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J Adv Pharm Technol Res. 2012 Jan;3(1):62-7. doi: 10.4103/2231-4040.93557.

Incidence of adverse drug reactions in human immune deficiency virus-positive patients using highly active antiretroviral therapy.

Journal of advanced pharmaceutical technology & research

B Akshaya Srikanth, S Chandra Babu, Harlokesh Narayan Yadav, Sunil Kumar Jain

Affiliations

  1. Department of Pharmacy Practice, P.R.R.M. College of Pharmacy, Kadapa, Andhra Pradesh, India.

PMID: 22470896 PMCID: PMC3312730 DOI: 10.4103/2231-4040.93557

Abstract

To estimate the incidence of adverse drug reactions (ADRs) in Human immune deficiency virus (HIV) patients on highly active antiretroviral therapy (HAART). To identify the risk factors associated with ADRs in HIV patients. To analyze reported ADRs based on various parameters like causality, severity, predictability, and preventability. Retrospective case-control study. An 18-month retrospective case-control study of 208 patients newly registered in ART center, RIMS hospital, Kadapa, were intensively monitored for ADRs to HAART. Predictability was calculated based on the history of previous exposure to drug. Multivariate logistic regressions were used to identify the risk factors for ADRs. Data were analyzed using the chi-square test for estimating the correlation between ADRs and different variables. All statistical calculations were performed using EpiInfo version 3.5.3. Monitoring of 208 retrospective patients by active Pharmacovigilance identified 105 ADRs that were identified in 71 patients. Skin rash and anemia were the most commonly observed ADRs. The organ system commonly affected by ADR was skin and appendages (31.57%). The ADRs that were moderate were 90.14% of cases. The incidence of ADRs (53.52%) was higher with Zidovudine + Lamivudine + Nevirapine combination. CD4 cell count less than <250 cells/μl were 80.28%, male gender were observed to be the risk factors for ADRs. Our study finding showed that there is a need of active pharmaceutical care with intensive monitoring for ADRs in Indian HIV-positive patients who are illiterate, of male and female gender, with CD4 count ≤250 cells/mm(3) with comorbid conditions.

Keywords: Adverse drug reactions; HIV/AIDS; India; antiretroviral therapy; pharmacovigilance

References

  1. AIDS. 2001 Sep 28;15(14):1843-8 - PubMed
  2. J Infect Dis. 2010 Feb 1;201(3):318-30 - PubMed
  3. J Acquir Immune Defic Syndr. 2004 Apr 15;35(5):538-9 - PubMed
  4. N Engl J Med. 1971 Jun 17;284(24):1361-8 - PubMed
  5. Dan Med Bull. 2004 Nov;51(4):371-92 - PubMed
  6. Br J Clin Pharmacol. 2008 Mar;65(3):396-406 - PubMed
  7. Pharm Pract (Granada). 2011 Jan;9(1):48-55 - PubMed
  8. J Acquir Immune Defic Syndr. 2003 Dec 1;34(4):407-14 - PubMed
  9. J Acquir Immune Defic Syndr. 2005 Apr 15;38(5):560-5 - PubMed
  10. Ann Hematol. 2003 Mar;82(3):184-5 - PubMed
  11. Adv Ther. 2002 Jan-Feb;19(1):1-8 - PubMed
  12. Pharmacoepidemiol Drug Saf. 2009 Sep;18(9):848-57 - PubMed
  13. J Acquir Immune Defic Syndr. 2009 Aug 1;51(4):450-3 - PubMed
  14. Clin Infect Dis. 2001 Jan;32(1):124-9 - PubMed
  15. AIDS. 2008 Mar 12;22(5):601-10 - PubMed
  16. HIV Med. 2007 Oct;8(7):465-71 - PubMed
  17. HIV Med. 2007 Nov;8(8):483-90 - PubMed

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