Why ZEPATIER – ZEPATIER use with PWIDs

ZEPATIER®▼ (elbasvir/grazoprevir)

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

Additional data and C-Edge Co-Star study design

Immediate treatment arm urine drug screen results: Day 1¹

Study design

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

Related content

Drug-drug interaction (DDI) profile and dosing simplicity of ZEPATIER

Prescribing Information (Great Britain) &
Prescribing Information (Northern Ireland)
[External links]

References

1. 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.
2. ZEPATIER Summary of Product Characteristics.
3. WHO global health sector strategy on viral hepatitis, 2016-2021.
4. European Association for the Study of Liver. J Hepatol. 2018;69;461-511.

Supporting documentation

Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland) 
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