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Eight- or 12-Week Treatment of Hepatitis C with Ledipasvir/Sofosbuvir: Real-World Experience in a Large Integrated Health System

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Abstract

Background

Second-generation direct-acting antiviral agents are integral to treatment of hepatitis C (HCV) infection. Eight-week courses of ledipasvir/sofosbuvir (LDV/SOF) have been supported in some studies, but data are limited on efficacy in real-world use. Controversy exists regarding applicability of clinical trials to real-world effectiveness. We report virologic responses of patients with HCV genotype 1 infection receiving LDV/SOF for 8 or 12 weeks in a large integrated healthcare system.

Methods

All patients receiving LDV/SOF, without ribavirin, were identified from pharmacy records, and outcomes are reported. Only treatment-naïve patients without evidence of cirrhosis and hepatitis C viral load less than 6 million IU/ml were candidates for 8-week therapy. Treatment was at clinician discretion, but delivered by a multidisciplinary team and reviewed for appropriateness and adherence to these criteria by one of the authors, all experienced in hepatitis C treatment. Sustained viral response at 12 weeks (SVR 12) was contrasted between those receiving 8 and those receiving 12 weeks of treatment.

Results

Completed prescriptions for LDV/SOF, without ribavirin, as of 30 September 2015 were identified in 1021 patients. Five patients discontinued therapy due to medical reasons and 35 had incomplete follow-up viral load data, thus there were 981 evaluable patients: 377 treated for 8 weeks and 604 treated for 12 weeks. SVR 12 was virtually identical at 93.6 and 93.5%, respectively. Baseline characteristics differed between the two groups, as only treatment-naïve, non-cirrhotic, non-HIV-infected patients were eligible for an 8-week course of therapy.

Conclusions

Eight-week courses of LDV/SOF are comparable to 12-week courses in real-world use among selected patients supported by a multidisciplinary team.

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Authors and Affiliations

  1. Division of Infectious Diseases, Kaiser Permanente, 99 Montecillo Rd, Northern California Region, San Rafael, CA, 94903, USA

    Jennifer B. Lai, Maxwell A. Witt, Michael Allerton & David J. Witt

  2. Division of Gastroenterology, Kaiser Permanente, Northern California Region, San Rafael, CA, USA

    Jennifer B. Lai, Mary Patricia Pauly, Joanna Ready & Suk Seo

Authors
  1. Jennifer B. Lai
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  2. Maxwell A. Witt
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  3. Mary Patricia Pauly
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  7. David J. Witt
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Corresponding author

Correspondence to David J. Witt.

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None of the authors have any conflicts of interest. There was no funding for this project.

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Lai, J.B., Witt, M.A., Pauly, M.P. et al. Eight- or 12-Week Treatment of Hepatitis C with Ledipasvir/Sofosbuvir: Real-World Experience in a Large Integrated Health System. Drugs 77, 313–318 (2017). https://doi.org/10.1007/s40265-016-0684-y

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