Acquired immune deficiency syndrome (AIDS) was discovered in 1981 among homosexuals in the USA, and the causative agent known as human immunodeficiency virus (HIV) was isolated in 1983 (Al-Mazrou et la., 2005). However, there is growing trend of HIV infection with 35million people were infected and 1.82 million HIV/AIDS associated death reported in 2010. It is also encouraging that epidemiological reports from 2010 shows decreases in the number of yearly HIV-infection by 21% (UNAIDS, 2011). The introduction of highly active antiretroviral therapy (HAART) has caused tremendous decreases in HIV transmission and death rate (Detels et al., 1998; Al Hajjar et al., 2012). Unfortunately, this achievement can be impaired by reports that showed that 25% of patients on HAART could discontinue their therapy because of toxic effects associated with therapy and HIV resistance to HAART (Lucas et al., 1999; Alrajhi AA, Almohaizeie, 2008).
Different treatment modalities have been introduced to improve treatment with HAART and to reduce toxic effects. Each antiretroviral medication is associated with its own specific adverse effects or may cause problems only in particular circumstances. Similarly, class specific adverse effects may occur. The Non nucleoside reverse transcriptase inhibitors (NNRITs) have been associated with skeletal and cardiomyopathy, autonomic and peripheral neuropathy, pancreatitis, lipoatrophy and steatohepatitis, (Lonergan et al., 2000). The nucleoside reverse transcriptase inhibitors (NRTI) have been associated with hepatotoxicity and hypersensitivity. The protease inhibitors are known to cause metabolic disorders (Carr et al., 1998). Also, some have been withdrawn from the market antiretroviral drugs because of their life-threatening adverse events (Smart, 2006).
Current guidelines for the management of HIV infection recommend the use of tenofovir/ lamivudine/efavirenz (TELE) (WHO, 2010;Musa et al., 2015).TELE is among the WHO-recommended regimens for the initiation of HIV therapy and is recommended in European and American guidelines as a first-line antiretroviral therapy (WHO, 2010). The efficacy of TELE in the treatment of HIV has been widely evaluated in several clinical trials (Gallant et al., 2006). An efficacy of 76%–84% has been reported at in HIV patients on TELE for 48 weeks with 5%–16% virological failure observed (Deeks and Perry, 2010). Unfortunately, there is lack of information on large multicentre cohort studies on the efficacy of TELE in clinical practice that allows efficacy analyses independent of co-formulation. Furthermore, despite the efficacy of TELE there is paucity of information on the safety of TELE especially in black population which is of clinical importance because different race could respond to same therapy differently. Also, the limited available safety data did not capture essential biomarkers that can be used to establish its safety profile , Therefore, to bridge this information gap the present study assessed the effect of TELE in black population taking into cognizance relevant parameters used as tools in the safety assessment of xenobiotics


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