DOI: http://dx.doi.org/10.18203/2320-6012.ijrms20170170

Characterization and comparative analysis of ADRs of various ART regimens: experience of our medical college from Western Himalayan region

Atal Sood, Himani Prajapati, Suruchi Bhagra, Rekha Bansal

Abstract


Background: It is estimated that there are 35.3 million PLHA worldwide and 1.6 million have received ART. ART is freely available in designated ART Centres. HAART (highly active antiretroviral treatment) has significantly reduced AIDS related morbidity and mortality. It involves using three different drugs from two different classes. The main challenge in prescribing HAART is ADRs associated with it affecting patient compliance and treatment outcomes.

Methods: A retrospective observational study was carried out in the ADR monitoring Centre of Dr. Rajendra Prasad Government Medical College, Tanda, Kangra, Himachal Pradesh, India.

Results: The data for ADEs was collected from 108 patients over a period of 17 months. A total of 280 ADEs were reported in 65 females and 43 males. TLE was the commonest regimen in 61 (56%) patients followed by ZLN in 37 (34%). Neurological ADRs were reported in 39.8% cases with TLE that was nearly double as reported with ZLN regimen 20.5%. Dermatological ADRs were highest with other regimens (57.4%) followed by ZLN 20.5%. Similarly the frequency of Gastrointestinal ADR was highest with other regimens. Hematological ADRs were maximum with ZLN (22.9%) followed by TLE (3.3%). Most commonly reported ADRs were dizziness (10.7%), rashes (8.2%), anorexia and dyslipidemia (6.8%), asthenia (6.4%), pruritus (6%), joint pains (4.6%), insomnia, alopecia and vomiting (4.3%), numbness or parasthesia (3.9%), hepatotoxicity (3.6%) and deranged RFTs (1.8%).

Conclusions: The real burden of ADRs due to ART cannot be estimated until voluntary and mandatory reporting system of ADRs works efficiently. A structured surveillance of the pharmacovigilance system can help to overcome these hurdles to ensure compliance with ART regimens.


Keywords


ART, ADRs, NACO, Pharmacovigilance

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References


Joint United Nations Program on HIV/AIDS (UNAIDS). Global report: UNAIDS report on global AIDS epidemic 2013. Available at: http://www.unaids.org/ sites/ default/ files/ en/ media/ unaids/ contentassets/ documents/ epidemiology/ 2013/gr2013/ UNAIDS_ Global_ Report_ 2013_en.pdf.

Carr A, Cooper DA. Adverse effects of antiretroviral therapy. Lancet. 2001;356:1423-30.

World Health Organization (WHO). (2003). Adherence for long-term therapies: Evidence for action. Retrieved from http://www.who.int/ chp/ knowledge/ publications/ adherence_report/en/.

Bangsberg DR, Perry S, Charlebois ED, Clark RA, Robertson M, Zolopa AR, et al. Non-adherence to highly active antiretroviral therapy predicts progression to AIDS. AIDS. 2001;15(9):1181-3.

Berg MB, Safren SA, Mimiaga MJ, Grasso C, Boswell S, Mayer KH. Non-adherence to medical appointments is associated with increased plasma HIV RNA and decreased CD4 cell counts in a community-based HIV primary care clinic. AIDS Care. 2005;17(7):902-7.

Sethi AK, Celentano DD, Gange SJ, Moore RD, Gallant JE. Association between adherence to antiretroviral therapy and human immunodeficiency virus drug resistance. Clin Infect Dis. 2003;37(8):1112-8.

Mehta U. Pharmacovigilance: the devastating consequences of not thinking about adverse drug reactions. Contin Med Educ. 2011;29(6):247-51.

Subbaraman R, Chaguturu SK, Mayer KH, Flanigan TP, Kurarasamy N. Adverse effects of Highly Active Antiretroviral Therapy in developing countries. Clin Infect Dis. 2007;45:1093-101.

Hawkins T. Understanding and managing the adverse effects of antiretroviral therapy. Antivir Res. 2010;85:201-9.

Katzung BG, Trevor AJ. Basic & Clinical Pharmacology. In: Safrin S, editors. Antiviral Agents. 13th ed. India: Mc Graw Hill; 2015;842-56.

Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. January 2008. Department of Health and Human Sciences. Available at: http://aidsinfo.nih.gov/ contentfiles/ AdultandAdolescentGL.pdf

Flexner C. Dual protease inhibitor therapyin HIV-infected patients: Pharmacological rationale and clinical benefits. Annu. Rev. Pharmacol. Toxicol. 2000;40:649-74.

