Start ART Now: A Top HIV Clinical Development of 2016

Top 10 Clinical Developments of 2016
1. Donald Trump6. Return of the Antibodies
2. Switch Frenzy7. Is an Unexpected Low HIV RNA Level Real?
3. 2-Drug ART8. Dolutegravir and the Central Nervous System
4. Is HIV PrEP at a Tipping Point?9. TAF in Hepatitis B
5. Start ART Now10. New HIV infections in U.S. Are Down -- a Bit

Antiretroviral therapy (ART) is for everyone regardless of CD4 cell count! No more T-cell thresholds! Starting ART early saves lives! You have heard it. I have heard it. We get it. Now that we do, new data suggests that we take the "earlier is better" philosophy one step further and offer HIV medication with the first handshake. Two studies presented this year provide evidence for the feasibility of same day (or close to it) HIV testing and ART initiation. Both also report fairly astounding and, to some, counterintuitive outcomes with this approach.

A team from San Francisco looked retrospectively at 39 patients, most with acute or recent HIV infection, who were offered ART at their first clinic visit rather than at a return visit following counseling and laboratory testing. Uptake of ART at the first visit was high at almost 95%, and the median time to virologic suppression was 1.8 months -- half that of those who were offered ART under the more traditional multi-visit schedule.

A randomized trial (N=762) of same-day ART initiation versus traditional ART initiation after laboratory testing and counseling visits conducted in Haiti found that same-day ART led to greater uptake of ART (100% versus 92%), lower mortality (3% versus 7%) and higher suppression rates (54% versus 42%) -- all differences were highly statistically significant.

The Bottom Line

There are plenty of reasons to believe that time spent counseling and preparing a patient for a lifetime of HIV therapy is well spent. However, these studies suggest that in many cases there is a cost for delaying the start of ART, even for a few weeks. Loss to follow-up, time to suppression (and therefore less infectiousness) and mortality in places such as Haiti were all worse when ART was made a multi-step process. Same-day treatment of HIV, beyond providing rapid biological responses, also may work by sending a strong message that HIV is a serious infection that deserves immediate attention. Talk is good, but the "walk" is found in medication, and this is the hook that keeps many patients returning to the clinic.

Clinics certainly need to sort out logistical issues, especially procuring a supply of medications -- a mean feat given the insane patchwork of health care insurance coverage here in the U.S. In California, ART is more accessible than in many other places in the country, and the San Francisco clinic that reported its experience with rapid ART administration had a five-day supply of medications available to dole out to those who needed it. In clinics where ART is readily available and for patients with easy, immediate access to HIV medications, same-day ART should be explored as a way to improve retention in care and to smooth those steps on the HIV care continuum cascade.

What are some other top clinical developments of 2016? Read more of Dr. Wohl's picks.

David Alain Wohl, M.D., is a professor in the Division of Infectious Diseases at the University of North Carolina at Chapel Hill, director of the North Carolina AIDS Training and Education Center and site leader of the University of North Carolina Chapel Hill AIDS Clinical Research Site.