July 2, 2013

Health-related QOL poorer during early HCV treatment with addition of telaprevir

Provided by Healio

Vera-Llonch M. Aliment Pharmacol Ther. 2013;38:124-133.

July 1, 2013

Patients with chronic hepatitis C experienced a temporary decrease to health-related quality of life during interferon-based therapy that was more pronounced with the addition of telaprevir in a recent study.

Researchers evaluated the health-related quality of life (HRQOL) of 722 patients with chronic HCV genotype 1 enrolled in the multicenter, phase 3, placebo-controlled, double blind ADVANCE study. All patients were treatment-naive and received either 48 weeks of therapy with pegylated interferon alpha-2a and ribavirin (PR; n=359), or 12 weeks of telaprevir with either 24 (T12PR24; n=210) or 48 weeks (T12PR48; n=153) of PR.

Patients responded to the EQ-5D-3L questionnaire (EQ), which assessed pain and discomfort, mobility, self-care, performance of usual activities and symptoms of anxiety and/or depression, upon initiation and at 4, 12, 24, 36, 48 and 72 weeks. The index ranged from 0 to 1, with a higher score indicating better HRQOL.

The pooled mean EQ score, after adjustment for age and sex, was 0.91, which was higher than the norm for patients aged 45 to 54 years (0.87). Regardless of treatment, the mean EQ score decreased after 12 weeks (mean 0.8 among telaprevir groups and 0.83 for PR alone), then returned to baseline at 72 weeks in the PR-only and T12PR48 groups, with higher values than baseline in the T12PR24 group (mean 0.94).

Evaluable patients who achieved SVR across all three groups had higher EQ values than those who did not (0.9 vs. 0.86). Multivariate analysis indicated significant associations between improvement to EQ score and SVR at 72 weeks (P<.0001).

“To the best of our knowledge, this is the first report from a large clinical trial on the estimated HRQOL impact of [direct-acting antiviral] combination therapy in adult genotype 1 treatment-naive chronic hepatitis C patients,” the researchers wrote. “Our results are consistent with published data on the HRQOL impacts of IFN-based regimens … and supportive of the value of shorter treatment duration (when clinically appropriate) and highly effective HCV therapies from a patient-reported outcomes perspective.”

Disclosure: See the study for a full list of relevant disclosures.


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