An estimated 3.2 million Americans live with hepatitis C. Traditional treatments didn’t always cure the viral infection and often came with severe side effects. Late last year, the Food and Drug Administration approved two new drugs, Sovaldi and Olysio, for the treatment of hepatitis C. But the drugs come with a hefty price tag, starting at $66,000 for Olysio and $84,000 for Sovaldi. Brandis Friedman has more on the treatments and their costs.
Dr. Mahesh Patel is an assistant professor of medicine at the University of Illinois at Chicago College of Medicine. Patel has been with the school since 2010. The majority of his outpatient work involves HIV and hepatitis C patients which includes servicing the inmate population at the Illinois Department of Corrections.
Q: What is hepatitis C?
It’s a chronic viral infection that affects the liver. It is primarily acquired through blood. We’re talking primarily about transfusions, injected drug use, and occasionally and uncommonly transmitted sexually.
Sovaldi and Olysio are the brand names. Sofosbuvir is the generic for Sovaldi, and the other drug, although the drug is likely to be used a lot less than the sofosbuvir, is simeprevir, which is the generic for Olysio.
In 2011 was when we entered the era where hepatitis C drugs were direct-acting agents. Interferon modulated the immune system. They basically altered the immune system or the immune system’s response to the virus, so the immune system could try to clear it out on its own. History dates back a little further. Then we had ribavirin added to interferon as a mainstay for hepatitis C treatment with cure rates around 50 percent at best for the hardest to treat genotype, genotype 1. There are lots of different types of hepatitis C; the primary ones we deal with in the United States are genotypes 1, 2 and 3, and sometimes 4. Genotype 1 comprises 75-80 percent of people infected with hepatitis C and is also, unfortunately, the harder one to treat.
Peginterferon alfa was injected once a week for 48 weeks and ribavirin, in general, was three pills twice a day. They have to be used together. Between 2001-2011, these were the drugs being used, and these drugs, I wouldn’t wish on my worst enemy. That’s how tough these drugs are to tolerate. Taking these drugs made taking HIV drugs look like a walk in the park. They caused low platelets, white blood cell drop, which predisposes people to infection, [and] it caused rash. They aren’t completely gone yet. We are using them. For genotype 1, you’re given Sovaldi along with peginterferon alfa and ribavirin, only you’re taking it for 12 weeks as opposed to 48 weeks. For genotype 2, you don’t need interferon.
Q: How do the new drugs – sofosbuvir (Sovaldi) and simeprevir (Olysio) – work?
These two drugs – what we would call direct-acting agents—one of them, simeprevir, is a protease inhibitor. It inhibits protease so the virus can’t replicate. It inhibits the replication of hepatitis C virus. There are other [drugs] coming out. In addition to simeprevir, we have sofosbuvir, which may be more potent than simeprevir as the studies show. For sofosbuvir, the mechanism of action is what’s called a polymerase inhibitor. Both drugs are direct-acting agents and work directly on the virus.
Q: What makes these drugs remarkable?
What makes them remarkable is the high cure rate. It’s the high cure rate and the very, very shortened duration of treatment. In order to describe what we’re doing now, we need to look into the future. By November, end of the year or early 2015, we will have drugs that can treat hepatitis C without the use of interferon or ribavirin, which have cure rates of 95 percent plus.
Some of [the future treatments] will be independent of genotype. Within the next two years, [treatment will be] one pill once a day for hepatitis C. It won’t be just a treatment but a cure. If you back into the past, there was a 50 percent cure rate if [patients] had hepatitis C alone—forget HIV and hepatitis C. [The cure rate for] that was 20 percent.
Starting in 2011, treatment looked more promising with direct-acting agents. Sofosbuvir, I think most people will use initially, with peginterferon and ribavirin have an 80 percent plus cure rate in genotype 1. Genotype 2 doesn’t need interferon; you will be using sofosbuvir and ribavirin for 12 weeks and you’re done. [There’s] no shots that cause rash and pain.
Cure rates are about 94 percent for people not treated in the past. [Cure rates] are lower for patients with severe liver disease or patients who have been treated in the past. If you look at genotype 1 patients, it’s 80 percent plus.
Q: How long is the treatment cycle?
For genotypes 1 and 2, it’s 12 weeks. For genotype 3 it will be 24 weeks of sofosbuvir and ribavirin or 12 weeks of peginterferon, sofosbuvir and ribavirin.
Q: What are some of the side effects of the new drugs?
These drugs have side effects that are significantly lower than previous [drugs]. With simeprevir, you can get a rash one third of the time, little muscle aches. Those are the real big ones. For sofosbuvir, you’re looking at 10 percent of the time of getting headaches, fatigue, skin rash – it’s not as common as with simeprevir—diarrhea, anemia.
