Gilead’s Hep C Dream Drug Faces Demanding Investors

For decades, Charlotte Stewart was carrying around a virus that was like the houseguest that refused to leave: hepatitis C.

Stewart was first diagnosed with HCV in 1998, but she believes she contracted it as much as 20 years earlier, when she received two blood transfusions and three injections with blood-related products.

By the time the virus was detected, her liver was already showing the scarring, known as cirrhosis, that appears in the more advanced cases of the disease.

“Fortunately, that didn’t get much worse, because I did do the treatment,” Stewart, now 66, told IBD. “I did six rounds of treatment, with the sixth being Harvoni.”

Harvoni is the new pill just launched this month by Gilead Sciences (NASDAQ:GILD), which Stewart got early because she participated in its clinical trials. Harvoni is a combination of the novel drug ledipasvir and sofosbuvir, which for nearly a year has been sold alone under the brand name Sovaldi.

High Hopes

Sovaldi’s launch smashed all previous new drug launches. Since it came out in December 2013 it has racked up nearly $ 6 billion in sales — and that’s before Gilead’s third-quarter report, which is due on Oct. 28. Since Harvoni is the new-and-improved Sovaldi, analysts expect it to treat even more patients.

Stewart’s previous treatment experience shows just why Gilead is rolling in money right now.

Her first four treatments were variations on the combination of interferon and ribavirin, which was the standard at the time. She credits those treatments with slowing her liver damage, but they didn’t get rid of the HCV and they did make her feel sick.

In fact, her third treatment round, which involved daily injections of interferon, drove down her blood-cell counts so low that she nearly landed in the hospital.

“It was very difficult going through those treatments,” she said. “I always developed anemia. Achiness, fevers, chills and no energy.”

In contrast, when she was in the Harvoni trial, she took one pill a day for 12 weeks and suffered no side effects. After 12 weeks, her viral load was undetectable — and still is, more than a year later.

“Physically, I have more energy, and just overall better health,” Stewart said. “Mentally and emotionally, it’s like having a huge weight taken off you.”

More than 90% of patients in the trial responded that way. Yet Gilead’s stock fell 2% the day Harvoni was approved, and it kept falling the next three days after that.

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