Title : Effect of ombitasvir/paritaprevir/ritonavir + dasabuvir regimen on health-related quality of life for patients with hepatitis C
link : Effect of ombitasvir/paritaprevir/ritonavir + dasabuvir regimen on health-related quality of life for patients with hepatitis C
Effect of ombitasvir/paritaprevir/ritonavir + dasabuvir regimen on health-related quality of life for patients with hepatitis C
Accepted Article
Effect of ombitasvir/paritaprevir/ritonavir + dasabuvir regimen on health-related quality of life for patients with hepatitis C
Sammy Saab, Darshan Mehta, Stacie Hudgens, Nathan Grunow, Yanjun Bao, Brett Pinsky
Effect of ombitasvir/paritaprevir/ritonavir + dasabuvir regimen on health-related quality of life for patients with hepatitis C
Sammy Saab, Darshan Mehta, Stacie Hudgens, Nathan Grunow, Yanjun Bao, Brett Pinsky
Accepted manuscript online: 5 January 2018
DOI: 10.1111/liv.13690
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Abstract
Background and Aims
This study analyzes health related quality of life (HRQoL) data from 8 randomized clinical trials using ombitasvir/paritaprevir/ritonavir and dasabuvir (3D) ± ribavirin [RBV] to investigate: [1] the impact of the treatment vs. placebo during treatment on HRQoL; [2] the sustainability of such treatment effect after 12-week treatment period; and [3] if results from [1] and [2] differ in subgenotypes 1a vs. 1b.
This study analyzes health related quality of life (HRQoL) data from 8 randomized clinical trials using ombitasvir/paritaprevir/ritonavir and dasabuvir (3D) ± ribavirin [RBV] to investigate: [1] the impact of the treatment vs. placebo during treatment on HRQoL; [2] the sustainability of such treatment effect after 12-week treatment period; and [3] if results from [1] and [2] differ in subgenotypes 1a vs. 1b.
Methods
Six registration trials and 2 post-approval trials were pooled and analyzed using longitudinal mixed models (MM) to estimate the effect of 3D + RBV on HRQoL outcomes adjusting for baseline scores, as well as patient demographics and clinical characteristics.
Six registration trials and 2 post-approval trials were pooled and analyzed using longitudinal mixed models (MM) to estimate the effect of 3D + RBV on HRQoL outcomes adjusting for baseline scores, as well as patient demographics and clinical characteristics.
Results
Patients treated with RBV free 3D regimen reported statistically significant increase in HRQoL outcomes as compared to placebo patients. While 3D+RBV treatment saw statistically significant decline in HRQoL outcomes during treatment vs. baseline and vs. placebo, effect on HRQoL outcomes associated with RBV did not persist in the post treatment period for 3D patients followed for up to 52 weeks. The analysis also found GT1b patients reported greater improvements in HRQoL as compared to GT1a patients.
Patients treated with RBV free 3D regimen reported statistically significant increase in HRQoL outcomes as compared to placebo patients. While 3D+RBV treatment saw statistically significant decline in HRQoL outcomes during treatment vs. baseline and vs. placebo, effect on HRQoL outcomes associated with RBV did not persist in the post treatment period for 3D patients followed for up to 52 weeks. The analysis also found GT1b patients reported greater improvements in HRQoL as compared to GT1a patients.
Conclusions
During active treatment period, small but statistically significant decrements in HRQoL outcomes were observed potentially driven by RBV, which were not sustained during the post treatment follow up period. Differences were observed by patient subgenotype, where HRQoL improvements were consistently higher for GT1b patients as compared to GT1a patients.
During active treatment period, small but statistically significant decrements in HRQoL outcomes were observed potentially driven by RBV, which were not sustained during the post treatment follow up period. Differences were observed by patient subgenotype, where HRQoL improvements were consistently higher for GT1b patients as compared to GT1a patients.
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