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Interventions to Improve Patient Adherence to Hepatitis C Treatment: Comparative Effectiveness
Comparative Effectiveness Reviews, No. 91
Investigators: Xin Sun, PhD, Carrie D Patnode, PhD, MPH, Clara Williams, MA, Caitlyn A Senger, MPH, Tanya J Kapka, MD, MPH, and Evelyn P Whitlock, MD, MPH.
Author Information and AffiliationsStructured Abstract
Objectives:
Patients with chronic hepatitis C often have difficulties adhering to antiviral therapy due to the complexities of treatment and the adverse events commonly experienced. This Comparative Effectiveness Review (CER) systematically assesses the comparative benefits and harms of treatment adherence interventions for adults receiving combination antiviral therapy for chronic hepatitis C.
Data sources:
We searched MEDLINE®, PubMed®, CENTRAL, PsycInfo, Embase, and CINAHL from 2001 through June 20, 2012, as well as reference lists of relevant review articles.
Review methods:
We developed the review protocol, including the analytic framework and Key Questions, with input from Key Informants and technical experts. Two investigators independently assessed titles and abstracts for eligibility against predefined inclusion/exclusion criteria. Two investigators reviewed full-text articles and independently quality-rated those meeting inclusion criteria. One reviewer abstracted data from all included studies; these data were verified by another reviewer. We summarized data qualitatively grouped by intervention type.
Results:
We included 12 studies from 1,629 identified reports. These studies included six randomized controlled trials (RCTs) and six cohort studies. All the studies enrolled patients receiving combination therapy of peginterferon-α and ribavirin. The RCTs were generally of poor quality and had small sample sizes (21 to 250). While two good-quality cohort studies included relatively large numbers of patients (674 and 1,560), the remaining studies had serious methodological limitations and small sample sizes. None of the studies reported data on important health outcomes, such as liver complications, mortality, and hepatitis C virus (HCV) transmission. The interventions and patient populations for these studies differed substantially. Although quality of life appeared to improve with interventions in two studies, no statistical significance was reported. In the eight studies reporting sustained viral response (SVR), two showed a statistically significantly higher proportion of patients achieving SVR compared with usual care, and three of the other six showed a tendency toward an improvement in SVR. Four of the eight studies reporting adherence showed statistically significant improvement in adherence, and two others achieved nonsignificant improvement. Two studies reported no harms associated with the interventions.
Conclusions:
Adherence interventions might improve patient adherence and viral response in patients with chronic hepatitis C. The strength of evidence from these interventions, however, is low. More adequately powered and rigorously conducted RCTs are needed to test HCV adherence interventions on intermediate and health outcomes, as well as in genotype 1 patients receiving triple therapy. Researchers must also adequately report details about the study’s design and conduct, including adopting a standard definition of adherence.
Contents
- Preface
- Key Informants
- Technical Expert Panel
- Peer Reviewers
- Executive Summary
- Introduction
- Condition Definition
- Prevalence and Disease Burden
- Etiology and Natural History of Hepatitis C Infection
- Hepatitis C Virus Genotypes and Detection
- Treatment of Chronic Hepatitis C Infection
- Adherence in the Context of Chronic Hepatitis C Treatment
- Risk Factors for Nonadherence to Antiviral Treatment
- Association of Adherence With Sustained Viral Response
- Interventions for Improving Adherence
- Scope and Purpose
- Key Questions
- Methods
- Results
- Summary and Discussion
- References
- Abbreviations and Acronyms
- Appendix A Original Search Strategy
- Appendix B Studies Pending Assessment
- Appendix C Excluded Studies
- Appendix D Quality of Included Randomized Controlled Trials
- Appendix E Quality of Included Cohort Studies
- Appendix F Quality of Life Outcomes
Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services1, Contract No. 290-2007-10057-I, Prepared by: Oregon Evidence-based Practice Center, Kaiser Permanente Center for Health Research, Portland, OR
Suggested citation:
Sun X, Patnode CD, Williams C, Senger CA, Kapka TJ, Whitlock EP. Interventions To Improve Patient Adherence to Hepatitis C Treatment: Comparative Effectiveness. Comparative Effectiveness Review No. 91. (Prepared by the Oregon Evidence-based Practice Center under Contract No. 290-2007-10057-I.) AHRQ Publication No. 13-EHC009-EF. Rockville, MD: Agency for Healthcare Research and Quality. December 2012. www.effectivehealthcare.ahrq.gov/reports/final.cfm.
This report is based on research conducted by the Oregon Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2007-10057-I). The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.
The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients.
This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.
None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.
- 1
540 Gaither Road, Rockville, MD 20850; www
.ahrq.gov
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