Researchers for the ADVANCE trial have found that the addition of telaprevir to therapy for patients with genotype 1 chronic hepatitis C did not further impair health-related quality of life.
For the trial, patients were randomly assigned to 12
weeks of telaprevir (Incivek, Vertex Pharmaceuticals) with 24 or 48 weeks of
peginterferon alfa-2a and ribavirin, or peginterferon alfa-21 and ribavirin
alone. More patients in the telaprevir arm achieved sustained virologic
response. For the current analysis, researchers set out to determine whether
telaprevir affected health-related quality of life.
“Although impairment of [quality of life] is
expected with two or three drug regimens for hepatitis C, it was encouraging to
see that addition of the third drug did not substantially impact [quality of
life],” Zobair Younossi, MD, vice president of research and
chairman of the department of medicine at Inova Health System in Falls Church,
Va., said in a press release. “For patients with HCV genotype 1, the
three-drug regimen with telaprevir not only improves sustained virologic
response, but also does not seem to substantially worsen [quality of
Younossi and colleagues administered the EQ-5D
questionnaire of quality of life to 722 patients enrolled in the ADVANCE study
at baseline and at weeks 4, 12, 24, 36, 48 and 72. Across all treatment arms,
quality-of-life scores worsened during the first 12 weeks, but they returned to
baseline by week 72.
In multivariate analyses, after adjusting for EQ-5D
baseline scores, age, sex, race, advanced liver disease, comorbidities and
adverse events, sustained virologic response was associated with improved EQ-5D
index scores at week 72.
- Younossi ZM. #SA1048. Presented at: Digestive Disease Week 2012 Annual
Meeting; May 29-22: San Diego.
- The study was funded by Vertex