Sofovir and Daclahep 12 Weeks

Discount 245.00 USD

485.00 USD
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Drug profile

Sofovir Daclahep tablets are anti-viral medication, containing two most predominant ingredients such as Sofosbuvir and Daclatasvir

Sofovir Daclahep tablets are single dose therapy, it is a prescription medicine used by the patients only under the knowledge of medical practitioner who are well practiced

Daclahep tablet is not used alone, for better action it should be combined with Sofovir tablet.

In some condition Sofovir Daclahep is combined with ribavirin, an anti-viral medicine used in decompensated (Child Pugh B or C) cirrhosis

Brand name: Sofovir Daclahep

Active components: Sofovir-Sofosbuvir, Daclahep-Daclatasvir

Strength of the components: 400mg & 60mg respectively

Mfg: Hetero healthcare

Package: 28 tablets in a container

Category: Anti-viral drug

Prescribing information for Sofovir Daclahep

The main indication of Sofovir Daclahep is;

This combination tablets are used to treat the chronic hepatitis C viral infection caused by genotype I or III

The major limitation occurred while using Sofovir Daclahep tablets are reduction of constant virological response rate in hepatitis C genotype I or III infected patients.

Mechanism of Sofovir Daclahep

The activity of Sofovir Daclahep tablets are occurred by involving in some mechanism;


Sofovir containing sofosbuvir has anti-hepaciviral activity, which is directly acting drug exhibits its action by prohibiting NS5B RNA reliant RNA polymerase enzyme; essential for hepatitis viral multiplication.

Sofosbuvir is metabolized to form uridine triphosphate, an essential active metabolite which exposes an anti-viral activity.

The infusion of this active metabolite into hepatitis viral RNA with the help of NS5B polymerase and causes viral chain discontinuation


Daclahep containing Daclatasvir expels anti-viral activity by prohibiting NS5A protein which is needful in viral production and virion accumulation


The peak plasma concentration of Daclahep tablets occurs within the range of 2 hours

The absolute bioavailability of Daclahep is 67%

The peak plasma concentration of Sofovir tablets occurs within the range of 0.5 to 2 hours approximately.

The food will not creates any variation in absorption of Sofovir Daclahep tablets, may be taken with or without food


The volume of distribution in Daclahep tablet is 47L

The human plasma protein bound with Daclahep tablet is nearly 99%

The blood to plasma ratio of Sofovir is relatively 0.7

The human plasma protein bound with Sofovir occurs nearly 61 to 65%


Sofovir is metabolized hepatically and formed as pharmacologically active metabolite uridine triphosphate, metabolism undergone with the help of cathepsin A or carboxylesterase 1

Daclahep metabolism occurred with the help of CYP3A4


88% of Daclatasvir is excreted through feces 53% as an unchanged form, 6.6% excreted through urine.

The terminal half life period of Daclatasvir is occurred at 12 to 15 hours

Sofosbuvir metabolites are excreted through 80% in urine, 14% in feces & 2.5% in exhaled air

The terminal half life period of sofosbuvir is nearly 0.51 hours

How to take the Tablet Sofovir Daclahep

Sofovir Daclahep tablets are administered with or without food, in the condition of hepatitis C viral infection originated by genotype I or III

Sofovir Daclahep is single dose regimen

Dosage regimens

Generally Daclatasvir is not used alone, it is combined with sofosbuvir

The recommended dosage of Sofovir Daclahep is one tablet should be taken as a single dose

If sofosbuvir is discontinued, Daclatasvir also get stopped

Genotype I:

Patient suffered without cirrhosis or with compensated cirrhosis:

The recommended dosage of Sofovir Daclahep is one tablet should be taken as a single dose with or without food

In decompensated cirrhosis patients:

Sofovir Daclahep should be combined with ribavirin as a single dose

Genotype III:

Patient suffered without cirrhosis or with compensated cirrhosis:

The recommended dosage of Sofovir Daclahep is one tablet should be taken as a single dose with or without food

In decompensated cirrhosis patients:

Sofovir Daclahep should be combined with ribavirin as a single dose

The dosage of ribavirin;

On basis of body weight & hemoglobin level of patients, dose can be calculated.

