A Study to Evaluate the Safety of Second Line Antiretroviral Therapy Given To HIV Patients At Tertiary Care Hospital In Western India
A Study to Evaluate the Safety of Second Line Antiretroviral Therapy Given To HIV Patients
Keywords:
Adverse Drug Reaction, HIV, Secondline ART, SafetyAbstract
Introduction: Prescription of multiple drugs are common in HIV positive individuals particularly after initiation of ART. Therefore, they are at a higher risk of drug interactions and adverse drug reactions. So monitoring of safety in drugs can be helpful to change or design future treatment protocols. Methods: In our ART plus centre patient had to come after 30 days of last visit to refill antiretroviral therapy for next month. After consultation with physician, patient was interviewed and details of any adverse drug reactions due to second line ART or with other drugs were recorded. Results: Most commonly documented ADRs were vomiting [17.02%] and itching [12.76%], followed by hyperbilirubinemia [10.64%] and GI upset [10.64%]. Nausea and vomiting were mainly recorded with tenofovir+lamivudine+atazanavir/ritonavir. There were more number of cases of hyperbilirubinemia with tenofovir+lamivudine+atazanavir/ritonavir than any other regimen. 87.24% of recorded ADRs were of mild severity, 12.76% were of moderate severity according to modified hartwieg and siegel scale. As per causality assessment 76.60 % ADRs were possible and 23.40% were probable ADRs. Conclusion: All the NACO prescribed regimens were well tolerated in majority of the patients, with mild and tolerable adverse effects.
References
2. Health & Family Welfare Department, Government of Tamil Nadu. Tamil Nadu State AIDS Control Society [Internet]. Health & Family Welfare Department, Government of Tamil Nadu;[cited 2015 Aug 20].Available from: http://www.tnhealth.org/tsaids.htm
3. Ghate M, Deshpande S, Tripathy S, Nene M, Gedam P, Godbole S, Thakar M, Risbud A, Bollinger HIV and AIDS in India AVERT [Internet] [cited 2015 Dec 05]. Available from: http://www.avert.org/hiv-aids-india.htm
4. National AIDS Control program, Department of AIDS Control. Operational guidelines foe ART services 2012.New Delhi: Department of AIDS Control, National AIDS Control Organization, Ministry of Health & Family Welfare, Government of India; 2012. 1 p.
5. National AIDS Control Organization, Department of AIDS Control. Annual report 2014-15. New Delhi: Department of AIDS Control, National AIDS Control Organization, Ministry of Health & Family Welfare, Government of India; 2015. 433 p.
6. Benichou C, Eliaszewicz M, Flahault A. Adverse drug reactions in HIV seropositive patients. Pharmaco epidemiology and Drug Safety 1994;3:31–40.Doi: 10.1002/pds. 2630030108
7. Sjoqvist F, Birkett D. Drug utilization. In: Introduction to Drug Utililsation Research. WHO office of publications 2003;p.10
8. National AIDS Control Organization, Ministry of Health and Family Welfare, Government of India. Antiretroviral Therapy Guidelines for HIV-infected Adults and Adolescents Including Post-exposure Prophylaxis. New Delhi: National AIDS Control Organization, Ministry of Health and Family Welfare, Government of India; 2013 May. p.55-56.
9. Sungkanuparph S. Thai national guidelines for antiretroviral therapy in HIV-1 infected adults and adolescents 2010.Asian Biomedicine. [Internet] August 2010 [cited 2015 Nov 22] vol. 4 No. 4; 515-528.
10. Renaud-Thery F, Nguimfack BD, Vitoria M, Lee E, Graaff P, Samb B, et al. Use of antiretroviral therapy in resource limited countries in 2006: distribution and uptake of first and second-line regimens.AIDS 2007; [cited 2015 Nov 27] 21(Suppl 4):S89–S95.
11. Agarwal D, Chakravarty J, Chaube L, Rai M, Agrawal NR,Sundar S.High incidence of zidovudine
induced anaemia in HIV infected patients in eastern India[Internet] Indian J Med Res 132, October 2010,[cited 2015 Nov 27] pp 386-389.
12. Desai S, Kurli S, Kambar C, Chavala S.Incidence of Atazanavir Induced Hyperbilirubinemia Among HIV/AIDS Patients Taking Second Line ART Drugs. [Internet] J. Basic. Appl. Sci. Res., 2014, [cited 2015 Nov 27] 4(1)173-178.
13. Rotger, M., P. Taffe, G. Bleiber, HF. Gunthard, H. Furrer, P. Vernazza, H. Drechsler, E. Bernasconi, M.Rickenbach and A. Telenti,.Gilbert Syndrome and the development of Antiretroviral Therapy associated Hyperbilirubinemia. [Internet] J Infect Dis., 2005,192: 1381– 1386.
14. Cheryl, Mc Donald., Uy. Jonathan, Hu. Wenhua, Victoria. Wirtz, Salome. Juether, David. Butcher, Donnie. McGrath, Awny. Farajallah and Graeme Moyle, AIDS Patient Care and STDs. 2012,26(5): 259-264.
15. Gogu SR, Malter JS, Agrawal KC. Zidovudine-induced blockade of the expression and function of the erythropoietin receptor. Biochemical Pharmacology 1992 Sept;44(6):1009-12.
16. Sharma A, Modi M, Sharma A, Marfatia YS. Stavudine vs. Zidovudine as antiretroviral therapy. Indian J Sex Transm Dis 2007;28:26-9.
17. Singh H, Dulhani N, Tiwari P, Singh P, Sinha T. A prospective, observational cohort study to elicit adverse effects of antiretroviral agents in remote resource-restricted tribal population of Chhattisgarh. Indian J Pharmacol 2009 Oct;41(5):224-6.
