1030. Adverse events (AE) and laboratory changes in a real-world population of Hepatitis C Virus (HCV)-infected patients with chronic kidney disease (CKD) treated with sofosbuvir (SOF)-based therapy
Session: Poster Abstract Session: Hepatitis Viruses
Friday, October 9, 2015
Room: Poster Hall
Posters
  • HCV poster 1030.pdf (519.3 kB)
  • Background: There is limited safety data available for patients with CKD treated with direct-acting antiviral therapy. Although no dosage adjustment of SOF is required for patients with mild to moderate renal impairment (CrCl 30 mL/min to 80 mL/min), SOF area under the curve (AUC) is increased in these individuals. 

    Methods: Data from 72 patients with CKD who began SOF-based therapy for chronic HCV infection between Nov 2013 - Dec 2014 were evaluated retrospectively for safety and tolerability. CKD was defined by the presence of albuminuria > 30mg/g or glomerular filtration rate < 60mL/min. Ribavirin (RBV)-containing regimens were compared to those without RBV.

    Results:

    Median age was 61 ± 8 years, 60% were white, 45% were transplant recipients, and 7% were HIV coinfected. At baseline, 41 (57%) had stage 3 CKD, and 31 (43%) had stage 1-2 CKD. RBV-containing regimens were used in 26 (36%) of patients, 36 (50%) received SOF & simeprevir. Transient creatinine rise ≥ 0.3mg/dL during treatment was noted in 63 patients but on-treatment average eGFR did not differ significantly from baseline [mean (95% CI): 57mL/min (52-62) vs 58mL/min (53-63) respectively, P=0.26]. 55 (76%) patients experienced an AE with 5 patients discontinuing due to AEs (Table 1). The sustained viral response rate (SVR12) was 75%. Change in hemoglobin at 8 weeks was greater in patients receiving RBV compared to those on a RBV-free regimen [median (Q1,Q3): -1.8g/dL (-3.6,-1.0) vs. -0.4g/dL (-1.4, 0.1), respectively; p=0.005]. Mean total bilirubin increased by 0.52mg/dL (p=0.01) from baseline to week 4 but post-treatment week 4 levels were on average 0.19mg/dL below baseline (p=0.015).

    Table 1.

    Adverse Reaction

    N

    %

    Serious Adverse Reaction

    N

    %

    Fatigue*

    20

    28

    Dizziness / lightheadedness*

    18

    25

    Mental status / mood change*

    15

    21

    Shortness of breath

    12

    17

    Nausea/vomiting

    10

    14

    Anemia (Grade 2/3)*

    10

    14

    Rash

    9

    13

    EKG changes

    7

    10

    Cough

    8

    11

    Hyperbilrubinemia (Grade 2/3)

    7

    10

    Loss of diabetic control

    7

    10

    Chest pain / discomfort

    7

    10

    Sun sensitivity

    6

    8

    Syncope

    6

    8

     

     

     

    Bradycardia

    3

    4

    *Prompted discontinuation in ≥ 1

    Conclusion: We identified higher than expected rates of side effects associated with SOF-based therapy in CKD patients, but few led to treatment discontinuation and significant nephrotoxicity was not noted.

    Elke Backman, PharmD, Guillermo Ortiz, MD, Gregory Hundemer, MD, Nneka Ufere, MD, Raymond Chung, MD and Meghan Sise, MD MS, Massachusetts General Hospital, Boston, MA

    Disclosures:

    E. Backman, None

    G. Ortiz, None

    G. Hundemer, None

    N. Ufere, None

    R. Chung, Gilead: Investigator , Research grant

    M. Sise, Gilead: Investigator , Research grant

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