIUS trial. Subjects were randomized to receive 24 weeks of Ledvir once daily by mouth without ribavirin or 12 weeks of placebo followed by 12 weeks of Ledvir once daily by mouth + ribavirin. Table 3 presents the adverse reactions, as defined above, that occurred with at least 5% greater frequency in subjects treated with 24 weeks of Ledvir or 12 weeks of Ledvir + ribavirin, compared to those reported for 12 weeks of placebo. The majority of the adverse reactions presented in Table 3 were Grade 1 or 2 in severity.
Table 3 : Adverse Reactions with ≥ 5% Greater Frequency Reported in Treatment-Experienced Subjects with Cirrhosis Receiving Ledvir for 24 Weeks or Ledvir + RBV for 12 Weeks Compared to Placebo for 12 weeks
Ledvir 24 weeks
(N=78)
Ledvir + RBV 12 weeks
(N=76)
Placebo 12 weeks
(N=77)
Asthenia
31%
36%
23%
Headache
29%
13%
16%
Fatigue
18%
4%
1%
Cough
5%
11%
1%
Myalgia
9%
4%
0
Dyspnea
3%
9%
1%
Irritability
8%
7%
1%
Dizziness
5%
1%
0
Adverse Reactions In Subjects Co-infected With HIV-1
The safety assessment of Ledvir was based on an open-label clinical trial in 335 genotype 1 or 4 subjects with HCV/HIV-1 co-infection who were on stable antiretroviral therapy in Study ION-4. The safety profile in HCV/HIV-1 co-infected subjects was similar to that observed in HCV mono-infected subjects. The most common adverse reactions occurring in at least 10% of subjects were headache (20%) and fatigue (17%).
Adverse Reactions In Liver Transplant Recipients And/Or Subjects With Decompensated Cirrhosis
The safety assessment of Ledvir with ribavirin (RBV) in liver transplant recipients and/or those who had decompensated liver disease was based on pooled data from two Phase 2 open-label clinical trials including 336 subjects who received Ledvir plus RBV for 12 weeks. Subjects with Child-Pugh-Turcotte (CPT) scores greater than 12 were excluded from the trials.
The adverse events observed were consistent with the expected clinical sequelae of liver transplantation and/or decompensated liver disease, or the known safety profile of Ledvir and/or ribavirin.
Decreases in hemoglobin to less than 10 g/dL and 8.5 g/dL during treatment were observed in 38% and 13% of subjects treated with Ledvir plus RBV for 12 weeks, respectively. Ribavirin was permanently discontinued in 11% of subjects treated with Ledvir plus RBV for 12 weeks.
Liver Transplant Recipients With Compensated Liver Disease
Among the 174 liver transplant recipients with compensated liver disease who received Ledvir with RBV for 12 weeks, 2 (1%) subjects permanently discontinued Ledvir due to an adverse event.
Subjects With Decompensated Liver Disease
Among the 162 subjects with decompensated liver disease (pre-or post-transplant) who received Ledvir with RBV for 12 weeks, 7 (4%) subjects died, 4 (2%) subjects underwent liver transplantation, and 1 subject ( < 1%) underwent liver transplantation and died during treatment or within 30 days after discontinuation of treatment. Because these events occurred in patients with advanced liver disease who are at risk of progression of liver disease including liver failure and death, it is not possible to reliably assess the contribution of drug effect to outcomes. A total of 4 (2%) subjects permanently discontinued Ledvir due to an adverse event.
Less Common Adverse Reactions Reported in Clinical Trials (less than 5%): The following adverse reactions occurred in less than 5% of subjects receiving Ledvir in any one trial. These events have been included because of their seriousness or assessment of potential causal relationship.
Psychiatric disorders: depression (including in subjects with pre-existing history of psychiatric illness). Depression (particularly in subjects with pre-existing history of psychiatric illness) occurred in subjects receiving Sofosbuvir (Ledvir) containing regimens. Suicidal ideation and suicide have occurred in less than 1% of subjects treated with Sofosbuvir (Ledvir) in combination with ribavirin or pegylated interferon/ribavirin in other clinical trials.
Laboratory Abnormalities
Bilirubin Elevations: Bilirubin elevations of greater than 1.5xULN were observed in 3%, less than 1%, and 2% of subjects treated with Ledvir for 8, 12, and 24 weeks, respectively. Bilirubin elevations of greater than 1.5xULN were observed in 3%, 11% and 3% of subjects with compensated cirrhosis treated with placebo, Ledvir + ribavirin for 12 weeks and Ledvir for 24 weeks, respectively, in the SIRIUS trial.
Lipase Elevations: Transient, asymptomatic lipase elevations of greater than 3xULN were observed in less than 1%, 2%, and 3% of subjects treated with Ledvir for 8, 12, and 24 weeks, respectively. Transient, asymptomatic lipase elevations of greater than 3x ULN were observed in 1%, 3% and 9% of subjects with compensated cirrhosis treated with placebo, Ledvir + ribavirin for 12 weeks and Ledvir for 24 weeks, respectively, in the SIRIUS trial.
Creatine Kinase: Creatine kinase was not assessed in Phase 3 trials ION-3, ION-1 or ION-2 of Ledvir. Creatine kinase was assessed in the ION-4 trial. Isolated, asymptomatic creatine kinase elevations of greater than or equal to 10xULN was observed in 1% of subjects treated with Ledvir for 12 weeks in the ION-4 trial and has also been previously reported in subjects treated with Sofosbuvir (Ledvir) in combination with ribavirin or peginterferon/ribavirin in other clinical trials.
Postmarketing Experience
The following adverse reactions have been identified during post approval use of Ledvir. Because postmarketing reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiac Disorders
Serious symptomatic bradycardia has been reported in patients taking amiodarone who initiate treatment with Ledvir.
Skin And Subcutaneous Tissue Disorders
Skin rashes, sometimes with blisters or angioedema-like swelling
If Ledvir Tablets are administered with ribavirin, the contraindications to ribavirin also apply to this combination regimen. Refer to the ribavirin prescribing information for a list of contraindications for ribavirin.
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).
The results of a survey conducted on ndrugs.com for Ledvir 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 Ledvir. 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 useful
No survey data has been collected yet
Consumer reported price estimates
No survey data has been collected yet
2 consumers reported time for results
To what extent do I have to use Ledvir before I begin to see changes in my health conditions? As part of the reports released by ndrugs.com website users, it takes 3 days and a few days before you notice an improvement in your health conditions. Please note, it doesn't mean you will start to notice such health improvement in the same time frame as other users. There are many factors to consider, and we implore you to visit your doctor to know how long before you can see improvements in your health while taking Ledvir. To get the time effectiveness of using Ledvir drug by other patients, please click here.
Users
%
3 days
1
50.0%
1 month
1
50.0%
2 consumers reported age
Users
%
16-29
1
50.0%
46-60
1
50.0%
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