- In cohort one, 100 percent of genotype 1, 2, 4, 5 and 6 treatment-naïve chronic HCV patients with compensated cirrhosis achieved SVR with 8 weeks of MAVYRET™ per protocol analysis1Brown RS, Hezode C, Wang S, et al. Preliminary Efficacy and Safety of 8-Week Glecaprevir/Pibrentasvir in Patients with HCV Genotype 1–6 Infection and Compensated Cirrhosis: The EXPEDITION-8 Study. Presented at The Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco, U.S., November 13, 2018.
- Cohort two of the study is ongoing, evaluating treatment-naïve genotype 3 (GT3) patients with compensated cirrhosis
- MAVYRET™ is currently approved as an 8-week, pan-genotypic treatment for treatment-naïve patients without cirrhosis
NORTH CHICAGO, Ill., Nov. 13, 2018 /PRNewswire/ – AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced new data for its pan-genotypic chronic hepatitis C virus (HCV) treatment, MAVYRETTM (glecaprevir/pibrentasvir), in treatment-naïve patients with compensated cirrhosis. Results from the Phase 3b EXPEDITION-8 study showed that with 8 weeks of MAVYRET™, 100 percent (n=273/273) of genotype 1, 2, 4, 5 and 6 patients achieved a sustained virologic response 12 weeks after treatment (SVR12) per protocol analysis.
These data are being presented today as a late-breaking, oral presentation at The Liver Meeting® 2018 organized by the American Association for the Study of Liver Diseases (AASLD) in San Francisco, California.
« Current guidelines recommend a 12-week pan-genotypic regimen for people who have hepatitis C, are treatment-naïve and have compensated cirrhosis, » said Robert S. Brown, Jr., M.D., the Gladys and Roland Harriman professor of medicine, Weill Cornell Medical College. « We are interested in investigating shorter treatment options, which may simplify care for patients with compensated cirrhosis while providing high cure rates. »
This analysis is part of the ongoing Phase 3b EXPEDITION-8 study evaluating the safety and efficacy of MAVYRET™ in treatment-naïve chronic HCV patients with compensated cirrhosis across all major genotypes (GT1-6). The study includes two cohorts; cohort one with genotype 1, 2, 4, 5, 6 chronic HCV-infected patients, and cohort two with genotype 3 (GT3) chronic HCV-infected patients.2Brown RS, Hezode C, Wang S, et al. Preliminary Efficacy and Safety of 8-Week Glecaprevir/Pibrentasvir in Patients with HCV Genotype 1–6 Infection and Compensated Cirrhosis: The EXPEDITION-8 Study. Presented at The Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco, U.S., November 13, 2018.
« MAVYRET™ is already having a significant impact on people living with HCV. However, there are still groups of patients who may benefit from a shorter treatment option, » said Janet Hammond, M.D., Ph.D., vice president, infectious diseases development, AbbVie. « We continue to investigate and understand the value of an 8-week treatment regimen for patients, something we recognize as an important step towards HCV elimination. »
To date, no virologic failures have been reported in cohort one of the study and no patients have discontinued treatment due to adverse events.1 Adverse events (>5%) reported of the study populations include pruritus (9.6%), fatigue (8.6%), headache (8.2%) and nausea (6.4%).1 Six serious adverse events (2%) have occurred during the study, none of which were deemed to be related to glecaprevir/pibrentasvir.1 No new safety signals were identified in this study.
Data from the ongoing EXPEDITION-8 Phase 3b study will be presented as a late-breaking, oral presentation during the Late-breaking Abstract Oral Session II on November 13 at 8:30 a.m. PST.
MAVYRET is approved in the U.S. as a 12-week pan-genotypic treatment for treatment-naïve patients with compensated cirrhosis.3MAVYRET™ tablets (glecaprevir/pibrentasvir) Prescribing Information. Chicago, U.S. AbbVie Inc
Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C.
About the EXPEDITION-8 Study1
EXPEDITION-8 is an ongoing non-randomized, single arm, open-label, multicenter Phase 3b study evaluating the safety and efficacy of glecaprevir/pibrentasvir in treatment-naïve GT1-6 chronic HCV patients with compensated cirrhosis. The study investigated two cohorts of patients:
- Cohort one: treatment-naïve genotype 1, 2, 4, 5, 6 patients with compensated cirrhosis (n=280)
- Cohort two: treatment-naïve GT3 patients with compensated cirrhosis (n=60)
The primary endpoint is the percentage of patients achieving SVR12 in a per-protocol analysis and the secondary endpoints are on-treatment virologic failure and relapse rates. For cohort one, 280 patients were enrolled and seven patients were excluded from the SVR12 per-protocol analysis (n=273); five patients were lost to follow up, and two patients received less than 8 weeks of treatment (one of these two patients achieved SVR12). Additional information on the clinical trials for MAVYRET™ is available at www.clinicaltrials.gov/.
About MAVYRETTM (glecaprevir/pibrentasvir)
MAVYRET™ is approved by the U.S. Food and Drug Administration (FDA) for the treatment of chronic hepatitis C virus (HCV) infection in adults across all major genotypes (GT1-6). MAVYRET™ is a pan-genotypic, 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, taken with food.
MAVYRET™ is an 8-week, pan-genotypic option for patients without cirrhosis and who are new to treatment, who comprise the majority of people living with HCV. MAVYRET™ is also approved as a treatment for patients with specific treatment challenges, including those (GT1) not cured by prior treatment experience to either a protease inhibitor or NS5A inhibitor (but not both), and in patients with limited treatment options, such as those with severe chronic kidney disease (CKD) or those with genotype 3 chronic HCV. MAVYRET is a pan-genotypic treatment approved for use in patients across all stages of CKD.
Glecaprevir (GLE) was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors.