458. Rapid Viral Response (RVR) as a Predictor of Treatment Failure in Hepatitis C Virus (HCV) Patients Receiving Ledipasvir and Sofosbuvir (LDV/SOF): A Retrospective Case-Control Analysis
Session: Poster Abstract Session: Hepatitis C
Thursday, October 27, 2016
Room: Poster Hall
Posters
  • ID Week 2016 - Poster 458 - Jansen.pdf (781.1 kB)
  • Background: New HCV therapies report cure rates of ~90% but are costly. Rapid viral response, defined as undetectable viral load at 4 weeks, is predictive of treatment failure with some previous HCV therapies. Limited data exists evaluating the role of RVR in new therapy options, including LDV/SOF.

    Methods: A pilot, single-center, retrospective case-control analysis of adult patients treated with LDV/SOF from 10/10/2013 to 12/19/2015 was conducted. Included patients had a viral load obtained between weeks 3-6 of therapy (RVR) and between weeks 12-16 after the end of therapy (SVR). Identified patients with SVR failure (viral load detectable) constituted the case population. The control population was randomly selected in a 1:4 case:control ratio from all identified SVR successes. The primary outcome was SVR failure. Variables with a p-value <0.2 in univariate analysis were included in the regression model.

    Results: Twelve SVR failures were identified. Forty-eight of 144 SVR successes were randomly selected for inclusion (1:4 case:control). Table 1 presents demographic information. Overall failure rate was 8.33%. Results of univariate analysis are shown in table 2.  Previous treatment failure, H2RA use, and CrCl >90 mL/min were included in the regression model, along with RVR per protocol. Nagelkerke’s R2 for the model was 0.312. CrCl >90 mL/min was independently associated with treatment failure (Odds Ratio: 7.27; 95% CI, 1.33 to 39.72; p=0.022); H2RA use approached significance but was limited by few patients taking H2RAs.

    Conclusion: Patients with CrCl >90 mL/min were 7.27 times more likely to fail SVR than patients with CrCl <90 mL/min. A possible explanation is that patients with CrCl >90 mL/min do not maintain adequate drug exposure for viral clearance. Further evaluation of increased CrCl and H2RA use with SVR failure utilizing a larger sample size is warranted.

    Table 1: Baseline Characteristics

    SVR Failure

    (n=12)

    SVR Success

    (n=48)

    Median Age (IQR)*

    62 (5)

    62 (7)

    Male*

    12

    48

    Ethnicity*

    White

    Black

    6

    6

    22

    26

    HCV Genotype*

    1a

    1b

    4

    9

    2

    1

    37

    10

    1

    *p>0.05

    Table 2: Univariate Analysis

    SVR Failure

    (n=12)

    SVR Success

    (n=48)

    p-value

    RVR

    8

    32

    1.0

    Previous Treatment Failure

    1

    14

    0.14

    H2RA Use

    2

    1

    0.04

    PPI Use

    5

    12

    0.23

    Ribavirin Use

    1

    4

    1.0

    Cirrhosis

    4

    15

    0.89

    CrCl >90 mL/min

    10

    20

    0.01

    Jeffrey W. Jansen, Pharm.D.1, Travis W. Linneman, Pharm.D.2 and Gillian Powderly, Pharm.D.1, (1)Pharmacy Services, VA Saint Louis Healthcare System, Saint Louis, MO, (2)Pharmacy Services, VA Saint Louis Health Care System, Saint Louis, MO

    Disclosures:

    J. W. Jansen, None

    T. W. Linneman, None

    G. Powderly, None

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