Drug profile (Hepcvir Cipla)
Hepcvir is comes under the pharmacological category of hepatitis C virus NS5B viral RNA polymerase inhibitor
Hepcvir is a single dose therapy, absorbed very rapidly within 0.5 to 2 hours after administration.
Hepcvir tablets are prescription medicine, not used ordinarily it is used for the patients who are all having a valid prescription and under the guidance of medical practitioner
In most of the patients, Hepcvir is not combined with peg interferon because of adverse effects produced by peg interferon. Even though this concomitant is avoided, the curable rate is outstanding rate.
Trade name: Hepcvir
Active ingredient: Sofosbuvir
Package: 28 tablets in a container
Category: Anti-hepaciviral activity
Prescribing information of Hepcvir
The prescribing information of Hepcvir tablets for the patients affected with chronic hepatitis C infection;
Hepcvir is majorly indicated for hepatitis C viral infection therapy by combining with other anti-viral medicines
The effective of Hepcvir is established in the genotype I, II III or IV infections, patients who are having HIV-1/HBV co infection.
Hepcvir mainly prescribed for adolescent patients, and for pediatric patients with age of 12 years or weighing at least 35kg in genotype II or III induced hepatitis C infection
Mechanism of Hepcvir
Hepcvir containing sofosbuvir is a pan genotype, HCV NS5B RNA polymerase inhibitor.
This RNA polymerase enzyme is involved in viral production. Hepcvir is a prodrug which converted into active pharmacological metabolite by undergoing intracellular metabolism.
The active metabolite is known as uridine triphosphate. This metabolite is get inserted into viral RNA by HCV viral RNA polymerase and exhibits anti-viral activity by chain termination process
After an oral administration, the peak plasma time of Hepcvir is reaches within 0.5 to 2 hours and its circulating metabolite GS-331007 has peak plasma time 2 to 4 hours
The human plasma protein bound capacity with Hepcvir is occur nearly at the range of 61 to 65%
The circulating metabolite has minimal protein bounding property.
Hepcvir is highly metabolized in liver, whereas Hepcvir is a substrate of P-gp & BCRP
Hepcvir is eliminated through urine by glomerular filteration
The terminal half life period of Hepcvir is 0.51 hours and its metabolite has 27 hours
How to take the Tablet Hepcvir
Generally Hepcvir is administered with or without food.
Hepcvir is taken as a single dose
Do not crush or chew the Hepcvir tablet, swallow the tablet as whole with some water
400mg of Hepcvir (sofosbuvir)
The recommended dosage of Hepcvir by combination with other medicines;
Patient acquired with genotype I, IV, V or VI chronic hepatitis C viral infection:
Hepcvir is combined with ribavirin and peg interferon alfa should be taken as a single dose for 12 weeks
Hepcvir and ribavirin should be taken in case of patients are undesirable to take peg interferon alfa for 24 weeks
Patients suffered with genotype II chronic hepatitis C:
Hepcvir should be combined with ribavirin as a single dose for 12 weeks
Patients with genotype III hepatitis:
Hepcvir combined with ribavirin and peg interferon alfa and it should be taken as a single dose for 12 weeks
Otherwise Hepcvir with ribavirin should be taken as single dose for 24 weeks
In liver transplantation:
Hepcvir should be concurrently used with ribavirin as a single dose until liver transmission.
Hepcvir tablet is recommended for the children at age 12 or weight of at least 35kg;
In without cirrhosis or with child Pugh A or compensated:
The recommended dosage is one tablet of Hepcvir should be combined with weight based ribavirin as a single dose for 12 weeks
In decompensated cirrhosis:
The prescribed dosage of Hepcvir is one tablet should be used with ribavirin for 24 weeks
Ribavirin is recommended to take in two divided doses only with food
Initial dose 600mg slowly increased up to 100mg per day in weight less than 75kg
1200mg should be taken per day with the weight at least 75kg
In pediatric ribavirin dosage;
47 to 49kg: 600mg/day
50 to 65kg: 800mg/day
66 to 80kg: 1000mg/day
No dosage adjustment is followed in the therapy using Hepcvir in case of renal and hepatic impairment.
Hepcvir caused side effects
General side effects of Hepcvir;
Influenza like syndrome
Loss of appetite
Hepcvir with vitamin K antagonist, fluctuate the effect of vitamin K antagonist
Hepcvir with anticonvulsants like phenytoin, Phenobarbital or carbamazepine causes decreasing the effect of Hepcvir
Hepcvir with anti-mycobacterials causes depletion in effect of concentration of Hepcvir
Hepcvir co administration with P-gp or BCRP inhibitors, causes increasing the plasma concentration of Hepcvir
Hepcvir with analeptic drug like modafinil causes decreasing the effect of concentration of Hepcvir.
Hepcvir is a substrate of P-gp & BCRP transporters. While using Hepcvir with P-gp or BCRP strong inducers like rifampin or st Johns wort may causes decreasing the plasma concentration of sofosbuvir. Thus the results depletion of therapeutic effect of Hepcvir
While combining with Hepcvir with amiodarone, no effect of concentration occurs but symptomatic bradycardia occurs
Food drug interaction
Diet should be followed under the guidance of physician
Drug with herbal interaction occurs like; Hepcvir with st Johns wort may cause depletion of therapeutic effect of Hepcvir
No food drug interaction occurs while taking Hepcvir, but caution should be taken during therapy
Hepcvir tablet combined with ribavirin or peg interferon alfa, contraindicated to pregnancy condition
Hypersensitive reaction produce because of patients contraindicated to the component present in Hepcvir tablet
While concomitant amiodarone with Hepcvir, patient must counsel about the exposure of this combination, on the other hand some alternative medicines should be prescribed to reduce the risk of symptomatic bradycardia
In HIV-1/HBV co infected patients, HBV reactivation occurs during or after the treatment, to avoid this problem patient must examine to calculate the level of HBV surface antigen & HBV core antibody before starting the treatment
Use with caution in decompensated condition; ribavirin should be combined with Hepcvir. Ribavirin causes fetal abnormalities and death. In pregnancy condition ribavirin not recommended
Hepcvir combined with P-gp or BCRP strong inducers leading to loss of therapeutic effect. Avoid this combination.
Pregnancy and lactation
Hepcvir comes under pregnancy category B1
Whereas Hepcvir combined with ribavirin in chronic condition, ribavirin has pregnancy category X; which means causes fetal damage even to death
Ribavirin should not be recommended in pregnancy
Breast feeding should not be recommended
Storage and handling
The storage condition of Hepcvir tablets;
Hepcvir tablet container stored at room temperature below 30oC
Container should be kept in dry and cool place, free from moisture, heat & light
Keep out of reach from children
The shelf life of the tablet is around 5 years
Hepcvir is a prescription medicine, if patient fail to take the dose of Hepcvir must consult with physician and take the dose within the time
Otherwise the missed dose should be skipped and follow the regular dosing schedule
Medicine schedule: prescription medicine
The maximum dose of sofosbuvir is 1200mg, there is no distinct antidote is required for over dose of Hepcvir.
If overdose occurs in the patients two possible way to overcome from this difficulty;
ü Patients first confirmed from the toxicity and Patients should be periodically monitored for their symptoms & clinical status. To maintain safety measures properly
ü Hemodialysis is another method which is involved in over dosage condition, predominantly eliminate the sofosbuvir circulating metabolite contents from the body with separating at the range of 54%