Adherence to Treatment and Quality of Life during Hepatitis C Therapy

A Prospective, Real-life, Observational Study

Patrick Marcellin; Michel Chousterman; Thierry Fontanges; Denis Ouzan; Michel Rotily; Marina Varastet; Jean-Philippe Lang; Pascal Melin; Patrice Cacoub

Disclosures

Liver International. 2011;31(4):516-524. 

In This Article

Abstract and Introduction

Abstract

Background: Adherence is important for therapy of chronic diseases, but has still not been well studied in real life in chronic hepatitis C.
Aims: To assess adherence to hepatitis C combination therapy in routine clinical practice and to identify factors associated with imperfect adherence.
Methods: This cohort study included unselected chronic hepatitis C patients initiating peginterferon α-2b plus ribavirin. 100% adherence was defined by taking all the prescribed doses of both drugs for the full initially intended duration, as declared by the patient or believed by the physician. Quality of life was assessed using the short-form health survey (SF-36) questionnaire.
Results: 1860 patients were analysed, including 72% treatment-naive, 36% genotype 2/3, 23% psychiatric, 44% drug addicts and 3% human immunodeficiency virus (HIV)-positive patients. Early treatment discontinuation occurred in 30% of patients. Overall, 38% of patients reported 100% adherence. Patient- and physician-reported adherences were discordant, with a 20–30% overestimation by physicians. HIV co-infection [odds ratio (OR) 2.52, 95% confidence interval (CI) 1.36–4.67], no drug use during follow-up (2.37, 1.30–4.31), genotype 3 (1.55, 1.20–2.00) and treatment-naive (1.32, 1.03–1.69) were associated with 100% adherence. Quality of life worsened during treatment but returned to baseline after the end of treatment.
Conclusions: Imperfect adherence to combination therapy is common in routine patients. Adherence is markedly overestimated by physicians and is associated with some patient's baseline characteristics. Knowledge of these factors might help identify patients who are most in need of intervention and plan more frequent and accurate follow-up.

Introduction

The current standard of care for chronic hepatitis C is the antiviral combination therapy with peginterferon α and ribavirin.[1,2] Peginterferon is administered subcutaneously once a week and ribavirin orally twice daily. Successful treatment, i.e. achievement of a sustained virological response, has been obtained in 79–93% of genotype 2 or 3 hepatitis C virus (HCV) patients after 24 weeks of treatment; as well as in 41–52% of genotype 1 patients and 77% of genotype 4 patients after 48 weeks of treatment in clinical trials.[3–6] Good adherence to treatment is believed to enhance the rate of sustained virological response, as shown in patients from prior trials who received ≥80% of both their total peginterferon and ribavirin doses for ≥80% of the expected duration of therapy.[7] However, adverse effects of interferon-based therapy – mainly flu-like symptoms, neuropsychiatric disorders, anaemia and neutropenia – are significant, justify frequent dose reduction of peginterferon and ribavirin and represent one major cause of premature treatment discontinuation.[8] Shortened antiviral therapy may be considered in some patients depending on genotype, baseline viral load and viral kinetics,[9–11] but only a minority of patients are concerned in routine practice, at least in France.

These data originate from randomised, controlled clinical trials. However, many patients in routine clinical practice are nonresponders or relapsers to previous interferon-based therapy and the majority present with a wide spectrum of comorbidities. In particular, the high prevalence of psychiatric or substance abuse disorders in patients with chronic HCV infection is well known.[12] Conversely, people with chronic psychiatric disorders[13,14] and intravenous drug users[15–17] are far more likely to be infected with HCV compared with the general population. In addition, one-fourth to one-third of human immunodeficiency virus (HIV)-infected patients are co-infected with HCV.[18,19] Besides strict contraindications, such diagnoses have constituted the most common reason patients have been denied treatment for HCV infection, not only in clinical trials[3,4] but also, until recently, in the real life.[20,21]

We performed a cohort study in chronic hepatitis C patients to evaluate the adherence to peginterferon α-2b and ribavirin combination therapy and to identify factors associated with good adherence in a real-life setting. We also assessed the coherence between patient-reported and physician-reported adherence, and the health-related quality of life.

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