Magnitude of adverse drug reaction and associated factors among HIV-infected adults on antiretroviral therapy in Hiwot Fana specialized university hospital, eastern Ethiopia

Introduction Human immunodefiecency virus infected patients did not adhere correctly to their Antiretroviral Therapy because of the drugs adverse effects. Thus, continuous evaluation of the adverse effect of Antiretroviral Therapy will help to make more effective treatment. The aim of this study was to assess the prevalence of Adverse Drug Reaction and associated factors on Antiretroviral Therapy among Human immunodefiecency virus infected Adults at Hiwot Fana Specialized University Hospital, Eastern Ethiopia. Methods A Hospital based retrospective study was conducted among 358 of adult patients clinical records on antiretroviral Therapy from April1 to June30, 2014. Results The overall prevalence of Adverse Drug Reaction among Human immunodefiecency virus infected patients on antiretroviral Therapy was 17.0%. Of reported Adverse Drug Reaction, 80.3%, 18% and 1.7% occurred in patients on Stavudine, Zidovudine and Tenofovir based regimens respectively. The common Adverse Drug Reaction were lipodystrophy (fat change) (49.2%), numbness/tingling (27.9%), peripheral neuropathy (18%) and (8.2%) anaemia (8.2%). Patients on Stavudine containing regimens were more likely to develop Adverse Drug Reaction compared to Zidovudine (AOR = 0.212, 95% CI 0.167, 0.914, p<0.001) and Tenofovir (AOR=0.451, 95% CI 0.532, 0.948, p<0.001). Conclusion The overall prevalence of Adverse Drug Reaction among Human immunodefiecency virus infected patients in this study was 17% and more common on those patients taking Stavudine based regimen. Lipodystrophy and peripheral neuropathy were significantly associated with stavudine-based regimens, while anaemia was significantly associated with zidovudine based regimens. Thus regular clinical and laboratory monitoring of patients on Antiretroviral Therapy should be strengthened.


Introduction
Antiretroviral Therapy (ART) is the cornerstone of management of patients infected with Human immune deficiency virus (HIV). The initiation ART has resulted in significant decreases in HIV-related morbidity and mortality in both the developed and developing countries [1][2][3]. It is also increases the length and quality of life and productivity of patients by improving survival and decreasing the incidence of opportunistic infections through reduction of the viral load and increasing the level of CD4 T cells [4]. Worldwide, it is estimated that between 250,000 and 350,000 deaths were averted in 2005 as a result of increased ART treatment accesses [5]. In Ethiopia, fee based ART program began in July 2003. By March 2005, Global Fund funded free ART service started in at least one site in all the regions [6,7]. The success of the ART is highly dependent on willingness of HIV infected patients to strictly adhere to the regimens [8,9]. However these drugs are associated with adverse effects. Adverse Drug Reactions (ADRs) are responses to a medicine which is noxious and unintended, and which occurs at doses normally used in human? [3]. It has been pointed as one of the main reason for discontinuation, switch and non-adherence to ART [10]. Up to 25% of patients discontinue their initial ART regimen within the first 8 months of therapy because toxic effect of ART [11]. The prevalence of ADRs is variably reported from different studies which were 66.7% in USA, 71.11% in India 71.11%, 4.7% in South Africa, and 88% in Ethiopia [12,13]. There was limited information about the magnitude and associated factors of ADRs among patients on ART in Ethiopia [3]. There is also no published report about the magnitude and associated factors of ADRs in Harari National Regional State. Therefore, this study assessed the magnitude of ADRs and associated factors on ART among HIV-infected adults at Hiwot Fana Specialized University Hospital, Eastern Ethiopia.

Methods
Study area and population: Harari People National Regional State is located in the Eastern part of Ethiopia which is 515 kms away from the capital city-Addis Ababa. It had a projected total population of 203,438 in 2010. It has 36 kebeles (17 rural and 19 urban), which are the lowest administrative clusters in the region.
The health service coverage of the region, which is calculated based on the number of health institutions giving health services per population in the region, is estimated to be about 100%. There were 6 Hospitals and 8 health centers in the region [14]. ART program was launched on March 26, 2006 (Table 4).

Discussion
In this study, 17% of the HIV/AIDS patients on ART were developed atleast one ADRs. This is similar to finding of study conducted in

Conclusion
The prevalence of ADRs was 17% and more common on those patients taking Stavudine based regimen. Lipodystrophy, peripheral neuropathy and anaemia were the common ADRs. Lipodystrophy and peripheral neuropathy were significantly associated with stavudine-based regimens, while anaemia was significantly associated with zidovudine based regimens. Therefore this study recommends, regular clinical and laboratory monitoring of patients on ART should be strengthened before and after initiation of ART according to guideline of institution particularly for stavudine and zidovudine based regimens. It also recommends further large scale study to assess the magnitude and associated factors ADRs by using clinical and laboratory examination.
What is known about this topic  The prevalence of ADRs was more common on those patients taking Zidovudine -based regimens;  Lipodystrophy and peripheral neuropathy were significantly associated with stavudine-based a regimen;  Anemia was significantly associated with zidovudine based regimens.
What this study adds  The prevalence of ADRs was more common on those patients taking Stavudine based regimen;  Lipodystrophy was the common ADRs.

Competing interests
The authors declare no competing interest.

Authors' contributions
FW designed the study, participated in data collection, analysis, interpretation, and write-up, drafted the manuscript and critically revised the manuscript. ZT and HM participated in study design, data collection, analysis, interpretation, and write-up, drafted the manuscript and critically revised the manuscript. All authors read and approved the final manuscript.

Acknowledgments
We acknowledged Haramaya University for financial support of this research. We also extended our thanks to Ms. Raheal Feleke for facilitation of data collection and Ms. Asmira Belay for helping us in data entry process.