Original article
Pancreas, biliary tract, and liver
Long-term Benefits of Sustained Virologic Response for Patient-Reported Outcomes in Patients With Chronic Hepatitis C Virus Infection

https://doi.org/10.1016/j.cgh.2019.07.047Get rights and content

Background & Aims

Patients with hepatitis C virus (HCV) infections who achieve a sustained virologic response (SVR) to treatment have improved patient-reported outcomes (PROs). We compared post-treatment PRO scores between patients with chronic HCV infection who did and did not achieve an SVR to treatment.

Methods

Patients who completed treatment in clinical trials were enrolled in 2 registries, depending on the treatment outcome (NCT01457755, NCT01457768), from 2016 to 2017 in 17 countries in North America, Europe, and the Asia–Pacific region. PRO scores (scale, 0–100) were collected at pretreatment (baseline); the last day of treatment; the post-treatment week 12 follow-up visit (in patients with SVR only); the registry baseline; and on registry weeks 12, 24, 36, 48, and 96 (the non-SVR registry) or every 24 weeks until week 96 (SVR registry), using the Short Form-36 (SF-36) instrument.

Results

Our analysis included 4234 patients with an SVR and 242 without an SVR from whom pretreatment PRO data were available (mean age, 54 ± 10 y; 63% male; 65% enrolled in the United States; 17% with cirrhosis; 12% with human immunodeficiency virus co-infection). Upon registry enrollment, patients with an SVR had significant increases in all PRO scores compared with pretreatment baseline levels (all P < .05). Patients without an SVR had mean reductions of 9.2 points or less in PRO scores while followed up on the registry (P < .05 for 4–8 of 8 PRO domains measured by the SF-36). In contrast, patients with an SVR had sustained increases in PRO scores (mean increase, ≤7.0 points) while on the registry. In multivariate analysis, achieving an SVR was associated independently with superior scores in all SF-36 domains at all registry time points (β, +4.8 to +15.9 points, all P ≤ .01).

Conclusions

In a follow-up analysis of participants in clinical trials, we found that those with an SVR to treatment for HCV infection had significant increases in well-being, based on PRO scores. Patients without an SVR had decreasing PRO scores over the follow-up period.

Section snippets

Data Source

The data used in this study came from 2 long-term follow-up registry studies of HCV subjects who had completed treatment with a DAA-based regimen in a clinical trial. Both registries were enrolling patients in 2016 to 2017 in 17 countries in North America, Europe, and the Asia–Pacific region.

The first registry enrolled subjects who had achieved SVR after treatment (NCT01457755). The second registry enrolled subjects who had not achieved SVR after treatment (NCT01457768). The definition of SVR

Results

The study included 4234 patients who achieved SVR and 242 who did not achieve SVR. All patients had clinical and laboratory data as well as pretreatment PRO data. Patients with SVR were less likely to be male, had a lower BMI, were more likely treatment-naive before treatment in a parent study, less cirrhotic, and had fewer instances of HIV co-infection and type 2 diabetes (P < .05) (Table 1).

Before treatment initiation, the PRO scores of both patient groups were similar or higher than those of

Discussion

In this study, we provide evidence about the sustainability of PRO improvement in HCV patients who achieved SVR. In fact, the long-term follow-up evaluation of patients enrolled in the SVR registry showed consistent PRO improvement in all aspects of patients’ well-being as captured by the SF-36 PRO instrument. These changes were not only statistically significant but also clinically meaningful by meeting minimally clinically important difference thresholds, which generally are believed to be

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    Conflicts of interest These authors disclose the following: Zobair M. Younossi has received research funds from Gilead Sciences, Intercept, Bristol-Myers Squibb; served as a consultant for NovoNordisk, AbbVie, Terns, and Viking; Ira M. Jacobson has served as a consultant for: AbbVie, Arbutus, Arrowhead, Assembly, Atea, BMS, Gilead, Intercept, Janssen, Novo Nordisk, Siemens; received research funding from: Assembly, BMS, Durect, Enanta, Janssen, Eli Lilly, Merck, Myr; Peter J. Ruane has received consulting fees and is a shareholder of Gilead Sciences; and Anuj Gaggar and Robert P. Myers are employees of Gilead Sciences. The remaining authors disclose no conflicts.

    Funding This project was supported in part by Gilead Sciences.

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