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Product Code: 97452
Availability: In Stock
Price: 1,600EGP
Ex Tax: 1,600EGP

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Composition :
Each film-coated tablet contains Sofosbuvir 400mg

Therapeutic indications :
SOFOLANORK is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults.

Recommended dosage :

The recommended dosage of Sofolanork / Soflanork is one 400 mg tablet, taken orally, once daily with or without food.

Administer Sofolanork / Soflanork in combination with ribavirin or in combination with pegylated interferon and ribavirin for the treatment of HCV. The recommended treatment regimen and duration for Sofolanork / Soflanork combination therapy

Mechanism of action:
Sofosbuvir is a pan-genotypic inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is essential for viral replication. Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analog triphosphate (GS-461203), which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator. In a biochemical assay, GS-461203 inhibited the polymerase activity of the recombinant NS5B from HCV genotype 1b, 2a, 3a and 4a with a 50% inhibitory concentration (IC50 ) value ranging from0.7 to 2.6 μM.

GS-461203 (the active metabolite of sofosbuvir) is not an inhibitor of human DNA and RNA polymerases nor an inhibitor of mitochondrial RNA polymerase.

pharmacokinetics : 

The effect of hepatic impairment was studied in a seven-day treatment with sofosbuvir in 17 patients with moderate-to-severe HCV-related hepatic impairment compared to eight non-cirrhotic patients infected with HCV. There was no significant difference in the half-life with or without hepatic impairment. The Cmax was 80% higher, and the AUC was 130% higher in subjects with hepatic impairment, while the viral decline was less pronounced. The safety profile was good in all the patients, thus suggesting that no dosage or interval modification was required in patients with moderate-to-severe hepatic impairment.

The effect of renal impairment on the pharmacokinetics of sofosbuvir has also been studied with a single 400 mg dose, in patients with varying degrees of renal impairment. The AUC of an inactive nucleotide metabolite, PSI-6206, is increased by 56% in mild, 90% in moderate, and 456% in severe renal impairment subjects, compared to normal subjects. Dosage or interval modifications are thus suggested in patients with moderate-to-severe renal impairment. Furthermore, 15% of sofosbuvir and 53% of PSI-6206 have been extracted by hemodialysis in patients with end-stage renal disease; dosage modifications will be recommended in this group of patients.

DRUG INTERACTIONS OF SOFOSBUVIR : 

Many patients with HCV have concomitant illnesses such as HIV requiring anti-retroviral therapy, or hepatocellular carcinoma/decompensated liver disease requiring liver transplants along with immunosuppressant medication. Thus, it is very important to study the possible drug interactions that may occur in these patients, who also require treatment of HCV. Studies have shown no clinically significant interactions between sofosbuvir and the following drugs: Cyclosporine, tacrolimus, methadone, efavirenz, rilpivirine, darunavir/ritonavir, raltegravir, and tenofovir. No dose adjustments are required in patients receiving these drugs along with sofosbuvir. As sofosbuvir is being tried for all-oral regimens combined with other directly acting antiviral agents, interactions with these drugs have also been studied. No clinically significant interactions have been found between sofosbuvir and daclatasvir, ledipasvir, or GS-9669. A 54-year-old liver transplant recipient with HCV type 1b and severe recurrent cholestatic hepatitis was given daclatasvir (HCV NS5A inhibitor) plus sofosbuvir for 24 weeks; SVR at 36 was achieved, and the level and dose of tacrolimus remained stable in this patient . 

 

 

 

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