Hepcinat® Sofosbuvir Tablets

Description

Overview of Sofosbuvir 400 mg

Sofosbuvir 400 mg is a nucleotide analog NS5B polymerase inhibitor used in the treatment of chronic hepatitis C virus (HCV) infection. It is included in several combination therapies that provide pan-genotypic coverage and high sustained virologic response (SVR) rates, marking it as a breakthrough in HCV management. It is used in both treatment-naïve and treatment-experienced patients, with or without cirrhosis.

Brand Names and Market Availability

Sofosbuvir is marketed under various brand names globally:

• United States & Canada: Sovaldi, Epclusa (with velpatasvir), Harvoni (with ledipasvir)

• European Union: Sovaldi, Epclusa

• United Kingdom: Epclusa, Sovaldi

• Australia: Epclusa, Sovaldi

• India & Global Generics: Velpanat, MyHep All, Hepcvir-L

Mechanism of Action

Sofosbuvir is a prodrug that is metabolized intracellularly to its active form, GS-461203. This active metabolite inhibits the NS5B RNA-dependent RNA polymerase, an essential enzyme in the HCV replication process. Its incorporation into the viral RNA chain results in chain termination.

This mode of action offers pan-genotypic activity, making it effective against all major HCV genotypes (1-6) when used in combination therapies .

On-Label Uses

Sofosbuvir 400 mg is approved for use in combination with other antiviral agents to treat:

• Chronic HCV genotypes 1 through 6

• Patients with and without compensated cirrhosis

• Adults and pediatric patients aged 3 years and older

Approved combination regimens include:

• Sofosbuvir + Velpatasvir (Epclusa)

• Sofosbuvir + Ledipasvir (Harvoni)

• Sofosbuvir + Daclatasvir

• Sofosbuvir + Ribavirin ± Pegylated interferon (historically)

These combinations achieve SVR rates above 95% in most patient groups .

Off-Label Uses and Emerging Indications

Although Sofosbuvir is primarily indicated for HCV, research has explored its off-label potential in:

• Hepatitis B Virus (HBV) reactivation suppression (not curative)

• Zika and Dengue virus inhibition (in vitro and animal studies)

• COVID-19 (SARS-CoV-2) treatment as an antiviral candidate, though clinical benefits remain unproven

Off-label use should only be considered in clinical trial settings or under specialist supervision.

Dosage and Administration

• Standard Adult Dose: One tablet (400 mg) orally once daily, with or without food.

• Duration: 8 to 24 weeks depending on genotype, combination partner, cirrhosis status, and prior treatment history.

• Pediatric dosing is weight-based.

Compliance with the full course is critical for achieving viral eradication.

Side Effects and Safety Profile

Sofosbuvir is generally well tolerated. Common adverse effects, especially when used in combination therapy, include:

• Fatigue

• Headache

• Nausea

• Insomnia

• Anemia (especially with ribavirin)

Serious adverse events are rare. There is no evidence of significant hepatotoxicity. It is not recommended during pregnancy when combined with ribavirin due to teratogenicity risk .

Drug Interactions

Sofosbuvir is a substrate of P-gp. Co-administration with strong P-gp inducers (e.g., rifampin, St. John’s wort) may reduce plasma concentrations and efficacy. It is not recommended to be used with amiodarone due to reports of serious bradycardia .

Always inform your healthcare provider of any medications or supplements taken concurrently.

Cost and Availability

• Epclusa price in the U.S. can exceed $24,000 for a 12-week course, with generic versions significantly reducing costs.

• Epclusa cost without insurance may be prohibitive; assistance programs or generic sourcing is recommended.

• Epclusa generic price (e.g., Velpanat) starts around $250–$400 for a full course when sourced internationally.

• Sofosbuvir price varies by brand and region. Generic forms are widely available and legally imported from countries like India.

Patients frequently velpanat buy online as a lower-cost alternative to branded medications.

Storage and Shelf Life

Store at room temperature (20°C to 25°C), away from moisture and direct sunlight. Keep out of reach of children. Do not use expired medication.

References

1. NIH LiverTox Database

2. CDC Hepatitis C Treatment Guidelines

3. ClinicalTrials.gov – Sofosbuvir Off-label Uses

4. FDA Prescribing Information – Sovaldi

5. University of Liverpool – HEP Drug Interactions

Frequently Asked Questions (FAQ)

What is Sofosbuvir 400 mg used for?
Sofosbuvir is used in combination with other medications to treat chronic hepatitis C virus (HCV) infections in adults and children.

Can Sofosbuvir cure hepatitis C?
Yes, when taken in combination with other DAAs like velpatasvir or ledipasvir, it achieves cure rates over 95% in most cases.

Is Sofosbuvir available in generic form?
Yes, several generics are available, including Velpanat, MyHep All, and SoviHep, offering lower-cost options to branded products.

What is the cost of Epclusa without insurance?
The cost can exceed $24,000 for a 12-week course. However, generic options like Velpanat can be purchased online for a fraction of the price.

Is Sofosbuvir safe during pregnancy?
When used alone, Sofosbuvir poses low risk, but when combined with ribavirin, it is contraindicated in pregnancy due to fetal harm.