In the Journals

Patient-reported outcomes greatly altered by HCV treatment results

Zobair M. Younossi, MD
Zobair M. Younossi

In a follow-up analysis of participants in clinical trials, researchers found that patient-reported outcome scores increased in patients who achieved sustained virologic response after treatment for hepatitis C, whereas scores decreased in those who did not.

“Although historical treatment regimens with interferon were plagued by low efficacy and significant side effects impairing patients’ well-being and, thus, PROs, the trajectory of HCV treatment changed about 5 years ago with the development of direct-acting antiviral (DAA) agents,” Zobair M. Younossi, MD, chairman of the department of medicine at Inova Fairfax Hospital in Virginia, and colleagues wrote. “The PRO evidence generated by these two prospective registry studies support the unquestionable benefit of SVR for patients’ experience as opposed to the clear deleterious impact of HCV viremia.”

Younossi and colleagues assessed the health-related quality of life of 4,234 patients who achieved SVR and 242 patients who did not using the SF-36 instrument. Before treatment, PRO scores of both groups were similar to or higher than the general U.S. population and similar to each other.

At baseline for this study, patients who achieved SVR experienced improvements in all eight domains of the SF-36 (range increase, 3.6-8.1; P < .0001), while the scores of those without SVR remained the same with the exception of the General Health domain, which decreased by 2.8 points (P = .008).

Patients without SVR experienced further PRO decrements at 12-week follow-up: up to –7 points from before treatment in the Role Physical, General Health, Social Functioning and Role Emotional domains and both summary scores; up to –9.2 points in all PRO domains at week 24; up to –8.3 points in five domains at week 48; and up to –9 points in four domains at week 96 (P < .05).

In contrast, patients with SVR experienced sustained improvement of PRO scores with up to 7 points at week 24, up to 6.9 points at week 48, and up to 6.1 points at week 96 (P < .001). Multivariate analysis confirmed that SVR correlated independently with superior scores in all PRO domains with an increased range of 4.8 points to 15.9 points (P < .01).

“In order to fully understand the comprehensive benefit of HCV cure, these PRO gains should always accompany the clinical consequences of SVR, such as lower rates of cirrhosis and hepatocellular carcinoma,” Younossi and colleagues concluded. “These data must be considered by providers, payers, and policy makers to fully appreciate the comprehensive benefit of HCV cure and to assure that all HCV patients are identified and treated with the most effective antiviral regimens.” – by Talitha Bennett

Disclosures: Younossi reports that the study was partially supported by Gilead Sciences and that he has received research funds or served as consultant to AbbVie, Bristol-Myers Squibb, Gilead Sciences, Intercept, Novo Nordisk, Terns and Viking. Please see the full study for all other authors’ relevant financial disclosures.

Zobair M. Younossi, MD
Zobair M. Younossi

In a follow-up analysis of participants in clinical trials, researchers found that patient-reported outcome scores increased in patients who achieved sustained virologic response after treatment for hepatitis C, whereas scores decreased in those who did not.

“Although historical treatment regimens with interferon were plagued by low efficacy and significant side effects impairing patients’ well-being and, thus, PROs, the trajectory of HCV treatment changed about 5 years ago with the development of direct-acting antiviral (DAA) agents,” Zobair M. Younossi, MD, chairman of the department of medicine at Inova Fairfax Hospital in Virginia, and colleagues wrote. “The PRO evidence generated by these two prospective registry studies support the unquestionable benefit of SVR for patients’ experience as opposed to the clear deleterious impact of HCV viremia.”

Younossi and colleagues assessed the health-related quality of life of 4,234 patients who achieved SVR and 242 patients who did not using the SF-36 instrument. Before treatment, PRO scores of both groups were similar to or higher than the general U.S. population and similar to each other.

At baseline for this study, patients who achieved SVR experienced improvements in all eight domains of the SF-36 (range increase, 3.6-8.1; P < .0001), while the scores of those without SVR remained the same with the exception of the General Health domain, which decreased by 2.8 points (P = .008).

Patients without SVR experienced further PRO decrements at 12-week follow-up: up to –7 points from before treatment in the Role Physical, General Health, Social Functioning and Role Emotional domains and both summary scores; up to –9.2 points in all PRO domains at week 24; up to –8.3 points in five domains at week 48; and up to –9 points in four domains at week 96 (P < .05).

In contrast, patients with SVR experienced sustained improvement of PRO scores with up to 7 points at week 24, up to 6.9 points at week 48, and up to 6.1 points at week 96 (P < .001). Multivariate analysis confirmed that SVR correlated independently with superior scores in all PRO domains with an increased range of 4.8 points to 15.9 points (P < .01).

“In order to fully understand the comprehensive benefit of HCV cure, these PRO gains should always accompany the clinical consequences of SVR, such as lower rates of cirrhosis and hepatocellular carcinoma,” Younossi and colleagues concluded. “These data must be considered by providers, payers, and policy makers to fully appreciate the comprehensive benefit of HCV cure and to assure that all HCV patients are identified and treated with the most effective antiviral regimens.” – by Talitha Bennett

Disclosures: Younossi reports that the study was partially supported by Gilead Sciences and that he has received research funds or served as consultant to AbbVie, Bristol-Myers Squibb, Gilead Sciences, Intercept, Novo Nordisk, Terns and Viking. Please see the full study for all other authors’ relevant financial disclosures.