16 HCV abstracts to be presented including 12 data presentations on the safety and efficacy of MAVYRET
- MAVYRET is recommended in new AASLD guidelines as a first line treatment option for 8 weeks in treatment-naïve non-cirrhotic HCV patients across all genotypes (GT1-6)
NORTH CHICAGO, Ill., Oct. 11, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development based biopharmaceutical company, today announced that it will present new data evaluating MAVYRET™ (glecaprevir/pibrentasvir), its once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6), at the annual meeting of the American Association for the Study of Liver Diseases (AASLD). Sixteen AbbVie scientific abstracts have been accepted, including two oral presentations studying the use of MAVYRET in patients across genotypes (GT1-6) with compensated cirrhosis and treatment-naïve patients with genotype 3 (GT3) HCV. These populations have historically had limited treatment options. A third oral presentation evaluates adherence to treatment with MAVYRET in the clinical development program. The Liver Meeting® 2017 will take place in Washington, D.C., from October 20 – 24, 2017.
"AbbVie's data presentations at this year's The Liver Meeting reinforce our commitment to people living with hepatitis C," said Janet Hammond, M.D., Ph.D., vice president, infectious diseases development, AbbVie. "These data add to a robust collection of clinical trial results to further enhance scientific knowledge of MAVYRET's safety and efficacy across a number of patient populations."
Researchers will also present data obtained from the MAVYRET clinical program evaluating patients with cardiovascular, metabolic and renal conditions as well as data on HCV patient preferences.
"On the heels of AASLD's newly released HCV treatment guidance, we are excited to see additional data on MAVYRET across a broad range of patients," said Fred Poordad, M.D., vice president, academic and clinical affairs, Texas Liver Institute and professor of medicine, University of Texas Health, San Antonio. "The updated recommendations on available treatments, including the use of MAVYRET in the majority of patients, serve as an additional source of information to help physicians make treatment decisions."
- MAVYRET is recommended in new AASLD guidelines as a first line treatment option for 8 weeks in treatment-naïve non-cirrhotic HCV patients across all genotypes (GT1-6)
NORTH CHICAGO, Ill., Oct. 11, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development based biopharmaceutical company, today announced that it will present new data evaluating MAVYRET™ (glecaprevir/pibrentasvir), its once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6), at the annual meeting of the American Association for the Study of Liver Diseases (AASLD). Sixteen AbbVie scientific abstracts have been accepted, including two oral presentations studying the use of MAVYRET in patients across genotypes (GT1-6) with compensated cirrhosis and treatment-naïve patients with genotype 3 (GT3) HCV. These populations have historically had limited treatment options. A third oral presentation evaluates adherence to treatment with MAVYRET in the clinical development program. The Liver Meeting® 2017 will take place in Washington, D.C., from October 20 – 24, 2017.
"AbbVie's data presentations at this year's The Liver Meeting reinforce our commitment to people living with hepatitis C," said Janet Hammond, M.D., Ph.D., vice president, infectious diseases development, AbbVie. "These data add to a robust collection of clinical trial results to further enhance scientific knowledge of MAVYRET's safety and efficacy across a number of patient populations."
Researchers will also present data obtained from the MAVYRET clinical program evaluating patients with cardiovascular, metabolic and renal conditions as well as data on HCV patient preferences.
"On the heels of AASLD's newly released HCV treatment guidance, we are excited to see additional data on MAVYRET across a broad range of patients," said Fred Poordad, M.D., vice president, academic and clinical affairs, Texas Liver Institute and professor of medicine, University of Texas Health, San Antonio. "The updated recommendations on available treatments, including the use of MAVYRET in the majority of patients, serve as an additional source of information to help physicians make treatment decisions."
Select AbbVie clinical presentations include:
MAVYRET Abstracts
The full AASLD 2017 scientific program can be found at www.aasld.org.
About MAVYRET™ (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.
Full prescribing information can be found here.
Source
MAVYRET Abstracts
- Adherence to Pangenotypic Glecaprevir/Pibrentasvir Treatment and SVR12 in HCV-Infected Patients: An Integrated Analysis of the Phase 2/3 Clinical Trial Program - Abstract 198; Oral Presentation; Monday, October 23, 2017; 4:15 p.m. ET
- Efficacy and Safety of Glecaprevir/Pibrentasvir for 8 or 12 Weeks in Treatment-Naïve Patients with Chronic HCV Genotype 3: An Integrated Phase 2/3 Analysis - Abstract 62; Oral Presentation; Sunday, October 22, 2017; 1:15 p.m. ET
- Efficacy, Safety, and Pharmacokinetics of Glecaprevir/Pibrentasvir in Adults With Chronic Genotype 1-6 Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis - Abstract 74; Oral Presentation; Sunday, October 22, 2017; 3:15 p.m. ET
- Efficacy and Safety of Glecaprevir/Pibrentasvir in Patients Infected with HCV GT1-3 by Renal Impairment Status: A Pooled Analysis of Two Phase 3 Japanese Trials - Abstract 1179; Poster Session; Saturday, October 21, 2017; 2:00 – 7:00 p.m. ET
- Safety and Efficacy of Glecaprevir/Pibrentasvir in Patients With Chronic Hepatitis C Genotypes 1–6 and Recent Drug Use - Abstract 1182; Poster Session; Saturday, October 21, 2017; 2:00 – 7:00 p.m. ET
- Safety and Efficacy of Glecaprevir/Pibrentasvir in Patients Aged 65 Years or Older With Chronic Hepatitis C: A Pooled Analysis of Phase 2 and 3 Clinical Trials - Abstract 1188; Poster Session; Saturday, October 21, 2017; 2:00 – 7:00 p.m. ET
- Impact of Hepatitis C Treatment With Glecaprevir + Pibrentasvir on Patient`s Health-Related Quality of Life: Results From Phase 3 CERTAIN Trials - Abstract 1187; Poster Session; Saturday, October 21, 2017; 2:00 – 7:00 p.m. ET
- Exposure-Safety Response Relationship for Glecaprevir and Pibrentasvir in Hepatitis C Virus-Infected Subjects in Phase 2 and 3 Studies - Abstract 1189; Poster Session; Saturday, October 21, 2017; 2:00 – 7:00 p.m. ET
- Exposure-Response Analyses of Virologic Response to Glecaprevir and Pibrentasvir in HCV Subjects from Phase 2 and 3 Studies - Abstract 1185; Poster Session; Saturday, October 21, 2017; 2:00 – 7:00 p.m. ET
- Glecaprevir and Pibrentasvir Exposures in Hepatitis C Virus-Infected Subjects in Phase 2 and 3 Studies - Abstract 1190; Poster Session; Saturday, October 21, 2017; 2:00 – 7:00 p.m. ET
- Assessing Patient Preferences for and Relative Importance of Features of New Direct Acting Antiviral (DAA) Treatments for Chronic Hepatitis C Virus (HCV) Infections - Abstract 741; Poster Session; Friday, October 20, 2017; 8:00 a.m. – 5:30 p.m. ET
The full AASLD 2017 scientific program can be found at www.aasld.org.
About MAVYRET™ (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.
Full prescribing information can be found here.
Source
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