Assessing the Risk of Decrease in Kidney Function in Patients Prescribed Direct-Acting Antivirals for Hepatitis C...

Area of Science:

• Pharmacology
• Nephrology
• Hepatology

Background:

• Hepatitis C treatment with direct-acting antivirals (DAAs) has advanced, but concerns about kidney function impact persist.
• Package insert warnings regarding kidney disease risk associated with DAAs vary, necessitating further investigation.

Purpose of the Study:

• To investigate the risk of decreased kidney function in patients using DAAs marketed in Japan.
• To determine if kidney disease risk is a common adverse event and class effect across all DAAs.

Main Methods:

• Retrospective analysis of new DAA users in Japan from the MID-NET® database.
• Patients had an estimated glomerular filtration rate (eGFR) ≥ 45 mL/min/1.73 m² and no specific risk factors.
• Kidney function changes were assessed by eGFR categories; 10 exposure patterns based on package inserts were analyzed.

Main Results:

• A significant increase in the incidence rate ratio for decreased kidney function was observed with specific DAA combinations: telaprevir with peginterferon alpha and ribavirin; daclatasvir hydrochloride with asunaprevir; and ombitasvir hydrate/paritaprevir hydrate/ritonavir with ribavirin.
• No increased risk was found for other DAA prescription patterns.
• P-value < 0.01 indicated statistical significance for the observed increased risks.

Conclusions:

• The impact of DAAs on kidney function appears to differ among individual drugs.
• The risk of kidney disease associated with DAAs may not be a class effect.
• Each DAA should be evaluated individually for its specific risk of kidney disease.