Thursday, April 13, 2017

Efficacy and safety of dual therapy with daclatasvir and asunaprevir in elderly patients

World J Hepatol. Apr 18, 2017; 9(11): 544-550
Published online Apr 18, 2017. doi: 10.4254/wjh.v9.i11.544
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Efficacy and safety of dual therapy with daclatasvir and asunaprevir in elderly patients
Kazuo Tarao, Katsuaki Tanaka, Akito Nozaki, Akira Sato, Toshiya Ishii, Hirokazu Komatsu, Takaaki Ikeda, Tatsuji Komatsu, Shozo Matsushima, Kenji Oshige

Core tip: Recently, it was demonstrated that dual oral therapy with daclatasvir and asunaprevir without pegylated-interferon/ribavirin was well tolerated and achieved high sustained virological response rates in Japanese patients with chronic hepatitis C virus genotype Ιb infection, including patients with liver cirrhosis (Child A stage). However, the efficacy and side effects of these drugs was previously studied in non-elderly patients (less than 70 years of age). Those in elderly patients, who are supposed to have higher incidence of hepatocellular carcinoma, have not been studied. We demonstrated that efficacy and side effects in elderly patients were nearly the same as in non-elderly patients.

To survey the efficacy and safety of dual therapy with daclatasvir and asunaprevir in the elderly hepatitis C virus (HCV) patients multicentricity.
Interferon-ineligible/intolerant patients and non-responders to previous pegylated-interferon/ribavirin therapy with chronic HCV genotype 1b infection were enrolled. Child B, C cirrhotic patients were excluded. Patients received oral direct acting antiviral treatment consisting of 60 mg daclatasvir once daily plus 200 mg asunaprevir twice daily for 24 wk. We divided the patients into two groups of 56 elderly patients (≥ 75 years-old) and 141 non-elderly patients (< 75 years old) and compared the efficacy and safety.
Ninety-one point one percent of elderly patients and 90.1% of non-elderly patients achieved sustained virological response at 24 wk (SVR24). In the former, 1.8% experienced viral breakthrough, as compared with 3.5% in the latter (not significant). Adverse events occurred in 55.4% of the former and 56.0% of the latter. In the former, 7 cases (12.5%) were discontinued due to adverse events, and in the latter 9 cases were discontinued (6.4%, not significant).
Dual therapy with daclatasvir and asunaprevir achieved the same high rates of SVR24 in HCV elderly patients without more adverse events than in the non-elderly patients.
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