A NEW study has for the first time provided conclusive evidence to show early treatment for HIV has significant benefits for individuals, a finding with major implications for HIV treatment guidelines worldwide.
The Kirby Institute today announced the early termination of the Strategic Timing of Antiretroviral Treatment (START) study due to conclusive evidence drawn from the study’s interim results.
Half of participants were put on treatment immediately, while the other half had treatment delayed until their CD4 T-cell count, an indicator of the health of a person’s immune system, fell to around 350 cells/mm3.
Current international guidelines generally recommend a HIV-positive person should begin treatment when their CD4 count drops below normal levels, which are around 500 cells/mm3.
The study found people who began treatment immediately were 50 per cent less at risk of “serious AIDS events, and deaths due to non-AIDS events including major cardiovascular events, renal and liver disease”, compared to those who delayed starting treatment.
The START results provide the first conclusive evidence to support antiretroviral therapy for HIV-positive people with normal CD4 counts, meaning there are benefits to beginning treatment as soon as a person is diagnosed.
The Kirby Institute’s Professor Sean Emery said the findings could go to addressing the gap worldwide between the numbers of people living with HIV, and the numbers of people on treatment.
“Part of the reason for that gap has been a concern that the use of these drugs in individuals with relatively early stages of disease lacks sufficiently rigorous and robust evidence… there’s been doubt for a long time as to whether antiretrovirals should be used in those individuals,” he said.
“The direct impact of the START trial that’s just been concluded is that that threshold (CD4 count below 500 cells/mm3) should no longer be in place, and that essentially anybody with HIV infection should commence treatment with antiretroviral therapy.”
Emery also said there was no evidence from the study that the use of antiretroviral medications was associated with significant harm to individuals.
Australia’s peak HIV sector organisations have all welcomed the conclusive findings from the START study.
“These study results will influence how HIV is treated and prevented around the world, in both developed and developing countries,” National Association of People with HIV Australia president Rob Mitchell said.
“Many researchers, clinicians and advocates have held this view, but the evidence to support it came mostly from smaller studies and expert opinion. It was argued that we lacked a large, definitive, randomised clinical study to prove the early treatment strategy.”
Australian Federation of AIDS Organisations executive officer Rob Lake agreed: “For health professionals, these results offer clear support for initiating treatment as soon as patients are ready. For people with HIV, who may be delaying treatment until their CD4 count starts to fall or who may be apprehensive for other reasons, these results should offer confidence that starting now is the best decision for long term health.”
Recent changes to the Pharmaceutical Benefits Scheme mean Australians living with HIV no longer need to wait for their CD4 count to drop below a certain level to qualify for PBS-supported treatment, but sector guidelines for treatment still indicate uncertainty around the benefits of early treatment.
Because people on treatment are much less likely to transmit HIV, the HIV sector in Australia has promoted the community-level benefits of early treatment. However, this new evidence about its individual benefits could prompt a shift in how HIV organisations and government bodies advocate early treatment.
“Now we have unequivocal evidence, we hope this will give people living with HIV greater confidence to consider the benefits of starting treatment as soon as they are ready to,” Living Positive Victoria chief executive Brent Allan said.
ACON chief executive Nicolas Parkhill said the results backed up their campaign for early treatment as one of the essential pillars for HIV prevention.
“There is no need to debate about whether treating early is a population or individual health decision: these findings clearly demonstrate that deferring treatment has no benefit and only risks to individual and population health goals,” he said.
Victorian AIDS Council chief executive Simon Ruth highlighted that while the START study provided definitive proof of the benefit of starting treatment immediately, the decision to start treatment requires careful consideration based on an individual’s “readiness and ability” to integrate treatment into their lives.
“Adherence is critical in the success of antiretroviral therapy (ART) and we need to provide people with every possible adherence support when they commit to life-long therapy,” he said.
Both ACON and VAC believe that in order to encourage people to start treatment early, potential barriers that may impact long-term adherence levels must be eliminated.
“The recent decision to make HIV medications available from community pharmacies from July of this year is a step in the right direction,” Ruth said.
“However, co-payments for people living with HIV, especially those who may be accessing multiple medications as part of their treatment, is a major barrier that will need to be addressed.”
ACON credited the NSW government for announcing they would remove the co-payment for s100 drugs such as HIV medication.
“In the face of this new evidence, we need to remain focussed on involving and engaging the community, working to ensure gay men access to the most up to date technology, and making HIV prevention and treatment more accessible and affordable,” Parkhill said.