HCV: real-world data support GLE/PIB efficacy in injection drug users

  • Persico M & al.
  • Liver Int
  • 7 Jun 2019

  • International Clinical Digest
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Takeaway

  • Real-world data support efficacy of glecaprevir/pibrentasvir (GLE/PIB; Mavyret) among difficult-to-treat HCV subgroups, including people who inject drugs (PWID).

Why this matters

  • PWID are considered HCV core-transmitters yet remained an underserved population because of concerns over adherence. Most patients in this study (90.1%) received an 8-week regimen.

Study design

  • Prospective 22-center Italian MISTRAL study of 1177 HCV-infected patients (49.5% male; median age, 62 years) receiving GLE/PIB; most (85%) were treatment-naive with HCV-1b (37.0%) or HCV-2 (34.5%).
  • GLE/PIB was given for 8 (90.1%), 12 (9.3%), or 16 weeks (0.5%).
  • 118 (10.0%) were PWID, 123 patients (10.5%) had HCV-3, and 104 (8.8%) had F4 fibrosis.
  • Primary outcome: sustained virologic response at week 12 (SVR12).
  • Funding: None.

Key results

  • Overall SVR12 rate, 98.9%.
  • SVR12 was similar in PWID vs non-PWID (98.3% vs 99.2%; P=.304).
  • SVR12 rates were not influenced by sex (P=.141), substance abuse (P=.304), prior treatment (P=.687), treatment duration (P=.578), fibrosis stage (P=.515), or chronic kidney disease stage (P=.577).
  • PWID had a significantly different genotype distribution (X2<.001 that favored hcv-3 vs non-pwid style="list-style-type:circle;">
  • In PWID, SVR12 was 100% in HCV1a/b, HCV-2, and HCV-4; 95% in HCV-3.
  • Serious adverse events occurred in 6 patients (0.5%).
  • Limitations

    • Field-practice design.
    • Resistance-associated substitutions not captured.

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