Impressive results from a demonstration study in San Francisco that dramatically cut time to starting antiretroviral therapy (ART) is likely to become the future model of care for public health settings.1
This is especially in the context of results from numerous other studies at IAS 2015 supporting earlier treatment.
Although this study initially involved a relatively small number of patients diagnosed in early infection it was expanded to include people with lower CD4 counts who were diagnosed in chronic infection. It has since become part of the citywide campaign to achieve zero new infections, zero HIV-related deaths and zero stigma.2
The model was designed to see whether HIV -- as for other communicable diseases -- could be treated on the day someone is diagnosed without compromising the effectiveness of long-term treatment. The model recognised that HIV treatment has important differences to other infections but set out to improve clinical outcomes over current standard of care (SoC), and the results were impressive.
From July 2013 to December 2014, the study enrolled 39 men, who had been referred to an HIV outpatient clinic after being diagnosed at a testing centre and who were given the option of starting treatment on the day of their initial visit (rapid visit group). Outcomes were compared to 43 people (92% men) identified by clinical record review who were diagnosed during the same period and treated using routine SoC.
Both groups received similar counseling, routine laboratory tests, social support including housing and medical insurance, initial medical consultation and prescribing using a multidisciplinary team. For the intervention group, this care was predominantly took place on the same day or shortly after the referral. For the SoC group these were spread over many visits, sometimes taking weeks or months before starting ART.
Baseline demographics for the rapid visit vs. SoC groups were similar including median age (range) 32 years (21 to 47) vs. 35 (19 to 68), non-white ethnicity 59% vs. 71%, and being homeless (28% vs. 25%). None of these people had medical insurance. Median (range) CD4 and viral load were 474 (3 to 1391) vs. 417 (11 to 1194) cells/mm3 and 4.9 (2.8 to 6.6) vs. 4.5 (1.6 to 6.1) log copies/mL respectively. A higher percentage of people in the rapid visit group were diagnosed during primary HIV infection (21/30 (70%) vs. 8/31 (26%).
Because of high levels of transmitted drug resistance (25% vs. 42%), predominantly to NNRTIs most people used integrase inhibitor-based (90% vs. 83%) or PI-based (10% vs. 10%) combinations.
Uptake for ART was high with 90% of the rapid group starting on day 0, 95% by day 1 and 100% by day 30. This compared to 12% in the SoC group starting within the first two days, 28% by a week and 60% by day 30. All participants were given the option to say when they wanted to start ART.
The median overall time from diagnosis to viral suppression was significantly shorter for the rapid vs. SoC groups at 1.9 vs. 4.2 months (p<0.001). Although much of this difference related to reduction referral and waiting time, median time for suppression after starting treatment was also significantly shorter (56 vs. 95 days). The rapid group had more treatment changes (26% vs. 0) mainly for simplification (ie reduced pill count following HLA-B*5701 results).
Although the researchers expected some reluctance from participants, the opposite occurred and the option to start on the same day was universally popular. The high levels of adherence and retention in care were perhaps explained by the "overwhelmingly nurturing and wrap around service that included counselors and social workers all working together on the same day".
These results showed that it is feasible to implement same-day ART for outpatients with newly diagnosed HIV in a well resourced public health setting. This approach has now been rolled out as the model for care in the "Getting to Zero" campaign.2
Several UK clinics already use a similar intense model of care with the option of same day ART, notably centres that have good experience of starting treatment during primary infection.
A presentation by Sarah Fidler from UCL during the same session highlighted some of the reasons same day ART is especially time-critical during this early window period: more rapid and complete immune recovery, limiting the size of the viral reservoir and reducing the risk of onward transmission.3
The rapid service and highly individualised person-centered care also perhaps helps to overcome the shock from an HIV diagnosis that commonly involves weeks and months of anxiety and stress. This highly practical and forward-looking approach has a roll to empower people to take control and move forward.
Calls to the i-Base phoneline from people who are recently diagnosed are increasingly over early access to ART for these reasons. People already know they want to start treatment and if anything the delay for referral appointments and also for time to viral suppression in many ways seems to add to the difficulties of coming to terms with an HIV diagnosis.
The results from START show that routine treatment has benefits that outweigh extremely low risk of serious side effects. This is especially true when using combinations that do not include efavirenz.
For webcasts of both presentations search the online Programme at a Glance for oral abstract session WEAB01 held from 14.30 to 16.00 on Wednesday 22 July in Ballroom A.
- Pitcher C et al. Providing same day, observed ART to newly diagnosed HIV+ outpatients is associated with improved virologic suppression. 8th IAS Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2015), 19-22 July 2015. Oral abstract WEAB0104.
- Getting to zero campaign: zero infections, zero deaths, zero stigma.
- Fidler S. PHI: State or the ART. 8th IAS Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2015), 19-22 July 2015. Oral abstract WEAB0105.