Next Steps on HCV: Gilead’s Four-Point Plan

In discussions with Pharm Exec, Gilead Sciences offered a single overriding goal for the hepatitis C virus (HCV) franchise over the next 18 months: to drive science that will lead to better regimens for treatment, especially for those patients who have been diagnosed. “Our emphasis is on access, which informs our entire strategy, from physician and patient liaison to price contracting with the major payers,” Joe Steele, Gilead’s vice president of commercial operations, told Pharm Exec. Key initiatives around this goal are:

Expanding and refining the therapy set. Phase III trial results are due later this year on an investigational single tablet regimen (GS-5816) that will cover all HCV genotypes. Development programs are also in place to cover patients co-infected with HIV, and for other non-viral liver diseases, including non-alcoholic steatohepatitis (NASH), primary sclerosing cholangitis, and advanced liver fibrosis.

Promoting HCV awareness. Gilead intends to build on non-promotional campaigns like the “Forget me Not” ads introduced last year to make sure untreated patients are aware of the options now available to them. “We think an empowered patient able to ask the right questions of providers is fundamental to defeating this disease,” notes David Johnson, VP for US sales and marketing in Gilead’s liver disease business unit.

This month, Gilead will launch a new branded DTP campaign on Harvoni that includes television, print, and digital advertising around the message tag “I am Ready to be Hepatitis Cured.” According to Mike Rutstein, CEO of STRIKEFORCE Communications, the creative agency for the campaign, the effort seeks to connect with and empower patients through a message based on understanding combined with insight about the condition. “Patients are ready to stop living with the uncertainties of HCV. They no longer want to wonder whether or not they should seek treatment, but to move forward to a cure. And Harvoni is what they’ve been waiting for.” Echoing Johnson, Gilead spokeswoman Amy Flood says “our goals in this campaign are to encourage patients with HCV to connect with a qualified health provider and support a better conversation to increase understanding of their condition and explore treatment options.”

Elsewhere on the stakeholder front, Gilead is supporting work to update specialty professional practice guidelines on HCV. Finally, it has established ties to HCV advocacy groups like the American Liver Foundation and the National Viral Hepatitis Roundtable to amplify the patient voice on access to HCV cures.

Leveraging the US distribution chain to increase HCV adherence. Gilead works through specialty pharmacies on the basis of an open channel model-any specialty pharmacy can access its HCV products. Says Johnson, “such relationships provide real value in not only helping patients get their script filled but also serving as a go-between with insurers. Together with our own Support Path assistance program, we help patients get what they may be entitled to in terms of co-pay relief and discounts.” Solving the payment riddle leads to higher rates of adherence, which is also advanced through work the participating specialty pharmacies do with Gilead in coordinating take-your-medicine call backs and refill reminders.

Growing ex-US sales. Despite its broad footprint globally, HCV expresses differently at the regional and country level: Egypt, which has the world’s highest rate of HCV infection, due largely to needle exchanges during a major outbreak of schistosomiasis in the 1980s, has one prevalent genotype; Japan and Italy have another. Japan is a key market target this year, and regulatory approval of Sovaldi in March now gives the company the opportunity to build a major business presence in a country that has the industrialized world’s highest incidence of liver cancer, caused by HCV. “Due to the HCV opportunity, Gilead now has a fully-staffed, permanent subsidiary in Japan, and we expect the Sovaldi authorization will be followed by approval for Harvoni by the third quarter,” says Steele.

Gilead is taking a special approach to marketing its HCV regimens in the developing world, having negotiated licensing deals with 11, mainly Indian, drug partners. The arrangements grant licensees authorization to manufacture, price, and market clinically approved versions of Sovaldi’s API in 91, mostly poor, countries. The deals exclude many of the larger middle-income emerging countries, which has attracted criticism from the World Health Organization (WHO) and advocacy relief groups like Medecins sans Frontieres.