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Influence of HCV or HBV coinfection on adverse drug reactions to antiretroviral drugs in HIV patients

  • Pharmacoepidemiology and Prescription
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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).

Conclusion

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.

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References

  1. Bruno R, Sacchi P, Puoti M, Soriano V, Filice G (2002) HCV chronic hepatitis in patients with HIV: clinical management issues. Am J Gastroenterol 97:1598–1606

    Article  PubMed  Google Scholar 

  2. Palella FJ Jr, Delaney KM, Moorman AC, Loveless MO, Fuhrer J, Satten GA, Aschman DJ, Holmberg SD (1998) Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. N Engl J Med 338:853–860

    Article  PubMed  Google Scholar 

  3. Lewden C, Salmon D, Morlat P, Bevilacqua S, Jougla E, Bonnet F, Heripret L, Costagliola D, May T, Chene G (2005) Causes of death among human immunodeficiency virus (HIV)-infected adults in the era of potent antiretroviral therapy: emerging role of hepatitis and cancers, persistent role of AIDS. Int J Epidemiol 34:121–130

    Article  PubMed  Google Scholar 

  4. Malavaud B, Dinh B, Bonnet E, Izopet J, Payen JL, Marchou B (2000) Increased incidence of indinavir nephrolithiasis in patients with hepatitis B or C virus infection. Antiviral Ther 5:3–5

    CAS  Google Scholar 

  5. Sulkowski MS, Thomas DL, Chaisson RE, Moore RD (2000) Hepatotoxicity associated with antiretroviral therapy in adults infected with human immunodeficiency virus and the role of hepatitis C or B virus infection. JAMA 283:2526–2527

    Article  PubMed  Google Scholar 

  6. Rodriguez-Rosado R, Garcia-Samaniego J, Soriano V (1998) Hepatotoxicity after introduction of highly active antiretroviral therapy. AIDS 12:1256

    Article  PubMed  CAS  Google Scholar 

  7. Soriano V, Rodriguez-Rosado R, Garcia-Samaniego J (1999) Management of chronic hepatitis C in HIV-infected patients. AIDS 13:539–546

    Article  PubMed  CAS  Google Scholar 

  8. Food and Drug Administration, HHS (2004) International Conference on Harmonisation; guidance on Addendum to E2C Clinical Safety Data Management: periodic safety update reports for marketed drugs. Fed Regist 69:5551–5552

    Google Scholar 

  9. Edwards IR, Aronson JK (2000) Adverse drug reactions: definitions, diagnosis, and management. Lancet 356:1255–1259

    Article  PubMed  CAS  Google Scholar 

  10. Begaud B, Evreux JC, Jouglard J, Lagier G (1985) Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France. Therapie 40:111–118

    PubMed  CAS  Google Scholar 

  11. Thiessard F, Roux E, Miremont-Salame G, Fourrier-Reglat A, Haramburu F, Tubert-Bitter P, Begaud B (2005) Trends in spontaneous adverse drug reaction reports to the French pharmacovigilance system (1986–2001). Drug Saf 28:731–740

    Article  PubMed  Google Scholar 

  12. Lemeshow S, Hosmer DW (1982) A review of goodness of fit statistics for use in the development of logistic regression models. Am J Epidemiol 115:92–106

    PubMed  CAS  Google Scholar 

  13. Begaud B, Martin K, Haramburu F, Moore N (2002) Rates of spontaneous reporting of adverse drug reactions in France. JAMA 288:1588

    Article  PubMed  Google Scholar 

  14. Belton KJ (1997) Attitude survey of adverse drug-reaction reporting by health care professionals across the European Union. Eur J Clin Pharmacol 52:423–427

    Article  PubMed  CAS  Google Scholar 

  15. Pierfitte C, Begaud B, Lagnaoui R, Moore ND (1999) Is reporting rate a good predictor of risks associated with drugs? Br J Clin Pharmacol 47:329–331

    Article  PubMed  CAS  Google Scholar 

  16. Gouezel P, Salmon D, Pialoux G, Holstein J, Delarocque-Astagneau E (2002) Co-infection VIH-VHC à l’hôpital, enquête nationale Juin 2001. Institut de Veille Sanitaire, pp 1–71

  17. Fellay J, Boubaker K, Ledergerber B, Bernasconi E, Furrer H, Battegay M, Hirschel B, Vernazza P, Francioli P, Greub G, Flepp M, Telenti A, Swiss HIV Cohort Study (2001) Prevalence of adverse events associated with potent antiretroviral treatment: Swiss HIV Cohort Study. Lancet 358:1322–1327

    Article  Google Scholar 

  18. Chiffoleau A, Veyrac G, Brunet-François C, Raffi F, Bourin M, Jolliet P (2002) Systematic survey of antiretroviral drugs’ adverse effects: first results of a co-operative study in the centre of pharmacovigilance and the centre for disease control and prevention of Nantes. Lett Pharmacol 16:13–19

