Systematic Review

Patient-reported Outcomes in Chronic Hepatitis C

The Impact of Liver Disease and New Treatment Regimens

Z. Younossi; L. Henry

Disclosures

Aliment Pharmacol Ther. 2015;41(6):497-520. 

In This Article

Abstract and Introduction

Abstract

Background Treatment for chronic hepatitis C (CH-C) is rapidly changing and moving away from an interferon and ribavirin-based therapy to interferon-free ribavirin-free all oral regimens. These regimens are simpler and shorter to administer with very high efficacy rates and better side effect profiles. As advances in the treatment of CH-C occur, it is imperative to capture both clinical outcomes (efficacy and safety) as well as patient-reported outcomes (PROs). In fact, PROs assesses and quantifies the impact of these regimens on patient experience. PROs assess patients' health-related quality of life (HRQOL) especially in the realms of fatigue and neuropsychiatric issues such as depression which can affect treatment adherence and work productivity.

Aim To review the literature related to PRO's in HCV patients and summarise the impact of CH-C and its treatment on PROs.

Methods Databases Ovid MEDLINE and PubMed were searched from 1990 to October 2014 using a combination of MEsh, thesaurus terms and relevant text words: hepatitis C, CH-C, treatment, quality of life, health-related quality of life, fatigue, work productivity, adherence, patient-reported outcomes, direct acting anti-viral agents and second generation direct acting anti-viral agents. Each manuscript was assessed for pertinence to the issue of PROs in CH-C as well as the quality of study design and publications.

Results From the literature, it is evident that CH-C patients have baseline PRO impairment. Furthermore, treatment with interferon with or without ribavirin and first generation DAAs causes additional PRO burden which can negatively impact treatment adherence and indirectly, treatment efficacy and work productivity. The new treatment regimens with interferon- and ribavirin-free regimens not only have very high efficacy, but also result in the improvement of PRO scores as early as 2 weeks into treatment as well as possibly better adherence to treatment regimens.

Conclusions CH-C and its treatment have been associated with patient-reported outcome impairment. The new IF-free and RBV-free regimens are associated with high efficacy and substantial improvement of patient-reported outcomes in clinical trial setting. Although very encouraging, more data are needed to assess patient-reported outcomes, adherence and work productivity of CH-C patients in the real world setting of clinical practice.

Introduction

The new treatment of chronic hepatitis C (CH-C), a prominent and potentially devastating liver disease worldwide, is evolving and promises higher cure rates with fewer side effects and shorter treatment duration.[1–5] To better understand the total impact of these regimens on CH-C patients' life and quality of life, the data on the efficacy and safety of these regimens must be combined with the data related to patient-reported outcomes (PROs). Patient reported outcomes are defined as measurements based on reports that come directly from the patient about the status of their health condition without amendment or interpretation by a clinician or anyone else.[6] In clinical research and clinical practice, capturing PRO data in addition to efficacy and safety data provides a complete assessment of the impact of the disease as well as a comprehensive net benefit that chronic disease treatment may provide to CH-C patients.[6]

One may argue that for CH-C patients, sustained virologic response (SVR) is a surrogate for clinical outcomes (such as improved survival). In contrast, PROs are surrogates for estimating patients' experience with the disease and its treatment. This is especially true for patients with CH-C who have historically been treated with regimens that have low efficacy and numerous side effects (anaemia, fatigue, depression and thrombocytopenia).[7–14] The newer regimens are free of interferon and some free of ribavirin, have the advantage of high SVR and a better PRO profile. By combining both clinical and PRO outcomes, the true value of these regimens can be appreciated.[15–23]

Although a number of PROs measurement tools and concepts provide important insight about patients' experience, in this manuscript, we will focus on the PRO's of health-related quality of life (HRQOL), fatigue and work productivity.[24–30] Therefore, the purpose of this article was to briefly describe the PRO literature as it pertains to CH-C, the historical treatment with interferon-based regimens, the new treatment regimens free of interferon and to discuss the implications of these findings in relation to treatment adherence and patient reported outcomes.

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