Behavioral and practice issues


Impact of Pre-existing Mental Health Disorders on Adherence and Sustained Virologic Response with an Interferon-Free Trial of Sofosbuvir and Ribavirin for Chronic Hepatitis C

Amy Nelson1, Yu-Jin Lee1, Laura Heytens4, Susan Wroblewski3, William T Symonds5, John G. McHutchison5, Shyam Kottilil1, Anu Osinusi1,2

1LIR, NIAID / NIH, Bethesda, MD; 2SAIC-Frederick, Inc., Frederick, MD; 3Clinical Center Nursing, NIH, Bethesda, MMD; 4CCMD, NIH, Bethesda, MD; 5Gilead Sciences, Foster City, CA

Purpose: Mental health disorders (MHD) have long remained a barrier to treatment for those with chronic hepatitis C (HCV) infections. The complexity and side effect profile of interferon based HCV therapy make many patients with MHD ineligible, or unwilling to be treated. Our objective was to determine the impact of baseline MHD on adherence during an interferon-free study with a treatment regimen of sofosbuvir in combination with ribavirin. Methods: Sixty chronic HCV genotype-1, treatment naīve participants were treated with the NS5B RNA polymerase inhibitor sofosbuvir with either weight based or low dose ribavirin for 24 weeks. We identified all participants with significant baseline MHD defined as major depression, bipolar disorder, schizophrenia, generalized anxiety, and depression with anxiety or those requiring anti-depressants, antipsychotics, mood stabilizers or psychotropics. Participant adherence to required study visits (up to 24) was reviewed through treatment and follow up to date. Sofosbuvir adherence was documented during 11 time points based on participant recall and pill counts. Missed doses were recorded only through the time of treatment discontinuation in the six participants who stopped treatment early. Results: Of 60 participants, 23 met the criteria for significant baseline MHD. The prevalence of disorders was as follows: depression (18%), bipolar disorder (8%), depression with anxiety (5%), anxiety (3%), and schizophrenia (2%). There were no significant differences in completion of total required visits (97% vs. 98%) or study visits completed within required timeframes (95% vs. 95%) between participants in each group. Similar percentages had 3 or fewer total missed doses of the 168 doses of study medication in the MHD group vs. no MHD (84% vs. 83%). 〇f the six participants who stopped treatment early, 5 were in the baseline MHD group (83%). Reasons for early discontinuation were needle anxiety, renewed substance abuse post injury, poor adherence and lost to follow up. The overall sustained virologic response rate (SVR24) was 57% in those with baseline MHD vs. 65% in those without (p = 0. 59). In the 54 total participants that completed treatment, SVR24 was similar between groups; 7% in the MHD group vs. 64% in those without respectively (p = 0. 76). Conclusions: Our study suggests that while baseline MHD may contribute to early treatment discontinuations in all-oral interferon-free HCV treatments, these participants are appear similarly capable of completing a 24-week interferon-free regimen and achieving modest to high SVR rates.


William T. Symonds - Employment: Gilead

John G. McHutchison - Employment: Gilead Sciences; Stock Shareholder: Gilead Sciences

The following people have nothing to disclose: Amy Nelson, Yu-Jin Lee, Laura Heytens, Susan Wroblewski, Shyam Kottilil, Anu Osinusi


A comparative study of patients' knowledge about hepatitis C (HCV) in the United States (US) and urban and rural China

Elizabeth Wu1, Shirley Chen2, Zhe Guan2, Claudia Cao2, Huiying Rao3, Bo Feng3, Melvin Chan1, Sherry Fu1, Andy Lin4, Lai Wei3, Anna S. Lok1

1Department of Internal Medicine, Division of Gastroenterology, University of Michigan Health System, Ann Arbor, MI; 2University of Michigan Medical School, Ann Arbor, MI; 3Peking University People's Hospital, Peking University Hepatology Institute, Peking University Health Science Center, Beijing, China; 4The Molecular and Behavioral Neuroscience Institute, University of Michigan, Ann Arbor, MI

