Treatment with ledipasvir and sofosbuvir improves patient-reported outcomes: Results from the ION-1, -2, and -3 clinical trials

Hepatology

Volumn 61, Issue 6, 2015, Pages 1798-1808

  Younossi, Zobair M ^a,g   Stepanova, Maria ^b,g   Marcellin, Patrick ^c   Afdhal, Nezam ^d   Kowdley, Kris V ^e   Zeuzem, Stefan ^f   Hunt, Sharon L ^g  

^a INOVA FAIRFAX HOSPITAL   (United States)

^b CLDQ LLC   (United States)

^c BEAUJON HOSPITAL   (France)

^d BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^e SWEDISH MEDICAL CENTER   (United States)

^f UNIVERSITY HOSPITAL FRANKFURT   (Germany)

^g BETTY AND GUY BEATTY CENTER FOR INTEGRATED RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

LEDIPASVIR; RIBAVIRIN; SOFOSBUVIR; ANTIVIRUS AGENT; BENZIMIDAZOLE DERIVATIVE; FLUORENE DERIVATIVE; LEDIPASVIR, SOFOSBUVIR DRUG COMBINATION; URIDINE PHOSPHATE;

ADULT; ARTICLE; CHRONIC HEPATITIS C; CONTROLLED STUDY; DEMOGRAPHY; DRUG RESPONSE; FEMALE; GENOTYPE; HUMAN; MAJOR CLINICAL STUDY; MALE; MENTAL DISEASE; PRIORITY JOURNAL; QUALITY OF LIFE; QUESTIONNAIRE; TREATMENT DURATION; TREATMENT OUTCOME; ANALOGS AND DERIVATIVES; CLINICAL TRIAL; HEPATITIS C, CHRONIC; MIDDLE AGED; MULTICENTER STUDY; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL;

ADULT; ANTIVIRAL AGENTS; BENZIMIDAZOLES; FEMALE; FLUORENES; HEPATITIS C, CHRONIC; HUMANS; MALE; MIDDLE AGED; QUALITY OF LIFE; RIBAVIRIN; URIDINE MONOPHOSPHATE;

EID: 84929607189     PISSN: 02709139     EISSN: 15273350     Source Type: Journal    
DOI: 10.1002/hep.27724     Document Type: Article

References (49)

