Abstract
BackgroundWe compared clinical outcomes among HIV-infected participants receiving ART who were randomized to viral load (VL) and CD4 cell count monitoring in comparison to CD4 cell count monitoring alone in Tororo, Uganda.MethodsBeginning in May 2003, participants with CD4 cell counts <250 cells/μL or WHO stage 3 or 4 disease were randomized to clinical monitoring alone, clinical monitoring plus quarterly CD4 cell counts (CD4-only); or clinical monitoring, quarterly CD4 cell counts and quarterly VL testing (CD4-VL). In 2007, individuals in clinical monitoring arm were re-randomized to the other two arms and all participants were followed until March 31, 2009. We used Cox Proportional Hazard models to determine if study arm was independently associated with the development of opportunistic infections (OIs) or death.ResultsWe randomized 1211 participants to the three original study arms and 331 surviving participants in the clinical monitoring arm were re-randomized to the CD4-VL and CD4 only arms. At enrolment the median age was 38 years and the median CD4 cell count was 134 cells/μL. Over a median of 5.2 years of follow-up, 37 deaths and 35 new OIs occurred in the VL-CD4 arm patients, 39 deaths and 42 new OIs occurred in CD4-only patients. We did not observe an association between monitoring arm and new OIs or death (AHR =1.19 for CD4-only vs. CD4-VL; 95 % CI 0.82–1.73).ConclusionWe found no differences in clinical outcomes associated with the addition of quarterly VL monitoring to quarterly CD4 cell count monitoring.
Highlights
We compared clinical outcomes among HIV-infected participants receiving antiretroviral therapy (ART) who were randomized to viral load (VL) and CD4 cell count monitoring in comparison to CD4 cell count monitoring alone in Tororo, Uganda
Study design Beginning in May, 2003, we assessed for eligibility for study enrolment of HIV positive adult patients ≥18 years who had registered with The AIDS Support Organization (TASO) - Tororo branch
Participants initiated ART with combinations of lamuvidine with either niverapine or efavirenz; and zidovudine or stavudine, In April, 2007, following analysis of the first phase of the study which demonstrated that clinical follow-up only participants were at increased risk for death and/or new opportunistic infections (OIs) [8], these participants were re-randomized to either clinical monitoring and quarterly CD4 cell counts and VL (CD4VL) or clinical monitoring and quarterly CD4 cell counts only (CD4-only) and all participants were followed until March 31, 2009
Summary
We compared clinical outcomes among HIV-infected participants receiving ART who were randomized to viral load (VL) and CD4 cell count monitoring in comparison to CD4 cell count monitoring alone in Tororo, Uganda. One of the greatest global public health achievements has been the rapid scaling up of antiretroviral therapy (ART) in resource limited settings over the past decade. This has largely been achieved through the “public health approach” promoted by the World Health Organization (WHO) [1,2,3]. The WHO 2013 guidelines recommend VL testing as the preferred monitoring approach to diagnose and confirm ART treatment failure in both adults and children. While there are advantages to providing access to VL testing such as earlier detection of treatment failure and a reduced likelihood of developing ART drug resistance, this approach is still debated in resource limited settings [7,8,9,10,11]
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