Long-term Patient-Centered Outcomes in Cirrhotic Patients With Chronic Hepatitis C After Achieving Sustained Virologic Response

被引:13
作者
Younossi, Zobair M. [1 ,2 ,3 ]
Racila, Andrei [1 ,2 ]
Muir, Andrew [4 ]
Bourliere, Marc [5 ]
Mangia, Alessandra [6 ]
Esteban, Rafael [7 ]
Zeuzem, Stefan [8 ]
Colombo, Massimo [9 ]
Manns, Michael [10 ]
Papatheodoridis, George, V [11 ]
Buti, Maria [7 ]
Chokkalingam, Anand [12 ]
Gaggar, Anuj [12 ]
Nader, Fatema [13 ]
Younossi, Issah [13 ]
Henry, Linda [13 ]
Stepanova, Maria [13 ]
机构
[1] Inova Fairfax Hosp, Dept Med, Ctr Liver Dis, Falls Church, VA 22042 USA
[2] Inova Hlth Syst, Inova Med, Falls Church, VA USA
[3] Inova Hlth Syst, Betty & Guy Beatty Ctr Integrated Res, Falls Church, VA USA
[4] Duke Univ, Med Ctr, Dept Med, Durham, NC 27710 USA
[5] Hosp St Joseph, Dept Hepatogastroenterol, Marseille, France
[6] IRCCS Casa Sollievo Sofferenza, Liver Unit, Med Sci, San Giovanni Rotondo, Italy
[7] Hosp Univ Vall Hebron & Ciberehd, Inst Carlos 3, Liver Unit, Barcelona, Spain
[8] Goethe Univ Hosp, Dept Med 1, Frankfurt, Germany
[9] IRCCS Humanitas, Liver Ctr Translat Res, Milan, Italy
[10] Hannover Med Sch, Hannover, Germany
[11] Laiko Hosp, Acad Gastroenterol Dept, Athens, Greece
[12] Gilead Sci, Foster City, CA USA
[13] Ctr Outcomes Res Liver Dis, Washington, DC USA
关键词
Health-Related Quality Of Life; Viral Hepatitis; Direct-Acting Antiviral; HRQL; Viral Clearance; QUALITY-OF-LIFE; EAST-ASIAN PATIENTS; REPORTED OUTCOMES; FREE REGIMENS; SOFOSBUVIR; VIRUS; QUESTIONNAIRE; VELPATASVIR; RIBAVIRIN; INTERFERON;
D O I
10.1016/j.cgh.2021.01.026
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
BACKGROUND & AIMS: Achieving sustained virologic response (SVR) among patients with hepatitis C virus (HCV) leads to patient reported outcome (PRO) improvement. We aimed to assess the long-term post-SVR PRO trends in HCV patients with cirrhosis. METHODS: Patients with HCV and cirrhosis treated in clinical trials with direct acting antiviral agents (DAAs) who achieved SVR-12 were prospectively enrolled in a long-term registry (clinicaltrials.gov #NCT02292706). PROs were collected every 24 weeks using the Short Form-36v2 (SF-36), CLDQ-HCV, and WPAI-HCV. RESULTS: Pre-treatment baseline data were available for 854 cirrhotic patients who achieved SVR after DAAs. Of these, 730 had compensated (CC) and 124 had decompensated cirrhosis (DCC) before treatment- patients with DCC reported severe impairment in their PROs in comparison to CC patients (by mean -5% to -16% of a PRO range size; p < .05 for 16 out of 20 studied PROs]. After achieving SVR and registry enrollment, significant PRO improvements were noted from pretreatment levels in 11/20 domains for those with DCC (+4% to + 21%) and 19/20 PRO domains in patients with CC (+3% to + 17%). Patients with baseline DCC had higher rates of hepatocellular carcinoma and mortality (P < .05). In patients with CC, the PRO gains persisted up to 168 weeks (3.5 years) of registry follow-up. In patients with DCC, the improvements lasted for at least 96 weeks but a declining trend after year 2. CONCLUSIONS: Patients with HCV cirrhosis experience severe PRO impairment at baseline with sustainable improvement after SVR. Though those with DCC experience improvement, there is a decline after 2 years.
引用
收藏
页码:438 / 446
页数:9
相关论文
共 28 条
[1]   French Patients with Hepatitis C Treated with Direct-Acting Antiviral Combinations: The Effect on Patient-Reported Outcomes [J].
