Antiretroviral therapy (ART) begun near the day of HIV diagnosis more than halved time to viral suppression compared with standard ART initiation in a public health setting comparison. A large majority of patients offered immediate ART accepted, and serious toxicity did not emerge with the rapid strategy.
In 2010, San Francisco General Hospital (SFGH) began recommending early ART after HIV diagnosis regardless of CD4 count, a strategy endorsed in national guidelines two years later. Early ART reduces morbidity and mortality and lowers risk of HIV transmission. But, structural barriers and provider attitudes may prevent ART initiation immediately upon diagnosis. In 2013, SFGH began its Rapid ART Program for Individuals With an HIV Diagnosis (RAPID) to offer observed day-of-referral treatment "even as other aspects of linkage and engagement are ongoing."
To assess the acceptability, safety and impact of RAPID ART, the SFGH team compared patients managed according to the RAPID protocol with two other groups: (1) patients managed in the same period (June 2013 through December 2014) according to the standard SFGH universal-ART practice and (2) a retrospective cohort of patients referred for care in 2006-2013. The retrospective cohort provided a preintervention and postintervention comparison. All participants were 18 or older and starting HIV care at the SFGH clinic with newly diagnosed infection.
Standard care addresses medical, socioeconomic and psychological concerns. The RAPID program involves (1) same-day HIV provider access and medical visit, (2) accelerated insurance approval, (3) five-day starter packs of preapproved ART regimens, (4) observed first-dose administration and (5) telephone follow-up. The RAPID group initially included people with acute or recent HIV infection, meaning an HIV-negative test within six months of referral. Later, the group included newly diagnosed people with a CD4 count below 200 cells/mm3
, active opportunistic infection or an HIV-negative sex partner.
Among 86 outpatients referred to begin HIV care in 2013-2014, 39 received RAPID intervention and 47 standard care. None had private health insurance, most were nonwhite men, 28% were homeless, 42% had a mental health disorder and 42% reported illicit substance use. Demographics, CD4 count and viral load did not differ substantially between the RAPID and standard-care groups. Three-quarters of the RAPID group had acute or recent HIV infection. Among 39 people offered RAPID ART, 35 took their first dose in the clinic and 37 started ART within the first 24 hours. Among the 47 non-RAPID patients, median time to ART prescription was 22 days (P < .001 versus RAPID ART).
More than 80% of participants in the RAPID and non-RAPID groups received an integrase inhibitor. No participants had observed major mutations that would compromise their initial regimen. Two patients (5%) in the RAPID group and none in the non-RAPID group had minor toxicity; two patients in the RAPID group changed their initial regimen because of rash. Four of 39 RAPID patients (10%) and seven of 47 non-RAPID patients (15%) were lost to follow-up.
Median time from diagnosis to clinic referral was six days in the RAPID group, 11 days in the non-RAPID group (P = .004), 33 days in 2006-2009 and 14 days in 2010-2013 (P = .008). Median time from diagnosis to a viral load below 200 copies/mL was 65 days with RAPID ART, 170 days in the non-RAPID group (P < .001), 580 days in 2006-2009 and 190 days in 2010-2013 (P < .001).
The SFGH team concludes that "[s]ame-day, observed initiation of antiretroviral treatment was well accepted, was well tolerated by patients, and did not seem to interfere with subsequent engagement in care." And RAPID intervention was associated with shorter time to HIV suppression. RAPID care did require additional time from the health care team. Because RAPID ART began before some lab results became available, providers also had to consider regimen modifications more often with RAPID ART than with standard care.
Mark Mascolini writes about HIV infection.