Community perspective on the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial

Abstract

Determining when to start antiretroviral treatment (ART) is vitally important for people living with HIV. Yet the optimal point to start to maximise clinical benefit remains unknown. In the absence of randomised studies, current guidelines rely on conflicting observational data and expert opinion, and consequently diverge on this point. In the United States, ART is recommended irrespective of CD4 cell count. The World Health Organization now recommends starting ART at a CD4 cell count of 500 cells/µL, while the threshold for the United Kingdom and South Africa remains at 350 cells/µL. The Strategic Timing of AntiRetroviral Treatment (START) study, one of the largest clinical trials on the treatment of HIV, will answer this question. START compares two treatment strategies: immediate treatment at a CD4 cell count of 500 cells/µL or higher versus deferring until the CD4 cell count decreases to 350 cells/µL or AIDS. START includes seven substudies, five of which will clarify the relative contribution of HIV and ART in common comorbidities. START is fully enrolled and expected to be completed in 2016. HIV advocates support the study’s design and have been involved from inception through enrolment. The trial will produce rigorous data on the benefits and risks of earlier treatment. It will inform policy and treatment advocacy globally, benefitting the health of HIV-positive people.

HIV-1 transmission networks in high risk fishing communities on the shores of Lake Victoria in Uganda: A phylogenetic and epidemiological approach

“…In 2013 ART national guidelines included Fisherfolk as a key population eligible to receive ART at the time of diagnosis. The recent findings from START study show a benefit of early ART for all HIV-positive individuals to prevent transmissions and to address the health needs of those living with HIV [45]. On this basis, the new national ART guidelines (2016) recommend ART initiation at the earliest opportunity in all people with confirmed HIV infection regardless of CD4 cell count, and a combination HIV prevention approach including ART and safe male circumcision (SMC) has been adopted.…”

Cascade of care and factors associated with virological suppression among HIV-positive persons linked to care in the Test and Keep in Care (TAK) project

“…Here we present that not only the time to starting cART, but also the time to achieving supressed viremia has improved over recent years. This can be contributed to substantial change in the understanding of early cART benefit resulting in physicians initiating treatment irrespective of CD4 count [ 29 , 30 ]. In addition, wider access to InSTI and one tablet regimens in Poland has facilitated the availability of regimens with better tolerability and reduced pill burden, which may partially contribute to this effect.…”

When to start antiretroviral treatment? A history and analysis of a scientific controversy

“…42 START was conceived in the mid-2000s to resolve definitively the question when it would be best to start treatment from the perspective of a patient with HIV. The trial was randomised but open-label because a placebo arm would have created insurmountable practical and ethical problems.…”