Is itraconazole (antifungal medication) safe to use for fungal infection in a 24-year-old male patient with a history of hepatitis B (infectious disease caused by the hepatitis B virus) in his childhood, now inactive?

From the Guidelines

Itraconazole can be used with caution in a 24-year-old male with a history of inactive hepatitis B, but requires close monitoring. Before starting treatment, baseline liver function tests should be obtained, and these should be monitored regularly throughout the course of therapy, as recommended by the Infectious Diseases Society of America 1. The typical adult dose for fungal infections is 100-200 mg daily for 1-6 months, depending on the specific infection being treated. The patient should take itraconazole with food to enhance absorption, and acidic beverages like cola can improve absorption if stomach acid is low. Since itraconazole is metabolized by the liver, there is a theoretical risk of liver injury, especially in someone with a history of liver disease. If the patient develops symptoms such as unusual fatigue, loss of appetite, nausea, vomiting, dark urine, or yellowing of the skin or eyes during treatment, they should contact their healthcare provider immediately. Additionally, itraconazole has many drug interactions, so the patient should inform their doctor about all medications they are taking, including over-the-counter drugs and supplements. Some key points to consider when using itraconazole in this patient include:

• Monitoring liver function tests regularly, as recommended by the guidelines for the management of blastomycosis 1 and histoplasmosis 1
• Informing the patient about the potential risks of liver injury and the importance of reporting any symptoms promptly
• Ensuring the patient is aware of the potential for drug interactions and the need to inform their doctor about all medications they are taking
• Considering the use of alternative antifungal agents if the patient is unable to tolerate itraconazole or has significant drug interactions. It is also important to note that the patient's history of inactive hepatitis B does not necessarily preclude the use of itraconazole, but it does require careful monitoring and consideration of the potential risks and benefits, as suggested by the guidelines for the management of sporotrichosis 1.

From the FDA Drug Label

In patients with elevated or abnormal liver enzymes or active liver disease, or who have experienced liver toxicity with other drugs, treatment with SPORANOX ® is strongly discouraged unless there is a serious or life-threatening situation where the expected benefit exceeds the risk. It is recommended that liver function monitoring be done in patients with pre-existing hepatic function abnormalities or those who have experienced liver toxicity with other medications.

The patient had a history of hepatitis B in his childhood, but it is now inactive. Caution should be exercised when administering itraconazole to this patient. Although the hepatitis B is inactive, the patient's liver function should be monitored while taking itraconazole, as the drug label recommends monitoring in patients with pre-existing hepatic function abnormalities. The decision to use itraconazole should be made on a case-by-case basis, weighing the potential benefits against the potential risks, especially since the patient's hepatitis B is inactive and not currently active 2.

From the Research

Safety of Itraconazole in Patients with History of Hepatitis B

• Itraconazole is a triazole antifungal agent with a broad spectrum of activity and is generally well tolerated 3.
• There is no direct evidence in the provided studies regarding the safety of itraconazole in patients with a history of hepatitis B.
• However, studies suggest that antifungal agents, including triazoles, may cause hepatic toxicity ranging from mild and asymptomatic abnormalities in liver function tests to substantial liver injury and fulminant hepatic failure 4, 5.
• A study on voriconazole hepatotoxicity in patients with severe liver dysfunction found that 69% of patients treated with voriconazole showed changes in liver function tests during therapy 6.
• Another study on itraconazole prophylaxis in chronic granulomatous disease found that one patient had elevated results on liver-function tests, which resolved with the discontinuation of itraconazole 7.
• It is essential to monitor liver function tests and use itraconazole with caution in patients with a history of liver disease, including hepatitis B 5.

Considerations for Patients with Inactive Hepatitis B

• Patients with inactive hepatitis B may still be at risk for hepatic toxicity when using antifungal agents 5.
• The risk of hepatotoxicity associated with itraconazole is not clearly established, but alternatives to ketoconazole, such as itraconazole, fluconazole, voriconazole, and terbinafine, are available 4.
• A thorough understanding of the distribution, metabolism, elimination, and drug-drug interactions of antifungal agents, along with safety data from clinical trials, pharmacokinetic, and pharmacodynamic studies, may guide the use of antifungal treatment in patients at high risk for the development of hepatic dysfunction 5.