Less than 75kg: 1000mg of ribavirin; in genotype I or III 600mg of ribavirin as an initial dose and followed as 1000mg/per

At least 75 kg: in decompensated cirrhosis 1200mg of ribavirin given as twice daily

The safety and efficacy of Daclahep has not been established <18 years

Sofovir used in ≥12 years or weight of ≥35kg

Dosage adjustment in drug interaction;

If concurrent use with strong CYP3A inhibitors, the dosage of Daclahep is reduced to 30mg while co administration

Concurrent use with moderate CYP3A inducers, the dosage of Daclahep increased to 90mg

Concomitant use of Daclahep with CYP3A strong inducers should be avoided, it is contraindicated

Sofovir Daclahep caused side effects

The most common side effects occurred during the therapy;





Elevation of lipase

Cardiac problems like symptomatic bradycardia





Loss of appetite





Influenza like symptoms




Drug interaction

While combining Sofovir Daclahep with strong CYP3A inducers causes loss of virological reaction rate of both products

Sofovir Daclahep tablets concomitant with amiodarone causes serious symptomatic bradycardia

Sofovir Daclahep tablets concomitant with anti-convulsants, anti-mycobacterials or herbal products like st Johns wort causes decrease in effect of concentration of Sofovir Daclahep

Sofovir Daclahep with HMG CoA reductase inhibitors, this combination leads to cause increasing the exposure of these drugs (statins)

CYP3A strong inducers like st Johns wort, rifampin, phenytoin or carbamazepine

If Sofovir combines with P-gp or BCRP inhibitors leads to cause elevation of sofosbuvir plasma concentration

Food drug interaction

No food drug interaction occurs

While using Sofovir Daclahep tablets, caution should be taken

Diet should be discussed with consultant

Sofovir Daclahep with herbal product like st. Johns wort causes decreasing the therapeutic effect of Sofovir Daclahep

Possible contraindications

Some anaphylactic reaction occurs if patients are contraindicated to the components present in Sofovir Daclahep

Some contraindications occurs while using Sofovir Daclahep tablets

In decompensated cirrhosis, combines with ribavirin contraindicated in pregnancy condition

Safety measures

Using Sofovir Daclahep with ribavirin, should not be recommended in pregnancy condition because of producing fetal damage due to ribavirin

While taking Sofovir Daclahep tablets, with CYP3A strong inducers causes loss of therapeutic response of Sofovir Daclahep tablets. Avoid this concomitant to reduce the adverse effects

Sofovir Daclahep causes serious bradycardia while concurrent use with amiodarone, to prevent this condition some alternative medicine is given or discontinue the amiodarone if possible. Counsel the patients about the exposure of bradycardia during the treatment.

Pregnancy and lactation

Sofovir Daclahep use in pregnancy, safe to use. The pregnancy category is B1

While combining with ribavirin, not recommended for pregnancy

Pregnancy category: X, causes fetal death

 Breast feeding should not be recommended

Storage and handling

The storage condition of Sofovir Daclahep should be stored at room temperature below 30oC (86oF) & 20oC and 25oC (68oF and 77oF) respectively

Container should be keep away from heat, light and moisture

Missed dose

Both Sofovir Daclahep tablets are single dose therapy, if patient fails to take the dose of these tablets, must consult the physician and take the dose within the time as per the instruction given by medical practitioner

Otherwise the missed dose should be skipped and follow the regular dosing schedule

Over dosage

The over dosage of Sofovir Daclahep tablets are occurred due to missed dose , if once over dosage occurs the patients must be monitored frequently for endorsement of toxicity and provide safety measures

Hemodialysis is a procedure used to eliminate the component from body, sofosbuvir removes with separation coefficient of 54% whereas Daclatasvir is problematic because nearly 99% of drug bounded to human plasma protein

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