Predictive factors of lopinavir/ritonavir discontinuation for drug-related toxicity: results from a cohort of 416 multi-experienced HIV-infected individuals
| Autor: | L. Testa, Federica Tordato, Paola Meraviglia, Simona Landonio, Antonio Di Biagio, Antonella d'Arminio Monforte, Teresa Bini, Paola Cicconi, Marco Bongiovanni, Elisabetta Chiesa |
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| Rok vydání: | 2005 |
| Předmět: |
Microbiology (medical)
Adult Male medicine.medical_specialty Lopinavir/ritonavir HIV Infections Pyrimidinones Pharmacology Lower risk Gastroenterology Drug Administration Schedule Lopinavir Cohort Studies Risk Factors Internal medicine Antiretroviral Therapy Highly Active Odds Ratio Medicine Humans Pharmacology (medical) Prospective Studies Drug-related toxicity HIV Adverse effect Aged Ritonavir Reverse-transcriptase inhibitor business.industry General Medicine Odds ratio HIV Protease Inhibitors Middle Aged Hepatitis C Discontinuation Infectious Diseases Female business medicine.drug |
| Zdroj: | International journal of antimicrobial agents. 26(1) |
| ISSN: | 0924-8579 |
| Popis: | The objective of this study was to find predictive factors of lopinavir/ritonavir (LPV/r) discontinuation for drug-related toxicities in highly pre-treated human immunodeficiency virus (HIV)-infected subjects. The study was an observational study of HIV patients starting LPV/r with HIV RNA3log10 copies/mL and a follow-upor = 6 months. Parameters studied were HIV RNA, CD4+ cell counts, metabolic parameters and drug-related adverse events. Acquired immune deficiency syndrome (AIDS) events and deaths were recorded. The Kaplan-Meier (KM) model was used to estimate time-dependent probability, and the multivariable Cox model to identify predictors of LPV/r discontinuation for adverse events. The study evaluated 416 HIV-infected patients. Seventy-seven patients (18.5%) discontinued LPV/r for toxicities. Adverse events leading to LPV/r discontinuation were gastrointestinal symptoms in 40 cases, hyperlipidaemia in 27 and increase of aspartate aminotransferase (AST)/alanine aminotransferase (ALT) in 10 patients. Nineteen patients (4.6%) developed an AIDS event during observation and 15 (3.6%) died. The KM probability of LPV/r discontinuation for toxicities was 5.3% (range 3.1-7.5%) at month 12 and 15.7% (range 12.1-19.3%) at month 24. Subjects with hepatitis C virus (HCV)-HIV co-infection (odds ratio (OR) 7.40; 95% confidence interval (CI) 3.73-14.66 versus HCV-negative; P = 0.001) and receiving LPV/r plus nucleoside reverse transcriptase inhibitors (NRTIs) and protease inhibitor (PI)/non-nucleoside reverse transcriptase inhibitor (NNRTI) (OR 1.74; 95% CI 1.04-2.91 versus LPV/r plus only NRTIs; P = 0.04) showed a higher risk of LPV/r discontinuation by a Cox analysis, whereas non-intravenous drug abusers (IVDUs) (OR 0.40; 95% CI 0.24-0.67 versus IVDUs; P = 0.001) had a lower risk. The rate of discontinuation for toxicity decreased by 17% for each additional month of LPV/r exposure (OR 0.83; 95% CI 0.80-0.86 for each additional month; P0.001). LPV/r was substantially well tolerated. Diarrhoea was the most frequent adverse event leading to discontinuation. HCV-HIV co-infected patients and patients with a short exposure to LPV/r have a higher risk of discontinuing LPV/r and should be strictly monitored. |
| Databáze: | OpenAIRE |
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