Background: HCV is the predominant cause of chronic liver disease in the US and is increasingly recognized as a common cause of liver disease in China. Studies of HCV patients in the US found major gaps in knowledge but little is known about HCV knowledge among patients in China. Aim: To compare patient knowledge about HCV in patients in the US and China. Methods: A survey assessing HCV knowledge was conducted in 3 cohorts of adult HCV patients seen in liver clinics in Ann Arbor, US, and in Beijing and Hebei (a rural area with a high prevalence of HCV), China. The survey was self-administered in English in the US and administered in Mandarin Chinese by a research staff in China. Results: 525 patients (US: 186; Beijing: 186; Hebei: 153) were enrolled between Apr-Nov, 2012. Mean ages of the 3 cohorts ranged from 52-56 years; 63% of US and 47% of Chinese patients were men. 63% of US and 39% of Beijing patients had college or postgraduate education compared to 0. 7% in Hebei. More than half of the US and Beijing patients but only 13% of Hebei patients had received HCV treatment. Majority of US and Beijing patients but less than half of Hebei patients knew that HCV can cause liver cancer and cirrhosis. Most patients in the US but less than half of the patients in China knew that HCV cannot be prevented by vaccination. More than 70% of patients in the US and Beijing but only ∼10% in Hebei correctly identified that interferon and ribavirin are used for HCV treatment. Majority of patients at all 3 sites knew that HCV can be spread by transfusion but less than half of the Hebei patients knew that HCV can be spread by sharing needles or contaminated medical/dental equipment. Almost all patients at the 3 sites knew that HCV is not spread by kissing, sharing food or drink, or shaking hands with someone with HCV. The average HCV knowledge score out of a total of 16 in the US, Beijing, and Hebei was 12. 7, 11. 7, and 6. 4 (p<0. 001). Study site, education and gender were independent predictors of HCV knowledge. Conclusions: Knowledge about HCV is similar among patients in the US and Beijing after adjusting for differences in education. Knowledge about HCV among patients in Hebei remains significantly lower than US and Beijing patients after adjusting for differences in education possibly related to their rural residence and overall health literacy. Our data show that efforts to improve HCV knowledge are necessary for all 3 cohorts and should be tailored to the education level and health literacy of the patients.

No. of patients Male Mean age, years Education College/postgraduate Some high school or less Prior HCV treatment HCV knowledge Mean composite score (0-16) HCV can cause liver cancer HCV can cause liver cirrhosis HCV cannot be prevented by vaccination Drugs used to treat HCV Interferon Ribavirin HCV can be spread by Sexual contact Blood transfusion Sharing needles Unclean medical or dental equipment Sharing food or drink Shaking hands with someone with HCV186 62. 9 54. 7±9. 8 62. 9 9. 1 65. 6 12. 7±2. 1 78. 5 94. 6 26. 5 76. 9 74. 7 57. 5 98. 9 96. 2 87. 1 7. 5 0. 5186 52. 2 51. 9±14. 9 39. 2 31. 2 53. 2 11. 7±3. 0 84. 4 92. 5 54. 3 82. 7 52. 8 98. 9 88.8 88. 2 7. 9 0. 6153 41. 2 56. 3±7. 9 0. 7 88. 0 13. 1 6. 4±2. 4 40. 5 47. 7 83. 7 13. 7 8. 5 30. 1 90. 4 43. 2 25. 3 13. 7 4. 8

Results expressed as % unless specified


Lai Wei - Consulting: Gilead; Grant/Research Support: BMS, Roche, Novartis; Speaking and Teaching: Gilead

Anna S. Lok - Advisory Committees or Review Panels: Gilead, Immune Targeting System, MedImmune, Arrowhead, Bayer, GSK, Janssen, Novartis; Grant/Research Support: Abbott, BMS, Gilead, Merck, Roche

The following people have nothing to disclose: Elizabeth Wu, Shirley Chen, Zhe Guan, Claudia Cao, Huiying Rao, Bo Feng, Melvin Chan, Sherry Fu, Andy Lin


Alcohol and tobacco use are infrequent in North American adults with chronic hepatitis B (HBV): Results from the NIDDK-Sponsored Hepatitis B Research Network (HBRN) Adult Cohort Study

Colina Yim1, Yona K. Cloonan2, Harry L. Janssen1, Jordan J. Feld1, Mandana Khalili3, David K. Wong1

1University of Toronto, Toronto, ON, Canada; 2University of Pittsburgh, Pittsburgh, PA; 3University of California, San Francisco, San Francisco, CA

