Sofosbuvir

Drug #2338

Sofosbuvir is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen SOfosbuvir efficacy has been established in subjects with HCV genotype 1, 2,3 or 4 infection, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplantation) and those with HCV/HIV-1 co-infection. The IUPAC name for sofosbuvir is (S)-Isopropyl 2-((S)-(((2R,3R,4R,5R)-5-(2,4-dioxo3,4-dihydropyrimidin-1(2H)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2yl)methoxy)-(phenoxy)phosphorylamino)propanoate.

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Primary Characteristics

It is of Synthetic origin.

It belongs to Antiviral Agents pharmacological group on the basis of mechanism of action.

Molecular Weight: 529.45 · Solubility in Water: slightly soluble · Non-proprietary name: Sofosbuvir.

Pharmacokinetics

Distribution: Sofosbuvir has a plasma protein binding is 61-65%.

Elimination: it is metabolised via liver, plasma half-life is 0.4hrs, renal excretion is 80%by urine, 14% by feces.

Indications

Sofosbuvir is primarily indicated in conditions like Chronic hepatitis C.

Contraindications

None recorded.

Dosage

Sofosbuvir's dosage details are as follows:

Dose	Single Dose	Frequency	Route	Instructions
Adult Dosage
0 – 400 mg	—	—	PO	should be used in combination with ribavirin or in combination with pegylated interferon and ribavirin
Paediatric Dosage (20kg)
No data.
Neonatal Dosage (3kg)
No data.

Drug Interactions

None recorded.

Side Effects

None recorded.

Warnings / Precautions

Pregnancy: sofosbuvir in combination with Ribavirin may cause birth defects and fetal death and animal studies have shown interferons have abortifacient effects;avoid pregnancy in female patients and female partners of malepatients. Patients must have a negative pregnancy test prior toinitiating therapy, use at least 2 effective non-hormonal methods of contraception and have monthly pregnancy tests

Interference in Pathology

Sofosbuvir may interfere in the diagnosis of Bilirubin (increased level), creatine Kinase elevation, lipase elevation.

Available Brands

None recorded.

Storage Conditions

Sofosbuvir should be stored Tablet (Dispense only in original container).

Drug Classification

1.6.5.2 — Antiretroviral drugs