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Hepcvir L 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. Hepcvir L 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. Hepcvir L 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.



MECHANISM


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.

ADME PROPERTIES

The pharmacokinetic property of Hepcvir L is; The median plasma concentration time of ledipasvir is 4 to 4.5 hours; sofosbuvir is absorbed rapidly and reaches median plasma concentration time is 0.8 to 1 hour; metabolite GS-331007 occurs between 3.5 to 4 hours.

Food should not cause any variation in pharmacokinetic property of Hepcvir L. Hepcvir L should be taken either with food or without food. Hepcvir L is widely distributed in body, the human plasma protein binding capacity of ledipasvir is around >99.8%; sofosbuvir is between 61 to 65%. Hepcvir L metabolism is mostly occurred in liver, ledipasvir metabolism is occurred by CYP1A2, 2C8, 2C9, 2C19, 2D6 & 3A4.

The metabolism of sofosbuvir is majorly occurs hepatically and leads by cathepsin A or carboxyl esterase 1. Hepcvir L is excreted through feces & urine. Ledipasvir dose are eliminated via urine by 87%.

Sofosbuvir is eliminated by 80% via urine, 14% via feces & 3.5% via exhaled air. Ledipasvir half life period is 47 hours; Sofosbuvir & GS-331007 Half life period is 0.5 to & 27 hours respectively.

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Brand : Hepcvir L
Ingredients : Ledipasvir + Sofosbuvir
Strength : 90mg 400mg
Manufactured : Cipla
Package : 28 tablets

DOSING AND ADMINISTRATING

Generally Hepcvir L tablet dosage recommended for adults & pediatric age 12 years to <18 years; The prescribed dose of Hepcvir L is one tablet should be administered as a single dose by administering with or without food. Recommendation of dosage of Hepcvir L 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 Hepcvir L for this condition is one tablet should be administered orally as a single dose for 12 weeks

Genotype I

Without cirrhosis or compensated cirrhosis: Hepcvir L should be used alone as a single dose followed for 12 weeks Therapy experienced without cirrhosis: Hepcvir L should be used as a single agent for once a day for 12 weeks Therapy experienced with compensated cirrhosis: Hepcvir L tablet should be used for 24 weeks In decompensated cirrhosis: Hepcvir L with ribavirin should be used followed for 12 weeks

Genotype I to IV

In liver transplantation patients with compensated cirrhosis or without cirrhosis: Hepcvir L tablet should be combined with ribavirin for 12 weeks.

Genotype IV, V or VI

Without cirrhosis or with compensated cirrhosis patients: Hepcvir L 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. Hepcvir L should be administered with or without food.

Pediatrics
Genotype I

Without cirrhosis or with compensated cirrhosis: Hepcvir L should be administered orally afor 12 weeks. Therapy experienced without cirrhosis: Hepcvir L should be administered orally for 12 weeks. Therapy experienced compensated cirrhosis: Hepcvir L tablet should be administered orally for 12 weeks.

Genotype IV, V or VI

Therapy naïve or experienced without cirrhosis or with compensated cirrhosis: Hepcvir L tablet should be administered orally for 12 weeks.

Renal impairment patients

Hepcvir L 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).

SIDE EFFECTS

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

The patients who are co infected with HBV/HCV will cause Exposure of hepatitis B virus reoccurrence

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 Hepcvir L 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 Hepcvir L with P-gp inducers

This combination causes loss of therapeutic effect of Hepcvir L. To avoid the problem, stop the combination.

Exposure of adverse effects associated with ribavirin

Hepcvir L ribavirin combination should be avoided. Ribavirin causes fetal damage and concludes as fetal death.



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DRUG INTERACTION

Ledipasvir is a component of Hepcvir L, which is involved in inhibition of P-gp or BCRP drug transporters. This combination causes elevation of intestinal absorption of these substrates. Hepcvir L with P-gp strong inducers, causes decreasing the plasma concentration of component of Hepcvir L. Finally leads to loss of effectiveness of Hepcvir L. Variation in INR values occurs due to combination of Hepcvir L with warfarin. Hepcvir L with gastric regulators drug causes decreasing the sofosbuvir & ledipasvir concentration. Avoid this co administration.

Hepcvir L with anti-arrhythmic drugs causes increasing the concentration of these drugs. Hepcvir L with anti-convulsants or anti-mycobacterials causes decreasing the concentration of both the component of Hepcvir L. Hepcvir L with anti-retroviral drugs causes increasing the concentration of these retroviral medicines. Hepcvir L with herbal supplements like st Johns wort leads to produce the elevation of concentration of st Johns wort and reduced the effect of concentration of Hepcvir L and causes loss of therapeutic effect of Hepcvir L. Hepcvir L with lipid lowering agents causes increasing effect of concentration of these drugs.




abdominal pain
abdominal pain
concluded as death
concluded as death
dark urine
dark urine
fatigue
fatigue
flu like syndrome
flu like syndrome
loss of apetite
loss of apetite
loss of weight
loss of weight


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