Cacoub, Patrice ;
Bourliere, Marc ;
Asselah, Tarik ;
De Ledinghen, Victor ;
Mathurin, Philippe ;
Hezode, Christophe ;
Henry, Linda ;
Stepanova, Maria ;
Younossi, Zobair M. .
VALUE IN HEALTH, 2018, 21 (10) :1218-1225
[2]   Incidence of Hepatocellular Carcinoma in Patients With HCV-Associated Cirrhosis Treated With Direct-Acting Antiviral Agents [J].
Calvaruso, Vincenza ;
Cabibbo, Giuseppe ;
Cacciola, Irene ;
Petta, Salvatore ;
Madonia, Salvatore ;
Bellia, Alessandro ;
Tine, Fabio ;
Distefano, Marco ;
Licata, Anna ;
Giannitrapani, Lydia ;
Prestileo, Tullio ;
Mazzola, Giovanni ;
Di Rosolini, Maria Antonietta ;
Larocca, Licia ;
Bertino, Gaetano ;
Digiacomo, Antonio ;
Benanti, Francesco ;
Guarneri, Luigi ;
Averna, Alfonso ;
Iacobello, Carmelo ;
Magro, Antonio ;
Scalisi, Ignazio ;
Cartabellotta, Fabio ;
Savalli, Francesca ;
Barbara, Marco ;
Davi, Antonio ;
Russello, Maurizio ;
Scifo, Gaetano ;
Squadrito, Giovanni ;
Camma, Calogero ;
Raimondo, Giovanni ;
Craxi, Antonio ;
Di Marco, Vito .
GASTROENTEROLOGY, 2018, 155 (02) :411-+
[3]  
Centers for Disease Control and Prevention. National Center for Health Statistics, Murder rates are from Multiple Cause of Death data from the Centers for Disease Control (CDC)
[4]   Sustained virologic response to direct-acting antiviral agents predicts better outcomes in hepatitis C virus-infected patients: A retrospective study [J].
Colussi, GianLuca ;
Donnini, Debora ;
Brizzi, Rosario Francesco ;
Maier, Silvia ;
Valenti, Luca ;
Catena, Cristiana ;
Cavarape, Alessandro ;
Sechi, Leonardo Alberto ;
Soardo, Giorgio .
WORLD JOURNAL OF GASTROENTEROLOGY, 2019, 25 (40) :6094-6106
[5]   MEASURING HEALTH-RELATED QUALITY-OF-LIFE [J].
GUYATT, GH ;
FEENY, DH ;
PATRICK, DL .
ANNALS OF INTERNAL MEDICINE, 1993, 118 (08) :622-629
[6]   Quality of life in cirrhosis [J].
Loria A. ;
Escheik C. ;
Gerber N.L. ;
Younossi Z.M. .
Current Gastroenterology Reports, 2013, 15 (1)
[7]   THE VALIDITY AND REPRODUCIBILITY OF A WORK PRODUCTIVITY AND ACTIVITY IMPAIRMENT INSTRUMENT [J].
REILLY, MC ;
ZBROZEK, AS ;
DUKES, EM .
PHARMACOECONOMICS, 1993, 4 (05) :353-365
[8]   The factorial structure of the Chronic Liver Disease Questionnaire (CLDQ) [J].
Schulz, Karl-Heinz ;
Kroencke, Sylvia ;
Ewers, Heike ;
Schulz, Holger ;
Younossi, Zobair M. .
QUALITY OF LIFE RESEARCH, 2008, 17 (04) :575-584
[9]   Prediction of Health Utility Scores in Patients with Chronic Hepatitis C Using the Chronic Liver Disease Questionnaire-Hepatitis C Version (CLDQ-HCV) [J].
Stepanova, Maria ;
Younossi, Issah ;
Racila, Andrei ;
Younossi, Zobair M. .
VALUE IN HEALTH, 2018, 21 (05) :612-621
[10]   THE MOS 36-ITEM SHORT-FORM HEALTH SURVEY (SF-36) .1. CONCEPTUAL-FRAMEWORK AND ITEM SELECTION [J].
WARE, JE ;
SHERBOURNE, CD .
MEDICAL CARE, 1992, 30 (06) :473-483