Background: There is limited information on alcohol and tobacco consumption in adults with chronic HBV, even though these are important risk factors for hepatocellular carcinoma in this patient population. We aimed to evaluate the prevalence and characteristics of alcohol and tobacco use within the ongoing multicenter HBRN Adult Cohort Study. Methods: As of March 2013, 1545 adults with chronic HBV had self-reported data on use of tobacco products categorized as never used, former smoker, or current smoker; and alcohol consumption categorized as none in the last 12 months, moderate, or at risk consumption (males >4 drinks/day or 14 drinks/week, females >3 drinks/day or 7 drinks/week or history of binge drinking). Estimates of tobacco and alcohol use (N per 100) were calculated for the overall sample, and separately by demographic and clinical variables. Results: 51% were male, age range 1880 years, 72% Asian, and 60% acquired HBV vertically. Overall estimates of current tobacco use were 9. 8 (per 100, 95%CI 8. 2-11. 5), with former tobacco use in 19. 4 (per 100, 95%CI 16.9 21. 8). Current (14. 7 male, 4. 5 female per 100) or former (27. 6 male, 10. 4 female per 100) tobacco use was more common in men (p<0. 001), and differed by age (p=0. 047), with the most differences seen for former use (12. 3 in age <30 years, 19. 6 in 30-<50 years, and 22. 9 in >50 years per 100). Whites had a higher rate of current (17. 7/100) or former (29. 0/100) tobacco use compared to blacks (10. 7/100, 17. 8/100) or Asians (8. 4/100, 17. 9/100). Current tobacco use was highest in those with income <$50, 000 (13. 7/100). The overall rates of at-risk and moderate alcohol intake within the past 12 months were 4. 8 (95%CI 3. 6-6. 1 per 100), and 21.5 (95%CI 19. 1-23. 9 per 100), respectively. Alcohol use differed by sex for both at-risk (6. 2/100 male, 3. 3/100 female) and moderate (25. 5/100 male, 17. 2/100 female) drinking (p<0. 001). Asians had the lowest (3. 6/100) and whites had the highest (12. 5/100) at-risk drinking. Both at-risk and moderate drinking rates were lowest in those >50 years old (3. 1 and 16. 9 per 100, respectively), and differed by income, with the highest at-risk drinking (8. 5/100) for income $50, 00099, 000. Neither tobacco nor alcohol use were associated with measures of disease activity, including ALT level, HBV DNA level or fibrosis by APRI score. Conclusions: Alcohol and tobacco use in adults with chronic HBV were lower than the general US population. White men had the highest alcohol and tobacco use. Impact of these parameters on disease progression will be prospectively tracked in this ongoing cohort study. The need of alcohol and smoking cessation education program remains.


Colina Yim - Advisory Committees or Review Panels: Merck Canada, Vertex, Roche Canada, Gilead, Janssen; Speaking and Teaching: Merck

Harry L. Janssen - Consulting: Abbott, Bristol Myers Squibb, Debio, Gilead Sciences, Merck, Medtronic, Novartis, Roche, Santaris; Grant/Research Support: Anadys, Bristol Myers Squibb, Gilead Sciences, Innogenetics, Kirin, Merck, Medtronic, Novartis, Roche, Santaris

Jordan J. Feld - Advisory Committees or Review Panels: Roche, Merck, Vertex, Gilead, Abbott, Tibotec, Theravance, Achillion; Speaking and Teaching: Merck, Roche, Abbott

Mandana Khalili - Advisory Committees or Review Panels: Gilead Inc.; Grant/Research Support: Gilead Inc., BMS Inc, BMS Inc

David K. Wong - Grant/Research Support: Gilead, BMS, Vertex, BI

The following people have nothing to disclose: Yona K. Cloonan


Perception of Effort During Exercise in Patients with Chronic Hepatitis C (CH-C) and Non-Alcoholic Fatty Liver Disease (NAFLD)

Ali A. Weinstein1, 2, Jillian K. Price1, 3, Patrice M. Winter2, 3, Bibiana Oe1, Carey Escheik1, Anthony Loria1, Lynn Gerber1, 2, Zobair M. Younossi1, 4

1Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, VA; 2Center for the Study of Chronic Illness and Disability, College of Health and Human Services, George Mason University, Fairfax, VA; 3Department of Rehabilitation Science, College of Health and Human Services, George Mason University, Fairfax, VA; 4Center for Liver Disease, Department of Medicine, Inova Fairfax Hospital, Falls Church, VA

