Draft Key Questions
Disposition of Comments Report
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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.
We searched MEDLINE®, PubMed®, CENTRAL, PsycInfo, Embase, and CINAHL from 2001 through June 20, 2012, as well as reference lists of relevant review articles.
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.
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-? 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.
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.