The effect of interferon‐free regimens on health‐related quality of life in East Asian patients with chronic hepatitis C

Younossi, Zobair M.; Stepanova, Maria; Henry, Linda; Han, Kwang Hyub; Ahn, Sang Hoon; Lim, Young Suk; Chuang, Wan‐Long; Kao, Jia Horng; Nguyen, Kinh Van; Lai, Ching Lung; Yuen, Man Fung; Chan, Henry Lik Yuen; Wei, Lai

doi:10.1111/liv.13650

Cited by 18 publications

(9 citation statements)

References 29 publications

(76 reference statements)

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“…The overall increase across domains of HRQL is similar to that previously reported in clinical trials in high‐income settings 8‐11,16 . Younossi (2015) reported robust improvements in most domains of the MOS Short‐Form General Health Survey (SF‐36) survey instrument, including physical functioning, role physical, bodily pain, general health, vitality, social functioning, and physical summary score of all fibrosis stages, also treated with LDV/SOF.…”

Section: Discussionsupporting

confidence: 79%

“…There are clear medical benefits of treatment for HCV infection in terms of liver‐related and all‐cause mortality and decreased incidence of hepatocellular carcinoma 7 . In addition, there is increasing evidence from high‐income settings that treatment with all‐oral direct‐acting antiviral (DAA) regimens also provides significant benefits in terms of health‐related quality of life (HRQL) 8‐11 . Results from clinical trials conducted in the USA and several European countries showed an improvement in HRQL after achievement of sustained virologic response (SVR) for participants who were treated with ledipasvir/sofosbuvir (LDV/SOF) regardless of fibrosis status 9 .…”

Section: Introductionmentioning

confidence: 99%

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Improved quality of life following direct‐acting antiviral treatment for chronic hepatitis C infection in Rwanda: Results from a clinical trial in sub‐Saharan Africa (the SHARED study)

Nuil

Umutesi

Shumbusho

et al. 2020

Journal of Viral Hepatitis

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Around 71 million people are living with chronic hepatitis C virus (HCV) infection, with approximately 14% residing in sub‐Saharan Africa. Direct‐acting antiviral (DAA) therapies offer clear benefits for liver‐related morbidity and mortality, and data from high‐income settings suggest that DAA treatments also provide significant benefits in terms of health‐related quality of life (HRQL). In this study, we assessed the effect of DAA treatment on HRQL for individuals treated for HCV in a clinical trial in Rwanda. We assessed the HRQL of participants using an 83‐question composite survey at Day 0 (‘baseline’) and Week 24 (‘endpoint’). Data were analysed in R. A total of 296 participants were included in this analysis. Their ages ranged from 19 to 90, and 184 (62.2%) were female. There were significant improvements from baseline to endpoint median scores for all physical and mental quality of life sub‐scales. Additionally, a reduction—before and after treatment—in the proportion of those classified as depressed and needing social support was statistically significant (both P < .001). Economic productivity increased after treatment (P < .001), and households classified as food secure increased from baseline to endpoint (P < .001). These results demonstrate that Rwandans with chronic HCV infection experience both clinical and HRQL benefits, including household‐level benefits like substantial gains in workforce stability, economic productivity, and poverty alleviation, from DAA treatment. A stronger demonstration of accurate and broader household‐level benefits achieved through treatment of HCV with DAAs will help financing and investment for HCV in resource‐constrained settings become an urgent priority.

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Section: Discussionsupporting

confidence: 79%

Section: Introductionmentioning

confidence: 99%

Improved quality of life following direct‐acting antiviral treatment for chronic hepatitis C infection in Rwanda: Results from a clinical trial in sub‐Saharan Africa (the SHARED study)

Nuil

Umutesi

Shumbusho

et al. 2020

Journal of Viral Hepatitis

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“…Outcomes of HCV treatment have improved substantially with the emergence of direct-acting antiviral (DAA) agents, which are associated with nearly 100% sustained virologic response (SVR) or HCV cure, defined as absence of detectable virus 12 weeks after therapy completion, convenient dosing, and few side effects (5). Sustained virologic response has been shown to improve quality of life (6)(7)(8) and to lengthen survival (9)(10)(11).…”

mentioning

confidence: 99%

Intensive Models of Hepatitis C Care for People Who Inject Drugs Receiving Opioid Agonist Therapy

et al. 2019

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Background: Many people who inject drugs (PWID) are denied treatment for hepatitis C virus (HCV) infection, even if they are receiving opioid agonist therapy (OAT). Research suggests that HCV in PWID may be treated effectively, but optimal models of care for promoting adherence and sustained virologic response (SVR) have not been evaluated in the direct-acting antiviral (DAA) era. Objective: To determine whether directly observed therapy (DOT) and group treatment (GT) are more effective than self-administered individual treatment (SIT) in promoting adherence and achieving SVR among PWID receiving OAT.

