AT AIDS 2016

DURBAN, SOUTH AFRICA (FRONTLINE MEDICAL NEWS) – Same-day HIV testing and initiation of antiretroviral therapy results in significantly better outcomes at 12 months than does the common practice of delaying ART for days to weeks in order to provide counseling and conduct further tests, Serena Koenig, MD, reported at the 21st International AIDS Conference.

“With standard testing protocols, patients are given the terrible news that they are HIV-positive and then discharged home without treatment. We believe that if we roll out the red carpet on that very challenging first day and provide extra attention and same-day ART, we increase a sense of hope, optimism, and connectedness to health care providers,” explained Dr. Koenig of Brigham and Women’s Hospital, Boston.

She presented a randomized, prospective clinical trial involving 577 patients at the GHESKIO Clinic in Port-au-Prince, Haiti, the world’s oldest HIV/AIDS treatment clinic and the largest provider of HIV/AIDS care in the Caribbean. Participants, all of whom had a positive HIV test, were randomized to same-day initiation of ART or to standard care, which was discharge home with instructions to return once per week for three counseling and clinical evaluation visits, with ART to begin on day 21.

Both groups received identical services and the same number of contacts with physicians and social workers in the first month following their HIV diagnosis. The only difference was the timing of ART initiation.

Study eligibility was restricted to patients with World Health Organization stage 1 or 2 HIV disease and a same-day chest x-ray showing no indication of tuberculosis or pneumonia.

The primary study endpoint was the rate of retention in care with a plasma HIV RNA viral load of less than 50 copies/mL at 12 months follow-up. This target was achieved in 54% of the same-day ART group, compared with 42% of controls.

Same-day ART also proved significantly better than the standard protocol in terms of the secondary study endpoints. It was associated with 3% mortality at 12 months, compared with 7% in the control arm. Also, 61% of patients in the same-day ART group were retained in care with a viral load of less than 1,000 copies/mL at 12 months, compared with 50% of controls.

In a multivariate regression analysis adjusted for patient demographics and clinical factors, same-day ART was independently associated with a 76% greater likelihood of retention in care with a viral load below 50 copies/mL at 12 months, a 65% reduction in the risk of mortality, and a 67% greater likelihood of retention in care with a viral load of less than 1,000 copies/mL.

The usual rationale for scheduling multiple pre-ART clinic visits is that patients may need time to come to grips with the reality that they require lifelong treatment, coupled with a feeling among many clinicians that there is no real urgency regarding ART initiation. But Dr. Koenig characterized the standard practice of requiring several clinic visits before starting ART as “a missed opportunity.”

“Delays in treatment are associated with increased mortality, diminished recovery of CD4+ cells, higher cost of treatment for opportunistic infections, and ongoing HIV transmission,” she said. “In addition to making things logistically easy, a big part of our study of same-day ART was the foundation of hope.”

Dr. Koenig reported having no financial conflicts with regard to this study, which was funded by the National Institute of Allergy and Infectious Diseases.