Understanding Sofosbuvir/Velpatasvir
Sofosbuvir 400 mg and velpatasvir 100 mg is a fixed-dose combination oral tablet used to treat chronic Hepatitis C virus (HCV) infection [1.4.4]. It is highly effective, with an overall cure rate of 98% in patients across all six major HCV genotypes [1.3.3]. The brand name for this combination is Epclusa, manufactured by Gilead Sciences [1.3.3]. An authorized generic version is also available from Asegua Therapeutics, a subsidiary of Gilead [1.3.7].
This medication is a direct-acting antiviral (DAA) treatment and is typically taken once daily for a 12-week course [1.3.7, 1.6.1]. It is approved for use in adults and children three years of age and older [1.3.3]. Depending on the patient's condition, such as the presence of cirrhosis (liver scarring), it may be prescribed alone or in combination with ribavirin [1.3.3].
The Science: How It Works (Pharmacology)
The combination of sofosbuvir and velpatasvir attacks the Hepatitis C virus from two different angles, which is key to its high efficacy:
- Sofosbuvir: This compound is a nucleotide analog HCV NS5B polymerase inhibitor. It is a prodrug, meaning it is converted into its active form within the body. This active form gets incorporated into the virus's RNA by an enzyme called NS5B polymerase, acting as a chain terminator and stopping the virus from making copies of itself [1.6.2, 1.4.5].
- Velpatasvir: This is an HCV NS5A inhibitor. It works by blocking the NS5A protein, which is essential for both viral replication and the assembly of new virus particles [1.6.1, 1.4.5].
By inhibiting both NS5B and NS5A, the medication effectively shuts down the virus's ability to multiply, allowing the body to clear the infection [1.6.2].
The High Cost of Treatment: A Breakdown
The price of Sofosbuvir 400 mg and Velpatasvir 100 mg varies dramatically depending on several factors, including whether it is the brand name or generic, the pharmacy, the country of purchase, and insurance coverage. Without insurance, the cost is prohibitive for most people.
The list price for a 12-week course of brand-name Epclusa can be around $78,078 in the United States [1.3.7]. The authorized generic version has a lower list price, which was initially announced as $24,000 for a full course [1.3.7]. However, retail and coupon prices show a wide spectrum.
Factors Influencing Price
- Brand vs. Generic: The most significant factor is the difference between the brand-name drug (Epclusa) and its generic counterparts. The list price for the authorized generic is substantially lower than the brand name [1.3.2].
- Insurance Coverage: Most insurance plans, including Medicare and Medicaid, cover this medication, but out-of-pocket costs depend on the specific plan's deductible, copay, and coinsurance [1.3.2]. Prior authorization is often required [1.5.1].
- Patient Assistance Programs: Manufacturers and non-profit foundations offer programs that can drastically reduce costs, sometimes to as little as $5 per prescription for eligible individuals [1.3.1, 1.7.1].
- Pharmacy and Location: Prices for the same drug can vary between different pharmacies and geographical locations. Using pharmacy discount cards or comparing prices at international online pharmacies can reveal significant savings [1.2.1, 1.2.3]. For example, some U.S. coupon prices for a 28-day supply of the generic can be around $7,766, while prices from accredited international pharmacies can be as low as a few hundred dollars [1.2.1, 1.2.3].
- Research & Development Costs: Pharmaceutical companies cite the high cost of research, development, and bringing a drug to market as a major reason for high initial pricing [1.5.2].
Price Comparison: Brand vs. Generic
| Feature | Brand Name (Epclusa) | Authorized Generic (Sofosbuvir/Velpatasvir) |
|---|---|---|
| Manufacturer | Gilead Sciences [1.3.3] | Asegua Therapeutics (Gilead Subsidiary) [1.3.7] |
| List Price (12-Week Course) | ~$78,000 [1.3.7] | ~$24,000 [1.3.7] |
| Retail Price (28 Tablets) | Averages ~$24,000-$39,000 without insurance [1.3.2, 1.3.8] | Averages ~$8,000-$9,000 without coupons [1.3.1] |
| Active Ingredients | Sofosbuvir 400 mg / Velpatasvir 100 mg [1.4.5] | Sofosbuvir 400 mg / Velpatasvir 100 mg [1.3.3] |
| Availability | Widely available | Available in U.S. pharmacies [1.3.3] |
Note: Prices are estimates and can vary significantly. [1.3.3]
Mitigating the Cost
Given the high prices, several avenues exist to reduce the financial burden.
- Manufacturer Copay Programs: Gilead's Support Path program offers a copay coupon for commercially insured patients, which can lower out-of-pocket costs significantly [1.7.1, 1.7.7].
- Patient Assistance Programs (PAPs): For uninsured or underinsured patients who meet income criteria, Gilead's Patient Assistance Program may provide the medication at no cost [1.3.3, 1.7.7]. Other foundations like the HealthWell Foundation and Patient Access Network (PAN) Foundation also offer financial aid [1.7.4].
- Insurance and Government Plans: Patients with Medicare Part D or Medicaid often have very low out-of-pocket costs, potentially as low as $5-$15 for a full course of treatment [1.3.2, 1.5.1].
- Pharmacy Discount Cards: Services like GoodRx can offer coupons that lower the retail price at many U.S. pharmacies [1.2.1, 1.3.6].
Potential Side Effects and Warnings
While highly effective, patients should be aware of potential side effects and warnings. The most common side effects include headache and fatigue [1.4.2, 1.6.1]. Other less common effects can include nausea, diarrhea, and difficulty sleeping [1.4.4, 1.4.6]. A serious boxed warning from the FDA notes the risk of Hepatitis B virus (HBV) reactivation in patients coinfected with HCV and HBV. Your doctor will test for HBV before starting treatment [1.4.2, 1.4.5].
Conclusion
The price of Sofosbuvir 400 mg and Velpatasvir 100 mg tablets is complex and highly variable. While the list price is exceptionally high, particularly for the brand-name version Epclusa, very few patients actually pay this amount [1.3.3]. A combination of generic availability, insurance coverage, pharmacy discounts, and robust patient assistance programs makes this life-saving Hepatitis C cure accessible to many. Patients concerned about the cost should speak with their healthcare provider and explore financial assistance options through manufacturer programs and foundations.
For more information on patient support, you may find resources at Gilead's Support Path.
