Why ZEPATIER – ZEPATIER use with PWIDs
Power to cure* in people who inject drugs (PWIDs)1
Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland) [External links
93% SVR for G1+G4 patients on OST, many of whom continued to take recreational drugs1
Study primary endpoint
The proportion of patients in the ITG achieving an SVR, defined as an HCV RNA level less than the lower limit of quantitation (<15 IU/mL) at 12 weeks after the end of treatment (SVR12)
Approximately 62% of patients in the immediate treatment arm continued to use recreational drugs throughout the trial1
- ZEPATIER has no drug-drug interactions with buprenorphine/naloxone and methadone2
- Concomitant recreational drug use did not affect efficacy of ZEPATIER in patients receiving OST1
- Patients receiving OST were highly (defined as >95%) adherent to ZEPATIER, due to study protocol, via post-hoc analysis†1
Immediate treatment arm urine drug screen results: Day 11
C-Edge Co-Star: A Phase 3, randomised, parallel-group, double-blind, placebo-controlled study in G1, G4 and G6 (ZEPATIER is only licensed in G1+G4 patients) treatment-naïve patients receiving OST for at least 3 months, with or without compensated cirrhosis. Patients (n=201) received ZEPATIER (immediate treatment arm) or placebo (deferred treatment arm) (n=100) for 12 weeks. Primary endpoint SVR12 (HCV RNA <15 IU/ml).
WHO draft global health sector strategy on viral hepatitis, 2016–2021
‘A goal of eliminating viral hepatitis as a major public threat by 2030’3
If we are to eliminate hepatitis C as a major public health threat, there are two main impact areas where we need to make progress: we need to reduce the numbers becoming seriously ill or dying from this infection, whilst at the same time reducing the number of people who become newly or re-infected.3
*Cure defined as cure of HCV infection = sustained virologic response (SVR), the primary endpoint in all studies, was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (LLOQ) (≤15 IU/ml) at 12 weeks after the cessation of treatment4
**Includes all patients; reinfections counted as failures
†C-Edge Co-Star, Full analysis set. 192 out of 199 patients in a post-hoc analysis took >95% of the 84 doses of ZEPATIER administered over 12 weeks1
- Dore GJ et al. Elbasvir–Grazoprevir to Treat Hepatitis C Virus Infection in Persons Receiving Opioid Agonist Therapy. Ann Intern Med. doi:10.7326/M16-0816.
- ZEPATIER Summary of Product Characteristics.
- WHO global health sector strategy on viral hepatitis, 2016-2021.
- European Association for the Study of Liver. J Hepatol. 2018;69;461-511.
Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland)
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