Description
Indication & Scope
Alfosbuvir is a pan-genotypic oral anti-HCV antiviral agent for adult patients with chronic HCV genotype 1, 2, 3, 6 infection, with or without compensated cirrhosis. It is used for chronic hepatitis C treatment and must be combined with daclatasvir hydrochloride.
- Mechanism
As a nucleotide HCV NS5B polymerase inhibitor, it selectively binds to HCV NS5B polymerase, blocks viral RNA replication, suppresses the proliferation of hepatitis C virus in hepatocytes, and achieves sustained virological response together with daclatasvir hydrochloride. - Drug class
Class 1 small-molecule innovative chemical drug, HCV NS5B nucleotide polymerase inhibitor, pan-genotypic anti-HCV direct antiviral agent (DAA). - Clinical use
Clinical trials have confirmed its high efficacy and favorable safety in combination with daclatasvir hydrochloride. Administered orally at a once-daily dose of 600mg, it is a domestic pan-genotypic NS5B inhibitor for adult patients with chronic HCV genotype 1, 2, 3, 6 infection.
| Generic Name | Alfosbuvir Tablets |
| Brand Name | Sanoldi® |
| Ingredient | Alfosbuvir |
| Dosage Form | Film-coated Tablets |
| Package | 100mg*42 tablets/box |
| Conditions Treated |
The treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 6 infection in adult patients who are treatment-naive or interferon-experienced, with or without compensated cirrhosis
|
| Taboos |
Contraindicated for patients with hypersensitivity to the active ingredient or any excipients of this product, or those with severe allergic history
|
| Place of origin |
Nanjing, Jiangsu, China
|
| Priscription Type | Prescription drug (Rx) |
| Storage Conditions |
Seal tightly, store below 30℃, protected from light and moisture
|
| Manufacturer |
Nanjing Sanhome Pharmaceutical Co., Ltd.
|
| Registration Authority | National Medical Products Administration (NMPA) |
| Approval number |
H20220010
|
| Date of Revision |
August 10, 2022
|
| Shelf Life | 24 months |
How to use ?
Recommended Dose:600mg (6 tablets) orally once daily, taken with food, combined with daclatasvir hydrochloride for a standard 12-week treatment course.
Time: Take at a fixed time every day; if a dose is missed, take it as soon as remembered unless the next dose is within 12 hours, do not take double doses.
Interaction: For oral administration only. Avoid strong P-gp inducers during treatment. Do not combine with other anti-HCV drugs without physician guidance.
Side effects:Common mild to moderate reactions: fatigue, headache, nausea, diarrhea, elevated blood bilirubin. Rare severe adverse reactions: severe liver function abnormality, hypersensitivity reaction; fatal adverse events are extremely rare.
Important Notice
This product shall only be used for post-exposure rabies prophylaxis by professional medical staff. It must be applied combined with rabies vaccine and injected via wound infiltration plus intramuscular routes as specified. Do not administer intravenously or alter the dosage at will. Hypersensitivity monitoring is required throughout the whole injection process.
Packaging & Shipping
Packaging
Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.
Shipping Methods
Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.
Export Support
Certificate of Analysis
GMP Certificate
Commercial Invoice
Packing List & CPP
Cold Chain Logistics
Customs Documentation
Scientific and regulatory sources
FAQ
Can Alfosbuvir be used alone for hepatitis C?
No, it must be used in combination with daclatasvir hydrochloride.
What drug class does Alfosbuvir belong to?
HCV NS5B nucleotide polymerase inhibitor, pan-genotypic direct-acting antiviral agent.
What is the recommended treatment course?
The standard treatment course is 12 weeks.
Can patients with decompensated cirrhosis take this product?
It is not recommended for patients with decompensated cirrhosis.
Sanoldi®Alfosbuvir Tablets | HCV | DengYueRX
INN: Alfosbuvir
Indications: Hepatitis C virus (HCV) genotype 1, 2, 3, 6 infection
Dosage Form: Film-coated Tablets
Strength: 100mg/tablet
