Overall Uptake and High Prescribing Rate in Retreatment for Gilead's Harvoni Solidify Its Stronghold on the Hepatitis C Market

BURLINGTON, Mass., June 29, 2016 /PRNewswire/ -- Decision Resources Group finds that despite increasing pressure from competitors, specifically AbbVie's Viekira Pak and Merck's Zepatier, Gilead's hepatitis C virus (HCV) franchise continues to dominate the market across all major genotypes in the United States. In addition to capturing the lion's share of the market across key genotypes, surveyed physicians report high prescribing rates of Gilead brands, mainly Harvoni, in difficult-to-treat populations and among patients with negative prognostic factors and comorbid conditions, including prior treatment failure, compensated and decompensated cirrhosis, post-liver transplant, and patients coinfected with HIV. While only a minority of patients fail treatment with current interferon-free options (1-7 percent of patients, depending on regimen), specialists note a strong preference for Harvoni in retreatment scenarios, even when asked to consider hypothetical cases of Harvoni treatment failure.

Other key findings from the U.S. Current Treatment report entitled Hepatitis C Virus:

• Compared to 2015 reporting, surveyed physicians indicate an uptick in treatment rates for HCV, notably in treatment-naive non-cirrhotic patients, where approximately half of the patients under care have undergone treatment in the past six months, suggesting improved access to premium-priced direct-acting antivirals (DAAs).

• Given the aggressive pricing of Zepatier, despite the deep discounts for public payers, it is no surprise that surveyed physicians report limited prescribing of the brand, likely reflective of ongoing pricing and reimbursement negotiations during the study period and its recent launch in early 2016.  However, physician preference for this agent in patients with renal impairment indicates a segment where Zepatier will gain traction.

• While the combination of Sovaldi with Bristol-Meyer Squibb's Daklinza is currently in a head-to-head competition with the Sovaldi + ribavirin regimen for the genotype 3 market, with each regimen capturing nearly one-third of the patient share for non-cirrhotic patients, Sovaldi + Daklinza is favored by specialists for the treatment of cirrhotic, genotype 3 patients.

• According to survey results, Viekira Pak stands to lose patient share in the near-term; a notable share of physicians expect to decrease prescribing of Viekira Pak in the next six months. Physicians point to pill burden and other factors constraining the uptake of the brand.

Comments from Decision Resources Group Business Insights Analyst, James Heeres, Ph.D.:

• "DAA-experienced patients represent a growing unmet need; even though treatment failure is not common for interferon-free regimens, the importance of this subpopulation is illuminated by the fact that several next-generation DAA combinations are targeting this patient segment. Generally, the physicians' preferred treatment strategy for DAA-experienced patients is to switch treatment. One notable exception is that surveyed physicians prefer to retreat patients with Harvoni, highlighting the agent's deeply-rooted market position that is likely to constrain the uptake potential of emerging therapies."

• "The findings indicating high treatment rates among the treatment-naive non-cirrhotic population are noteworthy, given that payer-imposed treatment restrictions have historically impacted the access of patients with less severe liver disease to novel therapies. Our data are consistent with recent improvements in access, including the relaxation of liver fibrosis restrictions in commercial and governmental insurance plans."