    Google Scholar 

  19. Baudrant M, Bagheri H, Cuzin L, Sommet A, Bassoua V, Guitton E, Bonnet E, Garipuy D, Lucas F, Aquilina C, Montastruc JL, Massip P Analysis of antiretroviral drug-induced adverse effects. Thérapie (in press)

  20. Bergersen BM, Sandvik L, Bruun JN, Tonstad S (2004) Elevated Framingham risk score in HIV-positive patients on highly active antiretroviral therapy: results from a Norwegian study of 721 subjects. Eur J Clin Microbiol Infect Dis 23:625–630

    Article  PubMed  CAS  Google Scholar 

  21. Mann R, Andrews E (2002) Pharmacovigilance. John Wiley and Sons, Chichester

    Google Scholar 

  22. Bica I, McGovern B, Dhar R, Stone D, McGowan K, Scheib R, Snydman DR (2001) Increasing mortality due to end-stage liver disease in patients with human immunodeficiency virus infection. Clin Infect Dis 32:492–497

    Article  PubMed  CAS  Google Scholar 

  23. Monga HK, Rodriguez-Barradas MC, Breaux K, Khattak K, Troisi CL, Velez M, Yoffe B (2001) Hepatitis C virus infection-related morbidity and mortality among patients with human immunodeficiency virus infection. Clin Infect Dis 33:240–247

    Article  PubMed  CAS  Google Scholar 

  24. Greub G, Ledergerber B, Battegay M, Grob P, Perrin L, Furrer H, Burgisser P, Erb P, Boggian K, Piffaretti JC, Hirschel B, Janin P, Francioli P, Flepp M, Telenti A (2000) Clinical progression, survival, and immune recovery during antiretroviral therapy in patients with HIV-1 and hepatitis C virus coinfection: the Swiss HIV Cohort Study. Lancet 356:1800–1805

    Article  PubMed  CAS  Google Scholar 

  25. Law WP, Dore GJ, Duncombe CJ, Mahanontharit A, Boyd MA, Ruxrungtham K, Lange JM, Phanuphak P, Cooper DA (2003) Risk of severe hepatotoxicity associated with antiretroviral therapy in the HIV-NAT Cohort, Thailand, 1996–2001. AIDS 17:2191–2199

    Article  PubMed  CAS  Google Scholar 

  26. Bonnet F, Lawson-Ayayi S, Thiebaut R, Ramanampamonjy R, Lacoste D, Bernard N, Malvy D, Bonarek M, Djossou F, Beylot J, Dabis F, Morlat P, French Aquitaine Cohort, Groupe d’Epidemiologie Clinique du SIDA en Aquitaine (GECSA) (2002) A cohort study of nevirapine tolerance in clinical practice: French Aquitaine Cohort, 1997–1999. Clin Infect Dis 35:1231–1237

    Article  PubMed  CAS  Google Scholar 

  27. Aceti A, Pasquazzi C, Zechini B, De Bac C, Group LIVERHAART (2002) Hepatotoxicity development during antiretroviral therapy containing protease inhibitors in patients with HIV: the role of hepatitis B and C virus infection. JAIDS 29:41–48

    PubMed  CAS  Google Scholar 

  28. Arribas JR, Ibanez C, Ruiz-Antoran B, Pena JM, Esteban-Calvo C, Frias J, Vazquez JJ, Gonzalez-Garcia JJ (1998) Acute hepatitis in HIV-infected patients during ritonavir treatment. AIDS 12:1722–1724

    PubMed  CAS  Google Scholar 

  29. Wit FW, Weverling GJ, Weel J, Jurriaans S, Lange JM (2002) Incidence of and risk factors for severe hepatotoxicity associated with antiretroviral combination therapy. J Infect Dis 186:23–31

    Article  PubMed  CAS  Google Scholar 

  30. Opravil M, Ledergerber B, Furrer H, Hirschel B, Imhof A, Gallant S, Wagels T, Bernasconi E, Meienberg F, Rickenbach M, Weber R, Swiss HIV Cohort Study (2002) Clinical efficacy of early initiation of HAART in patients with asymptomatic HIV infection and CD4 cell count >350×10(6)/l. AIDS 16:1371–1381

    Article  PubMed  CAS  Google Scholar 

  31. Mocroft A, Devereux H, Kinloch-de-Loes S, Wilson D, Madge S, Youle M, Tyrer M, Loveday C, Phillips AN, Johnson MA (2000) Immunological, virological and clinical response to highly active antiretroviral therapy treatment regimens in a complete clinic population. Royal free centre for HIV medicine. AIDS 14:1545–1552

    Article  PubMed  CAS  Google Scholar 

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Correspondence to Emmanuelle Guitton.

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The French Network of Pharmacovigilance Centres., Guitton, E., Montastruc, JL. et al. Influence of HCV or HBV coinfection on adverse drug reactions to antiretroviral drugs in HIV patients. Eur J Clin Pharmacol 62, 243–249 (2006). https://doi.org/10.1007/s00228-005-0080-0

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  • DOI: https://doi.org/10.1007/s00228-005-0080-0

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