What is Ledihep?Ledihep is an antiviral drug that prevents hepatitis C virus cells (HCV) from multiplying in your body.Ledihep is a combined drug used to treat hepatitis C in adults.Ledihep may also be used for purposes not listed in this medication guide.Mechanism of action Ledihep drugLedipasvir is a HCV inhibitor targeting the HCV NS5A protein, essential for both RNA replication and HCV virion assembly.

It is currently not possible to confirm biochemical inhibition of NS5A by ledipasvir because NS5A has no enzyme function.

In vitro and cross-resistance studies show that ledipasvir targets NS5A as its mode of action.Sofosbuvir is a pan genotype inhibitor of HCV NS5B-dependent RNA polymerase, which is essential for viral replication.

Sofosbuvir is a nucleotide precursor that undergoes intracellular metabolism to form pharmacologically active triphosphate (GS-461203), which can be combined into HCV RNA by NS5B polymerase.

GS-461203 (sofosbuvir's active metabolite) is neither a human DNA polymerase inhibitor nor a mitochondrial RNA polymerase inhibitor.Ledihep contraindications:You are allergic to any of the ingredients in ledipasvir and sofosbuvir.You are taking another medicine that has sofosbuvir in it.You are taking a medicine that has cobicistat, elvitegravir, emtricitabine and tenofovir in it.You are taking carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, rosuvastatin, simeprevir, St. John's wort, or tipranavir / ritonavir Contact your doctor or doctor.Drug interactionsTell your doctor about all medicines you use, and those you start or stop using during your treatment with Ledihep, especially:Atripla (efavirenz, emtricitabine and tenofovir);Digoxin (digitalis);Other medicines to treat hepatitis C, such as simeprevir (Olysio) or Sofosbuvir (Ledihep) (Sovaldi);Ritonavir (Norvir) when used with tipranavir (Aptivus);Rosuvastatin (Badge);Tenofovir when used in combination with atazanavir, darunavir, lopinavir or ritonavir;Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir);Epilepsy drugs - carbamazepine, oxcarbazepine, phenobarbital, phenytoin;Stomach acid reducers - cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), ranitidine (Zantac), and others; orTB medicines - rifabutin, rifampin, rifapentine.This list is not complete.

Other drugs may interact with Ledihep, including prescription and over-the-counter medicines, vitamins, and herbal products.

Description of the drug LedisofLedisof is a drug containing active ingredients Sofosbuvir 400mg and Ledipasvir 90mg used to treat hepatitis C genotypes 1a, 1b, 4,5,6 according to the MOH protocol.Ledisof is imported genuine from Hetero India and distributed into Vietnam market.Depending on the liver condition, Ledisof drug will be completely cured with 3 or 6 months of treatment.For patients with decompensated cirrhosis Ledisof in combination with Ribavin treatment from 3 to 6 months.Mechanism of actionLedisof is a fixed dose combination (FDC) of ledipasvir and sofosbuvir, which are antiviral drugs that act directly against hepatitis C virus (HCV).Ledipasvir is an inhibitor of the HCV NS5A protein, necessary for viral replication.

Sofosbuvir is an HCV NS5B-dependent RNA polymerase inhibitor, necessary for viral replication.Sofosbuvir is a nucleotide precursor that undergoes intracellular metabolism to form pharmacologically active uridine triphosphate (GS-461203), which can be combined with NS5B polymerase into RNA.Electrophysiology of the heartThorough research on QT has been conducted on ledipasvir and sofosbuvir.

The effect of ledipasvir 120 mg twice daily (2.67 times the maximum recommended dose); within 10 days for the QTc interval assessed at random; multiple doses, placebo and active control (moxifloxacin 400 mg); three times, throughout the QT Test in 59 healthy subjects.At a dose of 120 mg twice daily (2.67 times the maximum recommended dose), ledipasvir did not extend the QTc interval to any clinically appropriate level.

The effect of sofosbuvir 400 mg (maximum recommended dose) and 1,200 mg (triple the maximum recommended dose).For QTc intervals assessed in a randomized, single dose, placebo, and activity control (moxifloxacin 400 mg), four phases, cross-over meticulously tested in 59 healthy subjects.

At a dose three times the maximum recommended dose.How is this medicine Ledisof best taken?Use this medication as required by your doctor.

Follow all instructions closely.Take this medication at the same time of day.Bring with or without food.If you have trouble swallowing, talk to your doctor.Keep taking this medicine as you were told by your doctor or other health care provider, even if you feel fine.It is important that you do not miss or skip a dose of this medication during treatment.What do I do if I miss a dose?Miss a dose as soon as you think about it.If you do not think about the missed dose until the next day, skip the missed dose and return to your normal time.Do not exceed 1 dose of this medication on the same day.If you are not sure what to do if you miss a dose, call your doctor.Warning about drugs LedisofAlcohol: It is not known whether it is safe to use alcohol with Ledifos 90mg / 400mg Tablet.

