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Protease inhibitors: Telaprevir in combination with standard therapy in hepatitis C patients

A study has found Telaprevir ( VX-950; Incivek, Incivo ), a protease inhibitor, combined with standard hepatitis C treatment, cures a significantly higher number of difficult-to-treat patients than standard treatment alone.
The findings are published in the New England Journal of Medicine.

Hepatitis C is caused by a virus, transmitted by contact with blood, and may initially be asymptomatic. For patients who develop a chronic hepatitis C infection, inflammation of the liver may develop, leading to fibrosis and cirrhosis, as well as other complications including liver cancer and death.

The prognosis varies for patients with chronic hepatitis C. With the current standard therapy, about half fully recover after an initial course of Peginterferon and Ribavirin antiviral therapy that may last from six months to a year.
The remaining patients, known as non-responders, may improve with initial treatment but the virus is not eliminated. For this group, the only current option is to retreat patients with the same or similar drugs, which increase the likelihood of severe treatment side-effects. In addition, researchers have found that the success of treatment depends on the major strain, or genotype, of hepatitis C that a patient has.

In the current study, researchers examined the drug Telaprevir in combination with the standard treatment of Peginterferon and Ribavirin. They looked specifically at the retreatment of hepatitis C for those who were initial non-responders and whose hepatitis was genotype one, known to be the most difficult strain to treat.

The trial examined the efficacy and safety of Telaprevir in the treatment of 453 patients. The patients were separated into four treatment groups. Three groups were given varying combinations and durations of Telaprevir along with Peginterferon and Ribavirin. The control group was given the standard retreatment therapy of Peginterferon and Ribavirin.

Researchers found that patients retreated with Telaprevir fared better than patients not given Telaprevir; those who received both Telaprevir and Peginterferon and Ribavirin showed a cure rate ranging from 24 to 53% compared to the control groups of Peginterferon and Ribavirin only, which had a cure rate of 14%.

In addition, Telaprevir treatment for 12 weeks appears to be sufficient; longer durations of treatment were not necessary. The study also showed that patients who received only Telaprevir and Peginterferon had a lower response, suggesting that Ribavirin remains important in this combination therapy.

Source: Saint Louis University, 2010