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

• Published in: Liver international 2018-08, Vol.38 (8), p.1377-1394
• Main Authors: Saab, Sammy, Mehta, Darshan, Hudgens, Stacie, Grunow, Nathan, Bao, Yanjun, Pinsky, Brett, Thompson, Alexander
• Format: Article
• Language: English
• Subjects: Adult; Anilides - therapeutic use; Antiviral Agents - therapeutic use; Carbamates - therapeutic use; Clinical trials; Demographics; Demography; Drug Therapy, Combination; Female; Genotype & phenotype; Genotypes; GT1b; Health; health‐related quality of life; Hepacivirus; Hepatitis; Hepatitis C; Hepatitis C - drug therapy; Humans; Internationality; Macrocyclic Compounds - therapeutic use; Male; Medical research; Middle Aged; Patients; Quality of Life; Regression Analysis; Ribavirin; Ribavirin - therapeutic use; Ritonavir; Ritonavir - therapeutic use; Severity of Illness Index; Statistical analysis; Statistical significance; Sulfonamides - therapeutic use; Sustainability; Sustained Virologic Response; Uracil - analogs & derivatives; Uracil - therapeutic use
• ISSN: 1478-3223; 1478-3231
• DOI: 10.1111/liv.13690

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.