Z Gastroenterol 2018; 56(01): E2-E89
DOI: 10.1055/s-0037-1612887
Poster Visit Session V Viral Hepatitis and Immunology – Saturday, January 27, 2018, 11:00am – 11:45am, Foyer area East Wing
Georg Thieme Verlag KG Stuttgart · New York

Quality of life in HCV patients treated with OBV/PTV/r ± DSV ± RBV under real-life conditions – Data from the German observational study LIFE-C

P Buggisch
1   ifi Institut, Hamburg
,
R Link
2   MVZ Offenburg, Offenburg
,
U Naumann
3   Praxiszentrum Kaiserdamm, Berlin
,
G Teuber
4   Private Practice, Frankfurt
,
R Heyne
5   Leberzentrum am Checkpoint Berlin, Berlin
,
J Hülsenbeck
6   AbbVie Deutschland GmbH @ Co. KG, Medical Department, Wiesbaden
,
K Lohmann
6   AbbVie Deutschland GmbH @ Co. KG, Medical Department, Wiesbaden
,
M Kraus
7   Kreiskliniken Altötting-Burghausen, Burghausen
› Author Affiliations
Further Information

Publication History

Publication Date:
03 January 2018 (online)

Also available at
 
 

    Question:

    In clinical trials and first real-life data, ombitasvir/paritaprevir/r ± dasabuvir ± ribavirin (RBV) has shown high rates of sustained virologic response (SVR) and good tolerability. Nevertheless, real-life data regarding the health-related quality of life (QoL) are limited. Here, we report the QoL in a large cohort from Germany that enrolled patients between December 2015 and December 2016.

    Methods:

    All adult patients treated with OBV/PTV/r ± DSV ± RBV according to the local label were eligible for the study. Patients” visits were scheduled at the physician's discretion and according to clinical practice. At baseline, during and at the end of the treatment, and at post-treatment week 4, 12, and 24, patients filled in several validated questionnaires regarding QoL. This included PRISM, a brief quantitative method to assess perceived burden of suffering due to illness, FACIT-F to measure fatigue, and WPAI(HCV) to analyse work productivity and activity impairment.

    Results:

    472 patients were enrolled. QoL was analyzed in 252 patients and efficacy in all patients treated for 12 weeks with sufficient follow-up data (n = 235). Overall virological response rate was 97.4% (n = 229/235). At baseline, the mean score for PRISM was 11.8, for FACIT-F 36.0, for Total Work Productivity Impairment 17.3, and for Total Activity Impairment 26.8. Cirrhotic patients (n = 19) and those receiving opiate substitution therapy (OST; n = 27) exhibited values associated with lower QoL in all scores determined, while patients 70 years old (n = 38) exhibited values associated with higher QoL. The change of values recorded in the total cohort is displayed in the table. At 12 weeks after end of treatment, QoL improved with respect to all mean scores determined: PRISM 6.35, FACIT-F 4.74, Total Work Productivity Impairment -5.4, Total Activity Impairment -11.7. While this improvement was similar in cirrhotic patients and patients 70 years old, it was more pronounced in OST patients: PRISM 9.47; FACIT-F 13.3, Total Work Productivity Impairment -10.8, Total Activity Impairment -18.6.

    Questionnaire

    Baseline (Mean; N)

    On Treatment (Mean delta; N)

    End of Treatment (Mean delta; N)

    SVR12
    (Mean delta; N)

    PRISM

    11.8; 251

    –

    –

    6.35; 206

    FACIT

    36.0; 241

    0.987; 198

    1.96; 189

    4.74; 166

    WPAI (Work Prod Impairm)

    17.3; 96

    –

    4.4; 65

    –5.4; 54

    WPAI (Total Activity Impairm)

    26.8; 236

    –

    –1.5; 173

    –11.7; 155

    Conclusions:

    Under real-world conditions, QoL improved in patients treated with OBV/PTV/r ± DSV ± RBV. This improvement was observed in several subgroups and was most pronounced in OST patients, suggesting that this group especially profits from treatment of the hepatitis c virus infection.


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