Viroclear 12 Weeks

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Drug profile

Viroclear is comes under the pharmacological category of hepatitis C virus NS5B viral RNA polymerase inhibitor

Viroclear tablets are prescription medicine, single dose therapy 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, Viroclear is not combined with peg interferon because of adverse effects produced by peg interferon. Even though this concomitant is avoided, the curable standard of Viroclear tablet is outstanding rate.

Trade name: Viroclear

Active ingredient: Sofosbuvir

Strength: 400MG

Mfg: Abbott

Package: 28 tablets in a container

Category: Anti-hepaciviral activity

Prescribing information of Viroclear

The prescribing information of Viroclear tablets for the patients affected with chronic hepatitis C infection;

Viroclear is majorly indicated for hepatitis C viral infection therapy by combining with other anti-viral medicines

The effective of Viroclear is established in the genotype I, II III or IV infections, patients who are having HIV-1/HBV co infection.

Viroclear 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 Viroclear

Viroclear containing sofosbuvir is a pan genotype, HCV NS5B RNA polymerase inhibitor.

This RNA polymerase enzyme is involved in viral production. Viroclear 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 Viroclear 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 Viroclear is occur nearly at the range of 61 to 65%

The circulating metabolite has minimal protein bounding property.


Viroclear is highly metabolized in liver, whereas Viroclear is a substrate of P-gp & BCRP


Viroclear is eliminated through urine by glomerular filteration

The terminal half life period of Viroclear is 0.51 hours and its metabolite has 27 hours

How to take the Tablet Viroclear

Generally Viroclear is administered with or without food.

Viroclear tablet 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 Viroclear (sofosbuvir)

The recommended dosage of Viroclear by combination with other medicines;

Patients with genotype III hepatitis:

Viroclear combined with ribavirin and peg interferon alfa and it should be taken as a single dose for 12 weeks

Otherwise Viroclear with ribavirin should be taken as single dose for 24 weeks

Patient acquired with genotype I, IV, V or VI chronic hepatitis C viral infection:

Viroclear is combined with ribavirin and peg interferon alfa should be taken as a single dose for 12 weeks

Viroclear 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:

Viroclear should be combined with ribavirin as a single dose for 12 weeks

In liver transplantation:

Viroclear should be concurrently used with ribavirin as a single dose until liver transmission.

In pediatric:

Viroclear 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 Viroclear should be combined with weight based ribavirin as a single dose for 12 weeks

In decompensated cirrhosis:

The prescribed dosage of Viroclear 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 Viroclear in case of renal and hepatic impairment.

Viroclear caused side effects

General side effects of Viroclear;



HBV reactivation





Fever, chills



Loss of appetite




Influenza like syndrome





Drug interactions

Viroclear is a substrate of P-gp & BCRP transporters. While using Viroclear 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 Viroclear

Viroclear with vitamin K antagonist, fluctuate the effect of vitamin K antagonist

Viroclear with anticonvulsants like phenytoin, Phenobarbital or carbamazepine causes decreasing the effect of Viroclear

Viroclear with analeptic drug like modafinil causes decreasing the effect of concentration of Viroclear.

While combining with Viroclear with amiodarone, no effect of concentration occurs but symptomatic bradycardia occurs

Viroclear with anti-mycobacterials causes depletion in effect of concentration of Viroclear

Viroclear co administration with P-gp or BCRP inhibitors, causes increasing the plasma concentration of Viroclear

Food drug interaction

Diet should be followed under the guidance of physician

Drug with herbal interaction occurs like; Viroclear with st Johns wort may cause depletion of therapeutic effect of Viroclear

No food drug interaction occurs while taking Viroclear, but caution should be taken during therapy

Possible contraindications

Viroclear tablet combined with ribavirin or peg interferon alfa, contraindicated to pregnancy condition

Hypersensitive reaction produce because of patients contraindicated to the component present in Viroclear tablet

Safety measures

Use with caution in decompensated condition; ribavirin should be combined with Viroclear. Ribavirin causes fetal abnormalities and death. In pregnancy condition ribavirin not recommended

While concomitant amiodarone with Viroclear, 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

Viroclear combined with P-gp or BCRP strong inducers leading to loss of therapeutic effect. Avoid this combination.

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

Viroclear comes under pregnancy category B1

Whereas Viroclear 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 Viroclear tablets;

Viroclear 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

Viroclear is a prescription medicine, if patient fail to take the dose of Viroclear 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 Viroclear.

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%

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