New Hepatitis C Drug Expected to Challenge Dominance of Gilead in HCV Market

A recently approved drug for the treatment of hepatitis C (HCV) genotype 1 and 4 poses a threat to the popular Harvoni drug, which has generated over $12 billion in sales last year in the United States, according to research and consulting firm GlobalData.

Merck’s elbasvir and grazoprevir (Zepatier), which was approved on January 28, 2016, has been found to be comparable to the efficacy and safety of Harvoni.

GlobalData analyst Daian Cheng, PhD, predicts that Zepatier threaten Harvoni because of its similarities in clinical performance, despite differences in small patient populations, such as end-stage renal or liver diseases.

“Thus, the main reason it poses such a threat to Harvoni is its lower cost,” Cheng said. “Merck has listed Zepatier at a price over 40% lower than that of Harvoni, which should help the company gain patient share for this late-to-market product.”

Zepatier will also affect other drugs that have comparable prices to Harvoni, such as Sovaldi and Viekira Pak, according to Cheng. The Zepatier 12-week treatment regimen is priced at $54,600, considerably cheaper than the other regimens that can cost up to $95,000.

“Zepatier will quickly carve out a solid niche in the hepatitis C market due to the way in which it marries brilliant product performance in its efficacy, safety, and cost,” Cheng said. “However, the response of competitors in price negotiation with payers, especially Gilead, will impact the extent of Zepatier’s market penetration.”

There are many treatment options for hepatitis C patients, especially with improvements in patients who are difficult to treat, and those with treatments that are shorter than 12 weeks.

With Zepatier coming onto the drug market, Cheng believes that it will bring substantial changes to patient share and therapy costs for hepatitis C.

“In a bigger picture, Gilead’s products are already covering all hepatitis C genotypes, and the company expects its pan-genotypic, fixed-dose combination of velpatasvir/sofosbuvir to be approved in June this year,” Cheng continued. “Harvoni is also indicated for patients with genotypes 5 and 6 in the US.”