Clin Mol Hepatol.  2016 Jun;22(2):259-266. 10.3350/cmh.2016.0020.

Efficacy and safety of daclatasvir and asunaprevir for hepatitis C virus genotype 1b infection

• Nam HC
• Lee HL
• Yang H
• Song MJ

• KMID: 2373122
• DOI: http://doi.org/10.3350/cmh.2016.0020

Abstract

BACKGROUND/AIMS
The treatment strategy for hepatitis C virus (HCV) has been changing rapidly since the introduction of direct-acting antivirals such as daclatasvir (DCV) and asunaprevir (ASV). We evaluated the efficacy and safety of DCV and ASV for HCV in real-life practice.
METHODS
Patients were treated with 60 mg of DCV once daily plus 200 mg of ASV twice daily for 24 weeks, and followed for 12 weeks. The primary endpoint was a sustained virological response at 12 weeks after treatment (SVR12) and safety.
RESULTS
This retrospective study included eight patients with chronic HCV genotype 1b infection. All of the enrolled patients were diagnosed with liver cirrhosis, and their mean age was 65.75 years. One patient was a nonresponder and two patients relapsed with previous pegylated interferon (PegIFN) and ribavirin (RBV) treatment. None of the patient showed NS5A mutation. An SVR12 was achieved in 88% of cases by the DCV and ASV combination therapy. The serum transaminase level and the aspartate-aminotransferase-to-platelet ratio were improved after the treatment. DCV and ASV were well tolerated in most of the patients, with treatment discontinuation due to adverse events (elevated liver enzyme and decompensation) occurring in two patients.
CONCLUSIONS
In this study, combination of DCV and ASV treatment achieved a high sustained virological response with few adverse events even in those with cirrhosis, advanced age, and nonresponse/relapse to previous interferon-based therapy. Close monitoring of safety issues may be necessary when treating chronic HCV patients receiving DCV and ASV, especially in older patient and those with cirrhosis.

Keyword

Hepatitis C virus; Liver cirrhosis; Direct-acting antivirals; Daclatasvir; Asunaprevir

MeSH Terms

Aged
Alanine Transaminase/blood
Antiviral Agents/*therapeutic use
Aspartate Aminotransferases/blood
Drug Administration Schedule
Drug Resistance, Viral
Drug Therapy, Combination
Female
Genotype
Hepacivirus/*genetics/isolation & purification
Hepatitis C, Chronic/complications/*drug therapy/virology
Humans
Imidazoles/*therapeutic use
Isoquinolines/*therapeutic use
Liver/diagnostic imaging
Liver Cirrhosis/complications
Male
Middle Aged
RNA, Viral/blood
Retrospective Studies
Sulfonamides/*therapeutic use
Treatment Outcome
Alanine Transaminase
Antiviral Agents
Aspartate Aminotransferases
Imidazoles
Isoquinolines
RNA, Viral
Sulfonamides