Evaluation of the effectiveness and safety signals of first line regimens in antiretroviral therapy (ART) / Aliza Alias

The human immunodeficiency virus (HIV) inflicts one of the most severely debilitating
illnesses known as Acquired Immune-Deficiency Syndrome (AIDS). The current
practice of management of AIDS involves antiretroviral therapy (ART). The use of
ART must be judiciously evaluated to prevent treatment failure. This research focused
on the evaluation of treatment effectiveness and safety of ART regimens
tenofovir/emtricitabine/efavirenz; tenofovir/emtricitabine/nevirapine; zidovudine/
lamivudine/efavirenz and zidovudine/lamivudine/nevirapine. Effectiveness was
measured through immunological and virological responses, while disproportionality
analysis consisting of proportional reporting ratio (PRR) and reporting odd ratio (ROR)
was used to determine potential safety signals from reported adverse events. A
retrospective non-interventional study was conducted. The result showed no significant
difference in all recommended first line ART regimens in immunological and
virological response (P=0.99 and P=0.06) respectively. Ineffectiveness or poor
treatment outcome was highly associated with non-adherence, low baseline CD4, coinfected
tuberculosis, younger age, unhealthy diet and alcohol intake, use of
supplements and improper storage of the medicine (P<0.001). Moreover, safety signals
related to nausea, vomiting, anaemia, skin discolouration, renal impairment, dry skin,
lipid abnormalities, hepatotoxicity, central nervous system effects and rashes were
detected. The safety signals that were detected could potentially unveil hitherto
unknown aspects of adverse reactions especially the least reported adverse reaction. As
a conclusion, firstly since there is no statistically significant difference in treatment
effectiveness of the four ART regimens, the selection under health care environment
with limited resource may be based on other non-therapeutic considerations. Secondly,
understanding safety signals related to adverse drug reactions early and explicitly could
serve as an important guide to the healthcare team in providing better services to protect
HIV/AIDS patients. As recommendations, on novel potential safety signals detected in
this study, confirmation through reinvestigation of data from randomized trials or
experimental study together with specific and case control or cohort analysis is
proposed. Also, since concomitant intake of supplements could potentiate the risk of
poor treatment outcome, a quantitative prospective study is suggested to find out if any
specific types of supplement and diet could affect the treatment outcome.