Asunaprevir for hepatitis C: a safety evaluation.
BACKGROUND
The introduction of direct-acting antiviral (DAA) agents has revolutionized the treatment of hepatitis C virus (HCV) chronic infection. Non-structural 3 protease inhibitors are currently the most numerous class of DAAs on the market.


METHODS
This review mainly focuses on the tolerability and safety profile of asunaprevir (ASV)-containing DAA regimens. ASV is a second-wave protease inhibitor currently in Phase III clinical development in most countries and already available in Japan.


CONCLUSIONS
ASV shows potent antiviral effect and clinical efficacy on HCV genotypes 1 and 4. The all-oral combination daclatasvir/ASV reached high eradication rates in HCV genotype 1b and 4 infection, and a lower efficacy in genotype 1a infection. ASV presents a low potential for drug-drug interaction and a good tolerability as part of multiple, including all-oral, regimens. ASV is associated with a transient and usually mild increase in aminotransferase levels in a low percentage of cases. Due to the impaired pharmacokinetic profile observed in advanced liver disease, ASV use in patients with moderate or severe hepatic impairment is not allowed. In conclusion, ASV represents a powerful weapon against HCV infection and has to be considered an optimal option as a component of genotype tailored interferon-free combinations.
a University of Naples "Federico II", Department of Clinical Medicine and Surgery , via S. Pansini 5, I-80131 Naples, Italy +39 081 746 3178 ; +39 081 746 3190 ; c.fid@hotmail.com.
Ivan
I
Gentile
a University of Naples "Federico II", Department of Clinical Medicine and Surgery , via S. Pansini 5, I-80131 Naples, Italy +39 081 746 3178 ; +39 081 746 3190 ; c.fid@hotmail.com.
Emanuela
E
Zappulo
a University of Naples "Federico II", Department of Clinical Medicine and Surgery , via S. Pansini 5, I-80131 Naples, Italy +39 081 746 3178 ; +39 081 746 3190 ; c.fid@hotmail.com.
Antonio Riccardo
AR
Buonomo
a University of Naples "Federico II", Department of Clinical Medicine and Surgery , via S. Pansini 5, I-80131 Naples, Italy +39 081 746 3178 ; +39 081 746 3190 ; c.fid@hotmail.com.
Riccardo
R
Scotto
a University of Naples "Federico II", Department of Clinical Medicine and Surgery , via S. Pansini 5, I-80131 Naples, Italy +39 081 746 3178 ; +39 081 746 3190 ; c.fid@hotmail.com.
Guglielmo
G
Borgia
D000818:Animals; D000998:Antiviral Agents / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use; D002219:Carbamates; D004359:Drug Therapy, Combination; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage / Q000627:therapeutic use; D007546:Isoquinolines / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use; D011480:Protease Inhibitors / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D011759:Pyrrolidines; D013449:Sulfonamides / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use; D014633:Valine / Q000031:analogs & derivatives
D000998:Antiviral Agents; D002219:Carbamates; D007093:Imidazoles; D007546:Isoquinolines; D011480:Protease Inhibitors; D011759:Pyrrolidines; D013449:Sulfonamides; D014633:Valine; C549273:daclatasvir; C571889:asunaprevir
BMS-650032; DAA; HCV; NS3 protease; beclabuvir; daclatasvir; interferon-free