Health‐related quality of life in genotype 1 treatment‐naïve chronic hepatitis C patients receiving telaprevir combination treatment in the ADVANCE study

Vera-Llonch, Montserrat; Martin, Marie; Aggarwal, Jyoti; Donepudi, Mrudula; Bayliss, Martha; Goss, Thomas F.; Younossi, Zobair M.

doi:10.1111/apt.12354

Cited by 42 publications

(34 citation statements)

References 44 publications

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“…Each of 1 million hypothetical persons in the patient-level simulation was assigned a unique time from HCV infection to development of cirrhosis such that some progressed rapidly while others did not develop cirrhosis before they died of non–HCV-related causes (32, 33). Consistent with previous studies, all disease stages of HCV infection were associated with increased resource use and decreased QoL compared with no infection, with progressively higher resource use and lower QoL for each successive stage of disease (Table 2) (18, 19, 37–41). When persons became cirrhotic, they were subject to increased mortality attributable to liver disease, which further increased with decompensated cirrhosis (31, 42, 43).…”

Section: Methodssupporting

confidence: 89%

The Cost-Effectiveness of Sofosbuvir-Based Regimens for Treatment of Hepatitis C Virus Genotype 2 or 3 Infection

et al. 2015

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Background Chronic infection with hepatitis C virus (HCV) genotype 2 or 3 can be treated with sofosbuvir without interferon. Because sofosbuvir is costly, its benefits should be compared with the additional resources used. Objective To estimate the cost-effectiveness of sofosbuvir-based treatments for HCV genotype 2 or 3 infection in the United States. Design Monte Carlo simulation, including deterministic and probabilistic sensitivity analyses. Data Sources Randomized trials, observational cohorts, and national health care spending surveys. Target Population 8 patient types defined by HCV genotype (2 vs. 3), treatment history (naive vs. experienced), and cirrhosis status (noncirrhotic vs. cirrhotic). Time Horizon Lifetime. Perspective Payer. Intervention Sofosbuvir-based therapies, pegylated interferon–ribavirin, and no therapy. Outcome Measures Discounted quality-adjusted life-years (QALYs), costs, and incremental cost-effectiveness ratios (ICERs). Results of Base-Case Analysis The ICER of sofosbuvir-based treatment was less than $100 000 per QALY in cirrhotic patients (genotype 2 or 3 and treatment-naive or treatment-experienced) and in treatment-experienced noncirrhotic patients but was greater than $200 000 per QALY in treatment-naive noncirrhotic patients. Results of Sensitivity Analysis The ICER of sofosbuvir-based therapy for treatment-naive noncirrhotic patients with genotype 2 or 3 infection was less than $100 000 per QALY when the cost of sofosbuvir was reduced by approximately 40% and 60%, respectively. In probabilistic sensitivity analyses, cost-effectiveness conclusions were robust to uncertainty in treatment efficacy. Limitation The analysis did not consider possible benefits of preventing HCV transmission. Conclusion Sofosbuvir provides good value for money for treatment-experienced patients with HCV genotype 2 or 3 infection and those with cirrhosis. At their current cost, sofosbuvir-based regimens for treatment-naive noncirrhotic patients exceed willingness-to-pay thresholds commonly cited in the United States. Primary Funding Source National Institute on Drug Abuse and National Institute of Allergy and Infectious Diseases.

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Section: Methodssupporting

confidence: 89%

The Cost-Effectiveness of Sofosbuvir-Based Regimens for Treatment of Hepatitis C Virus Genotype 2 or 3 Infection

et al. 2015

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“…For details about the study design, please refer to original publication. 30 The SF-6D scores were derived from the SF-36 questionnaire that was implemented at baseline, weeks 4,12,16,20,24,28 and 40 (only those with undetectable HCV RNA at week 20 were followed up at subsequent visits). The NEUTRINO study was an open-label uncontrolled study that evaluated 12 weeks of triple sofosbuvir, ribavirin and pegylated interferon therapy in treatment-naive patients with HCV genotype 1, 4, 5 and 6.…”

Section: Study Cohortmentioning

confidence: 99%

“…Recently emerged direct anti-viral agents do not seem to directly contribute to HRQL impairment, but, as long as they are used in combination with interferon, will not eliminate any of interferon-associated side effects and the HRQL impairment either. [25][26][27][28] On the other hand, the newly emerging interferon-free regimens [29][30][31][32][33][34] are expected to result in less if any adverse events and, therefore, better health utility scores for patients undergoing anti-HCV treatment. However, the health utility scores that could be used in cost-effectiveness analyses of interferon-free anti-HCV therapies are yet to be reported.…”

mentioning

confidence: 99%

Patients' preferences and health utility assessment with SF‐6D and EQ‐5D in patients with chronic hepatitis C treated with sofosbuvir regimens

