BETHESDA, MD 30 Jun 2014—Recently approved drugs for the treatment of chronic hepatitis C virus (HCV) infection have been both acclaimed for their effectiveness and called out for their high costs.
Simeprevir, marketed as Olysio by Janssen Therapeutics, was approved last November, and Gilead's sofosbuvir, or Sovaldi, was approved about two weeks later.
"There are huge benefits to these drugs," said Ann McNamara, clinical development manager at Fairview Specialty Pharmacy in Minneapolis. "I think what's getting lost in this whole thing is they actually are curing patients of a chronic disease, which just doesn't happen; especially in pharmacy, you don't see that."
"The unfortunate thing is, they're just very expensive," she said.
The reported $1000-per-tablet price of sofosbuvir has even caught the attention of Democrats on the House Committee on Energy and Commerce, who in late March asked the company to brief them on issues related to the drug's U.S. price.
McNamara said that about 360 patients have enrolled in Fairview Specialty Pharmacy's hepatitis C management program with the goal of completing one of three regimens containing the new drugs: sofosbuvir, ribavirin, and a pegylated interferon alfa product; sofosbuvir and ribavirin; or sofosbuvir and simeprevir.
She said the regimens vary depending on the viral genotype and the patient's health and previous response to therapy. Treatment regimens follow recently published HCV treatment guidelines from the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America.
McNamara said about 100 patients have finished their course of therapy so far, and the overall completion rate—about 90%—is much higher than before the current generation of direct-acting anti-HCV drugs became available.
"We're going to see a lot more cures with this therapy," McNamara predicted.
According to the Centers for Disease Control and Prevention, about 3.2 million Americans have chronic HCV infection. Without effective treatment, chronic liver disease will develop in about 60–70% of those people; of those, 5–20% will eventually progress to cirrhosis and 1–5% will die as a consequence of the infection, according to the agency.
Less than five years ago, standard therapy for chronic HCV infection consisted of weekly injections of pegylated interferon alfa plus daily oral ribavirin for up to 48 weeks. According to FDA, fewer than half of HCV-infected patients treated with this regimen had a sustained virologic response (SVR), indicating the elimination of the virus.
With the approval in 2011 of the first HCV NS3/4A protease inhibitors, boceprevir and telaprevir, standard treatment regimens shifted to a shorter course of pegylated interferon alfa and ribavirin followed by several weeks of treatment with boceprevir or telaprevir. Regimens that include these anti-HCV drugs led to an SVR in up to 80% among clinical trial participants.
Treatment regimens containing the NS3/4A protease inhibitor simeprevir or the HCV NS5B RNA-dependent RNA polymerase inhibitor sofosbuvir resulted in an SVR rate of up to 95% in clinical trial participants.
Sofosbuvir is the first anti-HCV therapy labeled for use in without a concomitant interferon in certain patients. Other interferon-free regimens, some involving investigational HCV inhibitors, are currently being evaluated and may soon offer additional treatment options for patients.
McNamara said the current treatment regimens require less-frequent viral load monitoring and are better tolerated overall by patients than the older regimens. But she said adverse events still occur, in part because the new regimens still contain ribavirin and an interferon.
"With ribavirin and peginterferon, there are still some side effects, like anemia. And there are still some rashes that become a problem, and some insomnia that can be problematic," McNamara said.
She noted that although adherence is better with the current regimens, patients who have cognitive problems related to advanced liver disease can struggle with their therapy.
And McNamara said the issue of cost can affect compliance in unexpected ways.
"One patient wanted to get a replacement pill because their pill fell under the refrigerator. It's a thousand-dollar pill. So simple things like that come into play," she said.
She said the pharmacy has a "point person" who manages prior authorizations and other utilization management issues to ensure that patients have access to the new HCV medications.
Another issue the specialty pharmacy deals with is communicating with prescribers to ensure that their patients have a blood test three months after completing therapy to measure their viral load.
"We want to make sure [patients] come back, and their viral load is undetectable. They may think they're cured and not come back for that last test," she said.
McNamara said some physicians may be counseling their patients to wait a few months before starting treatment for chronic HCV infection to see if even better treatment options become available.
"And we're hoping for some competitive cost savings, too; I think that's what payers are hoping for," she said.