Background and Aim: Perception of effort (i. e., exertion) is widely used to monitor and prescribe exercise intensity. The correlates of perception of effort have not previously been examined in patients with chronic liver diseases (CLD) such as CH-C and NAFLD. Therefore, the purpose of this investigation was to determine if the correlates of perception of effort (RPE) were different between individuals with CH-C and NAFLD. Methods: Fifty-one patients (age: 51. 1 ± 8. 8; 65% male; 55% CH-C, 45% NAFLD; body mass index 31. 5 ± 5. 9; 73% Caucasian) completed a 6-minute walk test, in which participants were encouraged to walk as quickly as possible in six minutes. Cardiac output, blood pressure, heart rate, fasting laboratory tests (ALT, AST, glucose, insulin peptide, lipids, and a panel of cytokines), RPE (Borg Rating Scale of Perceived Exertion), and estimate of routine daily oxygen consumption (Human Activity Profile) were assessed. Spearman's rho (rs) correlations were calculated between the RPE, walk distance, and the above-mentioned variables. Only statistically significant correlations are highlighted. Results: For the entire CLD group, RPE was not related to performance (6-minute walk distance) (rs = 0. 11; p=0. 62). However, serum IL-8 and fasting glucose level were negatively associated with RPE (rs = -0. 45; p=0. 003; rs =0. 32; p=0. 04, respectively). On the other hand, in patients with CH-C, RPE was related to serum IL-8, TGF-βl, and glucose (rs = -0. 45; p=0. 037; rs = 0. 55; p=0. 014; rs = -0. 59; p=0. 003, respectively). In NAFLD patients, RPE was related to fasting serum glucose and self-reported maximal activity level in the self-reported activity measure (rs = -0. 77; p<0. 001; rs = 0. 44; p=0. 05, respectively). Conclusions: Perception of effort in subjects with CLD is related to inflammatory and metabolic measures, rather than distance walked. Age and body weight were not significantly related to perception of effort in this group of relatively sedentary patients. Individuals with CH-C and NAFLD have different correlates with perceived exertion. The former has strong associations with inflammatory and fasting glucose profiles; and the latter with fasting glucose and a self-report of activity. This suggests, that glucose metabolism is a common factor between the groups. However, inflammatory burden is an important contributor to RPE in subjects with CH-c while engagement in physical activity is an important contributor to RPE in subjects with NAFLD.


Zobair M. Younossi - Advisory Committees or Review Panels: Merck, Vertex, Tibotec/J and J; Consulting: Gilead Sciences

The following people have nothing to disclose: Ali A. Weinstein, Jillian K. Price, Patrice M. Winter, Bibiana Oe, Carey Escheik, Anthony Loria, Lynn Gerber


The Chronic Liver Disease Nurse: Role and Economic Impacts

Rachel Wundke, Rosemary J. McCormick, Wigg Alan

Hepatology and Transplant Medicine, Flinders Medical Centre, Bedford Park, SA, Australia

Introduction: A recent Deloitte Access Economics report estimated the economic costs of liver disease in Australia at more than $AUD50 billion per annum. A key recommendation of this report was creation of Chronic Liver Disease Nurse (CLDN) positions to improve the management of CLD patients but there is a paucity of literature describing the role of community-based CLDNs, their effectiveness and economic impact. In January 2009 the Hepatology and Liver Transplant Medicine Unit of Flinders Medical Centre initiated the first CLDN positions in Australia. Two advanced practice nurses fill the CLDN role. The aims of this paper are to describe the role of these community CLDN positions and to estimate the cost savings. Methods: Key performance indicators were monitored from Jan 2011 to mid 2013 including presentations to the Emergency Department (ED), hospital admissions, and outpatient department use. Costs savings were estimated using standard hospital accounting practices. RESULTS: The role of the CLDN is to provide care and support for cirrhotic patients. The program cares for 335 patients and has 2 arms - stable (screening and surveillance) and unstable (case management). The stable program involves arranging and monitoring the results of 6-monthly hepatoma screening, variceal screening and surveillance according to protocols, bone density screening and osteoporosis treatment, and immunisation for hepatitis A and B. Three CLDN community clinics provide reviews of stable patients with compensated cirrhosis. Case management assists up to 40 patients with decompensated cirrhosis to manage their health in the community. They receive education and monitoring via phone contact and home visits with the aim of transfer to the stable pathway when ready. Referrals for alcohol counselling, psychologists, and dieticians often result from the CLDN involvement. Since 2011, the CLDN program has saved an average of 234 occupied bed days, 287 outpatient department reviews and 155 ED presentations each year. The estimated average cost savings resulting from this hospital avoidance is $193, 728 per annum which exceeds the total annual salary costs of these positions ($160, 000). Conclusion: CLDN positions provide important care and support for patients with cirrhosis, who are often marginalized and poorly managed by both current primary and hospital care systems. The CLDN role also appears to have cost savings for hospitals via reductions in patient hospital utilization. Further studies are required to provide a more detailed cost effectiveness analysis, which includes potential benefits resulting from improved patient care from cirrhosis and its complications.


