People living with HIV (PLWH) with sustained HIV viral suppression and immune reconstitution may present with more severe clinical and biological outcomes when coinfected with other viruses or bacteria. Given the severity of the COVID-19 pandemic, there is an urgent and critical need to establish its impact in vulnerable populations including PLWH to plan for the clinical and research needs of this population. This study will focus on those PLWH living in resource-limited settings.
The existence of established HIV therapy studies, ADVANCE, D2EFT, DolPHIN2 and NAMSAL provides a unique opportunity to gather shared data on COVID-19 occurrence and outcomes in PLWH across a variety of clinical settings and a unique global range of study sites. Taken together, these pivotal trials provide an established population and clinical research structure to rapidly assess the clinical features and outcomes of COVID-19 coinfection in HIV. This evaluation could also accelerate the evaluation of HIV antiretroviral therapy (ART) as COVID-19 therapy.
The COHIVE study is an observational cohort nested within the parent studies ADVANCE, D2EFT, DolPHIN2 and NAMSAL, where participants living with HIV are randomised to different first- or second-line ART regimens. COHIVE will enrol eligible patients with confirmed or suspected infection with SARS-CoV-2 and all participants of the parent studies who agree to enrol in the SARS-CoV-2 seroprevalence group. We will then characterise the clinical features and course of symptomatic COVID-19 in PLWH, described overall as well as by HIV and comorbid disease factors, and pregnancy status.
We hypothesise that in PLWH, compared to the general population, there will be differences in incidence of COVID-19 and severity of clinical outcomes, depending on their ART, co-morbidities and therapeutic success. The direction of this difference may be contextual: given immunosuppression and higher rates of co-morbidities they may have higher rates of hospitalisations or other serious outcomes; conversely participants on ART may be protected. There may also be differences in the shedding of SARS-CoV-2 and relationship of infection with symptoms.
This study provides an immediate public health impact, delivering critical data for a key vulnerable population in this evolving crisis, and potentially accelerating the development of broadly applicable therapies. It also provides a health system impact, supporting availability of testing and freeing tests and personal protective equipment for other uses, and strengthening test provision in this environment.
The COHIVE Study is supported by the Kirby Institute, UNSW Sydney.