September 30, 2025 — Gilead’s Epclusa (sofosbuvir/velpatasvir, 400mg/100mg) continues to reshape hepatitis C management worldwide. As the first and only all-oral, pan-genotypic, single-tablet regimen, Epclusa represents a major milestone in the fight against HCV.
In June, the U.S. FDA approved Epclusa for all six major HCV genotypes (GT-1 through GT-6). The following month, the European Commission granted its marketing authorization, and shortly thereafter, the UK’s National Institute for Health and Care Excellence (NICE) endorsed the therapy for patients across England and Wales.
Epclusa is Gilead’s third sofosbuvir-based therapy, following the groundbreaking Sovaldi and Harvoni. More importantly, it is the first single-tablet regimen approved for genotypes 2 and 3, eliminating the need for ribavirin in many patients.
The treatment combines two key antivirals:
- Sofosbuvir, a nucleotide analog polymerase inhibitor;
- Velpatasvir, a pan-genotypic NS5A inhibitor.
This dual action ensures broad-spectrum efficacy and simplifies therapy across all major HCV genotypes.
Carole Longson, Director of NICE’s Health Technology Evaluation Centre, stated: “Previous therapies were genotype-specific and often required combination regimens, sometimes with unexpected side effects. Epclusa offers a unified, streamlined approach that improves patient outcomes.”
The high price remains a consideration. In the UK, a 12-week course costs £38,980, rising to £40,000 when combined with ribavirin. However, Gilead has entered into confidential discount agreements with NICE to expand access. With an estimated 214,000 people living with hepatitis C in the UK, the approval carries significant public health impact.
The widespread regulatory acceptance of Epclusa marks the beginning of a new era in hepatitis C treatment — one step closer to the global elimination of the disease.
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