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Randomized comparison of daclatasvir + asunaprevir versus telaprevir + peginterferon/ribavirin in Japanese hepatitis C virus patients
Author(s) -
Kumada Hiromitsu,
Suzuki Fumitaka,
Suzuki Yoshiyuki,
Toyota Joji,
Karino Yoshiyasu,
Chayama Kazuaki,
Kawakami Yoshiiku,
Fujiyama Shigetoshi,
Ito Takayoshi,
Itoh Yoshito,
Tamura Etsuko,
Ueki Tomoko,
Ishikawa Hiroki,
Hu Wenhua,
McPhee Fiona,
Linaberry Misti,
Hughes Eric
Publication year - 2016
Publication title -
journal of gastroenterology and hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.214
H-Index - 130
eISSN - 1440-1746
pISSN - 0815-9319
DOI - 10.1111/jgh.13073
Subject(s) - daclatasvir , telaprevir , medicine , ribavirin , gastroenterology , adverse effect , hepatitis c virus , boceprevir , hepatitis c , virology , virus
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 × 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 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%). Conclusion Marked differences were observed in the efficacy and safety profile of daclatasvir in combination with asunaprevir, compared with telaprevir plus peginterferon/ribavirin.