LediHep tablets are used to treat chronic hepatitis C viral infection in both adults & pediatric patient with the age of 12 years or older, or weighing of at least 35kg. LediHep tablets should be used in; Hepatitis C associated with genotype I, IV, V, or VI with compensated cirrhosis or without cirrhosis. HCV infection related to genotype I infection with decompensated cirrhosis by concomitant use of ribavirin. In liver transplanted patients, HCV associated to genotype I or IV without cirrhosis or with compensated cirrhosis by combining with ribavirin. LediHep tablets are used in pediatric patients with HCV infection caused by genotype I, IV, V or VI without cirrhosis or with compensated cirrhosis.
The common adverse produced during or after completion of therapy are; Exposure of HBV rejuvenation in HCV/HBV co infected patients.
Ledipasvir is a strong prohibitor of chronic hepatitis C viral associating non structural 5A protein which is a viral phosphoprotein. The vital role of ledipasvir in anti-viral activity mechanism; Inhibition of; Replication Assembly Secretion The mechanism of sofosbuvir involved in anti-viral activity is; Sofosbuvir is prohibitor of nucleotide analogue of hepatitis C viral infection related to non structural 5B polymerase. This enzyme is responsible for intervene the HCV RNA multiplication. The active form of sofosbuvir is in triphosphate form, which involved decreasing the natural cellular uridine nucleotide & is integrated by HCV RNA polymerase into the extended RNA primer strand, which is concluded in viral chain elimination.
Brand : LediHep
Ingredients : Ledipasvir + Sofosbuvir
Strength : 90mg 400mg
Manufactured : Zydus Heptiza
Package : 28 tablets
Generally LediHep tablet dosage recommended for adults & pediatric age 12 years to <18 years; The prescribed dose of LediHep is one tablet should be administered as a single dose by administering with or without food. Recommendation of dosage of LediHep in various conditions; including HIV-1 co infected patients Patient without cirrhosis: (adult or pediatric of 12 years of age or older with genotype I, IV, V or VI Chronic HCV) The advised dose of LediHep for this condition is one tablet should be administered orally as a single dose for 12 weeksGenotype I
Without cirrhosis or compensated cirrhosis: LediHep should be used alone as a single dose followed for 12 weeks Therapy experienced without cirrhosis: LediHep should be used as a single agent for once a day for 12 weeks Therapy experienced with compensated cirrhosis: LediHep tablet should be used for 24 weeks In decompensated cirrhosis: LediHep with ribavirin should be used followed for 12 weeksGenotype I to IV
In liver transplantation patients with compensated cirrhosis or without cirrhosis: LediHep tablet should be combined with ribavirin for 12 weeks.
Without cirrhosis or with compensated cirrhosis patients: LediHep tablets should be administered alone for 12 weeks The dose of ribavirin should be calculated on the basis of body weight; <75kg: 1000mg; ≥75kg: 1200mg Ribavirin should be administered with food. LediHep should be administered with or without food.Pediatrics
Without cirrhosis or with compensated cirrhosis: LediHep should be administered orally afor 12 weeks. Therapy experienced without cirrhosis: LediHep should be administered orally for 12 weeks. Therapy experienced compensated cirrhosis: LediHep tablet should be administered orally for 12 weeks.Genotype IV, V or VI
Therapy naïve or experienced without cirrhosis or with compensated cirrhosis: LediHep tablet should be administered orally for 12 weeks.Renal impairment patients
LediHep dosage adjustment should not be allowed in severe renal damaged condition. Due to greater exposure of sofosbuvir metabolite causes final stage of renal disease (ERSD).
Elevation of bilirubin Elevation of lipase Elevation of creatine kinase Severe bradycardia HBV reactivation Chest pain Dizziness Trouble in breathing Fatigue Headache Nausea Diarrhea Insomnia
This fatal case occurs in patient who are undergoing anti-viral treatment (during or completion of therapy) or fail to take the anti-hepatitis B drugs. To avoid this problem patient should be examine the HBsAg & anti-HBC counts before start the therapy. Monitor the hepatic function test frequently. Initiation of proper anti-hepatitis B viral therapy occurs.Severe bradycardia
This severe condition should be produced by concomitant use of LediHep with amiodarone. Overcome the problem by stop this combinational treatment. Counsel the patient before starting the treatment about the risk due to this combination. Check ECG periodically. Initiate supportive measures.Exposure of adverse effect due to combination of LediHep with P-gp inducers
This combination causes loss of therapeutic effect of LediHep . To avoid the problem, stop the combination.Exposure of adverse effects associated with ribavirin
LediHep ribavirin combination should be avoided. Ribavirin causes fetal damage and concludes as fetal death.