Health-Related Quality of Life and Health Care Resource Utilization in Patients With Chronic Liver Disease and Primary Liver Cancer in the United States: Analysis of Medical Expenditure Panel Survey.

Background: Worldwide, liver cancer (LC) is the fifth and third most common type of cancer and cancer-related mortality, respectively. Our aim was to assess health-related quality of life (HRQL) and resource utilization in chronic liver disease (CLD) patients with LC. Methods: We used the Medical Expenditure Panel Survey 2004-2013. All patients had HRQL (Short Form-12, Patient Health Questionnaire-2, Kessler Psychological Distress Scale) and resource utilization data. We used patients with CLD without LC and colon cancer (CC) as controls. Results: A total of 1882 CLD patients (53 ± 14 years, 45% male, 53% white, 15% black, 23% Hispanic, 6% Asian, 42% employed, 48% private insurance, and 11% uninsured) were included. Of the cohort, 102 (5.4%) patients had LC. LC patients were older, more likely to be male and white, less employed but less likely uninsured than CLD patients without LC (all P < 0.05). In comparison to both non-LC CLD and CC controls, LC had worse health: 40% vs. 27% vs. 25% reported fair health and 29% vs. 20% vs. 16% poor health status (P < 0.05). Furthermore, LC patients more frequently reported physical limitations: 51% vs. 35% vs. 35%, respectively (P = 0.01). Physical HRQL scores were lower in LC patients compared with both CLD and CC controls. Although mental health scores in LC were similar to non-LC CLD controls, they were lower than in CC. In addition, most aspects of healthcare resource utilization were higher for LC patients compared with both non-LC CLD and CC controls. Conclusion: While having CLD causes impairment of patients' HRQL, LC further adds to this impairment and also contributes to a substantial resource utilization.

Health utilities using SF-6D scores in Japanese patients with chronic hepatitis C treated with sofosbuvir-based regimens in clinical trials.

BACKGROUND: Health utilities are preference-based measures for health states which are typically used in economic analyses to estimate quality-adjusted life years. Our aim is to report the standard SF-6D health utility scores in Japanese patients with hepatitis C virus (HCV) during treatment with different regimens. METHODS: Japanese patients were enrolled in clinical trials of sofosbuvir (SOF) used in combination with or without ledipasvir (LDV) and/or ribavirin (RBV). The SF-6D health utility scores were calculated at multiple time points from the SF-36 instrument. RESULTS: Four hundred ninety-four patients with HCV (genotype 1 and 2) were enrolled: 19% with cirrhosis, 48% with a prior history of anti-HCV treatment. Of those, 153 received SOF + RBV, 170 received LDV/SOF + RBV, 171 received LDV/SOF for 12 weeks; the SVR rates were: 97, 98 and 100%, respectively. Patients treated with the three regimens had similar SF-6D scores before treatment (p = 0.87): 76.1 ± 11.5. During treatment with RBV containing regimen, patients experienced a decrement in their health utility scores to 74.3 ± 12.5 by the end of treatment (p = 0.03), while patients treated with RBV-free LDV/SOF had their SF-6D scores improved to 79.2 ± 12.8 after 12 weeks of treatment (p = 0.0004). At post-treatment week 12, in patients who achieved SVR-12, the SF-6D scores were similar between the treatment regimens (p = 0.36), and an average improvement of +1.4 points from baseline (p = 0.01) was noted. In multivariate analysis, the use of RBV was independently associated with lower utility score during treatment (beta = 4.7 ± 1.6, p < 0.0001). CONCLUSION: Health utilities are lower in Japanese HCV patients and tend to improve after clearance of infection.

Assessment of health utilities and quality of life in patients with non-alcoholic fatty liver disease.

BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) is one of the most common causes of chronic liver disease associated with increased liver-related mortality. Additionally, NAFLD could potentially impair health-related quality of life. Although an approved treatment for NAFLD does not exist, a number of new drugs for treatment of NAFLD are being developed. As the efficacy and safety of these regimens are being established, their cost-effectiveness, which requires the use of quality of life metrics and health utility scores to quality-adjusted outcomes, must also be assessed. The aim of this study was to report quality of life and health utilities in patients with NAFLD with and without cirrhosis for future use. METHODS: Patients with NAFLD were seen in an outpatient clinic setting. Each patient had extensive clinical data and completed the Short Form-36 (SF-36 V.1) questionnaire. The SF-6D health utility scores were calculated. RESULTS: There were 89 patients with the spectrum of NAFLD completed the SF-36 questionnaire: 59 with non-cirrhotic NAFLD and 30 with cirrhosis. Patients with NAFLD had significantly lower quality of life and health utility scores than the general population (all p<0.0001). Furthermore, patients with cirrhosis had lower quality of life and utility scores than non-cirrhotic NAFLD patients: SF-6D 0.660±0.107 in non-cirrhotic NAFLD vs 0.551±0.138 in cirrhotic NAFLD (p=0.0003). CONCLUSIONS: Health utilities and quality of life scores are impaired in patients with cirrhotic NAFLD. These values should be used in cost-effectiveness analysis of the upcoming treatment regimens for advanced NAFLD.

Quality of life of Japanese patients with chronic hepatitis C treated with ledipasvir and sofosbuvir.

The interferon (IFN)-free regimens for chronic hepatitis C (CHC) have high efficacy and superior health-related quality of life (HRQOL) in European/North American patients. The impact of these regimens on HRQOL of the Japanese CHC patients is not known.The Short Form-36 was administered before, during, and after treatment to CHC patients with genotype 1 treated with ledipasvir/sofosbuvir ±â€Šribavirin (LDV/SOF ±â€ŠRBV) for 12 weeks and genotype 2 treated with SOF + RBV for 12 weeks in clinical trials. The HRQOL data were analyzed with reference to treatment regimens and clinical factors.A total of 494 CHC patients were included (19% cirrhotic, 69% genotype 1, 52% treatment-naive; 153 received SOF + RBV, 170 received LDV/SOF + RBV, 171 received LDV/SOF). The sustained virologic response-12 rates for these regimens were 97%, 98%, and 100%, respectively. CHC patients treated with LDV/SOF, SOF + RBV, or LDV/SOF + RBV regimens had similar HRQOL scores at baseline. During treatment, more adverse events were experienced by those treated with RBV-containing regimens (46% vs 22%, P < 0.0001). The decrements in HRQOL were also significant in RBV groups: up to -3.8 points (treatment week-4), -5.2 (treatment week-12), and -3.2 (posttreatment week-12) (all P < 0.001). In contrast, RBV-free regimen (LDV/SOF) was associated with an improvement in HRQOL up to +4.1 points throughout the treatment (P < 0.01). In multivariate analysis, the use of RBV was independently associated with lower HRQOL during and after treatment (beta up to -6.4 points, P = 0.0001).Japanese CHC patients treated with RBV-containing regimens show mild HRQOL impairment. In contrast, patients treated with LDV/SOF not only showed high efficacy but also improvement of HRQOL.