title: Influence of HCV or HBV coinfection on adverse drug reactions to antiretroviral drugs in HIV patients.
abstract: OBJECTIVE
  To compare the profile of adverse drug reactions (ADRs) to antiretroviral (ARV) drugs in patients coinfected with hepatitis C virus (HCV) or hepatitis B virus (HBV) versus non-coinfected patients with human immunodeficiency virus (HIV) infection.
  
  
  METHODS
  We used the French Pharmacovigilance Database from 2000 to 2002. Selected patients were classified into four groups: HIV+HCV, HIV+HBV, HIV+HBV+HCV and HIV patients. We compared patients' characteristics and profiles of ADRs to ARV drugs between the four groups.
  
  
  RESULTS
  We identified 1,068 HIV, 172 HIV+HCV, 72 HIV+HBV and 26 HIV+HBV+HCV patients with 2,398, 446, 183 and 70 ADRs related to ARV drugs, respectively. The "seriousness" of these ADRs was similar in HIV and coinfected patients but death related to the ADRs was more frequent in HIV+HCV (9.4%) than in HIV (3.6%) patients (p<0.001). "Liver and bile system disorders" were more frequently reported in HIV+HCV and HIV+HBV patients than in HIV patients (17.3% and 20.8%, respectively, versus 8.9%, p<0.001). In HIV+HBV patients, the occurrence of these ADRs was independently associated in a logistic regression model to male gender [odds ratio (OR): 9.28, 95% confidence interval (CI): 2.74-31.36], exposure to zalcitabine (OR: 17.82, 95% CI: 1.49-212.95) or efavirenz (OR: 5, 95% CI: 1.44-17.33). "Red blood cell disorders" were also more frequent in HIV+HCV (7.4%) than in HIV (4.4%) patients (p<0.01).
  
  
  CONCLUSIONS
  Hepatic or haematological (mainly anaemia) ADRs to ARV drugs are more frequent in coinfected patients than in HIV patients. This study underlines the importance of hepatitis B or C in the occurrence of ADRs in HIV patients on ARV drugs.
authors.affiliation: Laboratoire de Pharamcologie Médicale et Clinique, Unité de Pharmacoépidémiologie EA3696, IFR 126, Faculté de Médecine, 37 Allées Jules Guesde, Toulouse Cedex 7, 31073, France. guitton@cict.fr
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Guitton
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Montastruc
authors.forename: Maryse
authors.initials: M
authors.lastname: Lapeyre-Mestre
mesh_terms: D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D000367:Age Factors; D019380:Anti-HIV Agents / Q000009:adverse effects* / Q000145:classification / Q000627:therapeutic use; D016208:Databases, Factual / Q000706:statistics & numerical data; D005260:Female; D005602:France; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy*; D016174:Hepacivirus / Q000187:drug effects / Q000254:growth & development; D006509:Hepatitis B / Q000150:complications / Q000188:drug therapy*; D006515:Hepatitis B virus / Q000187:drug effects / Q000254:growth & development; D006526:Hepatitis C / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D008107:Liver Diseases / Q000150:complications; D008297:Male; D008875:Middle Aged; D012737:Sex Factors; D019966:Substance-Related Disorders / Q000150:complications; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D019380:Anti-HIV Agents