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European Commission approves new twice daily dosing of INCIVO®


Janssen Infectious Diseases-Diagnostics BVBA (Janssen) has announced that the European Commission (EC) has approved a new twice daily (BID) dosing of INCIVO® (telaprevir), a direct acting antiviral (DAA) protease inhibitor, in combination with pegylated-interferon and ribavirin (PR) for naive and previous treatment experienced patients.
The newly approved dosing regimen for INCIVO® is now 1,125mg twice daily in combination with PR, which aligns a morning and evening dose to the already twice daily dosing schedule for ribavirin versus 750mg every eight hours in combination with PR.
The EC approval is based on results from OPTIMIZE, a randomized, open-label, multicenter Phase III study  in treatment naive patients with genotype-1 chronic HCV infection, which demonstrated that twice daily dosing of INCIVO®, 1,125mg in combination with PR was non-inferior to the previously approved dosing every eight hours in the proportion of patients who achieved sustained virologic response (74% versus 73%).(2) Twice daily dosing also showed similar cure rates with twice daily or every 8 hours INCIVO dosing in patients with cirrhosis.(3)
“The approval of INCIVO® twice daily is good news for patients with genotype-1 chronic HCV infection. Making treatments more simple and easier to manage, without compromising efficacy,  will help to increase adherence and give patients an even greater chance of achieving a cure,” said Dr Maria Buti, Hospital Valle Hebron and Ciberehd del Institut Carlos III, Barcelona, Spain.
The availability of new DAAs like telaprevir has transformed treatment options for HCV.(4) Telaprevir has already played a significant role in improving treatment outcomes with more than 80,000 patients treated with telaprevir combination therapy worldwide since it was first approved in 2011.(5) It also offers the shortest total treatment duration of any available HCV therapy, for a high proportion of treatment-naïve or relapse patients.(6,7)
“Before the availability of direct acting antivirals like telaprevir, the best clinicians could hope for was to cure only 40-50% of our genotype-1 HCV patients. DAAs now offer us the chance to cure approaching 80% of these patients, for many in a shorter amount of time. Successful treatment is effectively a cure and causes a massive reduction in the complications of HCV, such as liver cancer and cirrhosis. As with many diseases early therapy is most effective and has the greatest impact on complications. The twice daily dosing of telaprevir makes the treatment easier to administer and will make it easier for patients to take advantage of the opportunity for a cure. We now need to ensure that patients with HCV are identified and offered therapy, before their disease progresses,” said Graham Foster, Consultant Hepatologist, Barts Health London.
“We are pleased by the European Commission approval of twice daily dosing for telaprevir, which marks an improvement on an already important treatment option for HCV. This medicine is the cornerstone of our efforts to improve the lives of more people living with HCV and supporting healthcare professionals around the world,” said Gaston Picchio, Hepatitis Disease Area Leader at Janssen.
Telaprevir was first approved by the U.S. Food and Drug Administration (FDA) in May 2011, marketed by Vertex Pharmaceuticals under the brand name INCIVEKTM, and by the European Commission in September 2011, marketed by Janssen Pharmaceutical Companies under the brand name INCIVO®.
  1. Sievert W et al. Adherence with Telaprevir BID vs. Q8h Dosing in Treatment Naive HCV-infected Patients: Results from the Phase III OPTIMIZE Study. J Hepatol 2013; 58(Suppl 1): S373.
  2. Buti M, Agarwal K, Horsmans Y, et al. OPTIMIZE Trial: Non-inferiority of twice-daily telaprevir versus administration of every 8 hours in treatment-naïve, genotype 1 HCV infected patients. 2012. American Association for the Study of Liver Diseases (AASLD) Abstract. (Final ID: LB-8).
  3. Horsmans Y, Brown Jr. RS, Buti M, et al. Safety and efficacy of twice daily versus every 8 hour telaprevir with peginterferon/ribavirin (PR) in patients with cirrhosis. 2013. European Association for the Study of the Liver (EASL) Abstract 862.
  4. Casey L C, Lee W M. Hepatitis C Virus Therapy Update 2013. Curr Opin Gastroenterol. 2013;29(3):243-249.
  5. Janssen data on file.
  6. Sherman K, et al. Duration of Initial Telaprevir Treatment for HCV Infection: A phase 3 study of treatment duration. N Engl J Med. 2011;365:1014-24.
  7. INCIVO® Summary of Product Characteristics updated 2013.

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