Telaprevir and Health-Related Quality of Life

San Diego—Post hoc analyses of a large phase 3, randomized, placebo-controlled, double-blind study found that adding telaprevir to the standard of care for treating chronic hepatitis C does not significantly decrease a patient’s health-related quality of life.

The FDA approved telaprevir in May 2011 to be used in combination with pegylated interferon and ribavirin to treat adult genotype 1 chronic hepatitis C. Telaprevir, a direct-acting antiviral, is in a class of drugs known as protease inhibitors.

Zobair M. Younossi, MD, the study’s lead author and vice president of research at Inova Health System in Falls Church, Virginia, discussed the results at DDW during a news conference and poster session.

Dr. Younossi said patients with hepatitis C typically had an impairment in their quality of life during their treatment regimen. However, he added that interferon (and not telaprevir) was the most important contributor to the decrease in the quality of life.

The poster was titled Health-Related Quality of Life Among Genotype 1 Treatment-Naïve Chronic Hepatitis C Patients Receiving Telaprevir Combination Treatment: Post Hoc Analyses of Data from the ADVANCE Trial.

In the ADVANCE trial, 1088 treatment-naïve patients with chronic genotype 1 hepatitis C were randomized to receive telaprevir plus pegylated interferon and ribavirin for 24 or 48 weeks or pegylated interferon plus ribavirin alone for 48 weeks.

These analyses examined 722 patients who enrolled in the ADVANCE study and had completed the EuroQol Group 5-Dimension (EQ-5D) questionnaire at baseline and at weeks 4, 12, 24, 36, 48, and 72. They answered questions related to mobility, self care, usual activities, pain/discomfort, and anxiety/depression.

At baseline, the groups were similar in terms of demographics and clinical characteristics. In addition, age- and gender-adjusted EQ-5D values were similar.

During the first 12 weeks of treatment, the EQ-5D values were lower compared with baseline, indicating a decreased quality of life. From baseline to week 12, the mean EQ-5D value fell from 0.92 and 0.90 to 0.80 in the telaprevir groups and from 0.91 to 0.83 in the pegylated interferon plus ribavirin group.

At week 48, the EQ-5D values were 0.93 for patients who took telaprevir for 24 weeks, 0.83 for patients who took telaprevir for 48 weeks, and 0.84 for patients who took pegylated interferon plus ribavirin alone.

By week 72, the EQ-5D values had returned to baseline in both 48-week treatment groups and increased in the 24-week group. At week 72, the age- and gender-adjusted EQ-5D values were higher among patients who achieved a sustained virologic response (0.90) compared with those who did not have a sustained virologic response (0.86). Fewer patients who experienced a sustained virologic response reported problems in each of the 5 dimensions compared with those who did not achieve a sustained virologic response.

The authors indicated sustained virologic response was a statistically significant predictor of an improvement in health-related quality of life by week 72. They added that a shorter treatment duration seemed to have an impact on quality of life.

Limitations cited included that the EQ-5D was exploratory, the average health status was likely better at the start of the study compared with untreated patients in typical care settings, and patients were first informed of hepatitis C RNA at the end of week 24 and at later visits, which could have influenced the ratings.

The study was supported by Vertex Pharmaceuticals Incorporated and Janssen Pharmaceuticals, Inc.