09 May Hepatitis C: Patient Reported Outcomes After Treatment
MedicalResearch: What are the main findings of the study?
Dr. Younossi: We conducted the analysis of the patient reported outcomes (PROs) data that were systematically collected during clinical trials of sofosbuvir-containing regimens. The highlights of our findings are as follows:
- Patients with Hepatitis C (HCV) have a significant impairment of their health related quality of life including those related to activity and fatigue. Their work productivity is also impaired.
- Cirrhosis can add additional negative impact on some of these patient reported outcomes.
- During treatment, patients with cirrhosis who were treated with an interferon-free sofosbuvir and ribavirin containing regimen did experience mild decline in their patient related outcome scores. However, this decline was similar for HCV patients with or without cirrhosis.
- On the other hand, patients with cirrhosis who were treated with an interferon-containing regimen showed a significant decline in their patient reported outcomes scores compared to those with Hepatitis C and without cirrhosis.
- Nevertheless, at the end of week 12 follow up, there was no longer a significant deficit in PROs noted regardless of the treatment arm for patients with cirrhosis.
- Furthermore, for the patients (HCV and cirrhosis) who achieved a sustained virologic response at 12 weeks, there were significant improvements (compared to baseline) in some PRO scores.
- During treatment, changes in patient reported outcomes scores were similar between cirrhotics and non-cirrhotics for both treatment regimens (all p>0.05).
MedicalResearch: Were any of the findings unexpected?
Dr. Younossi: In general, our data shows that Hepatitis C patients with cirrhosis can tolerate the new regimens quite well. Additionally, HCV cirrhotic patients who achieve SVR, not only could potentially benefit clinically, but also in terms of their health related quality of life, fatigue and possibly work productivity.
MedicalResearch: What should clinicians and patients take away from your report?
Dr. Younossi: The most important take away messages from our study, as I alluded to above, are that at baseline, patients with HCV and cirrhosis have more patient impairment in patient reported outcomes than those with Hepatitis C without cirrhosis but during treatment, both groups are affected in a similar fashion.
But probably most important is that after achieving a sustained virologic response, patients with Hepatitis C induced cirrhosis actually show improvement in their patient reported outcomes most notably in their vitality, emotional well-being, fatigue and other quality of life domains. Finally, at any time point, fatigue and depression are the most important drivers of patient reported outcomes impairment.
MedicalResearch: What recommendations do you have for future research as a result of this study?
Dr. Younossi: It will be important that future studies investigating different type of interferon-free treatment regimens for Hepatitis C consider patients’ perspective by including validated patient reported outcomes endpoints..
Younossi, Z. M., Stepanova, M., Nader, F., Jacobson, I. M., Gane, E., Nelson, D., Lawitz, E. and Hunt, S. L. (2014), Patient-reported outcomes in chronic hepatitis C patients with cirrhosis treated with sofosbuvir-containing regimens. Hepatology. doi: 10.1002/hep.27161