AbbVie, the developer of glecaprevir (ABT-493) / pibrentasvir (ABT-530), has submitted a New Drug Submission to Health Canada for the treatment of chronic hepatitis C and has been granted a priority review for it. This means that it will receive a priority review from Health Canada.*
A couple of weeks ago, the same hepatitis C treatment received a Breakthrough Therapy Designation (BTD) from the FDA for the treatment of patients with hep C genotype 1 who were not cured with prior DAA therapies.
Glecaprevir/pibrentasvir was submitted to Health Canada as a short term, eight week, treatment, made up of a once-daily three pill regimen. The treatment is for patients with chronic hepatitis C virus (HCV) genotypes 1-6, all major genotypes, without liver cirrhosis or with compensated liver cirrhosis (Child-Pugh A).
Glecaprevir/pibrentasvir is intended to address the unmet medical needs of patients with specific treatment challenges, including those with severe chronic kidney disease and those not cured with previous direct acting antiviral treatment.
Additional information and AbbVie’s press release about their New Drug Submission to Health Canada can be found here.
Sampling of Phase III Clinical Trials for Glecaprevir / Pibrentasvir:
|Clinical Trial||Patients||Treatment Duration||Treatment Regimen||SVR12*|
|ENDURANCE-1||GT1 without cirrhosis, new to treatment or not cured with previous treatment||8 weeks||Glecaprevir / Pibrentasvir (G/P) once daily||99%|
|ENDURANCE-2||GT2 without cirrhosis, new to treatment or not cured with previous treatment||12 weeks||G/P vs Placebo||99%|
|ENDURANCE-3||GT3 without cirrhosis (NC), new to treatment (TN), treatment experienced (TE)||12 weeks||G/P||Ongoing|
|12 weeks||SOF + DCV|
|ENDURANCE-4||GT4-6 NC, TN, TE||12 weeks||G/P||GT4 99%, GT5 100%, GT6 100%|
|SURVEYOR-2 (Part 3)||GT3 TN, TE||12 weeks||G/P||91%|
|Compensated cirrhosis (CC), TE||16 weeks||96%|
|GT3 TN||12 weeks||G/P||98%|
|GT3 TE||16 weeks||96%|
|SURVEYOR-2 (Part 4)||GT2, GT4-6 NC, TN, TE||8 weeks||G/P||GT2 98%, GT4 93%, GT5 100%, GT6 90%|
|EXPEDITION-4||CKD4/5, GT1-6, +/- CC||12 weeks||G/P||98%|
|EXPEDITION-1||GT1, 2, 4-6 CC, TN, and TE||12 weeks||G/P||Ongoing|
|CERTAIN-1||GT1 without cirrhosis, some with the resistance-associated Y93H virus variant||8 weeks||G/P||99%|
|MAGELLAN-1 (Part 2)||GT1, 4, 6 +/- liver cirrhosis, DAA treatment experienced||12 weeks||G/P + RBV||Ongoing|
|16 weeks||G/P – RBV|
|*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. A SVR12 is an HCV viral load that has remained undetectable for 12 weeks after treatment, indicating a cure.
**Treatment-experienced means that the patients who took part in this trial had already unsuccessfully tried to cure their HCV with pegylated interferon.
Common Side Effects Reported in Clinical Trials:
- Tiredness (fatigue)
“HCV patients with severe chronic kidney disease present a complex challenge for physicians to treat. This is particularly true in those with genotype 2 and 3 infection, and those with cirrhosis,” said Dr. Curtis Cooper, Director of the Regional Hepatitis Program at the Ottawa Hospital. “Recent clinical trial results are a positive development in AbbVie’s investigation of the G/P regimen for patients with chronic kidney disease, who currently have limited HCV treatment options.”
*For more information about the drug approval system in Canada please see Approval Process.