Sofovir 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
Sofovir is comes under the pharmacological category of hepatitis C virus NS5B viral RNA polymerase inhibitor
Sofovir is a single dose therapy, absorbed very rapidly within 0.5 to 2 hours after administration.
Correlate to other preceding therapy, Sofovir based regimens are contribute an efficient curable rate, side effects are lesser in range
In most of the patients, Sofovir 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: Sofovir
Active ingredient: Sofosbuvir
Strength : 400MG
Mfg : Hetero Healthcare
Package: 28 tablets in a container
Category: Anti-hepaciviral activity
Prescribing information of Sofovir
The prescribing information of Sofovir tablets for the patients affected with chronic hepatitis C infection;
Sofovir is majorly indicated for hepatitis C viral infection therapy by combining with other anti-viral medicines.
The effective of Sofovir is established in the genotype I, II III or IV infections, patients who are having HIV-1/HBV co infection.
Sofovir 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 Sofovir
Sofovir containing sofosbuvir is a pan genotype, HCV NS5B RNA polymerase inhibitor.
This RNA polymerase enzyme is involved in viral production. Sofovir 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 Sofovir 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 Sofovir is occur nearly at the range of 61 to 65%
The circulating metabolite has minimal protein bounding property.
Sofovir is highly metabolized in liver, whereas Sofovir is a substrate of P-gp & BCRP
Sofovir is eliminated through urine by glomerular filteration
The terminal half life period of Sofovir is 0.51 hours and its metabolite has 27 hours
How to take the Tablet Sofovir
Generally Sofovir is administered with or without food.
Sofovir is taken as a single dose
Do not crush or chew the tablet, swallow the tablet as whole with some water
400mg of Sofovir (sofosbuvir)
The recommended dosage of Sofovir by combination with other medicines;
Patient acquired with genotype I, IV, V or VI chronic hepatitis C viral infection:
Sofovir is combined with ribavirin and peg interferon alfa should be taken as a single dose for 12 weeks
Sofovir 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:
Sofovir should be combined with ribavirin as a single dose for 12 weeks
Patients with genotype III hepatitis:
Sofovir combined with ribavirin and peg interferon alfa and it should be taken as a single dose for 12 weeks
Otherwise Sofovir with ribavirin should be taken as single dose for 24 weeks
In liver transplantation:
Sofovir should be concurrently used with ribavirin as a single dose until liver transmission.
Sofovir 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 Sofovir should be combined with weight based ribavirin as a single dose for 12 weeks
In decompensated cirrhosis:
The prescribed dosage of Sofovir 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 Sofovir in case of renal and hepatic impairment.
Sofovir caused side effects
General side effects of Sofovir;
Loss of appetite
Influenza like syndrome
Sofovir is a substrate of P-gp & BCRP transporters. While using Sofovir 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 Sofovir
Sofovir co administration with P-gp or BCRP inhibitors, causes increasing the plasma concentration of Sofovir
Sofovir with analeptic drug like modafinil causes decreasing the effect of concentration of Sofovir.
While combining with Sofovir with amiodarone, no effect of concentration occurs but symptomatic bradycardia occurs
Sofovir with vitamin K antagonist, fluctuate the effect of vitamin K antagonist
Sofovir with anticonvulsants like phenytoin, Phenobarbital or carbamazepine causes decreasing the effect of Sofovir
Sofovir with anti-mycobacterials causes depletion in effect of concentration of Sofovir
Food drug interaction
No food drug interaction occurs while taking Sofovir, but caution should be taken during therapy
Diet should be followed under the guidance of physician
Drug with herbal interaction occurs like; Sofovir with st Johns wort may cause depletion of therapeutic effect of Sofovir
Sofovir tablet combined with ribavirin or peg interferon alfa, contraindicated to pregnancy condition
Hypersensitive reaction produce because of patients contraindicated to the component present in Sofovir tablet
Use with caution in decompensated condition; ribavirin should be combined with Sofovir. Ribavirin causes fetal abnormalities and death. In pregnancy condition ribavirin not recommended
Sofovir combined with P-gp or BCRP strong inducers leading to loss of therapeutic effect. Avoid this combination.
While concomitant amiodarone with Sofovir, 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
Pregnancy and lactation
Sofovir comes under pregnancy category B1
Whereas Sofovir 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 Sofovir tablets;
Sofovir 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
Sofovir is a prescription medicine, if patient fail to take the dose of Sofovir 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 Sofovir.
If overdose occurs in the patients two possible way to overcome from this difficulty;
- Patients first confirmed from the toxicity and Patients should be periodically monitored for their symptoms & clinical status. To maintain safety measures properly
- 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%