Alfosbuvir Tablets

【Properties】

This product is a yellow film-coated tablet, which is white or off-white after removing the coating.

【Indications】

This product is used in combination with daclatasvir hydrochloride to treat chronic hepatitis C virus (HCV) infection in adults with genotypes 1, 2, 3, and 6 who are newly treated or have been treated with interferon, with or without compensated cirrhosis.

【Specifications】100mg

【Usage and Dosage】

This product is taken orally, on an empty stomach or with food.

Recommended dose and method of administration

This product should be used in combination with daclatasvir hydrochloride.

Recommended dosage of this product: Oral, 600 mg (6 tablets) each time, once a day, for 12 consecutive weeks; at the same time, take daclatasvir hydrochloride tablets orally, 60 mg (1 tablet) each time, once a day, for 12 consecutive weeks.

Animal carcinogenicity studies have not yet been completed for Ofosbuvir, and the total course of treatment should not exceed 12 weeks.

See [Precautions] for information on co-administration with other direct-acting antivirals for HCV.

Dose Adjustment

A dose reduction of Ofosbuvir is not recommended.

Special Patient Populations

Hepatic Impairment

For patients with mild or moderate hepatic impairment (Child-Pugh-Turcotte [CPT] grade A or B), no dose adjustment of Ofosbuvir is required (see [Pharmacokinetics]). The safety and efficacy of Ofosbuvir in patients with severe hepatic impairment (Child-Pugh-Turcotte [CPT] grade C) have not been established.

Renal Impairment

The pharmacokinetics of patients with renal impairment have not been studied.

[Precautions]

Ofosbuvir is not recommended as monotherapy and should be used in combination with Daclatasvir or other medicinal products to treat hepatitis C infection. If Daclatasvir or other co-medication is permanently discontinued, Ofosbuvir should also be discontinued. Before starting treatment with ofosbuvir tablets, please consult the prescribing information of daclatasvir hydrochloride tablets or other concomitant medicinal products.