I am feeling a bit defensive. In the past week, hepatitis C treatment has been making headlines in a disparaging way. Here are examples:
Hep C patients drop prescribed med Sovaldi at high rate, report shows (Daily Press)
Sovaldi, the expensive new drug that has a 90 percent-plus cure rate for liver disease caused by Hepatitis C, has proven controversial because of its cost...
About 8% of the patients who started taking Sovaldi to treat hepatitis C discontinued their treatment regimen prior to its conclusion... The findings raise questions about how effective the costly drug will be in a larger patient population outside of a controlled clinical trial...
Analysis of “Real World” SovaldiÂ® (sofosbuvir) - Use and Discontinuation Rates
Sovaldi is very costly...In this White Paper we present real-world evidence about trends in Sovaldi use, rates of therapy discontinuation, and correlates of non-adherence to treatment...
Journalism is supposed to report the facts, but in reality, sometimes the goal is to agitate readers and raise doubt. These “news items” are saying, “Hey we have this expensive hepatitis C drug and although it cures nearly everyone, quite a few people discontinue taking it. What a waste of money. We should pity these poor insurance companies and understand why they don’t want to pay for these expensive treatments.”
There are some basic problems with this reporting, and here’s why:
- You have to read past the headlines to see the truth. The highest discontinuation rate was among those who were taking ribavirin, peginterferon and Sovaldi (10%). The ribavirin/Sovaldi regimen had nearly a 9% discontinuation rate. Treatment with Sovaldi and Olysio had nearly the same discontinuation rate as it did in clinical trials at 4%. This tells me that ribavirin and interferon are the issue. New hepatitis C drugs that are coming out soon will largely push ribavirin out of the picture.
- Interferon is hard to take, and it overshadows the side effects caused by ribavirin. Interferon-free protocols showed us just how tough it is to take ribavirin. Two people with hepatitis C reported in the Hep Forums that their medical provider said that ribavirin didn’t have side effects. I was flabbergasted. Further, plenty of patients were not well supported through treatment. An unsupported patient is at higher risk for serious side effects leading to discontinuation. Contrast this to clinical trial subjects, who are more likely to receive state-of-the-art side effect management, which increases the likelihood that they will complete the study.
- Compare apples-to-apples. Clinical trial results are always better than real-world results. The various Sovaldi regimens had up to a nearly 4% discontinuation rate in clinical trials versus up to a 10% rate in the real world. Compare this to triple therapy (boceprevir or telaprevir with peginterferon and ribavirin) which had up to a 13% discontinuation rate in clinical trials versus up to a 39% rate in the real world. The world wasn’t screaming about the cost of triple therapy and all these patients dropping out.
- By the way, some of these patients had to discontinue because they died. This leads me to my last point. When calculating the real costs of treatment, insurance companies do not include the toll that hepatitis C treatment exacts on its patients. Patients treated with triple therapy were hospitalized, had blood transfusions, and took an arsenal of medications to manage the side effects of HCV medications. Treatment was longer, and these costs added it. Moreover, while we are calculating this, let’s include the work-loss costs.
- The follow-up analysis is incomplete. There have been cases of people obtaining sustained virologic responses (cures) even though hepatitis C treatment was prematurely discontinued. We had a patient at Stanford who was cured with only 2 weeks of peginterferon and ribavirin. Yes, it happens, but this data is often lost, as in the case of this CVS report.
In the mix of the outcry over the price of current hepatitis C treatments, we are losing the main point - that patients are being cured, and they are being cured without horrendous side effects, hospitalizations, and blood transfusions. Patients are able to work and feel alive throughout interferon-free, ribavirin-free hepatitis C treatment. Their success is so amazing that I don’t know why we are having this discussion. It’s time to move on.