Abstract:
Highly active antiretroviral therapy has markedly decreased the morbidity
and mortality due to HIV disease. However, toxicities and new TB drug treatment
would result in frequent modification or discontinuation of antiretroviral drugs.
Objective: To assess reasons for modification or discontinuation of first highly active
antiretroviral therapy and risk factors among HIV infected adult patients at Jimma
University Specialized Hospital, South West Ethiopia.
Methods and materials: Retrospective general cohort study was conducted on 1533 of
HIV infected adult naïve patients with > 15 years and on highly active antiretroviral
therapy from 2006 to 2010 at ART clinic of Jimma University Specialized Hospital.
Kaplan-Meier was used to estimate probability of highly active antiretroviral therapy
discontinuation or modification as well as Cox-regression models the associations
between modification or discontinuation and toxicities with baseline factors. Coxproportional hazard regression also used to evaluate effect of early modification or
discontinuation of highly active antiretroviral therapy on treatment failure.
Result: High prevalence (47.7%) of modification and discontinuation was found.
Estimated probability of modification or discontinuation within one year of HAART
start was 16.6% (15.6– 17.6%). Toxicities were the most frequent 431(71.9%), reason
for modification; however, no documented reason for discontinuation. Efavirenz and
non-stavudine had lower risk of modification or discontinuation (Hazard ratio (HR) of
95% CI = 0.573(0.465 - 0.707) and 0.397(O.323 – 0.487)) when compared with
nevirapine and stavudine based regimens respectively. Positive for tuberculosis screen
and bedridden patients had higher hazard of modification or discontinuation (Hazard
ratio (HR) = 1.411(1.162-1.714) and 1.485(1.054-2.093)). Early modification or
discontinuation had associated [(HR) = 2.29(1.56 - 23.36)] with treatment failure. Age
> 35 years and positive for Tuberculosis had high hazard of toxicities ((HR)
=1.326(1.091-1.612) and 1.473(1.120-1.938)) where efavirenz and non- stavudine
containing regimens had lower hazard ((HR= 0.570(0.425-0.765) and 0.298(0.217-
0.411)) for toxicities.
Conclusions: High prevalence of modification and discontinuation of highly active
antiretroviral therapy, particularly due to toxicities. Positive for TB screen and the use
of stavudine and nevirapine containing regimen had high risk of modification or
discontinuation and also for toxicities. Close monitoring and management of toxicities
are crucial for durability of highly active antiretroviral therapy.