*This Zepatier (grazoprevir / elbasvir) treatment facts sheet was updated January 21, 2016. It was originally put together in October 2015, while CADTH was seeking input for it from patient groups. This sheet is made up of Canadian treatment details. We will keep you updated as the treatment proceeds through the Canadian drug approval process.
Zepatier (grazoprevir / elbasvir)
Targeted Genotypes: 1, 3, 4
Treatment Description: Zepatier (grazoprevir / elbasvir) is made up of two direct-acting antivirals. Grazoprevir is a NS3/4A protease inhibitor. It works by blocking a viral enzyme (protease) that enables the hep C virus to survive and replicate in host cells. Elbasvir is a NS5A inhibitor. It blocks a virus protein, NS5A, that the virus needs to reproduce and for various stages of infection.
The treatment has been studied with ribavirin and Sovaldi (sofosbuvir) for multiple hep C genotypes and in patients with difficult-to-treat conditions, such as HIV/HCV co-infection and advanced chronic kidney disease.
Approximate Sustained Viral Response (SVR)/”Cure Rate”: 90% – 98%
Possible Length of Treatment: 8 – 16 weeks
|With hep C genotype 1 or 4 who have never tried treatment or have tried treatment with peginterferon and ribavirin (PR) but relapsed||12|
|With hep C genotype 1 who has tried treatment with a protease inhibitor but relapsed||12|
|With hep C genotype 1b who has never tried treatment and doesn’t have liver cirrhosis||8|
|With hep C genotype 1b who has tried treatment with peginterferon or PR but experienced on-treatment virologic failures||12|
|With hep C genotype 1a who has tried treatment with peginterferon (PI) or with peginterferon and ribavirin (PR) but experienced on-treatment virologic failures||16|
|With hep C genotype 4 who have tried treatment with PR but experienced on-treatment virologic failures||16|
|With hep C genotype 3 who have never tried treatment||12|
Availability: Zepatier is approved for use in Canada
Common Side Effects Reported During Clinical Trials:
- Tiredness (fatigue)
- Trouble sleeping
If you experience any side effects listed or not listed here, contact your healthcare professional.
Usage Warning: Do not take Zepatier if you have moderate or severe liver problems (Child-Pugh B or C). Tell your doctor about any medication (over the counter, prescribed, or recreational) you are taking before taking Zepatier.
Co-infected with HIV: Same dose and length of treatment required. Tell your doctor about any medication (over the counter or prescribed) you are taking before taking Zepatier.
- Health Canada’s Summary Basis of Decision (SBD) documents that provide information related to the original authorization of a product.
Sampling of Phase II/III Clinical Trials for Zepatier:
|Clinical Trial||Patients||Treatment Regimen||Duration in Weeks
|C-EDGE (looked at treatment-naive, treatment experienced and HIV co-infected patients)||GT 1, 4, 6 treatment naive with (C) or without cirrhosis (NC)||ZEPATIER||12||95% (total) NC 94%, C 97%, GT1a 92%, GT1b 99%, GT4 100%, GT6 80%|
|GT 1, 4, 6 HIV/HCV co-infected with (C) or without cirrhosis (NC)||ZEPATIER||12||95% (total) NC 94%, C 100%, GT1a 94%, GT1b 96%, GT4 96%, GT6 100%|
|GT 1, 4, 6 treatment- experienced with or without cirrhosis||ZEPATIER +/- Ribavirin (RBV)||16||92% (- RBV total), GT1a 94%, GT1b 96%, GT4 60%, GT6 75%|
|97% (+ RBV total), GT1a 95%, GT1b 100%, GT4 100%, GT6 100%|
|C-SALVAGE (looked at retreat duration)
||GT 1, previously failed with PR + a DAA**, with or without cirrhosis||ZEPATIER + RBV||12||96% (total)|
|C-SURFER (still ongoing)||GT 1, treatment-naïve and patients who failed pegylated interferon, with or without cirrhosis, chronic kidney disease stages 4 or 5||ZEPATIER||12||99%|
|*In clinical trials for hepatitis C virus (HCV) infection treatments, the goal is to cure/achieve SVR (sustained viral response)/reduce the virus so that it can’t be detected in the blood and liver disease from hep C is stopped.
**The direct antiviral agents listed were Incivek (telaprevir), Victrelis (boceprevir), and Galexos (simeprevir).