The following people have nothing to disclose: Rachel Wundke, Rosemary J. McCormick, Wigg Alan


Canadian Experience Developing Viral Hepatitis Nursing Standards and Competencies

Gail Butt1, Geri Hirsch2

1Clinical Prevention Services, Hepatitis, BC Centre for Disease Control, Vancouver, BC, Canada; 2Hepatology Services, Capital District Health Authority, Halifax, NS, Canada

Background: In 1999 the Canadian Association of Hepatology Nurses (CAHN) was formed to support the practice needs of the rapidly increasing number of nurses providing services to people with viral hepatitis, in particular those with hepatitis C. A major issue was the lack of viral hepatitis nursing standards and competencies for practice. Purpose: To develop nursing standards and competencies for viral hepatitis practice which nurses with two years or less experience could use to develop their education plans and evaluate their practice. Methods: A literature review and expert opinion were used to define the content. Decisions were made by consensus. A cyclical process of small and large group review was used to refine the content. Communication was through face-to-face meetings, conference calls and e-mail. Results: A search of English peer reviewed and grey literature for viral hepatitis nursing standards and competencies yielded 0 articles. A volunteer working group of 10-12 CAHN members from across Canada with experience in viral hepatitis research, policy, education, public health, outreach, primary and specialty care led the document development. The working group communicated face-to-face twice yearly, through regular conference calls and group e-mail. Each document was circulated several times to all CAHN members for review and revision. Final review and approval occurred at the CAHN annual general meeting. The Standards were underpinned by Benner's theory while the determinants of health provided the framework for the competencies to ensure a holistic, person-centered approach. Over 8 years three documents were produced: Hepatology Nursing Standards 2005-2007; the Viral Hepatitis Competencies 2008-2011 and Cirrhosis Competencies 2012-13. Reports reveal that the documents are used by nurses to support their practice. The BC Centre for Disease Control and the BC Institute of Technology used the Viral Hepatitis competencies to develop an accredited on-line course for health and social care providers. CAHN provides 10 yearly scholarships to members who complete the course. Conclusions: Volunteers from dispersed geographical areas and clinical backgrounds can work effectively to develop standards and competencies for practice that support new and evolving specialty practices. The competencies have been used successfully to support nursing practice and development of a viral hepatitis course.


Geri Hirsch - Advisory Committees or Review Panels: Gilead; Speaking and Teaching: Vertex

The following people have nothing to disclose: Gail Butt


Pre-Treatment Education and Treatment Completion in Patients with Hepatitis C (HCV) Treated with Boceprevir (BOC) or Telaprevir (TVR)

Deborah A. Mercier1, 2, Brenda A. Appolo3, Danielle E. Cardona4, Andrea C. Scherschel5, Patrick Horne6, Sarah B. Hubbard7, Lisa Richards9, Andrea L. Keller8, Thomas Stewart4, Monika Vainorius4, Joy A. Peter6

1SLU Liver Center, Saint Louis University St. Louis, MO; 2Sinclair School of Nursing, University of Missouri, Columbia, MO; 3Medicine; Division of Gastroenterology University of Pennsylvania, Philadelphia, PA; 4University of North Carolina, Chapel Hill, NC; 5The Scripps Clinic, La Jolla, CA; 6University of Florida, Gainesville, FL; 7Virginia Commonweath University Health System, Richmond, VA; 8Metropolitan Liver Diseases/Gastroenterology Center, Annandale, VA; 9Hepatology, UC San Diego Medical Center, San Diego, CA

