Safety of long-term lopinavir plasma-levels in patients with liver disease.

Abstract

Chronic liver disease is often found in HIV infected patients. LPV as first choice drug is often used over long time periods. TDM as a tool in patients care is important but the knowledge of LPV-plasma-levels in patients with chronic liver disease remain uncertain. With this retrosepective analysis we want to show if there are differences in LPV-plasma-levels between patients with and without chronic liver diseases over a long-time period. LPV-plasma-levels were analysed with an HPLC-based methode. The LPV-plasma-levels over the time course in patients with chronic liver disease (n = 30) and patients without liver disease (n = 38) was evaluated. Liver function tests, CD4-cell count and HI-viral load was also correlated with liver disease. The LPV plasma-levels of n = 450 samples from 30 patients with liver disease (Hepatitis B: n = 17, Hepatitis C: n = 16, Alcoholic liver disease: n = 7) were determined over 18.7 +/- 16,3 months (1 - 48.5 months). A median of 10 samples per patient was eligible (2 - 50 samples). There are no significant differences according to liver disease in LPV-plasma levels (mean Ctrough without: 5917 +/- 4811 ng/ml, mean Ctrough with liver-disease: 6564 +/- 4517 ng/ml, p > 0.05). The intraindividual and interindividual variation of LPV-plasma levels, CD-4 increase, HI-virus suppression and liver tests in patients with and without liver disease is comparable. In this clinical setting no differences in LPV-plasma levels between patients with and without chronic liver disease could be demonstrated. LPV-therapy in patients with chronic liver disease is therefore safe. In patients with impaired liver function TDM is a helpful tool for dose adjustment.

• Authors: Peter Langmann, C Hubert, W Heinz, A Trein, E Schnaitmann, M Leyh, H Klinker, R Winzer
• Journal: European journal of medical research (Eur J Med Res) Vol. 13 Issue 5 Pg. 205-8 (May 26 2008) ISSN: 0949-2321 [Print] England
• PMID: 18559302 (Publication Type: Journal Article)

Chemical References

• Anti-HIV Agents
• Pyrimidinones
• Lopinavir

Topics

• Adult
• Aged
• Anti-HIV Agents (adverse effects)
• CD4 Lymphocyte Count
• Chromatography, High Pressure Liquid
• Chronic Disease
• Drug Monitoring
• Female
• Humans
• Liver Diseases (metabolism)
• Lopinavir
• Male
• Middle Aged
• Pyrimidinones (adverse effects, blood)
• Retrospective Studies