Wednesday 29 June, 2016 13.00 EDT
1 June 2015
Study confirms starting HIV treatment early prevents illness and death
A large, well-designed clinical trial called START has confirmed that by initiating anti-HIV therapy early—when their CD4+ cell counts are still relatively high—HIV-positive people can significantly reduce their risk of developing AIDS, other serious illnesses unrelated to AIDS or dying. According to the U.S. National Institute of Allergy and Infectious Diseases (NIAID), the results from START “support offering treatment to everyone with HIV.”
About the study
START, short for strategic timing of antiretroviral treatment, began in April 2011 and recruited 4,685 HIV-positive adults from 35 countries—including both high- and low-income countries. About 73% of participants were men and 27% were women. The average age of participants was 36 years, and prior to START, none had taken anti-HIV therapy (commonly called ART or HAART). Upon entering the study, all of the participants had more than 500 CD4+ cells/mm3. Once in START, participants were randomly assigned to receive one of the following interventions:
- immediate initiation of ART
- delay initiation of ART until their CD4+ count had fallen below 350 cells/mm3
START was originally expected to finish by the end of 2016. However, after participants had been in it for an average of three years, an independent review body (called a data safety monitoring board, or DSMB) monitoring the study found that major medical events were distributed as follows:
- immediate initiation of ART – 41 cases of AIDS, serious non-AIDS events or death
- delayed initiation of ART – 86 cases of AIDS, serious non-AIDS events or death
The most common AIDS-related illnesses were as follows:
- tuberculosis in the lungs
- Kaposi’s sarcoma (KS) – a form of cancer
- non-Hodgkin’s lymphoma – a form of cancer
The most common serious non-AIDS events were as follows:
- heart attack
The DSMB informed NIAID of its analysis and NIAID confirmed the findings and agreed to release the results well ahead of schedule: Early ART cuts the risk of developing AIDS, serious non-AIDS events or death by 53%. All participants have been informed of the results and participants who have not yet started ART will be offered therapy.
For the future
The full details from START will be released in the future at a medical conference.
As a tremendous amount of data has been captured by START, future analyses will explore the impact of immediate vs. delayed ART on the health of the following organ-systems:
What some researchers are saying
Commenting on the START results, leading HIV researcher and NIAID director Anthony Fauci, MD, said:
“We now have clear-cut proof that it is of significantly greater health benefit to an [HIV-positive] person to start [ART] sooner rather than later… Moreover, early therapy conveys a double benefit, not only improving the health of individuals but at the same time, by lowering the [amount of HIV in their blood], reducing the risk they will [inadvertently spread] HIV to others. These findings have global implications for the treatment of HIV.”
START co-chair and leading European researcher Jens Lundgren, MD, University of Copenhagen, said, “We now have strong evidence that early treatment is beneficial to the HIV-positive person. These results support treating everyone irrespective of CD4+ cell count.”
Guidelines and testing programs
Since February 2013 the U.S. Department of Health and Human Services (DHHS) HIV treatment guidelines has recommended that all HIV-positive adults and adolescents begin ART regardless of their CD4+ count. This advice had been based on data from observational studies and randomized studies with HIV-positive people who had less than 350 cells/mm3. However, given the size of START and its robust statistical design, and its enrollment of people with more than 500 CD4+ cells, very strong evidence is now available to support the DHHS guidelines. Hopefully, the news about the exciting results from START will cause more doctors and nurses in Canada and elsewhere to recommend the early initiation of ART.
The results from START also strengthen efforts to offer widespread and confidential HIV testing and counselling, and to provide swift referral to care and treatment for those who test positive.
Here is some other information about participants in START collected at the beginning of the study.
START enrolled participants from many countries. Here are the proportions of participants recruited by key regions and countries (note that numbers do not total 100 due to rounding):
- Europe – 33%
- Latin America – 25%
- Africa – 21%
- North America (Canada did not participate in START) – 11%
- Asia – 8%
- Australia – 2%
Some lab test results
- average CD4+ count – 651 cells/mm3
- average HIV viral load – 13,000 copies/mL
- hepatitis B virus positive – 3%
- hepatitis C virus positive – 4%
Many regimens used by participants once START began included the following anti-HIV drugs as their backbone:
- efavirenz (Sustiva, Stocrin and in Atripla)
- atazanavir (Reyataz) + low-dose ritonavir (Norvir)
- darunavir (Prezista) + Norvir
- raltegravir (Isentress)
- rilpivirine (Edurant and in Complera and Eviplera)
The above regimens were accompanied by nucleoside analogues (commonly called nukes) such as the following:
- Truvada – a fixed-dose combination of tenofovir + FTC
- Combivir – a fixed-dose combination of AZT + 3TC
—Sean R. Hosein
Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents – U.S. Department of Health and Human Services
- NIAID. Starting antiretroviral treatment early improves outcomes for HIV-infected individuals. NIH News. Press release. 27 May 2015.
- START. 10th Review by the Data and Safety Monitoring Board. Report. 15 May 2015.