Harvoni will keep Gilead atop Hepatitis C virus treatment landscape, says GlobalData Analyst

The recent US Food and Drug Administration (FDA) approval of Harvoni (ledipasvir/sofosbuvir), Gilead Sciences’ once-daily, single-tablet regimen to treat chronic hepatitis C virus (HCV) genotype 1 (GT1) infection in adults, will enable the company to maintain its dominance in an increasingly competitive market, says an analyst with research and consulting firm GlobalData.

Christopher J. Pace, Ph.D., GlobalData’s Senior Analyst covering Infectious Diseases, expects Harvoni to quickly usurp other Sovaldi-based regimens as the preferred treatment option for GT1 patients, who comprise over 70% of all US adults with HCV. This is due to the drug’s stellar clinical profile and reduced pill burden relative to approved and off-label options.

Furthermore, by attributing the bulk of Harvoni’s wholesale acquisition cost (WAC) to Sovaldi, Gilead will also discourage the off-label use of more expensive Sovaldi-based, direct-acting antiviral (DAA) regimens, strengthening its position against competitors Bristol-Myers Squibb, Johnson & Johnson, AbbVie, and Merck.

Pace comments: “Gilead’s shrewd pricing strategy for the fixed-dose combination pill, with an anticipated WAC of $94,500 for a 12-week course, will help to facilitate its rapid uptake, particularly in the US.

“This approach will easily position Harvoni as the more cost-effective option for most GT1 patients, compared with the interferon-sparing Sovaldi regimens, which have an estimated WAC of $94,726 for a 12-week course of Sovaldi combined with Pegasys [peginterferon alfa-2a] and ribavirin. This pricing strategy will be especially effective for patients who can be cured with an eight-week course of Harvoni, which carries an expected WAC of $63,000.”

However, the analyst notes that while Gilead has a clear lead over competitors in the US, its position in other major markets is less tenable.

Pace explains: “Compared to the US, Gilead has faced a delayed uptake of Sovaldi-based regimens in the five European countries of Germany, Italy, Spain, France and the UK due to cost-effectiveness concerns, particularly in the latter two countries.

“Nevertheless, Harvoni’s convenient once-daily, single-tablet dosing will be hard for clinicians and eligible patients to ignore when it launches in these and the Japanese markets, especially if Gilead emulates its US pricing strategy.”