Treatment options for hepatitis C (HCV) have rapidly changed in the past several months and will continue to change in coming years as new medications are approved by the Food and Drug Administration (FDA). At the same time, updated treatment guidelines have been published to keep up with the new medications. We asked Dr. Donald Jensen, liver specialist at the University of Chicago, and co-chair of the panel of experts that recently published the new HCV treatment guidelines, to discuss current and future treatments.
Why has HCV become such a concern in recent years?
I think hepatitis C has been a concern, really, since it was first discovered back in 1989. I think what’s made it of more interest recently is perhaps that so many people have been infected with hepatitis C, and presumably infected for many years, and that a large group of these infected individuals happen to be baby boomers. Those born between 1945 and 1965 represent about 75 percent of all the people in the United States who carry the hepatitis C virus. Somewhere between 3.9 and 5.2 million people in the U.S. are infected with hepatitis.
So I think it’s become more apparent recently because, in part, therapies have gotten better and in part because the Centers for Disease Control and Prevention (CDC) has estimated that fewer than 50 percent of people with hepatitis C have actually been diagnosed or know that they have the infection. Of those, very few have been treated for their infection. Therapies are getting better so this is a great time to find those individuals who have hepatitis C and aren’t aware of it and get them in for treatment.
What are the current treatments available for hepatitis C?
Since 1992, the treatment for hepatitis C has involved interferon, which is an injectable medicine that has a lot of side effects and has to be given once a week. At best, it has a success rate of between 50 and 70 percent.
But in December, 2013, the FDA - for the first time - approved a medicine called sofosbuvir (Sovaldi), which is a pill medicine that can be given with another oral medicine called Ribavirin, for 12 weeks without interferon. It has cure rates in excess of 90 percent for one strain of hepatitis C called genotype 1. So, for the first time, there is FDA-approved therapy without interferon for at least one strain of hepatitis C. Another strain, genotype 3, also was treated with that same combination Sovaldi plus Ribavirin, although for 24 weeks. Not quite the same 90 percent cure rate, but very good cure rates around 70 percent. For the first time, there are therapies that are easily tolerated, have very good efficacy and don’t have the side effects of interferon.
(Since this interview was published, the FDA has approved another hepatitis C drug called Harvoni. It has been found to be equally effective at curing the genotype 1 strain of hepatitis C, but without the need to combine it with interferon or ribavirin. Harvoni is more expensive than Sovaldi, priced at $95,000 for a 12-week treatment.)
What does it mean to be cured of hepatitis C?
It means the virus is gone. The data for cure comes from studies over the last 10 or 20 years for hepatitis C. The current terminology is SVR--sustained viral response--and sustained viral response means that if we test a patient’s blood three months or six months after they stop therapy, the virus is no longer detectable in their blood. And that is considered a success. For many years we avoided using the term “cure,” because we weren’t really sure whether that really represented no virus anywhere in the body. But now several studies have followed up on patients up to 10 or 15 years or longer, and not only is the virus no longer detected in their blood, it’s no longer detected in the liver either, which is the site of replication of the virus. And, the damage that virus had done to the liver also starts to look more normal. So now we are pretty comfortable using the cure word.
Why was it important to publish these guidelines after these new medications came out?
Typically the guidelines for new therapies take months to be developed and be published in a print journal. For example, some of the last two guidelines published on hepatitis C took up to 18 months to prepare and publish. Eighteen months, even six months, is probably too long with how rapid the field is evolving. Two therapies were approved in November and December, and there will likely be several more before the year is out. So waiting 18 months means that many physicians providing care for hepatitis C patients wouldn’t know how to best use these medicines for a long period of time.
So we wanted to do two things. We wanted to first have those recommendations out rapidly and the way to make them rapidly available was to have a web-based system. So we had writers and experts in the field of hepatitis C from both the American Association for the Study of Liver Disease (AASLD) and the Infectious Disease Society of America (IDSA) divide up the work, and prepare evidence-based guidelines so they would be available soon after the new FDA approvals occurred. These were published online in late January. We also wanted to make recommendations for cases that may not have been covered by the FDA.
What are some of the special cases that could arise?
For example, the FDA didn’t make recommendations for patients who couldn’t take interferon because they were ineligible. So what do we do for a patient with genotype 1 who can’t take interferon? What do we do with a patient who needs a liver transplant? What do we do with a patient who has HIV coinfection with their hepatitis C? Our guidelines addressed each of those issues, even though the FDA might not have had specific recommendations.
In addition, when new drugs come out we will be able to very rapidly provide new recommendations. And when new data comes out, we can strengthen or weaken our recommendations to give providers a little more comfort and insurers a little more evidence to pay for these medications as well. We wanted to be nimble enough so we can constantly upgrade guidelines and alter them as the data suggested.
Are there any challenges with the new drugs?
Well, I think the biggest challenge right now is the cost. Twelve weeks of Sovaldi costs $84,000, about $1,000 a pill. And a lot questions have been raised in the press about the cost of these medications such as: Will insurers pay for this? Will Medicare pay for it? Will public aid pay for this? That said, there is less monitoring, fewer side effects and the treatment is of shorter duration. So although previous therapy cost less than that $84,000, when you added up the total cost of the older therapies, in terms of blood transfusions, hospitalizations and office visits, it turned out that the older therapy actually cost about $189,000 for every patient cured.
Although $84,000 is a lot of money, because the treatment cures 90 percent of patients with, for example, genotype 2, the cost per cure is still going to be much less than the older therapies. We think that going forward we’re going to have to look at this a little differently. We’re going to have to look at cost per patient cured and the cost of delivering that therapy over time. As the therapy gets easier and has shorter duration and fewer side effects, the cost per cure may actually be much less.
What is most important for patients to know about hepatitis C?
I think they need to know that if they are baby boomers, born between 1945 and 1965, they really need a one-time test for hepatitis C. And they may say, “I don’t have any risk factors, I never used injection drugs, I never had a blood transfusion,” but up to about 20 to 30 percent of patients with hepatitis C don’t have those risk factors. These new therapies are going to be so good, so easy, and so highly effective, that it would be silly to put your head in the sand and say ‘I don’t need to be tested” and then wind up with cirrhosis 20 years from now.