Journal
JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY
Volume 31, Issue 1, Pages 14-22Publisher
WILEY-BLACKWELL
DOI: 10.1111/jgh.13073
Keywords
asunaprevir; daclatasvir; efficacy; hepatitis C; safety
Categories
Funding
- Bristol-Myers Squibb
- AbbVie
- Ajinomoto
- Astellas
- Astrazeneca
- Bayer
- Chugai
- Daiichi Sankyo
- Dainippon Sumitomo
- Eisai
- GlaxoSmithKline
- Janssen
- Kowa
- Kyorin
- Meji Seika
- Mitsubishi Tanabe
- MSD
- Nippon Kayaku
- Nippon Seiyaku
- Nippon Shinyaku
- Otsuka
- Roche
- Takeda
- Teijin
- Toray
- Torii
- Tsumura
- Zeria
- Merck Sharp Dohme
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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. 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 x 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. Results: In treatment-naive patients, sustained virologic response at post-treatment week 12 in daclatasvir plus asunaprevir recipientswas 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 comparedwith 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%). Conclusion: Marked differences were observed in the efficacy and safety profile of daclatasvir in combination with asunaprevir, compared with telaprevir plus peginterferon/ribavirin.
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