[Darunavir in HIV/HVC/HVB coinfection]

Area of Science:

• Pharmacology
• Hepatology
• Infectious Diseases

Background:

• Darunavir/ritonavir is a key antiretroviral for HIV-1 treatment in pre-treated adults.
• Co-infection with hepatitis B (HBV) or C (HCV) is common in HIV-1 patients.
• Liver function abnormalities are a concern in patients with pre-existing liver disease.

Purpose of the Study:

• To evaluate the efficacy and safety of darunavir/ritonavir in HIV-1 patients with HBV/HCV co-infection.
• To assess the impact of hepatic impairment on darunavir pharmacokinetics.
• To provide recommendations for monitoring and dosing in co-infected and liver-impaired patients.

Main Methods:

• Review of clinical data on darunavir/ritonavir use in HIV-1 patients.
• Analysis of virological response and adverse events in co-infected versus non-co-infected patients.
• Pharmacokinetic studies in patients with varying degrees of hepatic impairment.

Main Results:

• Virological response to darunavir/ritonavir was unaffected by HBV/HCV co-infection.
• Adverse event incidence was similar, with only increased liver enzymes noted in co-infected patients.
• Darunavir pharmacokinetics were similar in mild (Child-Pugh A) and moderate (Child-Pugh B) hepatic impairment; no dose adjustment is needed.

Conclusions:

• Darunavir/ritonavir is safe and effective in HIV-1 patients with HBV/HCV co-infection.
• Monitoring of liver enzymes (AST/ALT) is recommended for patients with underlying chronic hepatitis.
• Darunavir is not recommended in severe hepatic impairment due to lack of data.