Effect of ombitasvir/paritaprevir/ritonavir + dasabuvir regimen on health-related quality of life for patients with hepatitis C.

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.

• Authors: Sammy Saab, Darshan Mehta, Stacie Hudgens, Nathan Grunow, Yanjun Bao, Brett Pinsky
• Journal: Liver international : official journal of the International Association for the Study of the Liver (Liver Int) Vol. 38 Issue 8 Pg. 1377-1394 (08 2018) ISSN: 1478-3231 [Electronic] United States
• PMID: 29314597 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Chemical References

• Anilides
• Antiviral Agents
• Carbamates
• Cyclopropanes
• Lactams, Macrocyclic
• Macrocyclic Compounds
• Sulfonamides
• ombitasvir
• Ribavirin
• Uracil
• Proline
• 2-Naphthylamine
• dasabuvir
• Valine
• Ritonavir
• paritaprevir

Topics

• 2-Naphthylamine
• Adult
• Anilides (therapeutic use)
• Antiviral Agents (therapeutic use)
• Carbamates (therapeutic use)
• Cyclopropanes
• Drug Therapy, Combination
• Female
• Hepacivirus
• Hepatitis C (drug therapy)
• Humans
• Internationality
• Lactams, Macrocyclic
• Macrocyclic Compounds (therapeutic use)
• Male
• Middle Aged
• Proline (analogs & derivatives)
• Quality of Life
• Regression Analysis
• Ribavirin (therapeutic use)
• Ritonavir (therapeutic use)
• Severity of Illness Index
• Sulfonamides (therapeutic use)
• Sustained Virologic Response
• Uracil (analogs & derivatives, therapeutic use)
• Valine