461. Effects of Acid-Reducing Agents on Cure Rates for Hepatitis C Patients Treated with Ledipasvir and Sofosbuvir
Session: Poster Abstract Session: Hepatitis C
Thursday, October 27, 2016
Room: Poster Hall
  • Banh_IDWeek_Poster.pdf (1.5 MB)
  • Background: The fixed dose combination of ledipasvir/sofosbuvir (LDV/SOF) is the first FDA-approved interferon- and ribavirin- free regimen to treat chronic Hepatitis C Virus (HCV). Despite the high cure rates with LDV/SOF, challenges exist, such as drug interactions with acid-reducing agents. Specifically, the solubility of LDV decreases as pH increases, impacting absorption. There is limited guidance on management for patients on LDV/SOF and acid-reducing agents. Recent data from the HCV-TARGET study group suggest that proton pump inhibitor (PPI) use is a negative predictor for achieving sustained virologic response 12 weeks post treatment (SVR12) rates. However, details surrounding use of PPI and other acid-reducers in LDV/SOF treated patients remain unclear.

    Methods: This retrospective, single-center study conducted at UCDMC Specialty Pharmacy clinic evaluates patients who have completed LDV/SOF treatment between 10/01/2014 to 10/31/2015. The primary endpoint evaluated the difference in SVR12 rates between HCV genotype 1 (GT1) patients treated with LDV/SOF in the presence or absence of acid-reducing agents. Secondary outcomes were as follows: (1) determined which acid suppressants, if any, or combinations thereof affect treatment outcomes and (2) determined whether other variables may affect treatment outcomes. Demographic data was analyzed using descriptive statistics. The Fisher's exact test was used to analyze the association between acid-reducing agents on LDV/SOF SVR12 rates.

    Results: Overall, 95% of patients achieved SVR12 rates when on acid-reducing agents with no significant difference between patients not receiving acid-reducing agents. Treatment of LDV/SOF based regimens with a PPI affected SVR12 rates by 8%. No specific PPI and dose were identified to affect SVR12 rates. Overall, 98% cirrhotic patients not receiving PPIs compared to 81% cirrhotic patients receiving PPI during LDV/SOF treatment achieved SVR12 rates. There was no significant difference in SVR12 rates for other acid-reducing agents, missed doses, or other unique populations.

    Conclusion: PPI use affected cure rates in HCV-infected GT1 patients treated with LDV/SOF, especially in cirrhotic patients.

    Cindy Banh, PharmD, Rebecca Hluhanich, PharmD, Kathleen Haight, PharmD and Patricia Poole, PharmD, UCDMC, Sacramento, CA


    C. Banh, None

    R. Hluhanich, None

    K. Haight, None

    P. Poole, None

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