1. Mühlberger N, Schwarzer R, Lettmeier B, Sroczynski G, Zeuzem S, Siebert U. HCV-related burden of disease in Europe: a systematic assessment of incidence, prevalence, morbidity, and mortality. BMC Public Health 2009;9:34.
2. Kanwal F, Hoang T, Kramer JR, Asch SM, Goetz MB, Zeringue A, et al. Increasing prevalence of HCC and cirrhosis in patients with chronic hepatitis C virus infection. Gastroenterology 2011;140:1182-1188.e1.
3. Davis GL, Alter MJ, El-Serag H, Poynard T, Jennings LW. Aging of hepatitis C virus (HCV)-infected persons in the United States: a multiple cohort model of HCV prevalence and disease progression. Gastroenterology 2010;138:513-521.
4. Benvegnù L, Gios M, Boccato S, Alberti A. Natural history of compensated viral cirrhosis: a prospective study on the incidence and hierarchy of major complications. Gut 2004;53:744-749.
5. Sangiovanni A, Prati GM, Fasani P, Ronchi G, Romeo R, Manini M, et al. The natural history of compensated cirrhosis due to hepatitis C virus: a 17-year cohort study of 214 patients. Hepatology 2006;43:1303-1310.
6. Asrani SK, Larson JJ, Yawn B, Therneau TM, Kim WR. Underestimation of liver-related mortality in the United States. Gastroenterology 2013;145:375-382.e1-2.
7. van der Meer AJ, Veldt BJ, Feld JJ, Wedemeyer H, Dufour JF, Lammert F, et al. Association between sustained virological response and all-cause mortality among patients with chronic hepatitis C and advanced hepatic fibrosis. JAMA 2012;308:2584-2593.
8. Guiltinan AM, Kaidarova Z, Custer B, Orland J, Strollo A, Cyrus S, et al. Increased all-cause, liver, and cardiac mortality among hepatitis C virus-seropositive blood donors. Am J Epidemiol 2008;167:743-750.
9. Jou JH, Chen PH, Jazwinski A, Bouneva I, Smith AD, Muir AJ. Rates of surveillance and management of hepatocellular carcinoma in patients evaluated at a liver transplant center. Digest Dis Sci 2010;55:3591-3596.
10. Tsui JI, Maselli J, Gonzales R. Sociodemographic trends in national ambulatory care visits for hepatitis C virus infection. Dig Dis Sci 2009;54:2694-2698.
11. Williams IT, Bell BP, Kuhnert W, Alter MJ. Incidence and transmission patterns of acute hepatitis C in the United States, 1982-2006. Arch Intern Med 2011;171:242-248.
12. Davis KL, Mitra D, Medjedovic J, Beam C, Rustgi V. Direct economic burden of chronic hepatitis C virus in a United States managed care population. J Clin Gastroenterol 2011;45:e17-e24.
13. Younossi ZM, Kanwal F, Saab S, Brown KA, El-Serag HB, Kim WR, et al. The impact of hepatitis C burden: an evidence-based approach. Aliment Pharmacol Ther 2014;39:518-531.
14. Jacobson IM, Cacoub P, Dal Maso L, Harrison SA, Younossi ZM. Manifestations of chronic hepatitis C virus infection beyond the liver. Clin Gastroenterol Hepatol 2010;8:1017-1029.
15. Adinolfi LE, Zampino R, Restivo L, Lonardo A, Guerrera B, Marrone A, et al. Chronic hepatitis C virus infection and atherosclerosis: clinical impact and mechanisms. World J Gastroenterol 2014;20:3410-3417.
16. Meillier A, McGee J, Kartan S, Baskin S. A case of multiple extrahepatic manifestations in a patient with untreated, chronic hepatitis C virus infection. Int J Infect Dis 2014;19:93-94.
17. Zalesak M, Francis K, Gedeon A, Gillis J, Hvidsten K, Kidder P, et al. Current and future disease progression of the chronic HCV population in the United States. PLoS One 2013;8:e63959.
18. Louie KS, St Laurent S, Forssen UM, Mundy LM, Pimenta JM. The high comorbidity burden of the hepatitis C virus infected population in the United States. BMC Infect Dis 2012;12:86.
19. Davis GL, Alter MJ, El-Serag H, Poynard T, Jennings LW. Aging of hepatitis C virus (HCV)-infected persons in the United States: a multiple cohort model of HCV prevalence and diseaseprogression. Gastroenterology 2010;138:513-521, 521.e1-6.
20. Alavi M, Law MG, Grebely J, Thein HH, Walter S, Amin J, Dore GJ et al. Lower life expectancy among people with an HCV notification: a population-based linkage study. J Viral Hepat 2014;21:e10-e18.
21. Younossi ZM, Stepanova M, Zeuzem S, Dusheiko G, Esteban R, Hezode C, et al. Patient-reported outcomes assessment in chronic hepatitis C treated with sofosbuvir and ribavirin: The VALENCE study. J Hepatol 2014;61:228-234.
22. Younossi ZM, Stepanova M, Nader F, Jacobson IM, Gane E, Nelson D, et al. Patient-reported outcomes in chronic hepatitis C patients with cirrhosis treated with sofosbuvir-containing regimens. Hepatology 2014;59:2161-2169.
23. Marcellin F, Roux P, Winnock M, Lions C, Dabis F, Salmon-Ceron D, et al. Using patient-reported outcomes to improve the management of co-infection with HIV and HCV: the ANRS CO13 HEPAVIH cohort. Expert Rev Gastroenterol Hepatol 2014;8:351-358.
24. Aggarwal J, Vera-Llonch M, Donepudi M, Suthoff E, Younossi Z, Goss TF. Work productivity among treatment-naïve patients with genotype 1 chronic hepatitis C infection receiving telaprevir combination treatment. J Viral Hepat 2015;22:8-17.
25. Younossi ZM, Stepanova M, Henry L, Gane E, Jacobson IM, Lawitz E, et al. Effects of sofosbuvir-based treatment, with and without interferon, on outcome and productivity of patients with chronic hepatitis C. Clin Gastroenterol Hepatol 2014;12:1349-1359.e13.
26. Stepanova M, Nader F, Cure S, Bourhis F, Hunt S, Younossi ZM. Patients' preferences and health utility assessment with SF-6D and EQ-5D in patients with chronic hepatitis C treated with sofosbuvir regimens. Aliment Pharmacol Ther 2014;40:676-685.
27. Dieperink E, Pocha C, Thuras P, Knott A, Colton S, Ho SB. All-cause mortality and liver-related outcomes following successful antiviral treatment for chronic hepatitis C. Dig Dis Sci 2014;59:872-880.
28. van der Meer AJ, Veldt BJ, Feld JJ, Wedemeyer H, Dufour JF, Lammert F, et al. The number needed to treat to prevent mortality and cirrhosis-related complications among patients with cirrhosis and HCV genotype 1 infection. J Viral Hepat 2014;21:568-577.
29. Ashtari S, Vahedi M, Pourhoseingholi MA, Karkhane M, Kimiia Z, Pourhoseingholi A, et al. Direct medical care costs associated with patients diagnosed with chronic HCV. Hepat Mon 2013;13:e8415.
30. Manos MM, Darbinian J, Rubin J, Ray GT, Shvachko V, Denis B, et al. The effect of hepatitis C treatment response on medical costs: a longitudinal analysis in an integrated care setting. J Manag Care Pharm 2013;19:438-447.
31. John-Baptiste AA, Tomlinson G, Hsu PC, Krajden M, Heathcote EJ, Laporte A, et al. Sustained responders have better quality of life and productivity compared with treatment failures long after antiviral therapy for hepatitis C. Am J Gastroenterol 2009;104:2439-2448.
32. U.S. Food and Drug Administration. FDA guidance for industry. Patient-reported outcome measures: use in medical product development to support labeling claims. December 2009. Available at: www.fda.gov/downloads/Drugs/Guidances/UCM193282.pdf. Accessed July 17, 2014.
33. Bonner JE, Esserman DA, Golin CE, Evon DM. Self-efficacy and adherence to antiviral treatment for chronic hepatitis C. J Clin Gastroenterol 2015;49:76-83.
34. Amodio P, Salari L, Montagnese S, Schiff S, Neri D, Bianco T, Minazzato L. Hepatitis C virus infection and health-related quality of life. World J Gastroenterol 2012;18:2295-2299.
35. Evon DM, Golin CE, Fried MW, Keefe FJ. Chronic hepatitis C and antiviral treatment regimens: where can psychology contribute? J Consult Clin Psychol 2013;81:361-374.
36. Kamal SM, Ahmed A, Mahmoud S, Nabegh L, El Gohary I, Obadan I, et al. Enhanced efficacy of pegylated interferon alpha-2a over pegylated interferon and ribavirin in chronic hepatitis C genotype 4A randomized trial and quality of life analysis. Liver Int 2011;31:401-411.
37. Afdhal N, Zeuzem S, Kwo P, Chojkier M, Gitlin N, Puoti M, et al.; ION-1 Investigators. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med 2014;370:1889-1898.
38. Afdhal N, Reddy KR, Nelson DR, Lawitz E, Gordon SC, Schiff E, et al.; ION-2 Investigators. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med 2014;370:1483-1493.
39. Kowdley KV, Gordon SC, Reddy KR, Rossaro L, Bernstein DE, Lawitz E, et al; ION-3 Investigators. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med 2014;370:1879-1888.
40. Hays RD, Morales LS. The RAND-36 measure of health-related quality of life. Ann Med 2001;33:350-357.
41. Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, et al. The Functional Assessment of Cancer Therapy (FACT) scale: development and validation of the general measure. J Clin Oncol 1993;11:570-579.
42. Webster K, Odom L, Peterman A, Lent L, Cella D. The Functional Assessment of Chronic Illness Therapy (FACIT) measurement system: validation of version 4 of the core questionnaire. Qual Life Res 1999;8:604.
43. Younossi ZM, Guyatt G, Kiwi M, Boparai N, King D. Development of a disease specific questionnaire to measure health related quality of life in patients with chronic liver disease. Gut 1999;45:295-300.
44. Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics 1993;4:353-365.
45. Mulhern B, Mukuria C, Barkham M, et al. Using generic preference-based measures in mental health: psychometric validity of the EQ-5D and SF-6D. Br J Psychiatry 2014;205:236-243.
46. SF- 6D. Available at: www.qualitymetric.com/Portals/0/Uploads/Documents/Public/SF-6D.pdf. Accessed July 14, 2014.
47. Matsushita H, Ikeda F, Iwasaki Y, Seki H, Nanba S, Takeuchi Y, et al. Assessment of health-related quality of life and how it predicts the outcome of pegylated interferon and ribavirin therapy for chronic hepatitis C. J Gastroenterol Hepatol 2014;29:337-343.
48. Bezemer G, Van Gool AR, Verheij-Hart E, Hansen BE, Lurie Y, Esteban JI, et al.; DITTO-HCV Study Group. Long-term effects of treatment and response in patients with chronic hepatitis C on quality of life. An international, multicenter, randomized, controlled study. BMC Gastroenterol 2012;12:11.
49. Spiegel BM, Younossi ZM, Hays RD, Revicki D, Robbins S, Kanwal F. Impact of hepatitis C on health related quality of life: a systematic review and quantitative assessment. Hepatology 2005;41:790-800.