| Is it safe to wait? HCV Treatment |
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Saturday, 03 July 2010 20:46
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Editorial - Is it safe to wait? —Alan Franciscus, Editor-in-Chief of HCV AdvocateIt is projected that there will be one million cases of cirrhosis due to HCV in 20201 – yes that’s one million people with HCV who will progress on to cirrhosis – a life-threatening disease. Can we wait until the newer therapies are approved before we start to aggressively treat the HCV population? Are people with HCV playing with a ticking bomb by waiting until the new drugs are approved? The answer is NO we can’t wait and YES, it is a gamble that people with HCV should take very seriously. The big picture issue is that in order to reduce the number of cases of cirrhosis, severe disease progression and the deaths that are projected to occur in the next ten years we must take a more aggressive approach to identifying, managing and treating people with HCV now—not when the new therapies become available. But looking at an individual who is living with hepatitis C the issue about waiting it is a much more complicated one—read on. In this month’s HealthWise column Lucinda K. Porter discusses a different aspect of the issue—the actual waiting itself. The cost justification for treating people with cirrhosis was proved in the Saab study, but I think the bigger issue is that we need to treat people with hepatitis C (HCV) sooner than later to prevent the serious disease progression and the complications that can result from being infected with HCV. Most everyone agrees that people with moderate to severe fibrosis, and compensated cirrhosis should be treated now, but for people who have mild damage the decision to treat isn’t as straightforward. In the past, it was believed that HCV disease progression was a slow process that took many years or decades. For some people this hypothesis has been proven to be a fact, but this is not true for all people who have decided to wait. For instance, many people living with HCV were told to hold off on treatment until better therapies became available and they were promised that their health wouldn’t be compromised. Now, we are learning that this is not necessarily the case as more people are finding out that their liver has become more damaged in the years they have been waiting for the new drugs. The ‘wait and see’ attitude is rapidly being replaced by more careful monitoring and a more aggressive consideration of current HCV therapy. In regards to people with little or no liver damage the “treat now” approach is tricky. In a perfect world everyone should be treated—it’s a viral disease that can be potentially eradicated. But the reality is that some people have work, insurance and/or support issues that prevent them from going on treatment. When you add in patient and/or medical provider reluctance to treat because of the many side effects of HCV therapy it’s not surprising that so many people and their medical providers have decided to delay treatment until the new and improved therapies become available. These newer HCV medications promise an increased efficacy and possibly even a shorter duration of treatment. But the increase in efficacy will also come with an added burden—more monitoring, stricter adherence to taking the medications to increase efficacy and prevent drug resistance. Better side effect management will also be needed to manage the new triple combination HCV therapies. As a result, the new and improved treatment scenario will become more difficult for patients and medical providers to deal with. The media trumpets these new HCV direct antiviral medications and they tell us that these new drugs will be available in the very near future. The reality is a much different story. We don’t really know when these new drugs will be approved. The current estimate and best case scenario is that telaprevir and boceprevir triple combination therapies will be approved in 2011 or 2012. However, under the Obama administration the ‘new’ Food and Drug Administration (FDA) has become more concerned about drug safety and has taken a more conservative approach in the drug approval process. In many ways this is a really good approach because it protects us from the potentially harmful side effects of any new medications. But in other (obvious) ways it could delay approval of drugs that could save many lives. If the FDA decides to sit on the marketing applications or requests more clinical data it could potentially push out the approval and availability date even farther. Waiting is a strategy that some people with hepatitis C should not take—especially people with moderate to severe fibrosis. To me it’s a no-brainer: Regardless of cost effectiveness, people who have moderate to severe fibrosis should be treated as soon as possible with pegylated interferon plus ribavirin therapy, and most people should not postpone treatment. Consider that even after the FDA approves the new therapies, it will take time for the pharmaceutical companies to gear up for production and distribution. Add in the time it will take to educate medical providers and patients about the new therapies and I think you get the picture. Gambling that HCV disease progression will not occur during this period is a risk that no one with HCV should take without very careful consideration and discussion with a medical provider and their loved ones. http://www.hcvadvocate.org/news/newsLet ... 710.html#4 Reference 1Gastroenterology. 2010 Feb;138(2):513-21, 521.e1-6. Epub 2009 Oct 25. Aging of hepatitis C virus (HCV)-infected persons in the United States: a multiple cohort model of HCV prevalence and disease progression. Davis GL, Alter MJ, El-Serag H, Poynard T, Jennings LW. Add this page to your favourite Social Bookmarking websites;         
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