OC-010 Final efficacy and safety in hcv genotype 1-infected patients receiving ombitasvir/paritaprevir/ritonavir and dasabuvir ± ribavirin: topaz-i results from the united kingdom and ireland. (17th June 2017)
- Record Type:
- Journal Article
- Title:
- OC-010 Final efficacy and safety in hcv genotype 1-infected patients receiving ombitasvir/paritaprevir/ritonavir and dasabuvir ± ribavirin: topaz-i results from the united kingdom and ireland. (17th June 2017)
- Main Title:
- OC-010 Final efficacy and safety in hcv genotype 1-infected patients receiving ombitasvir/paritaprevir/ritonavir and dasabuvir ± ribavirin: topaz-i results from the united kingdom and ireland
- Authors:
- Forton, D
Ustianowski, A
Aspinall, R
Ryder, S
Aldersley, M
Mutimer, D
Murray, F
McCormick, PA
Dillon, J
Foster, G
Agarwal, K
Charafeddine, M
Joy, A
Liu, L
Stanica, R-M
Pilot-Matias, T
O'Meara, M
Pollard, C
Cohen, DE
Norris, S - Abstract:
- Abstract : Introduction: Ombitasvir/paritaprevir*/ritonavir (*identified by AbbVie and Enanta) and dasabuvir (3-DAA) ± ribavirin (RBV) treatment is effective and safe for patients infected with hepatitis C genotype 1 (HCV GT1), including those with compensated cirrhosis. TOPAZ-I, an ongoing global phase 3b trial, assesses the impact of sustained virologic response (HCV RNA Method: The enrolled patients in TOPAZ-I received 3-DAA ± RBV, per label. These pooled, interim results included SVR12, adverse events (AEs), clinical outcomes, and liver stiffness evolution. SVR12 data were analysed using the intent-to-treat (ITT) population (missing data imputed as failures). Results: Among the 126 patients enrolled (table), the ITT SVR12 rate was 98%: one patient relapsed and 2 discontinued study drug prematurely, one due to AEs. AEs occurring in >10% of patients are listed in table. Six patients experienced serious AEs, none related to DAAs. Grade 3 laboratory abnormalities were rare and no Grade 4 abnormalities were reported. Three patients experienced adverse clinical outcomes, none deemed study drug-related: HCC (on treatment), fatal aspiration pneumonia (on treatment), and death from ischaemic heart disease (post-treatment week 18). Conclusion: These regional TOPAZ-I results confirm the efficacy and safety of 3-DAA ± RBV in HCV GT1-infected patients. Adverse clinical outcomes were rare. Liver stiffness changes post-treatment will be presented at the meeting. Disclosure of Interest:Abstract : Introduction: Ombitasvir/paritaprevir*/ritonavir (*identified by AbbVie and Enanta) and dasabuvir (3-DAA) ± ribavirin (RBV) treatment is effective and safe for patients infected with hepatitis C genotype 1 (HCV GT1), including those with compensated cirrhosis. TOPAZ-I, an ongoing global phase 3b trial, assesses the impact of sustained virologic response (HCV RNA Method: The enrolled patients in TOPAZ-I received 3-DAA ± RBV, per label. These pooled, interim results included SVR12, adverse events (AEs), clinical outcomes, and liver stiffness evolution. SVR12 data were analysed using the intent-to-treat (ITT) population (missing data imputed as failures). Results: Among the 126 patients enrolled (table), the ITT SVR12 rate was 98%: one patient relapsed and 2 discontinued study drug prematurely, one due to AEs. AEs occurring in >10% of patients are listed in table. Six patients experienced serious AEs, none related to DAAs. Grade 3 laboratory abnormalities were rare and no Grade 4 abnormalities were reported. Three patients experienced adverse clinical outcomes, none deemed study drug-related: HCC (on treatment), fatal aspiration pneumonia (on treatment), and death from ischaemic heart disease (post-treatment week 18). Conclusion: These regional TOPAZ-I results confirm the efficacy and safety of 3-DAA ± RBV in HCV GT1-infected patients. Adverse clinical outcomes were rare. Liver stiffness changes post-treatment will be presented at the meeting. Disclosure of Interest: D. Forton Conflict with: participated in AbbVie-sponsored research, A. Ustianowski Conflict with: participated in AbbVie-sponsored research, R. Aspinall Conflict with: participated in AbbVie-sponsored research, S. Ryder Conflict with: participated in AbbVie-sponsored research, M. Aldersley Conflict with: participated in AbbVie-sponsored research, D. Mutimer Conflict with: participated in AbbVie-sponsored research, F. Murray Conflict with: participated in AbbVie-sponsored research, P. McCormick Conflict with: participated in AbbVie-sponsored research, J. Dillon Conflict with: participated in AbbVie-sponsored research, G. Foster Conflict with: participated in AbbVie-sponsored research, K. Agarwal Conflict with: participated in AbbVie-sponsored research, M. Charafeddine Conflict with: AbbVie employee and may own company stock, A. Joy Conflict with: AbbVie employee and may own company stock, L. Liu Conflict with: AbbVie employee and may own company stock, R.-M. Stanica Conflict with: AbbVie employee and may own company stock, T. Pilot-Matias Conflict with: AbbVie employee and may own company stock, M. O'Meara Conflict with: AbbVie employee and may own company stock, C. Pollard Conflict with: AbbVie employee and may own company stock, D. Cohen Conflict with: AbbVie employee and may own company stock, S. Norris Conflict with: participated in AbbVie-sponsored research … (more)
- Is Part Of:
- Gut. Volume 66(2017)Supplement 2
- Journal:
- Gut
- Issue:
- Volume 66(2017)Supplement 2
- Issue Display:
- Volume 66, Issue 2 (2017)
- Year:
- 2017
- Volume:
- 66
- Issue:
- 2
- Issue Sort Value:
- 2017-0066-0002-0000
- Page Start:
- A5
- Page End:
- A6
- Publication Date:
- 2017-06-17
- Subjects:
- HCV -- Hepatitis C
Gastroenterology -- Periodicals
616.33 - Journal URLs:
- http://gut.bmjjournals.com ↗
http://www.bmj.com/archive ↗ - DOI:
- 10.1136/gutjnl-2017-314472.10 ↗
- Languages:
- English
- ISSNs:
- 0017-5749
- Deposit Type:
- Legaldeposit
- View Content:
- Available online (eLD content is only available in our Reading Rooms) ↗
- Physical Locations:
- British Library DSC - BLDSS-3PM
British Library HMNTS - ELD Digital store - Ingest File:
- 19736.xml