- En cas d’approbation de cette durée de traitement par la Commission Européenne (CE), MAVIRET® deviendra la seule option de traitement pan-génotypique (Génotype 1 à 6) de 8 semaines pour les patients atteints d’hépatite C chronique naïfs, sans cirrhose ou avec une cirrhose compensée;
- La décision de la Commission Européenne est attendue courant 2020.
AbbVie Receives Positive CHMP2Committee for Medicinal Products for Human Use Opinion for MAVIRET®(glecaprevir/pibrentasvir) to Shorten Treatment Duration to Eight Weeks in Genotype 3, Treatment-Naïve Patients with Chronic Hepatitis C and Compensated Cirrhosis
- If approved by the European Commission (EC), MAVIRET will be the only pan-genotypic (GT1-6) 8-week treatment option for treatment-naïve, chronic hepatitis C (HCV) patients, without cirrhosis or with compensated cirrhosis;
- Final European Commission decision expected in 2020.
NORTH CHICAGO, Ill., Jan. 31, 2020/PRNewswire/ — AbbVie (NYSE: ABBV), a research-based globalbiopharmaceutical company, today announced that the European Committee for Medicinal Products forHuman Use (CHMP) of the European Medicines Agency (EMA) has recommended a change to the marketing authorization for MAVIRET® (glecaprevir/pibrentasvir) to shorten once-daily treatment duration from 12 to 8 weeks in treatment-naïve, compensated cirrhotic, chronic hepatitis C (HCV) patients with genotype (GT) 3infection. MAVIRET is currently indicated as an 8-week, pan-genotypic (GT1-6), once-daily regimen for treatment-naïve HCV patients without cirrhosis, and as an 8-week, once-daily regimen for treatment-naïve GT1, 2, 4, 5 and 6 HCV patients with compensated cirrhosis3MAVIRET®tablets (glecaprevir/pibrentasvir) Summary of product characteristics. Maidenhead, UK. AbbVie, Ltd.The recommended duration of MAVIRET is 12 weeks in liver or kidney transplant recipients with or without cirrhosis. If approved by the European Commission (EC), MAVIRET will be the only 8-week treatment option for treatment-naïve chronic HCV patients, without cirrhosis or with compensated cirrhosis, regardless of genotype4The recommended duration of MAVIRET is 12 weeks in liver or kidney transplant recipients with or without cirrhosis.
« The HCV treatment pathway can be a complicated journey for the millions of patients affected by the disease, » said Janet Hammond M.D., Ph.D., vice president, general medicine and virology therapeutic area, AbbVie. « Today’s positive CHMP opinion for MAVIRET moves us further toward our goal of providing an effective 8-week therapeutic option with the potential to simplify the treatment journey for the majority of people living with HCV, regardless of disease genotype.
« The CHMP positive opinion is supported by data from the Phase 3b EXPEDITION-8 study, which showed that with 8 weeks of MAVIRET, 97.7 percent (n=335/343) of GT1-6 patients achieved a sustained virologic response 12 weeks after treatment (SVR12) (ITT). For patients with GT3, the SVR12 rate was 95.2% (n=60/63) (ITT). To date, one virologic failure has been reported in these patients and no patients have discontinued treatment due to adverse events. Adverse events (frequency >5%) reported in the study include pruritus (8%), fatigue (9%), headache (8%)and nausea (6%). Six serious adverse events (2%) occurred during the study, none of which were deemed to be related to lecaprevir/pibrentasvir. No new safety signals were identified in this study5Brown RS et al. Glecaprevir/pibrentasvir for 8 weeks in treatment-naïve patients with chronic HCV genotypes 1–6 and compensated cirrhosis: The EXPEDITION-8 trial. J Hepatol (2019).
The Phase 3b EXPEDITION-8 study evaluated the safety and efficacy of MAVIRET in treatment-naïve chronic HCV patients with compensated cirrhosis across all major genotypes (GT1-6). The results have been reported for GT1, 2, 3, 4, 5, and 6 (n=343) patients6Brown RS et al. Glecaprevir/pibrentasvir for 8 weeks in treatment-naïve patients with chronic HCV genotypes 1–6 and compensated cirrhosis: The EXPEDITION-8 trial. J Hepatol (2019).
« Successfully treating people with HCV has historically been challenging, in part because of the length of the treatment duration and the need for additional testing to determine the patient’s disease genotype and fibrosis stage to match them with the most appropriate therapy, » said Stefan Zeuzem, M.D., chief of the department of medicine at the J.W. Goethe University Hospital in Frankfurt, Germany. « A clinically validated HCV therapeutic option that can reduce both the treatment timeframe and diagnostic burden may help providers treat more patients and reduce how many are lost to follow-up, ultimately potentially helping to hasten elimination of the disease globally.
About the EXPEDITION-8 Study7Brown RS et al. Glecaprevir/pibrentasvir for 8 weeks in treatment-naïve patients with chronic HCV genotypes 1–6 and compensated cirrhosis: The EXPEDITION-8 trial. J Hepatol (2019)
EXPEDITION-8 is a single-arm, open-label, Phase 3b study in treatment-naïve, GT1-6 chronic HCV patients with compensated cirrhosis (n=343) who received MAVIRET for 8 weeks.
The primary efficacy endpoints were SVR12 in patients with GT1, 2, 4, 5, and 6 in a per-protocol (PP) and intent-to-treat (ITT) population versus historical SVR12 rates based on the efficacy of MAVIRET for 12 weeks in treatment-naïve patients with compensated cirrhosis. The key secondary efficacy endpoints were the percentages of GT1-6 patients achieving SVR12in a PP and ITT population.
Additional information on the clinical trials for MAVIRET is available at www.clinicaltrials.gov/.
About MAVIRET® (glecaprevir/pibrentasvir)8MAVIRET®tablets (glecaprevir/pibrentasvir) Summary of product characteristics. Maidenhead, UK. AbbVie, Ltd.
MAVIRET is approved in the European Union for the treatment of chronic hepatitis C virus (HCV) infection in adults and adolescents aged 12 to <18 years across all major genotypes (GT1-6). MAVIRET is a pangenotypic, once-daily, ribavirin-free treatment that combines glecaprevir (100mg), an NS3/4A protease inhibitor, and pibrentasvir (40mg), an NS5A inhibitor, dosed once-daily as three oral tablets.
MAVIRET is an 8-week, pan-genotypic (GT 1-6) option for patients without cirrhosis and who are new to treatment and for GT1, 2, 4, 5 and 6 patients who are new to treatment with compensated cirrhosis. The recommended treatment duration for treatment-naïve, compensated cirrhotic GT3 HCV patients is 12 weeks.
MAVIRET is also approved as a treatment for patients with specific treatment challenges, including those withcompensated cirrhosis across all major genotypes, and those who previously had limited treatment options, such as patients with severe chronic kidney disease (CKD) or those with genotype 3 chronic HCV infection. MAVIRET is a pan-genotypic treatment approved for use in patients across all stages of CKD.
MAVIRET is contraindicated in patients with severe hepatic impairment (Child-Pugh C) and is not recommended in patients with moderate hepatic impairment (Child-Pugh B). Glecaprevir (GLE) was discovered during the ongoing collaboration between AbbVie and EnantaPharmaceuticals for HCV protease inhibitors and regimens that include protease inhibitors.
MAVIRET is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults and adolescentsaged 12 to <18 years old.