Description of Ledihep
Brand Name : LediHep
Content : Ledipasvir and sofosbuvir
Strength : Ledipasvir 90 mg ; Sofosbuvir 400 mg
Manufactured by : Zydus Heptiza
Trade name : Harvoni
Dosage Form : Tablets
Packed container with 28 tablets
LediHep is a antiviral drug which contain fixed-dose combination tablet of Ledipasvir and Sofosbuvir that administrated through mouth. LediHep marketed by Zydus Heptiza.LediHep is a prescription medicine ,the medicine purchased by a patient with valid prescription obtained from doctor. LediHep package is a pack of 28 tablet in a container.
Pharmacology of Ledihep
Mechanism of action
LediHep (ledipasvir) is a HCV NS5A polymerase inhibitor, which is mainly required for viral multiplication. Ledipasvir mode of action targets NS5A protein which used for resistance selection in cell culture and cross-resistance studies.
Sofosbuvir(LediHep) is a hepatitis C virus NS5B RNA dependent and polymerase that used for viral reproduction. A nucleotide prodrug (Sofosbuvir) which undergoes intracellular metabolism to form uridine analog triphosphate. It will inhibit the viral replication and blocks the new production of HCV. Sofosbuvir (LediHep) acts as chain terminator by NS5B polymerase.
Absorption – LediHep ( ledispavir/Sofosbuvir) and predominant circulating metabolite (GS-331007) have been subjected to healthy adult with chronic hepatitis C.
Median Peak Plasma Concentration(MPPC)
DRUGS RANGE(hrs post dose)
Sofosbuvir 0.8-1(absorbed quickly)
Effect with food: For fasting conditions- Single dose of LediHep
administration with moderate fat or high fat meal increased Sofosbuvir have no significant effect. Therefore LediHep response rate was equal in phase trials and HCV infected patient can administrated with or without food.
Distribution: LediHep (ledipasvir) bound to human plasma protein is >99.8% where as Sofosbuvir(LediHep) is approx 61-65% (human plasma protein bound). For metabolite GS-331007 the protein binding is minimal in human plasma.
Metabolism: LediHep (Ledipasvir) metabolism was observed by human is CYP1A2,CYP2C8,CYP2C9,CYP2C19,CYP2D6,CYP3A4
Extensively Sofosbuvir (LediHep) metabolized in the Hepato (liver) in which it form pharmacologically active nucleoside analog triphosphate GS-461203
Elimination: Ledipasvir (LediHep) 90mg oral dose mean total elimination of the radioactivity in feces and urine was approx 87% and half life of 47hrs administration
LediHep (Sofosbuvir 400mg) oral dose mean total elimination dose was >92%, be found in approximately of 80%,14% and 2.5% eliminate through feces,urine and expired air while in metabolite dose of 78% eliminated in urine. The half life of Sofosbuvir and GS-331007 is 0.5-27hrs respectively.
Indication of Ledihep
* LediHep used for treatment of long lasting hepatitis C ( liver viral infection ).
* LediHep also used with combination of another (antiviral drug) ribavirin.
* LediHep acts by reducing the quantity of hepatitis C virus in our body
* LediHep recover the liver from infection by fighting against infection in immune system.
Dose & Dosage's of Ledihep
LediHep should take One tablet administrated once in a day, orally with or without food
~ Avoid taking antacids within 4 hours of LediHep
~ If you feel better than also continue the LediHep tablet
~ Do not skip the dose during treatment of LediHep
Side Effects of Ledihep
LediHep involves Common effects:
• Appetite loss
• Difficulty to concentrate
• Irregular heartbeat
• Weakness & head pain
• Discomfort in chest
• Loss of consciousness
Contraindication of Ledihep
LediHep has a contraindications with other antiviral drugs as follows:
• Allergic to the ledispavir/Sofosbuvir
• Child and adolescence to 18 years
• Pregnancy and breast feeding.
Drug Interaction of Ledihep
Drug-drug interaction by LediHep with Pgp-inducers Rifampicin,by continuse use will reduce blood concentration and therapeutic action.
Interaction with H2 receptors and proton pump inhibitors will decrease the ledipasvir concentration hence take the medicine before 2 hrs dose of LediHep.
LediHep with amiodarone will leads to reduce heart rate hence stop this combination of treatment.
Precaution of Ledihep
~ Avoid LediHep,If allergic to Ledipasvir/Sofosbuvir
~ If you are in treatment with another medicine or contains Sofosbuvir.
~ Avoid LediHep during pregnancy, planning for pregnancy or breast feeding
~ Avoid LediHep, if you are affected by kidney or liver problems
~ Avoid using LediHep, if you have allergic to food, medicines or other substsnce
Usage & Safety profile of Ledihep Pregnancy & Lactation
LediHep with Ribavirin will affect the Birth Defects And Fetal Death. In Animal Studies, it have been Shown Interferons have Abortifacient Effects. Avoid in Pregnant women And Male Partner. Negative Pregnancy Test Prior To Initiating Therapy for pregnant women should monitored.
Use 2 Effective Methods Of Contraception And check Monthly Pregnancy Tests.
Storage of Ledihep
* LediHep is stored in a closed container. Keep away from heat, moisture and direct light.
* Kept at room temperature and reach out of children.
* Keep it in original bottle and do not freeze it.
* LediHep is Stored under 30"C.