Heterosofir plus 90/400 mg 28 tablets

Tradename

Heterosofir Plus

Compound:

Each tablet contains:

Sofosbuvir 400 mg

Ledipasvir 90 mg

Properties

Combined antiviral agent.

Ledipasvir is an inhibitor of the hepatitis C virus (HCV), which acts on the non-structural 5A (NSSA) protein of HCV, which is required for RNA replication and the formation of HCV virions. Biochemical confirmation of NSSA inhibition by ledipasvir is currently not possible, since NSSA does not have an enzymatic function. Selective studies of resistance and cross-resistance in mvigo show that the mechanism of action of ledipasvir is through the effect on NSSA.

Sofosbuvir is a pangenotypic 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), a uridine analogue that is inserted into the HCV RNA by NSSB polymerase and acts as a chain terminator. GS-461203 (an active metabolite of sophosbuvir) 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.

Method of administration and dosage:

The optimal dosage regimen is determined by the doctor. It is necessary to strictly observe the compliance of the used dosage form of a particular drug with the indications for use and the dosage regimen.

Contraindications

Hypersensitivity to ledipasvir and sophosbuvir; pregnancy, breastfeeding period; children under 18 years of age; joint use 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 sophosbuvir.

Precautionary measures:

In patients with severe renal failure (eGFR <30 ml / min / 1.73 m2) or end-stage renal failure, 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. Not recommended for use with moderate inducers of P-glycoprotein in the intestine (including oxcarbazepine, rifapentine, tipranavir, boosted ritonavir).

Side effects

From the nervous system: very often — headache.

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

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