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According to findings presented at the IDWeek conference in Washington, D.
C.
, initiation of antiretroviral therapy (ART) early when the immune system is strong during HIV infection has better long-term health outcomes than postponing antiretroviral therapy
The findings are based on long-term follow-up
of participants in the National Institutes of Health-funded Strategic Timing of Antiretroviral Treatment (START) study.
In 2015, the START study showed that participants who started antiretroviral therapy when their CD4+ T-cell count, a key indicator of immune system health, were greater than 500 cells per cubic millimeter (mm3) of 500 cells per cubic millimeter (mm3) had a 57 percent lower risk of developing HIV, compared to
those who did not start antiretroviral therapy until their CD4+ cell count was less than 350 cells per cubic millimeter or they developed AIDS.
After reporting these findings in 2015, participants in the deferred treatment group were advised to start antiretroviral therapy
.
According to the Centers for Disease Control and Prevention, about 1.
2 million people in the United States are living with HIV, and about 13 percent don't know they're
infected.
HIV continues to replicate
when HIV diagnosis and treatment are delayed.
This can negatively affect the health of an infected person and increase the risk of
spreading the virus to others.
The International START study demonstrated the benefits of early antiretroviral therapy, but conducted long-term follow-up of 4,446 participants to determine whether the health benefits of early antiretroviral therapy increased, remained the same, or decreased
compared with deferred antiretroviral therapy after participants who were recommended to delay antiretroviral therapy started it.
Primary study endpoints included the number of participants living with HIV; Presence of serious non-AIDS health conditions such as major cardiovascular disease, kidney failure, liver disease and cancer; And those who
died.
For participants who started ART before the end of 2015, the median CD4+ cell count at the start of ART was 648 cells/mm3 in the immediate group and 460 cells/mm3
in the delayed group.
The analysis presented today compares the primary endpoint up to the end of 2015 with the primary endpoint
of the extended follow-up period from 1 January 2016 to 31 December 2021.
In the latter phase, most delayed arm subjects were receiving ART
.
In the second phase, the HIV viral load of those who started antiretroviral therapy in the delayed group decreased rapidly and continuously (less than or equal to 200 copies/ml); However, CD4+ cell counts were still an average of 155 cells
lower than individuals in the immediate ART group.
While the delayed treatment group had a substantially lower risk of serious health consequences shortly after initiation of antiretroviral therapy, there were still some excesses in the immediate treatment group
.
The risk of serious health consequences or death (21%) remained slightly higher
in the delayed antiretroviral treatment group compared with the immediate treatment group.
There were 27 cases of AIDS in the deferred treatment group during the five-year follow-up period, compared with 15 cases
in the early treatment group.
Similarly, 88 serious non-AIDS health problems occurred in the delayed treatment sector and 76 in
the immediate treatment sector.
In the end, 57 people died in the delayed treatment group, compared to 47 in
the point-of-care group.
These findings confirm that antiretroviral therapy significantly improves the health of people living with HIV and reduces their risk of HIV and serious health problems, and that early diagnosis and treatment are key to
maximizing these benefits and reducing risk.
The START study and its extended follow-up are conducted by the Global HIV Trials Strategic Action International Network (INSIGHT), funded in part by the NIH's National Institute of Allergy and Infectious Diseases (NIAID
).
The study was led
by lead researcher James D.
Neaton, Ph.
D.
, and co-chair of the START study, Dr.
Abdel Babiker of University College London and Jens Lundgren, M.
D.
, of the University of Copenhagen.