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Randomized comparison of daclatasvir + asunaprevir versus telaprevir + peginterferon/ribavirin in Japanese hepatitis C virus patients.
- Source :
-
Journal of gastroenterology and hepatology [J Gastroenterol Hepatol] 2016 Jan; Vol. 31 (1), pp. 14-22. - Publication Year :
- 2016
-
Abstract
- Background and Aim: Daclatasvir combined with asunaprevir is the first all-oral, ribavirin-free treatment of hepatitis C virus genotype 1b infection in Japan. This study compared the efficacy and safety of daclatasvir plus asunaprevir versus telaprevir plus peginterferon/ribavirin in Japanese treatment-naive patients infected with hepatitis C virus genotype 1b.<br />Methods: Treatment-naive patients (20-70 years; baseline viral load, ≥ 100,000 IU/mL) were randomly assigned (stratified by IL28B rs8099917 TT/non-TT status) to receive either daclatasvir 60 mg tablets once daily and asunaprevir 100 mg softgel capsules twice daily for 24 weeks or telaprevir 750 mg (3 × 250 mg tablets) three times daily for 12 weeks and peginterferon/ribavirin per Japanese prescribing information for 24 weeks. A cohort of prior relapsers to peginterferon/ribavirin (20-75 years; baseline viral load, ≥ 100,000 IU/mL) received daclatasvir plus asunaprevir.<br />Results: In treatment-naive patients, sustained virologic response at post-treatment week 12 in daclatasvir plus asunaprevir recipients was non-inferior (treatment difference, +25.8% in favor of daclatasvir plus asunaprevir) and higher (89.1%, 106/119) than telaprevir plus peginterferon/ribavirin recipients (62.2%, 69/111); sustained viral response was achieved in 95.5% (n = 21/22) of relapsers. Numerically, fewer patients receiving daclatasvir plus asunaprevir compared with telaprevir plus peginterferon/ribavirin experienced serious adverse events (4.2% vs. 5.4%), adverse events leading to discontinuation of any drug (5.0% vs. 62.2%), grade 3/4 treatment-related adverse events (14.3% vs. 72.1%), rash-related events (0% vs. 13.5%), or anemia (0% vs. 47.7%).<br />Conclusion: Marked differences were observed in the efficacy and safety profile of daclatasvir in combination with asunaprevir, compared with telaprevir plus peginterferon/ribavirin.<br /> (© 2015 Bristol-Myers Squibb. Journal of Gastroenterology and Hepatology published by Wiley Publishing Asia Pty Ltd. and Journal of Gastroenterology and Hepatology Foundation.)
- Subjects :
- Adult
Aged
Asian People
Carbamates
Cohort Studies
Drug Therapy, Combination
Female
Humans
Interferon alpha-2
Male
Middle Aged
Pyrrolidines
Recombinant Proteins administration & dosage
Treatment Outcome
Valine analogs & derivatives
Young Adult
Antiviral Agents administration & dosage
Hepatitis C drug therapy
Imidazoles administration & dosage
Interferon-alpha administration & dosage
Isoquinolines administration & dosage
Oligopeptides administration & dosage
Polyethylene Glycols administration & dosage
Ribavirin administration & dosage
Sulfonamides administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1440-1746
- Volume :
- 31
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Journal of gastroenterology and hepatology
- Publication Type :
- Academic Journal
- Accession number :
- 26252875
- Full Text :
- https://doi.org/10.1111/jgh.13073