Researchers have found that initiating antiretroviral therapy (ART) immediately among patients who have been recently infected with HIV modestly staves off disease progression and the need for long-term HIV treatment later down the road.
The study results are published in the latest issue of The Journal of Infectious Diseases in an article entitled, “The Setpoint Study (AIDS Clinical Trials Group A5217): Effect of Immediate Versus Deferred Antiretroviral Therapy on Virologic Set Point in Recently HIV-1–Infected Individuals.”
Investigators enrolled 130 men and non-pregnant women who had been infected with HIV within the last six months and had not previously taken HIV medication at 25 sites in the United States and two in Peru. They were then randomized into two groups: one receiving immediate ART (a fixed-dose combination of emtricitabine-tenofovir plus lopinavir-ritonavir, or any other physician-prescribed potent ART regimen) for 36 weeks after which treatment was stopped, and the other where treatment was deferred. Seventy-two weeks later, investigators compared the immediate ART group’s virologic setpoint with that of the deferred group’s. The investigators also compared the immediate ART group’s average viral load (virologic setpoint) at 72 weeks with that of the deferred group’s at 36 weeks.
Overall, the Setpoint Study showed that the immediate group had a better outcome than the deferred group, where patients experienced “higher than anticipated disease progression, necessitating the start of HIV treatment before the study endpoint,” according to the JID press release. Half of the deferred group required treatment on medical grounds within 18 months. Also of note, 88 percent of the initial therapy group achieved complete virologic suppression by 24 weeks into treatment.
Investigators also found that early treatment “modestly delayed” the need for subsequent treatment, demonstrating a brief sustainment of the protective effect of therapy after treatment had stopped. Seven out of 66 patients (11 percent) in the immediate treatment group required treatment during the study follow up period, versus 23 of the 64 patients (36 percent) in the deferred treatment group. Within the first 36 weeks, 20 percent of those in the deferred group met the criteria for ART initiation.
According to lead author Christine Hogan, MD, from The Medical College of Wisconsin, and colleagues the results suggest that “if immediate therapy is not begun, progression to meeting standard criteria for ART initiation may occur more rapidly than expected, especially with changing treatment paradigms.”
In an accompanying opinion piece, Drs. Harout Tossonian and Brian Conway use the new study to inform the “When to treat?” debate. “…An initial 36-week course of treatment at presentation may delay the need to restart treatment for longer than those 36 weeks. Thus, over the lifetime of the patient, there will be less cumulative drug exposure,” according to the piece, an added benefit to the decreased risk of transmitting the virus to others as proven by the HPTN 052 trial, and a likely better overall health prognosis.