- New medicines are curing cases of hepatitis C at a rapid pace, prompting Gilead to turn to different patient population as a means of mitigating lower revenues.
- The latest of those efforts came to fruition last week, when the Food and Drug Administration approved the hep C virus (HCV) treatments Harvoni (ledipasvir/sofosbuvir) and Sovaldi (sofosbuvir) for children ages 12 and up. In the U.S., the disease occurs in .4% of 12- to 19-year-olds and as many as 46,000 juveniles overall, according to the American Liver Foundation.
- There are six strains, called genotypes, of HCV. Harvoni gained approved for genotypes 1, 4, 5 and 6, while Sovaldi, in combination with the anti-viral medication ribavirin, is for genotypes 2 and 3.
Gilead has worked diligently to clot its hemorrhaging hepatitis C revenues. While Harvoni and Sovaldi raked in more than $13 billion in 2016, sales for each decreased by 34% and 24%, respectively, from 2015. That's a major problem, considering the two drugs account for almost half of the company's total product sales.
Another problem is the crowded HCV drug market. AbbVie, Bristol-Myers Squibb and Johnson & Johnson's Janssen are just a few of the companies with competing treatments.
Regardless of an overcrowded market, the effectiveness of HCV meds has cured patients and widdled down the size of the market — which is great for patients but not so great for bottom lines. With that tide unlikely to reverse, Gilead has focused its efforts on untapped populations. Despite the disease being significantly more prevalent in older populations, Gilead is trying to tap into any remaining revenue sources.
"Gilead’s goal is to develop and deliver treatments that provide all patients with HCV the potential to be cured," the company's Chief Scientific Officer Norbert Bischofberger said in an April 7 statement. "For the first time, children 12 and older in the United States with genotypes 1 through 6 chronic HCV infection now have options of two direct-acting antiviral regimens that offer high cure rates while eliminating the need for interferon injections."
But Gilead knows its bread and butter are from older patients. In 2016, Gilead rolled out a commercial advocating that Baby Boomers, those born after World War II, mostly in the age range of 50 to 70, get tested for HCV. The 60-second commercial has had 7,879 national airings as of April 12, according to iSpotTV.
"For millions of baby boomers, there's a virus out there — a virus that's serious like HIV, but it hasn't been talked about much. A virus that's been almost forgotten. It's hepatitis C," a voiceover on the commercial says, adding that one in 30 Baby Boomers has hep C, though many aren't aware they do.
Gilead has also pushed for treatment options outside Harvoni and Sovaldi. The FDA gave the go-ahead last June to the big biotech's drug Epclusa (sofosbuvir/velpatasvir), which targets all six genotypes of the disease. The medication helped offset some of the revenue declines seen in 2016 by bringing in $1.75 billion over the year.