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“…Health‐related quality of life data accompanied by similarly collected demographic and clinical data from historic controls included in our HRQL registry were used for comparison . The controls were patients with HCV enrolled from the same countries in East Asia (China, Taiwan and South Korea) using similar inclusion/exclusion criteria and treated with pegylated interferon, ribavirin and sofosbuvir for 12 weeks (Peg‐IFN + RBV + SOF) or sofosbuvir plus ribavirin for 12 or 24 weeks.…”

Section: Methodsmentioning

confidence: 99%

“…The controls were patients with HCV enrolled from the same countries in East Asia (China, Taiwan and South Korea) using similar inclusion/exclusion criteria and treated with pegylated interferon, ribavirin and sofosbuvir for 12 weeks (Peg‐IFN + RBV + SOF) or sofosbuvir plus ribavirin for 12 or 24 weeks. Those data were collected as a part of another multinational phase 3 clinical trial (GS‐US‐334‐0115, clinicaltrials.gov #NCT02021643), and the HRQL analysis has been published …”

Section: Methodsmentioning

confidence: 99%

Sofosbuvir and ledipasvir are associated with high sustained virologic response and improvement of health‐related quality of life in East Asian patients with hepatitis C virus infection

Younossi

Stepanova

Henry

et al. 2018

Journal of Viral Hepatitis

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Although HCV infection is highly prevalent in East Asia, these patients have been underrepresented in HRQL studies. Here, we assess HRQL in East Asian HCV patients treated with different anti-HCV regimens. Patients completed Short Form-36 (SF-36) before, during and after treatment. A total of 989 HCV patients were enrolled in two phase 3 clinical trials [China: 60.2%, South Korea: 22.4%, Taiwan: 17.4%; genotype 1: 55.3%, treatment-naïve: 57.5%; cirrhosis: 14.0%]. Patients received pegylated interferon, sofosbuvir and ribavirin (Peg-IFN + SOF + RBV; n = 130, genotypes 1, 6) or SOF + RBV (n = 475, all genotypes) or SOF and ledipasvir (LDV/SOF; n = 384, genotype 1). The SVR-12 rates were 94.6%, 96.2% and 99.2%, respectively (P = 0.005). During treatment, Peg-IFN + SOF + RBV-treated group experienced significant declines in most HRQL scores (by the end of treatment, mean decline up to -12.0 points, all P < 0.05). Patients on SOF + RBV had milder HRQL impairment (up to -5.8 points, P < 0.05 for 5 of 8 HRQL domains). In contrast, patients receiving IFN- and RBV-free regimen with LDV/SOF had their HRQL scores improve (mean up to +4.3 points, P < 0.0001 for 3 of 8 scales). In multivariate analysis, receiving Peg-IFN + SOF + RBV was consistently independently associated with HRQL impairment during treatment (β: -10.3 to -16.4) and after achieving SVR-12 (β: -4.4 to -9.1) (all P < 0.01). The results were reproduced in a subgroup of patients enrolled in China. We conclude that in East Asian patients with HCV, HRQL improved from baseline after treatment with LDV/SOF but not with Peg-IFN + RBV-containing or Peg-IFN-free RBV-containing regimens. The HRQL impairment associated with the use of Peg-IFN persists even after achieving sustained virologic clearance.

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The effect of interferon‐free regimens on health‐related quality of life in East Asian patients with chronic hepatitis C

Abstract: East Asian HCV patients treated with an IFN-free regimen had better on-treatment HRQL scores. These data should inform policymakers about the comprehensive benefits of IFN-free regimens in East Asian patients with HCV.

Cited by 18 publications

References 29 publications

Improved quality of life following direct‐acting antiviral treatment for chronic hepatitis C infection in Rwanda: Results from a clinical trial in sub‐Saharan Africa (the SHARED study)

Improved quality of life following direct‐acting antiviral treatment for chronic hepatitis C infection in Rwanda: Results from a clinical trial in sub‐Saharan Africa (the SHARED study)

Intensive Models of Hepatitis C Care for People Who Inject Drugs Receiving Opioid Agonist Therapy

Sofosbuvir and ledipasvir are associated with high sustained virologic response and improvement of health‐related quality of life in East Asian patients with hepatitis C virus infection

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