Lopinavir/ritonavir treatment in HIV antiretroviral-experienced patients: Evaluation of risk factors for liver enzyme elevation

Paola Meraviglia, M. Schiavini, A. Castagna, P. Viganò, T. Bini, S. Landonio, A. Danise, M. C. Moioli, E. Angeli, M. Bongiovanni, H. Hasson, P. Duca, A. Cargnel

Research output: Contribution to journalArticle

36 Citations (Scopus)

Abstract

Objectives. To evaluate the risk factors for lopinavir/ritonavir (LPV/r)-related liver enzyme elevation (LEE) in HIV antiretroviral-experienced patients. Methods. An open prospective observational study was carried out to analyse the incidence and time of LEE development during LPV/r treatment, and to determine whether LEE development was correlated with epidemiological, clinical and biochemical data, immune and virological profiles, concomitant hepatic diseases, antiretroviral therapy, or histological and ultrasonography liver examination results. A diagnosis of LEE was considered when LEE symptoms occurred after LPV/r introduction and was confirmed by a second control within 2 weeks. Results. A total of 782 HIV-positive outpatients have been enrolled in six different Infectious Diseases Departments in Northern Italy since August 2000. Of these patients, 71 (9.1%) developed LEE within 115 ± 85 days (mean ± standard deviation); 13 of these subjects discontinued LPV/r and four were hospitahzed. Of the patients with LEE, 74.6% and 25.4% had grade 2 and ≥3 toxicity, respectively. No correlation between LEE and sex, baseline CD4 cell count, viral load, HIV stage, triglyceride values, histological and ultrasonography liver examination results, nevirapine use, or increase in CD4 cell count was observed. Higher baseline alanine aminotransferase (ALT) and γ -glutamyltransferase (GGT) values (P <0.0001 and P = 0.004, respectively), younger age (P = 0.008), previous hepatitis B virus (HBV) infection (P = 0.012), efavirenz use (P = 0.04), and hepatitis C virus (HCV) and/or HBV coinfection (P <0.0001, relative risk 4.78) were significantly related to LEE. No correlations between LEE and the same risk factors as investigated in the whole study population were found in subgroups of patients with HCV and/or HBV infection. Conclusions. HCV and HBV testing and measurement of baseline ALT values are essential for screening subjects at risk of LEE before starting LPV/r. Strict monitoring of clinical and biochemical parameters should be performed in these patents.

Original languageEnglish
Pages (from-to)334-343
Number of pages10
JournalHIV Medicine
Volume5
Issue number5
DOIs
Publication statusPublished - Sep 2004

Fingerprint

Lopinavir
Ritonavir
HIV
Liver
Enzymes
Hepatitis B virus
Therapeutics
Hepacivirus
efavirenz
Virus Diseases
CD4 Lymphocyte Count
Alanine Transaminase
Ultrasonography
Nevirapine
Patents
Viral Load
Coinfection

Keywords

  • Liver enzyme elevation
  • Lopinavir/ritonavir
  • Viral hepatitis coinfection

ASJC Scopus subject areas

  • Virology
  • Medicine(all)
  • Immunology

Cite this

Lopinavir/ritonavir treatment in HIV antiretroviral-experienced patients : Evaluation of risk factors for liver enzyme elevation. / Meraviglia, Paola; Schiavini, M.; Castagna, A.; Viganò, P.; Bini, T.; Landonio, S.; Danise, A.; Moioli, M. C.; Angeli, E.; Bongiovanni, M.; Hasson, H.; Duca, P.; Cargnel, A.

In: HIV Medicine, Vol. 5, No. 5, 09.2004, p. 334-343.

