The protease inhibitors boceprevir and telaprevir, in phase 3 development, are poised to become a new therapeutic category of medications to be added to the current standard of care to increase sustained virologic response rates and prevent liver disease in patients with hepatitis C.
With a prevalence of <2%, it seems as if hepatitis C would not be a disease of great concern. However, chronic hepatitis C is the primary reason for liver transplants, which cost about $280,000 per patient leading to an annual cost of nearly $300 million to the US healthcare system. Thus, society needs new therapies that increase the sustained virologic response rates of patients with hepatitis C.
The protease inhibitors in phase 3 development, boceprevir and telaprevir, are poised to become a new therapeutic category of medications to be added to the current standard of care (pegylated interferon and ribavirin). Beyond another mechanism of action, they offer the benefit of being oral agents. Several additional new therapeutic categories are in phase 2 development. The viral polymerase inhibitors are causing excitement among hepatologists.
Medical regimens for treating hepatitis C infection will become increasingly complex. Thought leaders emphasize the need to avoid catastrophic costs by earlier identification of patients with hepatitis C and attaining sustained viral response sooner, thereby avoiding the potential sequelae of cirrhosis, liver failure, and transplantation.
Up to 85% of patients with hepatitis C virus (HCV) will develop chronic infection, and more than half will progress to chronic liver disease.1 It is a great disappointment that about half of all those treated do not sustain a virologic response.2–4 These statistics show the importance of developing new agents that will improve therapeutic outcomes without sacrificing safety.
Current first-line therapies cost about $3,000 a month. At least 1 phase 3 study of interferon alfacon-1 showed some benefit in patients whose disease did not respond to Pegasys plus ribavirin-but at a cost twice that of present treatments.5
With payers facing the potential for a $300,000 liver transplant, and patients facing the prospect of considerable pain and suffering, these new HCV therapies are important and warranted if the patient is compliant and medication effectively maintains a virologic response.
If improvement in virologic response is limited, conventional management tools will be used. Newer agents that demonstrate efficacy in patients who had treatment failures with conventional therapies will draw the greatest interest.
The PBM industry is relying more on services from specialty pharmacy providers, particularly in care management programs. Specialty pharmacy providers are responding by offering better education, monitoring adherence, and being vigilant for assessing side effects.
Steven G. Avey, MS, RPh, vice president, managed care, PartnersRx, Phoenix, AZ
1. Centers for Disease Control and Prevention. Hepa-titis C FAQs for health professionals. 2009. Available at: http://www.cdc.gov/hepatitis/HCV/HCVfaq.htm. Accessed October 29, 2010.
2. Manns MP, McHutchison JG, Gordon SC, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: A randomised trial. Lancet. 2001:358:958–965.
3. Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002:347:975–982.
4. Hadziyannis SJ, Sette J Jr, Morgan TR, et al. Peginterferon-α2a and ribavirin combination therapy in chronic hepatitis C: a randomized study of treatment duration and ribavirin dose. Ann Intern Med. 2004;140:346–355.
5. Bacon BR, Shiffman ML, Mendes F, et al. Retreating chronic hepatitis C with daily interferon alfacon-1/ribavirin after nonresponse to pegylated interferon/ribavirin: DIRECT results. Hepatology. 2009;49:1838–1846.
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