Changes in quality of life and sexual health are associated with low-dose peginterferon therapy and disease progression in patients with chronic hepatitis C

Abstract

Background: Primary analysis of the Hepatitis C Antiviral Long-Term Treatment against Cirrhosis (HALT-C) Trial showed long-term peginterferon therapy did not reduce complications in patients with chronic hepatitis C and advanced fibrosis or cirrhosis.

Aim: To assess the effects of long-term peginterferon therapy and disease progression on health-related quality of life (HRQOL), symptoms and sexual health in HALT-C patients.

Methods: A total of 517 HALT-C patients received peginterferon alfa-2a (90 microg/week); 532 received no additional treatment for 3.5 years. Patients were followed up for outcomes of death, hepatocellular carcinoma and hepatic decompensation. Sexual health, SF-36 scores and symptoms were serially assessed by repeated-measures analyses of covariance.

Results: Patients with cirrhosis (n = 427) reported lower general well-being and more fatigue (P < 0.001) than patients with fibrosis (n = 622). Physical scores declined significantly over time, independent of treatment, and patients with cirrhosis reported lower scores. Vitality scores were lower in those with cirrhosis, and treated patients experienced a greater decline over time than untreated patients; HRQOL rebounded after treatment ended. Patients with a clinical outcome had significantly greater declines in all SF-36 and symptom scores. Among men, Sexual Health scores were significantly worse in treated patients and in those with a clinical outcome.

Conclusion: Clinical progression of chronic hepatitis C and maintenance peginterferon therapy led to worsening of symptoms, HRQOL and, in men, sexual health in a large patient cohort followed up over 4 years (NCT00006164).

Figure 1

Enrollment, Randomization, and Follow-up of Study Participants. Patients were enrolled in either the lead-in cohort of patients who underwent another course of antiviral treatment with peginterferon and ribavirin within the study or in the express cohort of patients who were initially treated outside the study. They were then randomly assigned to either the treatment or the control group and were followed for clinical outcomes and histological evidence of progression of liver disease.

Figure 2

Means of General Well-Being and Fatigue Scores over time. General Well-Being Scores ranged from 0 (very good) to 10 (very bad). Fatigues scores ranged from 0 (none) to 10 (worst ever).

Figure 2

Means of General Well-Being and Fatigue Scores over time. General Well-Being Scores ranged from 0 (very good) to 10 (very bad). Fatigues scores ranged from 0 (none) to 10 (worst ever).

Figure 3

Means of SF-36 Mental Summary Scores, Physical Summary Scores, and Vitality Scores over time. SF-36 scores range from 0 (worst score) to 100 (best score).

Figure 3

Means of SF-36 Mental Summary Scores, Physical Summary Scores, and Vitality Scores over time. SF-36 scores range from 0 (worst score) to 100 (best score).

Figure 3

Means of SF-36 Mental Summary Scores, Physical Summary Scores, and Vitality Scores over time. SF-36 scores range from 0 (worst score) to 100 (best score).

Figure 4

Means of Sexual Health Scores over time. Sexual Health scores range from 0 (worst score) to 100 (best score).