Safety and efficacy of dual direct-acting antiviral therapy (daclatasvir and asunaprevir) for chronic hepatitis C virus genotype 1 infection in patients on hemodialysis.
BACKGROUND
Hepatitis C virus (HCV) infection is a major comorbidity in patients receiving hemodialysis. Interferon-based antiviral therapy to eradicate HCV is less effective in patients receiving hemodialysis than patients without renal dysfunction. Recently reported combination therapy with two oral direct-acting antiviral drugs, daclatasvir and asunaprevir, both of which are metabolized in the liver and excreted into the bile ducts, reportedly showed a high rate of HCV eradication. We evaluated the safety and efficacy of this therapy in patients receiving hemodialysis.


METHODS
The safety and viral responses were compared among patients infected with HCV genotype 1, between 28 patients receiving hemodialysis, and propensity score-matched 56 patients without renal dysfunction.


RESULTS
The reduction in serum HCV RNA levels 1 day after the start of therapy was significantly larger (p = 0.0329) and the disappearance of serum HCV RNA occurred significantly earlier (p = 0.0017) in patients receiving hemodialysis than those without renal dysfunction. The rates of sustained virologic response, i.e., the eradication of HCV, were comparable between two groups; the rate of SVR12 was 100 % in patients receiving hemodialysis and 94.6 % in patients without renal dysfunction. No adverse constitutional events were observed in either of the groups. The elevation of serum alanine aminotransferase levels, a known adverse effect of these drugs, was observed in comparable rate of patients between the two groups.


CONCLUSIONS
The therapy with daclatasvir and asunaprevir has high antiviral efficacy in patients receiving hemodialysis with a comparable safety profile to patients without renal dysfunction.
['Toyoda|Hidenori|H|', 'Kumada|Takashi|T|', 'Tada|Toshifumi|T|', 'Takaguchi|Koichi|K|', 'Ishikawa|Toru|T|', 'Tsuji|Kunihiko|K|', 'Zeniya|Mikio|M|', 'Iio|Etsuko|E|', 'Tanaka|Yasuhito|Y|']
D000368:Aged D000998:Antiviral Agents D002219:Carbamates D004359:Drug Therapy, Combination D005260:Female D016174:Hepacivirus D019698:Hepatitis C, Chronic D006801:Humans D007093:Imidazoles D007546:Isoquinolines D007676:Kidney Failure, Chronic D008297:Male D008875:Middle Aged D011759:Pyrrolidines D006435:Renal Dialysis D013449:Sulfonamides D016896:Treatment Outcome D014633:Valine
Safety Chronic hepatitis C Hemodialysis Direct-acting antiviral drugs Viral response