Tuesday, June 14, 2016

Outcomes in patients with chronic Hep C treated with different anti-viral regimens

Outcomes in patients with chronic Hep C treated with different anti-viral regimens

The latest issue of the American Journal of Gastroenterology performs an in-depth analysis of patient-reported outcomes in patients with chronic hepatitis C treated with different anti-viral regimens.

Interferon- and ribavirin-containing regimens negatively impact patients’ experience.

Dr Zobair Younossi and colleagues from Virginia, USA quantified the impact of different anti-viral regimens for hepatitis C on patients’ work productivity, fatigue, and other patient-reported outcomes.

The patient-reported outcome data from multicenter multinational phase 3 clinical trials of sofosbuvir with and without interferon or ribavirin were retrospectively used.

Treatment regimens were classified as interferon+ribavirin-containing, interferon-free ribavirin-containing, and interferon-free ribavirin-free.

The team administered 4 patient-reported outcome instruments to subjects at baseline, during, and up to 24 weeks after treatment.

Interferon was associated with up to −26% worsening of the patient-reported outcome scores
American Journal of Gastroenterology


The researchers included 3,425 subjects with chronic hepatitis C infection with patient-reported outcome data.

The team found that patients were 63% male, 62% treatment naive, 18% with cirrhosis, and 73% with HCV genotype 1.

Of the study participants, 546 received interferon+ribavirin+sofosbuvir, 1,721 received sofosbuvir+ribavirin, and 1,158 received interferon- and ribavirin-free ledipasvir+sofosbuvir.

At baseline, there were no difference in patient-reported outcomes between treatment groups.

During treatment, the decrements in patient-reported outcomes were up to −24% for the interferon+ribavirin group, up to −7% in the sofosbuvir+ribavirin group, whereas there was an improvement of up to +12% in the interferon-free ribavirin-free group.

The researchers found that use of interferon was independently associated with up to −26% worsening of the patient-reported outcome scores during treatment and the use of ribavirin with up to −9% worsening.

The team noted that after 12 weeks post-treatment, in patients with sustained virologic response-12, improvements were observed regardless of the regimen, and these improvements continued to increase by week 24 of follow-up.

Dr Younossi's team concludes, "The use of interferon- and ribavirin-free regimens for HCV is associated with better patients’ experience, and work productivity during treatment."

Am J Gastroenterol 2016; 111:808–816
14 June 2016

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