Epclusa (sofosbuvir/velpatasvir) is a cure for hepatitis C. (1) It treats all six major types of chronic hepatitis C virus (HCV). Gilead launched an earlier version of the treatment, sofosbuvir, for $1000 per pill in 2014 to significant outrage. (2) “Gilead pursued a calculated scheme for pricing and marketing its Hepatitis C drug based on one primary goal, maximizing revenue, regardless of the human consequences. Gilead knew these prices would put treatment out of the reach of millions and cause extraordinary problems for Medicare and Medicaid, but still the company went ahead,” said Senator Wyden (D.-Ore.) after an investigation into the drug. (3)
Since then, Gilead has introduced authorized generics, including for Epclusa, with a list price of $24,000. (4) Researchers estimate a course of Epclusa costs $85 to produce. (5) Access is still seriously constrained. Several states still arbitrarily restrict access to the drug, including based on substance use and liver damage progression. (6) The drug is grossly underutilized, and 14,242 people died from hepatitis C in 2019 despite the availability of this highly effective cure. (7) Black and Indigenous people die at far higher rates than other groups. (8)
Table: Epclusa patents
| Patent Number | Patent Expiration (9) |
| 7,964,580 | 09/26/2029 |
| 8,334,270 | 09/21/2028 |
| 8,590,765 | 09/21/2028 |
| 8,618,076 | 06/11/2031 |
| 8,633,309 | 09/26/2029 |
| 8,735,372 | 09/21/2028 |
| 8,889,159 | 09/26/2029 |
| 8,921,341 | 05/16/2033 |
| 8,940,718 | 05/16/2033 |
| 9,085,573 | 03/21/2028 |
| 9,284,342 | 03/13/2031 |
| 9,757,406 | 07/30/2034 |
| 10,086,011 | 07/30/2034 |
| 11,116,783 | 07/30/2034 |
The U.S. is not on track to meet national public health goals. In 2015, the National Academies of Science and Medicine (NAM) estimated that treating at least 260,000 people each year could help the U.S. achieve hepatitis C elimination by 2030. (10) But according to the CDC, between 2014 to 2020, less than 850,000 people initiated treatment with the new wave of hepatitis C cures, which includes sofosbuvir/velpatasvir. (11) This represents about 120,000 people per year—or less than half the target.
Acute hepatitis C infections are also increasing rapidly, fueled by the opioid crisis. The U.S. Viral Hepatitis National Strategic Plan (2021-2025) notes the importance of treatment as prevention, since people who are treated and cured of hepatitis C cannot transmit the virus to others. However, the plan notes that “the main barriers to treatment as prevention are stigma and the high price of treatment.” (12)
There are multiple global generic suppliers for Epclusa that sell the drug for a fraction of the U.S. list price. (13) The U.S. government can help expand affordable access and lower prices by using Section 1498. Authorizing generics in the U.S. could help produce significant savings, expand access to treatment, and help turn the tide against the HCV epidemic.
(1) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208341s007lbl.pdf
(2) Wyden-Grassley Sovaldi investigation finds revenue-driven pricing strategy behind $84000 hepatitis drug
(3) Wyden-Grassley Sovaldi investigation finds revenue-driven pricing strategy behind $84000 hepatitis drug
(4) Gilead Subsidiary to Launch Authorized Generics of Epclusa® (Sofosbuvir/Velpatasvir) and Harvoni® (Ledipasvir/Sofosbuvir) for the Treatment of Chronic Hepatitis C
(5) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7646676/
(6) https://stateofhepc.org/wp-content/uploads/2022/01/HCV_State-of-Medicaid-Access_Jan-2022_v2.pdf
(7) https://www.cdc.gov/nchhstp/newsroom/docs/factsheets/Hepatitis-c-by-the-numbers.pdf
(8) https://www.cdc.gov/hepatitis/statistics/2019surveillance/Table3.8.htm
(9) This includes six months pediatric exclusivity.
(10) 2014-2020 Hepatitis C Treatment Estimates | Newsroom | NCHHSTP | CDC
(11) https://www.cdc.gov/nchhstp/newsroom/2021/2014-2020-hepatitis-c-treatment-estimates.html
(12) Viral Hepatitis National Strategic Plan Overview | HHS.gov
(13) https://www.theglobalfund.org/media/7500/ppm_strategicmedicineshivreferencepricing_table_en.pdf