Patient-reported outcomes assessment in chronic hepatitis C treated with sofosbuvir and ribavirin: the VALENCE study.
OBJECTIVE
Interferon (IFN) negatively impacts patients' well-being and patient-reported outcomes (PROs). Our aim was to assess PROs during treatment with an IFN-free regimen [sofosbuvir (SOF)+ribavirin (RBV)].


METHODS
Four PRO questionnaires [Short Form-36 (SF-36), Chronic Liver Disease Questionnaire-HCV (CLDQ-HCV), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Work Productivity and Activity Index: Specific Health Problem (WPAI:SHP)] were administered at baseline, end-of-treatment and post-treatment to 334 HCV genotype 2 and 3 patients (naïve or treatment-experienced) enrolled in the VALENCE study. Of these, 250 genotype 3 patients were treated for 24 weeks while 73 genotype 2 and 11 genotype 3 patients received 12 weeks of treatment.


RESULTS
Baseline PRO scores were similar between the two arms of the study. Throughout and after treatment, patients receiving 12 or 24 weeks had similar FACIT-F, CLDQ-HCV, SF-36 and WPAI:SHP scores (all p>0.05). Compared to their own baseline scores, patients receiving SOF+RBV experienced modest declines in some aspects of SF-36, CLDQ-HCV, fatigue and WPAI:SHP scores (p = 0.04 to <0.0001). By follow-up week 12, all PRO scores returned to the pre-treatment levels (p>0.05). In patients achieving SVR-12 (regardless of the regimen), significant improvements were noted in general health (p = 0.0004), CLDQ-HCV (p<0.0001), fatigue (p = 0.005), emotional well-being (p<0.0001) and physical component summary score of SF-36 (p = 0.0022). In multivariate analysis, baseline depression, fatigue, insomnia, cirrhosis, and treatment-related adverse events were the most consistent predictors of PRO impairment (all p<0.05).


CONCLUSIONS
PROs are minimally impacted by SOF+RBV regimens. An additional 12 weeks of treatment does not substantially add to the PRO burden.
Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, VA, United States; Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, VA, United States. Electronic address: zobair.younossi@inova.org.
Zobair M
ZM
Younossi
Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, VA, United States; Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, VA, United States.
Maria
M
Stepanova
Johann Wolfgang Goethe University, Frankfurt, Germany.
Stefan
S
Zeuzem
Royal Free Hospital, London, England, UK.
Geoffrey
G
Dusheiko
Hospital Universitario Val d'Hebron, Barcelona, Spain.
Rafael
R
Esteban
Hôpital Henri Mondor, Université Paris-Est, Créteil, France.
Christophe
C
Hezode
Academic Medical Center, Amsterdam, The Netherlands.
Hendrik W
HW
Reesink
Karolinska Institutet, Karolinska University Hospital, Huddinge, Stockholm, Sweden.
Ola
O
Weiland
Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, VA, United States.
Fatema
F
Nader
Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, VA, United States; Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, VA, United States.
Sharon L
SL
Hunt
D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D008297:Male; D008875:Middle Aged; D063868:Patient Outcome Assessment; D012254:Ribavirin / Q000008:administration & dosage* / Q000009:adverse effects; D000069474:Sofosbuvir; D014542:Uridine Monophosphate / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*
D000998:Antiviral Agents; D012254:Ribavirin; D014542:Uridine Monophosphate; D000069474:Sofosbuvir
CLDQ-HCV; Clinical trial; FACIT-F; Hepatitis C; Patient-reported outcomes; SF-36; WPAI