New Oral Hepatitis C Drugs: FAQ
Latest Digestion News
By Kathleen Doheny
Reviewed by Michael W. Smith, MD
Dec. 9, 2013 -- Experts call two new drugs for hepatitis C ''game changers" that they expect will dramatically improve treatment for many of the 3 million Americans with a chronic infection. Hepatitis C can lead to liver failure.
Both new pills -- Olysio (simeprevir) and Solvadi (sofosbuvir) -- work better than the current treatment for hepatitis C. They cure it more often and in less time. They also have fewer side effects.
In a major advance, the drugs could eliminate the need for some patients to take interferon, which is injected and can have unpleasant, even intolerable side effects.
"Most hepatitis C patients and most physicians would like never to use interferon again,'' says Henry Masur, MD, past president of the Infectious Diseases Society of America.
The FDA approved both new oral drugs in combination with other drugs, he says. "Neither can be taken alone.'' The next question, he says, is "What is the best combination?''
Doctors hope -- and predict -- that the combinations deemed best will often exclude the need for interferon for more and more patients. But the new drugs are expected to be more expensive.
Here, three experts address questions they get from patients about the new options.
How do Olysio and Solvadi work?
Both Olysio and Solvadi prevent the virus from copying itself, Masur says.
What is each drug approved for?
Solvadi is approved for people with genotypes 1 and 4, in combination with interferon and ribavirin.
In a first, people with genotypes 2 and 3 can use Solvadi with ribavirin alone. That means they will no longer have to take interferon.
How effective is each drug?
The two newest drugs have never been compared head to head, Masur says.
When they are added to the interferon and ribavirin, though, the success rate is significantly higher than the older regimen.
"Both drugs in general are better than what is available today," says Benedict Maliakkal, MD. He is director of hepatology and medical director of the liver transplantation program at Strong Memorial Hospital of the University of Rochester. He conducted clinical trials of both drugs. He is on the speaker's bureau for Merck, Genentech, and Vertex.
The older regimen -- interferon, ribavirin, and either Incivek or Victrelis – cures hepatitis C about 50% to 70% of the time, Masur says. Adding either of the two newest drugs to ribavirin and interferon instead produces a cure rate of about 80% to 95% or higher, he says.
"They will shorten the treatment time and increase the sustained response rate." That means you may not have to take medicine as long, and your chance of curing hepatitis C is greater.
Treatment time may decline from up to 48 weeks to 12 or even less, at least in some patients.
What about side effects?
The two new drugs do not seem to have the same troubling side effects as interferon and ribavirin, which include insomnia, flu-like symptoms, and depression. For the two new drugs, fatigue, headache, and a mild skin rash are among the side effects reported, Maliakkal says.
Even though the new drugs, by themselves, have fewer troubling side effects, the side effects due to the interferon and ribavirin will still be an issue for many, doctors say.
What will they cost?
The drugs are expensive, with experts predicting costs of $60,000 or more for the 12-week course.
The wholesale cost of a 12-week course of Olysio, for instance, will be about $66,000, according to Craig Stoltz of Janssen.
Janssen will offer programs for patients in need of financial help, Stoltz says.
The wholesale cost of a 12-week course of Solvadi will be about $84,000, according to Cara Miller of Gilead Sciences. Gilead is launching a patient-assistance program to help those in need pay for the drug, she says.
Costs to patients for both drugs will depend on their insurance plan.
What's on the horizon for hepatitis C treatment?
Even better treatment options are coming soon, experts say.
"This is a minor revolution," Maliakkal says of the two new oral drugs. "What is coming is truly revolutionary."
Within a year, he predicts, the FDA will approve other drugs for hepatitis C. These will be combined with the two newly approved drugs, or each other, and make interferon and ribavirin unnecessary, he says.
As more data come out about various combinations of the oral drugs, doctors will find the most effective regimen, Masur says. He predicts the treatment time will decline and the success rate will rise.
One option could be combining the two new drugs, says William Carey, MD, a staff hepatologist at Cleveland Clinic.
Research has shown it's effective, even in hard-to-treat patients.
But Maliakkal says combining the two would cost patients far too much. He doubts insurance plans would cover the two together.
The future looks bright, but financial obstacles remain, he says. "Hepatitis C is going to be completely treatable," Maliakkal says, "except for the cost."
SOURCES: William Carey, MD, staff hepatologist, Cleveland Clinic. FDA press release, Nov. 22, 2013. FDA press release, Dec. 6, 2013. Benedict Maliakkal, MD, director of hepatology and medical director of the liver transplantation program, Strong Memorial Hospital at the University of Rochester Medical Center, New York. Cara Miller, Gilead spokesperson. Craig Stoltz, Janssen Global Services. Henry Masur, MD, past president, Infectious Diseases Society of America. William Carey, MD, staff hepatologist, Cleveland Clinic.