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- Title
Effect of ombitasvir/paritaprevir/ritonavir + dasabuvir regimen on health‐related quality of life for patients with hepatitis C.
- Authors
Saab, Sammy; Mehta, Darshan; Hudgens, Stacie; Grunow, Nathan; Bao, Yanjun; Pinsky, Brett
- Abstract
Abstract: Background & Aims: This study analyses health‐related quality of life data from 8 randomized clinical trials using ombitasvir/paritaprevir/ritonavir and dasabuvir ± ribavirin to investigate: (i) the impact of the treatment vs placebo during treatment on health‐related quality of life; (ii) the sustainability of such treatment effect after 12‐week treatment period; and (iii) if results from (i) and (ii) differ in subgenotypes 1a vs 1b. Methods: Six registration trials and 2 post‐approval trials were pooled and analysed using longitudinal mixed models to estimate the effect of ombitasvir/paritaprevir/ritonavir and dasabuvir ± ribavirin on health‐related quality of life outcomes adjusting for baseline scores, as well as patient demographics and clinical characteristics. Results: Patients treated with ribavirin‐free ombitasvir/paritaprevir/ritonavir and dasabuvir regimen reported statistically significant increase in health‐related quality of life outcomes as compared to placebo patients. While ombitasvir/paritaprevir/ritonavir and dasabuvir + ribavirin treatment saw statistically significant decline in health‐related quality of life outcomes during treatment vs baseline and placebo, effect on health‐related quality of life outcomes associated with ribavirin did not persist in the post‐treatment period for ombitasvir/paritaprevir/ritonavir and dasabuvir patients followed for up to 52 weeks. The analysis also found Genotype 1b patients reported greater improvements in health‐related quality of life as compared to genotype 1a patients. Conclusions: During the active treatment period, small but statistically significant decrements in health‐related quality of life outcomes were observed potentially driven by ribavirin, which were not sustained during the post‐treatment follow‐up period. Differences were observed by patient subgenotype, where health‐related quality of life improvements were consistently higher for genotype 1b patients as compared to genotype 1a patients.
- Subjects
HEPATITIS C virus; QUALITY of life; DRUG efficacy; CLINICAL trials; PUBLIC health
- Publication
Liver International, 2018, Vol 38, Issue 8, p1377
- ISSN
1478-3223
- Publication type
Article
- DOI
10.1111/liv.13690