Harvoni’s approval also set to expire…HCV drugs leave market

Marketing authorization set to expire on October 13

Affected by the market occupation of pangenotypic direct-acting antivirals

First-generation oral direct-acting antivirals (DAAs) that transformed hepatitis C treatment in Korea are disappearing from the domestic market one after another.

Following the recent withdrawal of Gilead Sciences Korea’s Sovaldi after its marketing authorization expired, the company’s combination therapy Harvoni is also expected to be removed from the authorization list on Oct. 13 when its approval expires.

According to industry sources on the 17th, Gilead’s hepatitis C combination therapy Harvoni (ledipasvir/sofosbuvir) is approaching the expiration of its marketing authorization on October 13th. The company is understood not to have sought renewal. Domestic supply of Harvoni was already reported as discontinued in December last year, meaning its removal from the authorization list would mark its complete official exit from the Korean market.

Harvoni expected to be removed from the list on Oct. 13…first-generation treatments exit in succession

The Ministry of Food and Drug Safety previously announced the withdrawal of Sovaldi (sofosbuvir) following the expiration of its marketing authorization. Approved in Korea in 2015, Sovaldi was a landmark drug that rapidly shifted the treatment of chronic hepatitis C away from interferon injections toward oral therapy, generating annual prescriptions of KRW 40 billion to KRW 50 billion. Harvoni, which combines the Sovaldi ingredient sofosbuvir with the NS5A inhibitor ledipasvir, also became a leading treatment, but is now set to follow Sovaldi out of the market.

As a result, the early therapies that ushered in the DAA era in Korea are nearing a complete exit. After the market withdrawal of Korea’s first DAA regimen, BMS’s Daklinza/Sunvepra regimen, in March 2021, AbbVie’s Viekira/Exviera and MSD’s Zepatier subsequently left the market. Now, Sovaldi and Harvoni are joining that list.

Genotype-specific therapies show limitations…Market shifts to pangenotypic Mavyret and Epclusa

A key factor behind the successive withdrawal of early DAA therapies is the firm market dominance of pangenotypic therapies.

Early DAAs offered limited treatment choices depending on factors such as viral genotype (1–6), prior treatment experience, and the presence of cirrhosis, making treatment strategies relatively complex.

By contrast, AbbVie’s pangenotypic Mavyret (glecaprevir/pibrentasvir), launched in the second half of 2018, and Gilead’s subsequent pangenotypic therapy Epclusa (sofosbuvir/velpatasvir) rapidly captured the prescription market with high cure rates across genotypes and greater convenience.

According to 2025 pharmaceutical import data, Epclusa recorded imports of USD 10.39 million (about KRW 13.9 billion), while Mavyret recorded USD 9.48 million (about KRW 12.7 billion), with the two products firmly splitting the market. As the market has shifted decisively toward pangenotypic combinations, older treatments have increasingly lost their place.

An industry official said, “The expiration of Harvoni’s authorization following Sovaldi is a clear example of the generational transition in Korea’s hepatitis C treatment landscape reaching completion. Clinical guidelines and the market structure will become even more firmly centered on pangenotypic DAAs, as they can be prescribed without the burden of genotype testing.”