Researchers say that the addition of a hepatitis C-specific protease inhibitor, called telaprevir, to the current standard therapy may significantly enhance a patient's likelihood of being cured.
The researchers at Duke Clinical Research Institute, say that this effect may become visible in just half the time taken by the standard therapy alone.
AdvertisementThey came to this conclusion after analyzing the results of the Phase IIb clinical trial conducted at the institute and 36 other sites, including NewYork-Presbyterian Hospital/Weill Cornell Medical Center.
Writing about the trial in the New England Journal of Medicine, the researchers revealed that the drug works by blocking an enzyme that the hepatitis C virus needs in order to replicate itself.
"These findings point the way to a new era in the treatment of hepatitis C," says Dr. Ira M. Jacobson, a co-author of the study and chief of the Division of Gastroenterology and Hepatology at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, and the Vincent Astor Distinguished Professor of Clinical Medicine at Weill Cornell Medical College.
"Not only does adding telaprevir make standard hepatitis C treatment more effective, but it makes it work much more quickly. We showed that the duration of therapy can be reduced from 48 weeks to 24 weeks for most patients. This could help reduce the potentially severe side effects of longer regimens with standard therapy," the researcher added.
The trial followed 250 patients with untreated hepatitis C genotype 1.
Its results showed that 67 percent of patients taking telaprevir in combination with standard therapy for 12 weeks followed by standard therapy alone for 36 weeks were cured.
Sixty-one percent of those taking telaprevir in combination with standard therapy for 12 weeks followed by standard therapy alone for 12 weeks were cured, 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 was much lower than the control group.
The most common reported side effect in the telaprevir groups was rash, and contributed to some patients discontinuing the therapy.
The study's results match those of a similar study conducted in Europe that was reported on in the same issue of the New England Journal of Medicine.
Two Phase III studies currently under way at NewYork-Presbyterian/Weill Cornell and centers worldwide will attempt to confirm the results, potentially leading to FDA approval of telaprevir.