World Health Organization. Technical report series no. 425. Geneva, Switzerland: World Health Organization; 1966. International drug monitoring: the role of the hospital. 1-24.

World Health Organization (2002) Safety of Medicines: A guide to detecting and reporting adverse drug reactions. Geneva, Switzerland.

Sood A, Sood V, Prajapati H, Sharma A, Bansal R, Mahajan V. Pharmacovigilance analysis in a rural tertiary care hospital in North India: a retrospective study. Int J Basic Clin Pharmacol. 2016;5(4):1425-31.

Nagpal M, Tayal V, Kumar S, Gupta U. Adverse drug reactions to antiretroviral therapy in AIDS patients at a tertiary care hospital in India: A prospective observational study. Indian J Med Sci. 2010;64:245-52.

Masenyetse LJ, Manda SO, Mwambi HG. An assessment of adverse drug reactions among HIV positive patients receiving antiretroviral treatment in South Africa. AIDS Research and Therapy. 2015;12:6

Brunton LL, Chabner B, Knollman B. Goodman & Gilman’s The Pharmacological basis of Therapeutics. In: Flexner C, editors. Antiretroviral Agents and Treatment of HIV Infection. 12th ed. New York: Mc Graw Hill. 2011:1635.

Rotunda A, Hirsch RJ, Scheinfeld N, Weinberg JM. Severe cutaneous reactions associated with the use of HIV medication. Acta Derm Venereol. 2003;83:1-9.

Martinez E, Arnaiz JA, Podzamczer D. Substitution of nevirapine, efavirenz or abacavir for protease inhibitors in HIV infection. N Engl J Med. 2003;349:1036-46.

Sulkowski MS, Thomas DL, Chaison RE, Moore RD. Hepatotoxicity associated with antiretroviral therapy in adults infected with HIV and the role of hepatitis C or B virus infection. JAMA. 2000;283:74-80.

Singh A, Singh A, Chouhan O, Gehlot A, Tandi GP, Dua M. The study of adverse drug reactions (ADRS) of antiretroviral therapy (ART) on HIV infected persons (PLHIV) at our ART centre, Jodhpur, Rajasthan. Sch. J App Med Sci. 2016;4(3A):696-703.

Reddy K, Lihite RJ, Lahkar M, Choudhary U, Baruah SK. A Study of adverse drug reactions in HIV infected patients at an ART centre of tertiary care hospital in Guwahati, India. Asian J Pharm Clin. 2013; 6(2):102-4.

WHO. Rapid advice. Antiretroviral therapy for HIV infection in adults and adolescents. 2009 November. Available from: http://www.who.int/ hiv/ pub/ arv/ rapid_advice_art.pdf

Wolday D, Hailu B, Girma M, Hailu E, Saunders E, Fontanet AL. Low CD4+T-cell count and high HIV viral load precede the development of tuberculosis disease in a cohort of HIV-positive Ethopians. Int J Tuberc Lung Dis. 2003;7:110-16.

Dean GL, Edwards SG, Ives NJ, Matthews G, Fox EF, Navaratne L, et al. Treatment of tuberculosis in HIV-infected persons in the era of highly active antiretroviral therapy. AIDS. 2002;16:75-83.

Santoro LG, Felix AM, Harrison LH, Schechter M. Reduced risk of tuberculosis among Brazilian patients with advanced human immunodeficiency virus infection treated with highly active antiretroviral therapy. Clin Infect Dis. 2002;34:543-6.

American Thoracic Society Documents. American Thoracic Society/Centre of Disease Control and Prevention/Infectious Diseases Society of America. Treatment of tuberculosis. Am J Respir Crit Care Med. 2003;167:603-62.

López-Cortés LF, Ruiz-Valderas R, Viciana P, Alarcón-González A, Gómez-Mateos J, León-Jimenez E, et al. Pharmacokinetic interactions between efavirenz and rifampin in HIV-infected patients with tuberculosis. Clin Pharmacokinet. 2002;43:681-90.

Oliva J, Moreno S, Sanz J, Ribera E, Molina JA, Rubio R, et al. Co-administration of rifampin and nevirapine in HIV-infected patients with tuberculosis. AIDS. 2003;17:637-38.

Department of Health and Human Services (DHHS). Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Bethesda, MD: DHSS, National Institute of Health, March 2004. http://aidsinfo.nih.gov/ guidelines/adult/AA_111003.pdf.