Daclatasvir and Sofosbuvir 60mg/400mg Tablets are oral antiviral medicines used in the treatment of chronic hepatitis C virus (HCV) infection. This combination contains two direct-acting antiviral (DAA) medicines that work at different stages of the HCV replication process. WHO lists daclatasvir and sofosbuvir as a pangenotypic combination when used together.
For buyers, distributors, hospitals, and healthcare professionals sourcing hepatitis C medicines, understanding the composition, uses, dosage form, storage requirements, and supply considerations is important.
What Are Daclatasvir and Sofosbuvir 60mg/400mg Tablets?
Daclatasvir and Sofosbuvir 60mg/400mg Tablets are a fixed-dose combination formulation containing:
- Daclatasvir – 60 mg
- Sofosbuvir – 400 mg
The daclatasvir component is commonly present as daclatasvir dihydrochloride. WHO has listed a 60mg/400mg film-coated tablet combination and has prequalified a product containing daclatasvir (dihydrochloride) and sofosbuvir.
Uses of Daclatasvir and Sofosbuvir Tablets
The primary use of this combination is the treatment of chronic hepatitis C virus infection.
Hepatitis C is a viral infection that primarily affects the liver. If left untreated, chronic HCV infection can contribute to serious liver complications, including cirrhosis and liver cancer.
Daclatasvir and sofosbuvir are direct-acting antivirals that target HCV replication. Current WHO guidance supports the use of curative DAA treatment for hepatitis C.
The exact treatment regimen can depend on factors such as the patient's age, body weight, HCV characteristics, liver condition, previous treatment history, and other medicines being taken.
Composition of Daclatasvir and Sofosbuvir 60mg/400mg
Each tablet contains two active pharmaceutical ingredients:
Daclatasvir 60 mg:
Daclatasvir is an HCV NS5A inhibitor. It interferes with viral proteins required for HCV replication.
Sofosbuvir 400 mg:
Sofosbuvir is an HCV nucleotide analogue NS5B polymerase inhibitor. It interferes with the viral RNA polymerase required for HCV replication.
Using two antiviral agents with different mechanisms helps provide combination antiviral activity against HCV.
WHO's prequalified 60mg/400mg product is supplied as a film-coated tablet. One WHO-prequalified presentation is packaged as 28 tablets and has a listed shelf life of 36 months when stored according to the specified conditions.
Daclatasvir and Sofosbuvir 60mg/400mg Dosage
The appropriate dose and treatment duration should be determined by a qualified healthcare professional according to current treatment guidelines and the patient's clinical condition.
The 60mg/400mg strength should not be treated as a universal dosage for every patient. Different patient groups may require different treatment approaches, and other medicines may be added in particular clinical situations.
Patients should take the medicine exactly as prescribed and should not change, stop, or extend treatment without medical advice.
Important Information Before Use
Before treatment, healthcare professionals may assess liver function, HCV status, previous antiviral treatment, and potential drug interactions.
Patients should inform their healthcare provider about all prescription medicines, over-the-counter medicines, and supplements they use. Some medicines can interact with antiviral treatment and may affect its safety or effectiveness.
The product should be obtained from an authorized pharmaceutical source and used according to the approved prescribing information applicable in the destination country.
Storage and Packaging
Storage conditions can vary by manufacturer and product. For example, a WHO-prequalified 60mg/400mg product specifies storage not above 30°C and in the original container. Buyers should always follow the manufacturer's approved product information and packaging instructions.
For pharmaceutical procurement, buyers should also verify:
- Product strength and dosage form
- Manufacturer details
- Batch and expiry information
- Packaging configuration
- Required documentation
- Destination-country regulatory requirements
- Shipping and storage conditions
Sourcing Daclatasvir and Sofosbuvir 60mg/400mg Tablets
Global Pharma Trade supplies pharmaceutical products from India for international buyers, subject to applicable regulations and destination-country requirements.
Hospitals, pharmaceutical distributors, wholesalers, and other eligible buyers can contact Global Pharma Trade to enquire about Daclatasvir and Sofosbuvir 60mg/400mg Tablets, product availability, packaging, documentation, and export supply options.
For international pharmaceutical procurement, buyers should confirm that the product and import process comply with the regulations of the destination market.
Frequently Asked Questions
What are Daclatasvir and Sofosbuvir 60mg/400mg Tablets used for?
They are used as an antiviral treatment for chronic hepatitis C virus infection under the direction of a qualified healthcare professional.
What is the composition of Daclatasvir and Sofosbuvir 60mg/400mg?
Each tablet contains daclatasvir 60 mg and sofosbuvir 400 mg. The daclatasvir component may be present as daclatasvir dihydrochloride.
Is Daclatasvir and Sofosbuvir a direct-acting antiviral combination?
Yes. Both medicines are direct-acting antivirals that act on different HCV proteins involved in viral replication.
How should these tablets be stored?
Follow the specific manufacturer's storage instructions. A WHO-prequalified 60mg/400mg product specifies storage below 30°C in the original container.
Can buyers purchase Daclatasvir and Sofosbuvir 60mg/400mg for pharmaceutical supply?
Eligible international buyers can contact a pharmaceutical supplier to discuss availability, packaging, documentation, and export requirements, subject to the regulations of the destination country.
Medical disclaimer: This information is provided for educational and pharmaceutical procurement purposes. It is not a substitute for medical diagnosis or prescribing advice. Treatment decisions should be made by a qualified healthcare professional using current clinical guidelines and approved product information.