For patients with the most common form of hepatitis C, the addition of a hepatitis Cspecific protease inhibitor called Telaprevir to the current standard therapy can significantly improve the chances of being cured, and it does it in half the time of standard therapy alone.
Results of the Phase IIb clinical trial are published in the New England Journal of Medicine ( NEJM ).
Telaprevir works by blocking an enzyme that the hepatitis-C virus needs in order to replicate itself.
The randomized, double-blinded trial followed 250 patients with untreated hepatitis C genotype 1. Researchers measured rates of sustained viral response or viral cure 24 weeks after the end of completion of therapy. They compared a 12-week regimen of Telaprevir combined with two different durations of the standard therapy, Peginterferon alfa-2a ( Pegasys ) and Ribavirin ( Rebetol ), to a control group taking 48 weeks of standard therapy alone.
Results showed that 67% of patients taking Telaprevir in combination with standard therapy for 12 weeks followed by standard therapy alone for 36 weeks were cured; and 61% of those taking Telaprevir in combination with standard therapy for 12 weeks followed by standard therapy alone for 12 weeks were cured. This is compared to 41 percent cure rate in the 48-week control group.
The study also showed that the percentage of patients who relapsed in the 24-week and 48-week Telaprevir-based groups ( 2% and 6%, respectively ) was much lower than the control group ( 23% ).
The most common reported side effect in the Telaprevir groups was rash, and contributed to some patients discontinuing the therapy.
Peginterferon alfa-2a is an antiviral drug given by injection that is also used to treat HIV and hepatitis B; it works in conjunction with a drug called Ribavirin, a nucleoside analogue, to suppress the viral activity of hepatitis C. Side effects can include severe flu-like symptoms, depression, fatigue, insomnia and anemia.
Treating genotype 1 hepatitis C, the most common form of the infection in the United States, can be challenging because the side effects are difficult for many people to endure, the duration of treatment is long, and traditionally less than half of patients are able to be cured of their disease.
Even though Telaprevir does produce side effects of its own, its addition to standard therapy was able to improve response rates and shorten the duration of treatment. ( Xagena )
Source: New York- Presbyterian Hospital / Weill Cornell Medical Center/Weill Cornell Medical College, 2009