Stepanova

Nader

Cure

et al. 2014

Aliment Pharmacol Ther

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Summary Background Health utilities measure patients' preferences for a health state. Aim To assess health utilities for sofosbuvir‐containing therapy for chronic hepatitis C. Methods The SF‐6D utility scores were derived from the SF‐36 instrument administered at baseline, during and post‐treatment to participants of the previously reported clinical trials of sofosbuvir. EQ‐5D utility scores were also approximated from the SF‐36 using a regression model. Results Nine hundred and ninety‐four patients were enrolled. Baseline SF‐6D and EQ‐5D scores were 0.66 ± 0.13 and 0.71 ± 0.22, respectively (the POSITRON trial), 0.71 ± 0.16 and 0.76 ± 0.23 (FISSION), 0.70 ± 0.14 and 0.75 ± 0.22 (FUSION), 0.72 ± 0.15 and 0.79 ± 0.22 (NEUTRINO). In all studies, SF‐6D and EQ‐5D scores were highly correlated with each other. (r = 0.83–0.87, P < 0.0001). After 12 weeks, patients receiving sofosbuvir + ribavirin (POSITRON) had similar utility scores to placebo (P > 0.05). Patients receiving 12 and 16 weeks of sofosbuvir + ribavirin (FUSION) had similar utility scores (P > 0.05). In FISSION, patients receiving sofosbuvir + ribavirin had significantly better utilities compared to patients receiving interferon + ribavirin (P < 0.001). Patients receiving sofosbuvir + ribavirin + interferon (NEUTRINO) had a decrease in utilities during treatment (SF‐6D: from 0.72 to 0.62, EQ‐5D: 0.79 to 0.65; P < 0.0001) similar to that observed in patients receiving pegylated interferon + ribavirin for 24 weeks in FISSION (0.72 to 0.62 and 0.77 to 0.65, respectively, P < 0.0001). After 12 weeks post‐treatment, patients with SVR (FUSION) had improvement in SF‐6D (+0.026 from baseline, P = 0.013) and EQ‐5D (+0.043, P = 0.013). In multivariate analyses, baseline depression, anxiety, fatigue, insomnia and treatment‐related anaemia were the most consistent predictors of utilities. Conclusions Patients' health utilities are minimally impacted by sofosbuvir + ribavirin treatment, as compared to interferon‐based, therapy regardless of treatment duration. Clinical trials' numbers: NCT01542788 (POSITRON), NCT01497366 (FISSION), NCT01604850 (FUSION), NCT01641640 (NEUTRINO).

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“…In summary, the current data suggest that significant PRO gains occur with the new DAA treatment regimens regardless of the patient population (coinfected, advanced fibrosis, retreatments, and treatment failures) with the largest gains noted in those patients who obtain SVR [84][85][86][87][88][89][90][91][92][93][94][95][96][97][98][99][100][101][102]. Therefore, regardless of the treatment needed, SVR should be the goal, not only to improve clinical outcomes, but also to improve patients' experience as documented by improving PRO scores.…”

Section: The Clinical Pro and Economic Implications Of New Anti-hcv mentioning

confidence: 90%

“…In contrast, the use of the new interferon-and ribavirin-free all oral regimens for HCV treatment have resulted in significant improvement in patients' HRQOL scores as early as 2 weeks into the treatment, especially in those domains most affected by the hepatitis C virus [physical functioning, work productivity (presenteeism), social functioning, activity]. In fact, by the end of treatment with the DAA's many of the significantly improved scores closely approximated or surpassed the HRQOL scores of the general population without HCV [84][85][86][87][88][89][90][91][92][93][94][95][96][97][98][99][100][101]. These PRO gains have also been observed in patients with both early and advanced fibrosis [90,98].…”

Section: The Clinical Pro and Economic Implications Of New Anti-hcv mentioning

confidence: 99%

Hepatitis C infection: A multi-faceted systemic disease with clinical, patient reported and economic consequences

Younossi

Birerdinc

Henry

2016

Journal of Hepatology

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Hepatitis C virus infection (HCV) affects approximately 170-200 million individuals globally. HCV is one of the primary causes of hepatocellular carcinoma (HCC) and cirrhosis and has been identified as the leading indication for liver transplantation in most Western countries. Because HCV is a systemic disease with hepatic, extrahepatic, economic and patient reported consequences, it is important for healthcare practitioners to understand the comprehensive and multi-faceted picture of this disease. In this context, it is important to fully appreciate the impact of HCV on the individual patient and the society. With the recent advent of the new generation of direct antiviral agents, the long standing goal of eradicating HCV in most infected patients has been accomplished. Therefore, now more than ever, it is critical to assess the total benefits of sustained virological response in a comprehensive manner. This should not be limited to the clinical benefits of HCV cure, but also to account for the improvement of patient reported health and economic outcomes of HCV cure. It is only through this comprehensive approach to HCV and its treatment that we will understand the full impact of this disease and the tremendous gains that have been achieved with the new antiviral regimens.

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Health‐related quality of life in genotype 1 treatment‐naïve chronic hepatitis C patients receiving telaprevir combination treatment in the ADVANCE study

Abstract: SUMMARY Background

Cited by 42 publications

References 44 publications

The Cost-Effectiveness of Sofosbuvir-Based Regimens for Treatment of Hepatitis C Virus Genotype 2 or 3 Infection

The Cost-Effectiveness of Sofosbuvir-Based Regimens for Treatment of Hepatitis C Virus Genotype 2 or 3 Infection

Patients' preferences and health utility assessment with SF‐6D and EQ‐5D in patients with chronic hepatitis C treated with sofosbuvir regimens

Hepatitis C infection: A multi-faceted systemic disease with clinical, patient reported and economic consequences

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