Factors determinant for change of initial antiretroviral treatment regimen among patients on ART follow-up clinic of Mekelle Hospital, Mekelle, Ethiopia

Tigist Bayou, Minyahil Woldu, Gebrehiwot G. Meskel, Haftay Mezgebe


Background: Treatment interruption and switch to a new Highly Active Antiretroviral Therapy (HAART) regimen act as competing risks for patient on HAART.

Methods: The study was conducted in Mekelle hospital. A case-control study was conducted. Socio-demographic, immunologic and clinical characteristics were components of the checklist. Data was compiled, processed, and analyzed using Statistical Package for Social Sciences (SPSS) for windows version 16. Ethical consideration was obtained from Mekelle University.

Results: 105 patients’ records were sampled and studied. Twenty one (20%) of the patients had changed their initial ART regimen and about three-fourth 15 (71.4%) of the reasons for change was attributable to toxicity while 3 and 2 were due to treatment failure and pregnancy respectively. The odds of Adverse Drug Reactions (ADRs) who had one initial ART change (cases) were 2.37 times greater than the odds who did not change (controls) Patients, initiated ZDV based ART regimen had 9.93 times greater chance of changing their initial ART regimen compared to those initiated with D4T based ART regimen and patient on ART for treatment duration of 12-36 months were relatively at higher risk compared to patients with lesser duration of treatment. Patients who’s ART had 99.94% lesser chance of changing their baseline ART regimen compared to those who did take other medications

Conclusions: The main factor determining the change of initial ART regimen in our study was the occurrence of adverse drug reactions, with ZDV being the most dominant drug.


Antiretroviral therapy, Case-control, ART follow up, Determinant factors, ART regimen change

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UNAIDS. Joint United Nations Programme on HIV/AIDS (UNAIDS). AIDS epidemic update 2007.

Palella FJ DK, Moorman AC. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. N Engl J Med 1998;338:853-60.

Hamer SM SK, Hughes MD. A controlled trial of two nucleoside analogues plus indinavir in persons with human immunodeficiency virus infection and CD4 cell counts of 200 per cubic millimetre or less. AIDS Clinical Trials Group 320 Study Team. N Engl J Med 1997;337:725-33.

Jahn A FS, Crampin AC, Mwaungulu F, Mvula H, Munthali F. Population-level effect of HIV on adult mortality and early evidence of reversal after introduction of antiretroviral therapy in Malawi. Lancet 2008;371(9624):1603–11.

Bhaskaran K HO, Sannes M, Boufassa F, Johnson AM, Lambert PC. Changes in the risk of death after HIV seroconversion compared with mortality in the general population. Jama 2008;300:51–59.

Gilks CF CS, Ekpini R, Gove S, Perriens J, Souteyrand Y. The WHO public-health approach to antiretroviral treatment against HIV in resource-limited settings. Lancet 2006;368(4):505-10.

WHO. Anti Retroviral Therapy for HIV infection in adults and adolescents in resource-limited settings: towards universal access: recommendations for a public health approach In: Programme HA, ed. Geneva: WHO; 2006.

Olawale Ajose SM, Edward J. Mills, Andrew Boulled and Nathan Fordd. Treatment outcomes of patients on second-line antiretroviral therapy in resource-limited settings: a systematic review and meta-analysis. AIDS 2012;26:929–38.

Ajith S AO, Priscilla R, Susanne A, Joyce R, Rajkumar S. High Rates of Regimen Change due to Drug Toxicity among a Cohort of South Indian Adults with HIV Infection Initiated on Generic, First-Line Antiretroviral Treatment 2009.

Paterson D SS, Mohr J. Adherence to protease inhibitor therapy and outcomes in patients with HIV infection Ann Intern Med 2000;133:21-30.

The UK Collaborative Group on HIV Drug Resistance UCSG. Long term probability of detection of HIV-1 drug resistance after starting antiretroviral therapy in routine clinical practice. AIDS 2005;19:487-94.

Carr A CD. Adverse effects of antiretroviral therapy. Lancet 2000;356:1423-30.

Taffe P RM, Hirschel B. Impact of occasional short interruptions of HAART on the progression of HIV infection: results from a cohort study. AIDS 2002;16:747-55.

Park-Willie LY SA, Tseng A. High rate of discontinuation of highly active antiretroviral therapy as a results of antiretroviral intolerance in clinic practice: missed opportunities for adherence support AIDS. 2002;16:1084-86.

Kalbfleisch J PR. The statistical analysis of failure time data. New York: Wiley. 1980:163-78.

Fine JP GR. A proportional hazards model for the subdistribution of a competing risk J Am Stat Assoc 1999;94:496-509.

Boule A OC, Kaplan R, Cutsem G, Mcnally M, Hilderbrand K, London Myer, Matthias Egger, David Coetzee, Gary Maartens and Robin Wood. Substitutions due to antiretroviral toxicity or contraindication in the first 3 years of antiretroviral therapy in a large South African cohort. Antiviral therapy 2007;12:753-60.

Organization WH. Guidelines for the Use of Antiretroviral Agents in Pediatric HIV infection 2005.

Lima D, Arruda E, Lima A, Oliveira B, FonteLes M. Factors determining changes in initial antiretroviral therapy. Medical Bras 2012;58 (2):222-28.

Boule A, Orrell C, Kaplan R, et al. Substitutions due to antiretroviral toxicity or contraindication in the first 3 years of antiretroviral therapy in a large South African cohort. Antivrial Therapy 2007;12:753-60.

Sivadasan 28. A AO, Rupali P, Pulimood SA, Rajan J, Rajkumar S, . High rates of regimen change due to drug toxicity among a cohort of South Indian adults with HIV infection initiated on generic, first-line antiretroviral treatment. J Assoc Physicians India 2009;57:384-88.

Moeketsi N, Supa P. Treatment and regimen change in a cohort of HIV positive patients on Anti-Retroviral Treatment Tshepang Wellness Clinic, Dr George Mukhari Hospital.: School of Public Health University of Limpopo;2010.

O’brien ME CR, besch CL, Myers L, Kissinger P. Patterns and correlates of discontinuation of the initial HAART regimen in an urban outpatient cohort. J Acquir Immune Defic Syndr 2003;34(407-14).