Research output: Contribution to journalArticle

Meraviglia, P, Schiavini, M, Castagna, A, Viganò, P, Bini, T, Landonio, S, Danise, A, Moioli, MC, Angeli, E, Bongiovanni, M, Hasson, H, Duca, P & Cargnel, A 2004, 'Lopinavir/ritonavir treatment in HIV antiretroviral-experienced patients: Evaluation of risk factors for liver enzyme elevation', HIV Medicine, vol. 5, no. 5, pp. 334-343. https://doi.org/10.1111/j.1468-1293.2004.00232.x
Meraviglia, Paola ; Schiavini, M. ; Castagna, A. ; Viganò, P. ; Bini, T. ; Landonio, S. ; Danise, A. ; Moioli, M. C. ; Angeli, E. ; Bongiovanni, M. ; Hasson, H. ; Duca, P. ; Cargnel, A. / Lopinavir/ritonavir treatment in HIV antiretroviral-experienced patients : Evaluation of risk factors for liver enzyme elevation. In: HIV Medicine. 2004 ; Vol. 5, No. 5. pp. 334-343.
@article{34f31d44c91b4815a0e20c4c54470672,
title = "Lopinavir/ritonavir treatment in HIV antiretroviral-experienced patients: Evaluation of risk factors for liver enzyme elevation",
abstract = "Objectives. To evaluate the risk factors for lopinavir/ritonavir (LPV/r)-related liver enzyme elevation (LEE) in HIV antiretroviral-experienced patients. Methods. An open prospective observational study was carried out to analyse the incidence and time of LEE development during LPV/r treatment, and to determine whether LEE development was correlated with epidemiological, clinical and biochemical data, immune and virological profiles, concomitant hepatic diseases, antiretroviral therapy, or histological and ultrasonography liver examination results. A diagnosis of LEE was considered when LEE symptoms occurred after LPV/r introduction and was confirmed by a second control within 2 weeks. Results. A total of 782 HIV-positive outpatients have been enrolled in six different Infectious Diseases Departments in Northern Italy since August 2000. Of these patients, 71 (9.1{\%}) developed LEE within 115 ± 85 days (mean ± standard deviation); 13 of these subjects discontinued LPV/r and four were hospitahzed. Of the patients with LEE, 74.6{\%} and 25.4{\%} had grade 2 and ≥3 toxicity, respectively. No correlation between LEE and sex, baseline CD4 cell count, viral load, HIV stage, triglyceride values, histological and ultrasonography liver examination results, nevirapine use, or increase in CD4 cell count was observed. Higher baseline alanine aminotransferase (ALT) and γ -glutamyltransferase (GGT) values (P <0.0001 and P = 0.004, respectively), younger age (P = 0.008), previous hepatitis B virus (HBV) infection (P = 0.012), efavirenz use (P = 0.04), and hepatitis C virus (HCV) and/or HBV coinfection (P <0.0001, relative risk 4.78) were significantly related to LEE. No correlations between LEE and the same risk factors as investigated in the whole study population were found in subgroups of patients with HCV and/or HBV infection. Conclusions. HCV and HBV testing and measurement of baseline ALT values are essential for screening subjects at risk of LEE before starting LPV/r. Strict monitoring of clinical and biochemical parameters should be performed in these patents.",
keywords = "Liver enzyme elevation, Lopinavir/ritonavir, Viral hepatitis coinfection",
author = "Paola Meraviglia and M. Schiavini and A. Castagna and P. Vigan{\`o} and T. Bini and S. Landonio and A. Danise and Moioli, {M. C.} and E. Angeli and M. Bongiovanni and H. Hasson and P. Duca and A. Cargnel",
year = "2004",
month = "9",
doi = "10.1111/j.1468-1293.2004.00232.x",
language = "English",
volume = "5",
pages = "334--343",
journal = "HIV Medicine",
issn = "1464-2662",
publisher = "Blackwell Publishing Ltd",
number = "5",

}

TY - JOUR

T1 - Lopinavir/ritonavir treatment in HIV antiretroviral-experienced patients

T2 - Evaluation of risk factors for liver enzyme elevation

AU - Meraviglia, Paola

AU - Schiavini, M.

AU - Castagna, A.

AU - Viganò, P.

AU - Bini, T.

AU - Landonio, S.

AU - Danise, A.

AU - Moioli, M. C.

AU - Angeli, E.

AU - Bongiovanni, M.

AU - Hasson, H.

AU - Duca, P.

AU - Cargnel, A.

