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IlLLUMINATE trial of Incivek is published in NEJM Infectious Diseases Page

The New England Journal of Medicine (NEJM) published data from a Phase III study of Incivek(telaprevir) tablets in people with genotype 1 chronic Hepatitis C who were new to treatment. In ILLUMINATE, Incivek was given for the first 12 weeks in combination with pegylated-interferon and ribavirin. Nearly two-thirds of patients responded early to Incivek combination treatment (measured by having undetectable hepatitis C virus at weeks 4 and 12 of treatment) and were randomly assigned to receive an additional 12 weeks or 36 weeks of treatment with pegylated-interferon and ribavirin alone. Similarly high rates of sustained viral response (SVR, or viral cure) were achieved by people in both treatment groups. Rash and anemia were the most common side effects reported with Incivek in this study and each led to treatment discontinuation of all medicines in about 1 percent of people during the Incivek treatment phase. Data from ILLUMINATE are published in the September 15, 2011 issue of NEJM.

Incivek treatment still effective when course is half as long in treatment of Hepatitis C genotype 1 Infectious Diseases Page

A Phase III study (ADVANCE) of Incivek (telaprevir) tablets in patients with genotype 1 chronic Hepatitis C published in The New England Journal of Medicine (NEJM) reveals that a 24-week treatment course that adds Incivek to peginterferon alfa and ribavirin is just as effective as a 48-week regimen for many patients. Shortening the duration of treatment reduces a patient's exposure to side effects including rash and anemia.see Response-Guided Telaprevir Combination Treatment for Hepatitis C Virus Infection September 15, 2011Sherman K.E., Flamm S.L., Afdhal N.H., et al.N Engl J Med 2011; 365:1014 - 1024.

Vibativ is EU approved for nosocomial pneumonia caused by MNSA Infectious Diseases Page

Astellas and Theravance have received marketing authorisation from the European Commission for Vibativ (telavancin hydrochloride) for nosocomial pneumonia caused by methicillin-resistant Staphylococcus aureus (MRSA).Its labelling will include its use in the treatment of adults with nosocomial pneumonia (hospital-acquired), including ventilator-associated pneumonia, known or suspected to be caused by MRSA when other alternatives are not suitable. In the US and Canada, the drug was approved in 2009 for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of certain Gram-positive microorganisms, including Staphylococcus aureus ,including methicillin-susceptible and-resistant isolates but is not approved in these territories for the pneumonia indication. Vibativ is not yet available in Europe for use with skin such infections as are approved in the USA.

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