Background: Pre-treatment HCV patient education is considered standard practice when initiating HCV treatment (tx), however teaching platforms vary among HCV tx providers. Some providers administer pre-treatment education in a group setting (defined in the medical record as taking a class), and others instruct patients (pts) individually in the clinic. Few data are available on education practices and their effectiveness in helping patients complete HCV tx. Methods: The HCV-TARGET consortium of academic and community investigators utilizes novel, standardized source data abstraction and a common database to enroll sequential pts treated with regimens that include BOC and TVR. Demographic, clinical, adverse event, and virological data are collected throughout tx and post-treatment follow-up, including data on the method of pre-treatment education. Results: In this ongoing study, 2, 212 pts have been enrolled. This preliminary descriptive analysis includes 618 pts that started triple therapy prior to July 2012 and had exclusively group (GRP) or exclusively individual (INDV) education prior to tx initiation. Of those with a documented exclusive method of education, 519 (84%) received INDV teaching, while 99 (16%) received education in a GRP setting. Patient demographics (sex, age, ethnicity, cirrhosis, and previous HCV tx) were similar between education groups as was the median duration of tx. Overall, pts receiving INDV pre-treatment education had a higher rate of tx completion compared to premature discontinuation (60% vs 40%). Similar differences were found when looking tx completion rates vs premature discontinuation by DAA with INDV education prior to TVR tx (64% vs 36%) and INDV education prior to BOC tx (52% vs 48%). Overall, GRP education tx completion rates were similar to premature discontinuation rates (48% vs 52%). Conclusion: INDV pre-treatment HCV education is the most common method of education in this cohort. INDV education may lead to higher tx completion rates than GRP teaching methods for pts initiating HCV tx. This study was observational and not designed to compare INDV vs. GRP patient education. The analysis provides preliminary descriptive data to support a prospective, randomized study comparing modalities of pre-treatment education including tx completion rates and cost effectiveness.

TOTALBOC N=160 (26%) INDV N=145 GRP N=15TVR N=458 (74%) INDV N=374 GRP N=84
Premature D/CCompleted TxPremature D/CCompleted TxPremature D/CCompleted Tx
INDV (N=519) (84%)208/519 (40%)322/519 (60%)70/145 (48%)75/145 (52%)133/374 (36%)241/374 (64%)
GRP (N=99) (16%)51/99 (52%)48/99 (48%)6/15 (40%)9/15 (60%)45/84 (54%)39/84 (46%)


Brenda A. Appolo - Advisory Committees or Review Panels: Janssen, Gilead; Speaking and Teaching: Genetech, Vertex, Merck

Andrea C. Scherschel - Advisory Committees or Review Panels: Jensen, Gilead; Speaking and Teaching: Vertex, Kadmon

Patrick Horne - Consulting: Vertex Pharmaceuticals, Gilead Sciences, Kadmon Pharmaceuticals; Grant/Research Support: Bayer Pharmaceuticals

Lisa Richards - Speaking and Teaching: Kadmon, BMS, Vertex, Merck

The following people have nothing to disclose: Deborah A. Mercier, Danielle E. Cardona, Sarah B. Hubbard, Andrea L. Keller, Thomas Stewart, Monika Vainorius, Joy A. Peter


Skin reaction is a significant predictor for favorable response to sorafenib in patients with hepatocellular carcinoma

Masako Shomura1, Tatehiro Kagawa2, Koichi Shiraishi2, Shunji Hirose2, Yoshitaka Arase2, Tetsuya Mine2

1 Department of Nursing, Tokai University School of health sciences, Isehara city, Japan; 2Division of Gastroenterology, Department of Internal Medicine, Tokai University School of Medicine, Isehara city, Japan

Purpose: Sorafenib therapy for advanced hepatocellular carcinoma (HCC) often causes adverse events (AE), which subsequently lead to dose reduction or discontinuation. Conversely, some studies showed that serious AE were associated with favorable response to this drug. In this study we aimed to elucidate the relationship between the occurrence of AE and treatment effectiveness. Also, we examined the impact of nursing intervention on the adherence to the treatment. Methods: In consecutive patients with advanced HCC who received sorafenib treatment, the relationship between baseline characteristics, occurrence of AE and nursing intervention, and tumor response, overall survival (OS) and treatment duration were retrospectively analyzed by Cox's proportional hazards model. Nursing intervention program including education of self-monitoring and self-care about prevention and coping with AE on daily life was provided on the patient's request. Results: Subjects were 37 patients. Disease control rate was 41%, and median OS and treatment duration were 259 and 108 days, respectively. Patients younger than 70 years, occurrence of grade (G) 2 or G3 skin toxicity, and the absence of G2 or G3 hypoalbuminemia were significantly associated with longer OS . The median OS was 437 and 185 days in patients with and without skin reaction, respectively (p=0. 03). Nursing intervention was not associated with longer OS, but significantly contributed to the longer treatment period; 118 and 36 median days in patients with and without nursing intervention, respectively. Conclusions: Skin reaction was significantly associated with favorable outcome in the sorafenib treatment for patients with advanced HCC. Nursing intervention contributed to greater adherence, which may improve effectiveness of this drug.



The following people have nothing to disclose: Masako Shomura, Tatehiro Kagawa, Koichi Shiraishi, Shunji Hirose, Yoshitaka Arase, Tetsuya Mine