PY - 2004/9

Y1 - 2004/9

N2 - Objectives. To evaluate the risk factors for lopinavir/ritonavir (LPV/r)-related liver enzyme elevation (LEE) in HIV antiretroviral-experienced patients. Methods. An open prospective observational study was carried out to analyse the incidence and time of LEE development during LPV/r treatment, and to determine whether LEE development was correlated with epidemiological, clinical and biochemical data, immune and virological profiles, concomitant hepatic diseases, antiretroviral therapy, or histological and ultrasonography liver examination results. A diagnosis of LEE was considered when LEE symptoms occurred after LPV/r introduction and was confirmed by a second control within 2 weeks. Results. A total of 782 HIV-positive outpatients have been enrolled in six different Infectious Diseases Departments in Northern Italy since August 2000. Of these patients, 71 (9.1%) developed LEE within 115 ± 85 days (mean ± standard deviation); 13 of these subjects discontinued LPV/r and four were hospitahzed. Of the patients with LEE, 74.6% and 25.4% had grade 2 and ≥3 toxicity, respectively. No correlation between LEE and sex, baseline CD4 cell count, viral load, HIV stage, triglyceride values, histological and ultrasonography liver examination results, nevirapine use, or increase in CD4 cell count was observed. Higher baseline alanine aminotransferase (ALT) and γ -glutamyltransferase (GGT) values (P <0.0001 and P = 0.004, respectively), younger age (P = 0.008), previous hepatitis B virus (HBV) infection (P = 0.012), efavirenz use (P = 0.04), and hepatitis C virus (HCV) and/or HBV coinfection (P <0.0001, relative risk 4.78) were significantly related to LEE. No correlations between LEE and the same risk factors as investigated in the whole study population were found in subgroups of patients with HCV and/or HBV infection. Conclusions. HCV and HBV testing and measurement of baseline ALT values are essential for screening subjects at risk of LEE before starting LPV/r. Strict monitoring of clinical and biochemical parameters should be performed in these patents.

AB - Objectives. To evaluate the risk factors for lopinavir/ritonavir (LPV/r)-related liver enzyme elevation (LEE) in HIV antiretroviral-experienced patients. Methods. An open prospective observational study was carried out to analyse the incidence and time of LEE development during LPV/r treatment, and to determine whether LEE development was correlated with epidemiological, clinical and biochemical data, immune and virological profiles, concomitant hepatic diseases, antiretroviral therapy, or histological and ultrasonography liver examination results. A diagnosis of LEE was considered when LEE symptoms occurred after LPV/r introduction and was confirmed by a second control within 2 weeks. Results. A total of 782 HIV-positive outpatients have been enrolled in six different Infectious Diseases Departments in Northern Italy since August 2000. Of these patients, 71 (9.1%) developed LEE within 115 ± 85 days (mean ± standard deviation); 13 of these subjects discontinued LPV/r and four were hospitahzed. Of the patients with LEE, 74.6% and 25.4% had grade 2 and ≥3 toxicity, respectively. No correlation between LEE and sex, baseline CD4 cell count, viral load, HIV stage, triglyceride values, histological and ultrasonography liver examination results, nevirapine use, or increase in CD4 cell count was observed. Higher baseline alanine aminotransferase (ALT) and γ -glutamyltransferase (GGT) values (P <0.0001 and P = 0.004, respectively), younger age (P = 0.008), previous hepatitis B virus (HBV) infection (P = 0.012), efavirenz use (P = 0.04), and hepatitis C virus (HCV) and/or HBV coinfection (P <0.0001, relative risk 4.78) were significantly related to LEE. No correlations between LEE and the same risk factors as investigated in the whole study population were found in subgroups of patients with HCV and/or HBV infection. Conclusions. HCV and HBV testing and measurement of baseline ALT values are essential for screening subjects at risk of LEE before starting LPV/r. Strict monitoring of clinical and biochemical parameters should be performed in these patents.

KW - Liver enzyme elevation

KW - Lopinavir/ritonavir

KW - Viral hepatitis coinfection

UR - http://www.scopus.com/inward/record.url?scp=4644341941&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=4644341941&partnerID=8YFLogxK

U2 - 10.1111/j.1468-1293.2004.00232.x

DO - 10.1111/j.1468-1293.2004.00232.x

M3 - Article

C2 - 15369508

AN - SCOPUS:4644341941

VL - 5

SP - 334

EP - 343

JO - HIV Medicine

JF - HIV Medicine

SN - 1464-2662

IS - 5

ER -