But the key here is, even if you get symptoms, flu like symptoms, the key is it’s only for 12 weeks as opposed to 48 weeks. The problem with these symptoms is they are cumulative over time. Previously with 48 weeks of treatment, we’d check a patient’s blood once a month and bring them back every six weeks, check [his/her] blood to see if [he/she] could continue or not.
[With the new treatment], we’d do baseline blood work, and you might have a rash. We’d say here’s the medication to take, we’ll see you in six weeks, and you’d have blood work done in four weeks and then the final visit. That’s why these drugs are revolutionary. This is a disease that was previously not treatable for a lot of people, and it has become more treatable in a shorter period of time with a higher rate of cure with much less side effects. This is an exciting time during hepatitis C treatment.
Q: Are the costs of these drugs excessive?
Let me start by saying I’m really cost conscious. You’re talking about; in general, sofosbuvir costs $1,000 a day, which will be $84,000 for 12 weeks or $168,000 for 24 weeks if it’s genotype 3. It ain’t cheap. It’s interesting to me that people are going crazy over this. When the first direct-acting agents were introduced, they cost roughly $55,000 for the course of treatment. The treatment was a little longer, certainly longer than treatment with sofosbuvir. One may argue you’re getting more drugs for the price, but I don’t think that’s how patients think. If there was an antibiotic that treated you in one day versus 10 days, you’d take it.
To me, $200,000 seems like a lot. If it were $150,000, in the long run, I think it would probably be worth it. I’m quite shocked and surprised people are going crazy over the amount of money this is. You have to look at this in perspective among other things. Nothing against my oncology colleagues, they have drugs that cost $100,000 a pop, and these drugs at most give three months of life, they don’t cure anything. You really have to look at the grand scheme of money that we spend in health care. We’re talking about a cure for an illness of 95 percent of all genotypes by early 2015. That may be money well spent.
Q: What about low-income and the inmate population, who covers the cost for these groups?
That’s going to come from the state of Illinois. It’s an expense. As people already said, the truth is we’re kind of at a point now where, essentially, we’re medically obligated to give patients the best care that we can, and especially for our prison population. It’s a very vulnerable population. It has advocacy, and it also has a lot of litigation over there. I think the state of Illinois decided they are going to pursue treating patients.
What most people are doing, including the Illinois Department of Corrections, is treating patients with advanced liver disease and this is something I’m applying outside of that, too. I think everyone is treating stage 3 or stage 4 of the disease.
It’s such a big topic right now. The American Association for the Study of Liver Diseases and the Infectious Diseases Society of America created a website, hcvguidelines.org….and in their long spiel, they do say patients who have stage 2 or less are better off waiting until newer treatments come out…we’re not spending money willy-nilly, whether it’s Medicaid or the Illinois Department of Corrections. If you have stage 3 of the disease, you don’t know if it will progress to stage 4. By the time you get to stage 4, some of it is not reversible. You can treat it, you won’t get any worse, but you won’t get any better. We like to prevent people from getting to that point.
Q: What are other health needs of the inmate population in terms of infectious diseases?
We see right now that all prisoners with HIV in the Department of Corrections and also see patients referred to us based on the Illinois Department guidelines to see if [patients] are suitable for treatment for hepatitis C. We see maybe 25 percent of patients, we probably see less than that. According to national studies, 50 percent of the people with hepatitis C have been veterans or incarcerated. [The local number] would be a disproportionally high number. Nobody knows the exact numbers. In the Herald News, the spokesman for the Illinois Department of Corrections was asked how many inmates they treat. The truth is nobody knows. I don’t even know, and we do this all the time. The pharmacist we work with doesn’t know.
Patients are treated on a case-by-case basis. It takes a minimum of 15-20 years for patients to develop significant scarring of the liver….in six months, there may be a single pill combination patients take for8-12 weeks for treatment. So I tell a lot of my patients to sit tight and wait. It’s an interesting time for hepatitis C treatment. It’s more like a cookbook now with the art of medicine. You know what I had a patient who could qualify under what I consider for treatment [using sofosbuvir or simeprevir] and I had a patient who said, “I ain’t touching interferon with a 10-foot pole….I’m not going to do that. I’m going to wait. I’m at stage 3 but I’m going to wait.” So it’s not only just us [doctors], it’s inmates and patients too who know here are these new drugs and they want to wait for the better stuff to come out.
Q: What’s the likelihood of an infectious disease spreading within the prison population?
About 20-25 percent of patients who have hepatitis C don’t have any obvious classic identifiable risk factor—injected drug use, tattoos. In prison, it’s more of a concern because people do “prison” tattoos. They’re not supposed to, and they may share razors more often. These are ways to transmit hepatitis C…It’s probably higher risk because of people’s behavior not because the illness cannot be contained like an outbreak.
-Interview by Kristen Thometz.
Interview has been condensed and edited.