Peginterferon and Ribavirin, With or Without Telaprevir, for Genotype 1 Hepatitis C and IL28B CC Polymorphism
Status:
Withdrawn
Trial end date:
2011-07-01
Target enrollment:
Participant gender:
Summary
Chronic hepatitis C is a major cause of liver disease and is thus an important public health
problem. Although some strains (genotypes) of the hepatitis C virus are highly responsive to
treatment with a combination of peginterferon and ribavirin, the most common form of the
virus (genotype 1) is relatively resistant to this treatment. Recently, telaprevir has been
approved by the Food and Drug Administration to be given in combination with peginterferon
and ribavirin. This 3-drug combination boosts the remission rate for genotype 1 hepatitis C
to that seen with other more responsive hepatitis C genotypes treated with only peginterferon
and ribavirin. However, telaprevir has additional side affects such as rash and anemia that
may limit its usefulness. Intriguingly, about one third of patients infected with genotype 1
hepatitis C, who have a specific variation (polymorphism) in the DNA sequence (CC) near an
immune response gene (IL28B), in fact are highly responsive to 2-drug treatment with
peginterferon and ribavirin. This raises the possibility that individuals who have the IL28B
CC polymorphism may not need to be treated with the addition of telaprevir and could
therefore be spared unnecessary side effects. Thus, the purpose of this study is to determine
among genotype 1 hepatitis C patients with the IL28B CC polymorphism the success rate and
side effects of 3-drug treatment compared with 2-drug treatment.
In this study, patients with genotype 1 chronic hepatitis C who have the IL28B CC
polymorphism will be randomly assigned to be treated with telaprevir, peginterferon, and
ribavirin or with only peginterferon with ribavirin. These medications and the procedures
involved, including patient history, physical examination, and obtaining small volume blood
specimens (less than 4 teaspoons) for laboratory testing, are within the scope of standard
management of hepatitis C treatment. All patients will be monitored during treatment with
periodic blood testing (weeks 2, 4, and every 4 weeks thereafter while on treatment, and 24
weeks after stopping treatment) and office visits (weeks 5, 12, 25, 49 while on treatment and
25 weeks after stopping treatment). The success of treatment will be judged by the presence
or absence of detectable virus in blood, as measured by a sensitive diagnostic test (PCR).
The data to be generated will include measurement by PCR of hepatitis C viral loads before,
during, and after treatment, as well as reporting of adverse drug effects.