This article is more than 5 years old. Information may no longer be current.

START: Early ART benefits all HIV-positive adults

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

The immediate initiation of ART in asymptomatic HIV-positive adults with a CD4+ count of more than 500 cells/mm³ significantly reduced rates of serious AIDS-related and non-AIDS–related events, according to recent findings from the Strategic Timing of Antiretroviral Treatment, or START, trial.

“The results show that early treatment not only reduces opportunistic infections, which offers a bigger benefit in lower-income countries, but it also prevents a significant amount of illness in higher-income countries as well by reducing the risk of serious non-AIDS events that consisted largely of cancer and cardiovascular disease,” Jens D. Lundgren, MD, chief physician and director of the Copenhagen HIV Program in Denmark and co-chair of the START trial, said in a press release.

Lundgren presented the findings at IAS 2015.

Jens D. Lundgren

The study included 4,685 HIV-positive adults who were ART naive and asymptomatic. At enrollment, all participants had CD4+ cell counts in the normal range — above 500 cells/mm³.

The researchers randomly assigned patients to two treatment groups: immediate initiation or deferred initiation. The 2,359 participants assigned to deferred initiation delayed treatment until their CD4+ counts decreased to 350 cells/mm³, or until they developed AIDS or another condition requiring ART. This was consistent with the treatment guidelines available in 2009, when the study was initiated, the researchers noted.

The composite primary endpoint included any serious AIDS-related event, serious non-AIDS–related event, or any-cause death.

In May, an interim analysis revealed that the study question about the benefits of ART initiation had been answered, so participants in the deferred group were offered ART.

The researchers reported that the primary endpoint occurred in 42 patients in the immediate-initiation group (1.8%; 0.6 events per 100 person-years), compared with 96 patients (4.1%; 1.38 events per 100 person-years) in the deferred-initiation group (HR = 0.43; 95% CI, 0.3-0.62).

Anthony S. Fauci

Starting treatment earlier reduced rates of serious AIDS-related events, such as AIDS-related cancer, by 72%, the investigators said. In addition, the rate of serious non-AIDS events, including cardiovascular disease and end-stage renal disease, decreased by 39%.

The overall risk for developing serious AIDS events, serious non-AIDS events or death decreased 57% in patients who initiated ART immediately.

“This study conclusively shows that the benefits of early therapy far outweigh any adverse outcomes, and reinforces recommendations to offer immediate antiretroviral therapy to all patients,” NIAID Director Anthony S. Fauci, MD, said in the release. “[These] findings show that early antiretroviral treatment presents no additional risk of serious, non-AIDS–related disease to people taking treatment, but actually confers valuable protection against these illnesses, helping keep HIV-infected people healthier longer.”

In a related editorial, Salim S. Abdool Karim, MD, PhD, director of the Center for the AIDS Program of Research in South Africa at the University of KwaZulu-Natal, said the findings from START — along with other studies like the African TEMPRANO trial — provide additional evidence in support of early ART initiation. The expansion of early treatment for everyone with HIV, however, faces significant hurdles, particularly with so many unaware of their infection status.

Salim S. Abdool Karim

“Without the more effective use of available funding and mobilization of additional resources, there is little prospect of a world rising to the challenge of ensuring that every HIV-positive person knows his or her HIV status, seeks care early, is started on ART immediately, and is retained in care with viral suppression. With the evidence from these trials, it is now more important than ever to make the motto of ‘Test, Treat, Retain, Respect, and Prevent’ a global action statement.” — by Colleen Owens

References:

Karim, SSA. N Engl J Med. 2015;doi:10.1056/NEJMe1508527.

Lundgren JD, et al. N Engl J Med. 2015;doi:10.1056/NEJMoa1506816.

Lundgren, JD. Session MOSY0302. Presented at: International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention; July 19-22, 2015; Vancouver, British Columbia.

Disclosure s : Karim reports being a member of WHO’s Strategic Use of ARVs Steering Committee. Lundgren reports receiving grant support from the Danish National Research Foundation and the University of Minnesota during the conduct of the study. Please see the full study for a list of all other authors’ relevant financial disclosures.