Patients with genotype 1 chronic hepatitis C with functioning but damaged livers (compensated liver disease), including cirrhosis may now be prescribed Incivek (telaprevir), which was approved today for such indications by the FDA (Food and Drug Administration). Specifically, the approval is for treatment-naïve patients and individuals who did not respond adequately to treatment, such as null responders, partial responders and relapsers - i.e. those who did not achieve a viral cure.
Vertex Pharmaceuticals Inc., the makers and marketers of Incivek, says the drug will be on pharmacy shelves next week.
Patients receive Incivek - two 375-mg tablets three times daily - for 12 weeks along with two other approved hepatitis drugs, pegylated-interferon and ribavirin. Then Incivek stops, but they continue with just pegylated-interferon and ribavirin for 12 or 36 weeks.
Over 60% of those on Incivek combination therapy are expected to complete treatment in 24 weeks, compared to 48 weeks on just pegylated-interferon and ribavirin.
The medication is packed in daily blister strips in weekly boxes, making it easier to track their doses.
The FDA evaluated three Phase III studies which demonstrated that those on Incivek combination therapy achieved considerably superior rates of SVR (sustained viral response, or viral cure) compared to patients on just pegylated-interferon and ribavirin, irrespective of what previous treatment they had received.
The results of the studies showed:
Patients new to treatment:
- 79% of those on Incivek combined with pegylated-interferon and ribavirin achieved SVR
- 46% of those on just pegylated-interferon and ribavirin achieved SVR
Patients previously treated, but who did not achieve a viral cure:
- 86% of Relapsers on Incivek combined with pegylated-interferon and ribavirin achieved SVR
- 22% of Relapsers on just pegylated-interferon and ribavirin achieved SVR
- 59% of Partial Responders on Incivek combined with pegylated-interferon and ribavirin achieved SVR
- 15% of Partial Responders on just pegylated-interferon and ribavirin achieved SVR
- 32% of Null Responders on Incivek combined with pegylated-interferon and ribavirin achieved SVR
- 5% of Null Responders on just pegylated-interferon and ribavirin achieved SVR
The most serious side effects linked to Incivek are anemia and rash. Side effect associated with combination Incivek included itching, rectal problems, taste changes, diarrhea, nausea, and fatigue.
Ira Jacobson, M.D., Chief of the Division of Gastroenterology and Hepatology, Weill Cornell Medical College and principal investigator for a Phase 3 study of Incivek, said:
"Hepatitis C can lead to liver failure, cancer and the need for a transplant, and for the past decade, the best we could offer patients was a year of difficult treatment that resulted in a viral cure for fewer than half of them. With INCIVEK, 79 percent of people new to treatment achieved a viral cure."
Matthew Emmens, Chairman, President and Chief Executive Officer of Vertex, said:
"Today marks a turning point in the fight against hepatitis C, particularly for people who have been living with this silent disease for decades, hoping for a better chance of a viral cure. The approval of Incivek was only possible thanks to more than 4,000 people who volunteered for our clinical studies, the doctors, nurses and coordinators who managed the studies, and our own pioneering scientists who have worked for more than 15 years to bring this new medicine to people with hepatitis C."
Sources: FDA, Vertex
View drug information on Incivek.