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Sofovir 400mg

Sofovir 400mg

Trade NameSofovir

Active ingredientSofosbuvir

Strength 400MG

Mfg Hetero Healthcare

Package28 tablets in a container

CategoryAnti-hepaciviral activity

Active substance:
28 Tablets
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Drug profile

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 NameSofovir

Active ingredientSofosbuvir

Strength 400MG

Mfg Hetero Healthcare

Package28 tablets in a container

CategoryAnti-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


Dosage regimens

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.


In pediatric:

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 dosage:

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;

<47kg: 15mg/kg/day

47 to 49kg: 600mg/day

50 to 65kg: 800mg/day

66 to 80kg: 1000mg/day

>80kg: 1200mg/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;








Fever, chills



Loss of appetite




Influenza like syndrome



HBV reactivation


Drug interactions

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

Possible contraindications

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

Safety measures

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

Missed dose

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

Over dosage

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;

  1. Patients first confirmed from the toxicity and Patients should be periodically monitored for their symptoms & clinical status. To maintain safety measures properly
  2. 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%
Active substance
28 Tablets
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