Trial Supports Addition of Telaprevir for HCV Genotype 2

September issue of Gastroenterology

Trial Supports Addition of Telaprevir for HCV Genotype 2

BY DENISE NAPOLI
Elsevier Global Medical News Adding telaprevir to the standard regimen of peginterferon-alfa and ribavirin reduced the time needed to attain decreased viral loads in genotype 2 hepatitis C virus infection, reported Dr. GrahamR. Foster and his colleagues in the September issue of Gastroenterology.

The drug was less effective in patients with genotype 3 hepatitis C virus (HCV),in the first study to assess use of telaprevir for treating these strains. Dr. Foster,of Queen Mary University of London,and colleagues looked at treatment-naivepatients with HCV genotypes 2 and 3 (23and 26 participants, respectively).Patients received either telaprevir monotherapy (750 mg every 8 hours), telaprevir plus peginterferon alfa-2a (180mcg/week) and ribavirin (400 mg twice daily),or placebo plus peginterferon/ribavirin for 15 days, followed by the standard peginterferon/ribavirin regimen for 22 or 24weeks.

On day 8 of treatment, the proportion of patients with undetectable HCV RNA was 0% in the telaprevir monotherapy group, 20% in the telaprevirplus peginterferon/ribavirin group,and 0% in the peginterferon/ribavirin only cohort. By day 15, the proportions were 0%, 40% (2 of 5 patients), and22% (2 of 9 patients), respectively.The median times to undetectableHCV RNA were 31, 12, and 43 days in thetelaprevir monotherapy group, the telaprevir plus peginterferon/ribavirin group, and the peginterferon/ribavirin only group.

Moreover, the proportions of patients with a sustained virologic response(SVR), defined as undetectable HCV RNA at end of treatment and 24weeks after final study medication, were56% in the monotherapy cohort (5 of 9patients), 100% in the dual telaprevir plus peginterferon/ribavirin group (5 of 5 patients),and 89% in the peginterferon/ribavirin-only group (8 of 9 patients).

There was less success among patients with genotype 3 of the disease. The median times to first undetectable HCV RNA result among these patients were 99, 43,and 29 days for the monotherapy cohort,the telaprevir plus peginterferon/ribavirin group, and the peginterferon/ribavirin only group, respectively. Likewise, the corresponding SVR rates were 50% (4/8),67% (6/9), and 44% (4/9), respectively.The most frequently reported adverse events were flu like illnesses and pruritis.

Of the five reported serious adverse events,only one – pneumonia – was considered related to the study medication, in this case, peginterferon/ribavirin. Based on theefficacy shown among treatment-naive patients, “the potential of telaprevir-based triple combination therapy in patients with HCV genotype 2 who have not responded to peginterferon/ribavirin should be explored,” said the authors.And while the drug’s poor performance among genotype 3 patients makes it “unlikely to have major clinical utility in this patient sub population,… for treatment-naive patients with genotype 2 HCV, studies to examine a shortened duration of therapy that includes telaprevir should be considered.”

The study was sponsored by Janssen Pharmaceuticals and Vertex Pharmaceuticals.

Several authors had financialrelationships with multiple pharmaceuticalcompanies, including Tibotec Pharmaceuticals.
Two investigators were alsoemployees of Tibotec or Janssen. ■