HCV: pharmacist-driven DAA therapy yields high clearance rates

  • Open Forum Infect Dis
  • 03.07.2019

  • von Yael Waknine
  • Clinical Essentials
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Takeaway

  • Pharmacist-delivered direct-acting antiviral (DAA) therapy yields high HCV clearance rates.

Why this matters

  • Expanding HCV care to include clinical pharmacists can help meet national HCV elimination goals.

Study design

  • Observational study of 1253 HCV+ patients initiating DAA therapy at 4 US institutions with a pharmacist-driven treatment model, January 1, 2014-March 12, 2018.
  • Primary outcome: sustained virologic response at ≥12 weeks posttreatment (SVR12).
  • Funding: Gilead Sciences.

Key results

  • Most patients were treatment-naive (81.6%) baby-boomers (birth years, 1945-1965; 74.1%) with HCV-1 (88.4%); 63.9% were male and 53.7% were black.
  • 40.3% had cirrhosis (Child-Turcotte-Pugh [CTP] class A, 82.8%).
  • Comorbidities included psychiatric illness (33.5%), diabetes (24.2%), and HIV (18%); 31.1% used alcohol within the preceding 6-12 months (illicit substances, 15.9%).
  • 60.4% received ledipasvir/sofosbuvir (Harvoni) ±ribavirin.
  • Intent-to-treat (ITT) SVR12 was 86.1%.
    • Non-SVR12: 54.6% lost to follow-up, 13.8% stopped treatment.
  • Per-protocol SVR12 rate (n=1134) was 95.1%.
  • ITT SVR12 was lower with cirrhosis (82.2% vs 88.8%), particularly CTP class B (69.4% vs CTP-A, 84.9%).
  • Missing ≥1 dose yielded lower SVR12 than full adherence (74.9% vs 90.0%; P<.0001>
  • 798 drug-drug interactions were identified at baseline (47.6% of patients); 184 baseline medications were adjusted to optimize DAA safety and efficacy; SVR12 was not compromised (P=.0543).

Limitations

  • Retrospective design.