Efficacy and safety of daclatasvir plus asunaprevir therapy for chronic hepatitis C patients with renal dysfunction
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Yuki Nakamura1, Michio Imamura1, Yoshiiku Kawakami1
1Department of Gastroenterology and, Metabolism, Applied Life Science, Institute of Biomedical & Health Science, Hiroshima University, Hiroshima, Japan.
Insights
Daclatasvir and asunaprevir combination therapy is safe and effective for treating chronic hepatitis C virus (HCV) infection in patients with renal dysfunction not on hemodialysis. Renal function did not impact treatment outcomes or safety.
Area of Science:
- Hepatology
- Nephrology
- Infectious Diseases
Background:
- Chronic hepatitis C virus (HCV) infection is linked to kidney dysfunction.
- Daclatasvir and asunaprevir combination therapy has shown efficacy in HCV patients on hemodialysis.
- Limited data exists on this therapy's safety and efficacy in non-hemodialysis patients with renal impairment.
Purpose of the Study:
- To evaluate the safety and efficacy of daclatasvir plus asunaprevir in chronic HCV genotype 1 patients with varying degrees of renal function.
- To assess the impact of renal dysfunction on the pharmacokinetics of daclatasvir and asunaprevir.
- To determine the virological response and adverse event profile in patients with and without renal dysfunction.
Main Methods:
- A total of 147 patients with chronic HCV genotype 1 infection were treated with daclatasvir and asunaprevir for 24 weeks.
- Patients were categorized into two groups: normal renal function (eGFR ≥ 50 ml/min/1.73 m²) and renal dysfunction (eGFR < 50 ml/min/1.73 m²).
- Plasma drug concentrations, early virological response, end-of-treatment response, sustained virological response, and adverse events were monitored.
Main Results:
- Plasma concentrations of daclatasvir and asunaprevir were similar between groups.
- Early and sustained virological responses were comparable, with high rates in both normal renal function (94.4%) and renal dysfunction (95.2%) groups.
- Adverse event frequencies were similar, with no significant changes in renal function during or after treatment.
Conclusions:
- Renal function does not significantly impact the pharmacokinetics of daclatasvir and asunaprevir.
- Daclatasvir and asunaprevir combination therapy is effective and safe for chronic HCV genotype 1 patients with renal dysfunction who are not on hemodialysis.
- This treatment offers a viable option for a broader HCV patient population, including those with impaired kidney function.
Abstract:
Chronic hepatitis C virus (HCV) infection is associated with renal dysfunction. Daclatasvir and asunaprevir combination therapy showed a high virological response for genotype 1 chronic HCV-infected patients with renal dysfunction on hemodialysis. However, the safety and efficacy of the therapy for patients with renal dysfunction who are not on hemodialysis are not well-known. In total, 147 patients with chronic HCV genotype 1 infection were treated with 24 weeks of daclatasvir plus asunaprevir therapy. Among these patients, 126 had normal renal function (estimated glomerular filtration rate [eGFR] ≥ 50 ml/min/1.73 m2 ) and 21 had renal dysfunction (eGFR < 50 ml/min/1.73 m2 ). Plasma concentrations of daclatasvir and asunaprevir after 5 days of treatment were the same in the normal renal function and renal dysfunction groups. Early virological response (4, 8, 48, 96, and 168 hr after the start of the therapy) was similar between the two groups. End-of-treatment response was achieved in 122 (96.8%) and 20 (95.2%) patients with normal renal function and with renal dysfunction, respectively, and sustained virological response was achieved in 119 (94.4%) and 20 (95.2%) patients. The frequency of adverse events was also comparable between the two groups. Treatment discontinuation due to adverse events was required for only one patient in each group. Renal function did not change either during or after treatment in both groups. In conclusion, renal function is unlikely to have a significant impact on blood kinetics of daclatasvir and asunaprevir. This combination therapy was effective and safe for patients without hemodialysis. J. Med. Virol. 89:665-671, 2017. © 2016 Wiley Periodicals, Inc.
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