Results Summary
What was the research about?
Hepatitis C virus, or HCV, attacks a person’s liver. Chronic HCV can lead to liver failure, liver cancer, and death. In the United States, more than 12,000 people die from illness related to HCV every year. In 2013, the Food and Drug Administration approved a new type of HCV treatment called direct-acting antiviral, or DAA, medicine. Compared with older HCV treatments, DAAs have higher cure rates, take less time to get rid of the virus, and are safer.
In this study, the research team wanted to learn more about the short- and long-term changes in symptoms, side effects, and quality of life among people who took DAAs and who no longer had HCV in their blood.
What were the results?
Three months after completing treatment, patients reported
- Less fatigue
- Better sleep quality
- Better ability to do daily tasks
Patients also reported small improvements in symptoms of depression, anger, anxiety, memory and decision making, effect of pain on their life, belly pain, headaches, and overall burden of symptoms in general. However, the improvements in these symptoms weren’t large enough to be clearly meaningful to patients.
One year after completing treatment, patients maintained the improvements that were seen after three months. Patients also reported less belly pain than before treatment.
Who was in the study?
The study included 1,346 patients who no longer had HCV in their blood three months after treatment with DAAs. Patients received care from one of 11 health centers across the United States. Of these patients, 60 percent were white, 33 percent were black, and 6 percent were of other races. The average age was 59, and 55 percent were men.
What did the research team do?
The research team surveyed patients before and during treatment and again at three months and at one year after completing treatment. The surveys asked patients about their symptoms and side effects from HCV and quality of life.
An advisory board of people with HCV provided feedback throughout the study.
What were the limits of the study?
Because the study didn’t compare DAA treatment with no treatment, the research team can’t say for sure that the DAAs caused the improvements seen in the study.
Future research could continue to look into the long-term effects of DAAs.
How can people use the results?
Patients and their doctors can use these results when considering treatments for HCV.
Professional Abstract
Objective
To characterize the short- and long-term benefits of achieving sustained virological response (SVR) among patients who received direct-acting antiviral medicines for chronic hepatitis C virus (HCV)
Study Design
| Design Elements | Description |
|---|---|
| Design | Observational, cohort study |
| Population | 1,346 patients who achieved SVR after receiving direct-acting antiviral medicine for HCV |
| Interventions/ Comparators |
Direct-acting antiviral medicine for chronic HCV |
| Outcomes | Depression, anger, anxiety, cognitive concerns, pain interference, fatigue, sleep disturbance, abdominal pain, diarrhea, nausea, headache, overall symptom burden, functional well-being (ability to do daily tasks) |
| Timeframe | 1-year follow-up for study outcomes |
This prospective, observational cohort study examined changes in patient-reported symptoms, side effects, and quality of life among patients who received direct-acting antiviral medicines for HCV and achieved SVR three months after completing treatment.
Patients in the study received direct-acting antiviral medicine for HCV at one of 11 health centers across the United States. Three months after treatment, the study cohort included 1,346 patients who achieved SVR. Of these, 60% were white, 33% were black, and 6% were of other races. The average age was 59, and 55% were male.
Patients completed surveys about their experiences with HCV before starting treatment, during HCV treatment, and again at three months and at one year after completing treatment. The research team defined a 5% or greater change in survey score from baseline as a minimally important clinical difference.
An advisory board of people with HCV provided feedback throughout the study.
Results
Three months after completing treatment, patients had less fatigue and sleep disturbance and higher functional well-being than at baseline. Patient scores improved in all other outcome measures but did not reach the minimally important clinical difference threshold.
One year after completing treatment, patients reported maintaining the improvements from the three-month follow-up; also, they reported less abdominal pain compared with baseline scores.
Limitations
Because the study did not include a no-treatment comparison group, it cannot establish with certainty that the changes from before to after treatment were results of the direct-acting antiviral medicine.
Conclusions and Relevance
This study assessed the benefits of achieving SVR among patients who received direct-acting antiviral medicine for HCV. Short- and long-term benefits included clinically significant improvements in fatigue, sleep disturbance, abdominal pain, and functional well-being.
Future Research Needs
Future research could continue to examine longer term effects of direct-acting antiviral medicines.
Final Research Report
View this project's final research report.
Journal Citations
Results of This Project
Related Journal Citations
Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:
- The reviewers asked how the researchers administered the surveys and whether the researchers considered the health literacy level of the patient population in developing the surveys. The researchers explained that they used multiple ways to collect survey results, which they characterized as a strength of their study, leading to high retention and data collection rates. The researchers added that past research has shown that different methods of collecting survey responses obtain similar results except when addressing sensitive data, such as drug use, which was a small component of this study. The researchers responded that they did not evaluate the health literacy of the study cohort, but 95 percent of the cohort had an education level of eighth grade or higher. They noted also that some of the survey measures had been developed to target a sixth-grade reading level, but the reading level for other measures was not known.
- The reviewers asked for clarification on the group of patients with cirrhosis, since the report only stated that the patient-reported outcomes measures were similar for patients with and without cirrhosis. The researchers said that they started off considering patients with and without cirrhosis as distinct subgroups but de-emphasized this focus after observing minimal differences between the groups. But in response to the reviewers’ request, they added a new figure (Figure 14: Change in PROs one-year post-treatment (T5) after SVR by CIRRHOSIS-MELD STATUS) with results comparing patients without cirrhosis and those with less- and more- advanced cirrhosis.
- The reviewers suggested that the analysis on treatment adherence seemed superfluous to the rest of the study and could be dropped from the report. The researchers agreed that the analysis of medication adherence was not well integrated with other aims in the report and that self-reporting on medication use can be subject to recall bias. However, they explained that they included this as an aim because this was found to be an important outcome to stakeholders. The reviewers also objected to the use of self-reported medication adherence to measure this outcome but acknowledged that nonadherence was unlikely to be a major issue in this population. The researchers agreed with reviewers regarding the limitations of self-reported adherence, but they used their available resources to collect this information once it was clear that stakeholders were interested in the results.
- Reviewers had difficulty understanding how the study handled missing data posttreatment related to sustained virological response (SVR) and asked for more detail, as this outcome has typically been key to determining treatment success or failure in hepatitis C (HCV) studies. The researchers explained that for the primary outcomes they used the full sample, regardless of whether they had SVR status on all patients posttreatment. They excluded patients with missing SVR measures when SVR status was necessary for the analysis. The researchers acknowledged that most HCV studies would not have 10 percent missing SVR data. They speculated that the higher than expected incidence of missing SVR status was related to patients’ expectations of cure and greater psychosocial instabilities.