Tuberculosis symptoms as defined by the World Health Organization were effective in identifying patients with TB for the purposes of same-day antiretroviral therapy (ART) initiation in patients diagnosed with HIV, according to a pooled study of patients in two clinical trials. Guidelines suggest that patients with one or more TB symptoms be investigated for active TB before initiation of ART.
However, more than 80% of patients with TB symptoms did not have the disease and faced a delay of ART initiation, despite the many benefits of same-day ART initiation, according to the study presented online at the Conference on Retroviruses & Opportunistic Infections. This year CROI organizers chose to hold a virtual meeting because of concerns about the spread of COVID-19.
In her presentation,of the Boston University School of Public Health discussed the pooled results of 834 patients in the SLATE (Simple Algorithm for Treatment Eligibility) I and SLATE II trials. These two trials, conducted in South Africa and Kenya, respectively, assessed two variations of a simplified algorithm for eligibility for same-day ART initiation.
A total of 834 patients at baseline reported any self-described symptoms of TB using the WHO four-symptom TB screen (cough, fever, weight loss, night sweats). Those patients with any TB symptoms were assessed by sputum samples. The outcomes were prevalence of TB symptoms, TB diagnosis, and treatment.
Among the 834 patients, 493 (60%) reported no symptoms; 215 (26%) reported one to two symptoms, and 120 (14%) reported three to four symptoms. Only 66% of the patients with one to two symptoms were tested for TB; 78% of the patients with three to four symptoms were tested. Of these, only 1% of the patients with one to two symptoms tested positive for TB, and only 2% of the patients with three to four symptoms tested positive, according to Dr. Brennan.
“More than 80% of patients with TB symptoms did not have TB, but faced delay in ART initiation. No same-day [ART] initiators reported adverse events, so we hope that there would be some reconsideration of the requirement of TB testing prior to ART initiation due to any symptom of TB. … A potential consideration of the severity of the symptoms a patient has is necessary,” Dr. Brennan concluded.
Dr. Brennan reported that there were no disclosures.
SOURCE: Brennan AT et al. CROI 2020, .