Sofolanork Plus

Trade Name:

Sofolanork Plus

Compound:

Properties

Combined antiviral agent.

Ledipasvir is a hepatitis C virus (HCV) inhibitor that acts on the HCV non-structural 5A (NSSA) protein required for RNA replication and the formation of HCV virions. Biochemical confirmation of NSSA inhibition by ledipasvir is currently not possible because NSSA has no enzymatic function. Selective studies of resistance and cross-resistance with t-vigo indicate that the mechanism of action of ledipasvir is an effect on NSSA.

Sofosbuvir is a pan-genotypic inhibitor of HCV RNA-dependent RNA polymerase NSSB, which is required for viral replication. Sofosbuvir is a nucleotide prodrug that, as a result of intracellular metabolism, is converted to the pharmacologically active triphosphate (GS-461203), an analogue of uridine, which is inserted into the RNA of the hepatitis C virus using NSSB polymerase and acts as a chain terminator. GS-461203 (the active metabolite of sofosbuvir) is not an inhibitor of human DNA and RNA polymerases, nor is it an inhibitor of mitochondrial RNA polymerase.

Indications

Treatment of chronic hepatitis C (CHC) in adults and adolescents aged 12 to 18 years.

Dosage and administration

The optimal dosing regimen is determined by the doctor. Compliance of the dosage form of a particular drug with indications for use and dosing regimen should be strictly observed.

It is taken orally in a fixed combination 1 time / day according to a special scheme.

Contraindications

Hypersensitivity to ledipasvir and sofosbuvir; pregnancy, breastfeeding period; children’s age up to 18 years; co-administration with rosuvastatin; in patients receiving powerful inducers of P-glycoprotein in the intestine (rifampicin, rifabutin, St. John’s wort, carbamazepine, phenobarbital, phenytoin); combined use with drugs containing sofosbuvir.

Warnings and precautions:

In patients with severe renal insufficiency (eGFR <30 ml / min / 1.73 m2) or end-stage renal disease, when hemodialysis is necessary; concomitantly with amiodarone, digoxin, atazanavir/ritonavir, darunavir/ritonavir or lopinavir/ritonavir combinations used in combination with tenofovir disoproxil fumarate; use with a combination of elvitegravir/cobicistat/emtricitabine/tenofovir. It is not recommended to use with moderate inducers of P-glycoprotein in the intestine (including oxcarbazepine, rifapentine, tipranavir, boosted with ritonavir).

Side effects

From the nervous system: very often — headache.

From the skin and subcutaneous tissues: often — rash; frequency unknown — angioedema, Stevens-Johnson syndrome.

Since the cardiovascular system: there have been cases of severe bradycardia and heart block when taking this combination in combination with amiodarone and / or other drugs that reduce heart rate.

Storage

Store at a temperature not exceeding 30 degrees.

Package:

Cardboard box contains 4 blisters of 7 tablets and paper leaflet.