Hepcvir-L is an antiviral drug containing 2 active ingredients: 90mg ledipasvir and 400mg sofosbuvir.Ledipasvir, HCV NS5A and sofosbuvir protein inhibitors, HCV NS5B-dependent RNA polymerase inhibitors, work together to prevent transcription of the HCV viral genotype.Some notes about patients needing attentionPopulation pharmacokinetic analyzes of HCV-infected subjects indicate that gender has no clinical effect on sofosbuvir and GS-331007 exposures.

The AUC and C max of ledipasvir were 77% and 58% higher, respectively, for women than men.However, the relationship between sex exposure and ledipasvir is not considered clinically relevant, since a high response rate (SVR> 90%) has been achieved in men and women in the studies.

Phase 3 studies and safety profiles are similar in women and men.For childrenThe pharmacokinetics of ledipasvir or sofosbuvir in pediatric patients has not been established.For older peoplePopulation pharmacokinetic analyzes of HCV-infected subjects showed that in the age group (18 to 80 years) analyzed, the age had no clinical effect on exposure to ledipasvir, sofosbuvir and GS-331007.For patients with renal insufficiencyThe pharmacokinetics of ledipasvir was studied in a single dose of 90 mg of ledipasvir in HCV-negative subjects with severe renal impairment (estimated glomerular filtration rate 80 mL / minute / 1.73 m2); sofosbuvir AUC 0-inf is 61%, 107% and 171% higher in people with mild, moderate and severe renal impairment, while GS-331007 AUC 0-inf is 55%, 88% and 451% higher, respectively.In subjects with ESRD, with regard to subjects with normal renal function, sofosbuvir and GS-331007 AUC0-inf were 28% higher and 1,280% when sofosbuvir was administered 1 hour before hemodialysis compared to 60% and 2.070% higher when sofosbuvir is administered 1 hour after hemodialysis.

A 4-hour dialysis session removes approximately 18% of the dose.For patients with hepatic impairmentThe pharmacokinetics of ledipasvir was studied with a single dose of 90 mg of ledipasvir in subjects negative for HCV with severe hepatic impairment (Child-Pugh Class C).

Ledipasvir (AUC 0-inf) plasma exposure was similar in subjects with severe hepatic impairment and control subjects with normal liver function.Population pharmacokinetic analyzes of HCV-infected subjects indicate that cirrhosis has no clinical effect on ledipasvir exposure.The pharmacokinetics of sofosbuvir was studied after 7 days of using 400 mg of sofosbuvir in subjects infected with HCV with moderate and severe hepatic impairment (Children B and C).

Regarding subjects with normal liver function, sofosbuvir AUC 0-24 is 126% higher and 143% higher in moderate and severe hepatic impairment, while GS-331007 AUC 0-24 is 18% higher and respectively 9%.Population pharmacokinetic analysis of HCV-infected subjects indicates that cirrhosis has no clinical effect on sofosbuvir and GS-331007 exposures.What are the interactions with Hepcvir L?Sofosbuvir is the substrate of the P-gp drug transporter and breast cancer protein (BCRP) while the circulating metabolite predominates GS-331007 does not.

About HepCVel medicine:• Hepcvel is a combined medicine used to treat chronic hepatitis C infection.

It can also be used in combination with ribavirin for patients with advanced cirrhosis.• This drug is not recommended for use in patients with a history of hepatitis B infection due to the risk of serious side effects.• You will usually need this medication every day for 12 or 24 weeks.• Skipping doses increases the risk of treatment failure.

Make sure you take all your doses at the right time.• It may cause fatigue, dizziness and blurred vision.

Do not drive or do anything that requires concentration until you know how it affects you.Note the dose and overdose when using HepCVel• Missing dose: take the missed dose as soon as you remember.

If it is almost time for your next dose, skip the missed dose.

Do not double your dose to make up for the missed one.• Overdose: seek emergency medical treatment or contact a doctor in case of an overdose.Some side effects of HepCVel:• The following serious adverse reactions are described below and elsewhere in the labeling: severe arrhythmia when Sofosbuvir (Hepcvel) is combined with Amiodarone and another direct HCV antiviral drug.• If Hepcvel is taken with ribavirin, refer to the ribavirin prescription information for a description of the adverse reactions associated with ribavirin.Less common adverse reactions have been reported in clinical trialsThe following adverse reactions occurred in less than 5% of subjects who did not have cirrhosis or compensated cirrhosis treated with Hepcvel for 12 weeks and included because of a potential causal relationship.• Rash: In the ASTRAL-1 study, rash occurred in 2% of subjects treated with Hepcvel and 1% of subjects treated with placebo.