A clinical trial study found that people living with the HIV should start treatment before the virus weakens their immune system, as is the case now.
The important randomaised clinical trial study showed that if HIV positive people receive treatment when their CD4 cell count is higher, instead of waiting until their CD4 cell count drops to lower levels, have a considerably lower risk of developing AIDS or other serious illnesses if they start taking antiretroviral treatment (ART) after diagnosis.
The Strategic Timing of AntiRetroviral Treatment (START) study was stopped because of unequivocal evidence showing that starting ART before a person’s CD4 count drops below 500 cells/mm3 leads to less illness and fewer adverse events, both AIDS- and non-AIDS-defining, compared to waiting till their CD4 count drops below 350 cells/mm3.
The groundbreaking international START study commenced its research in 2011 in a large-scale randomised clinical trial that tested whether earlier ART benefitted all people with HIV.
The trial enrolled 4685 men and women with HIV who had never taken ART. They were aged 18 and older, with a median age of 36, and their CD4 counts were all over 500 cells/mm3.
Half of the study participants were randomised to start ART immediately and the other half deferred treatment until their CD4 cell count declined to 350 cells/mm3. On average, participants in the study were followed for three years.
The study measured a combination of outcomes that included serious AIDS events (such as AIDS-related cancer), serious non-AIDS events (major cardiovascular, renal and liver disease and cancer), and death.
Although it was expected to end in December 2016, an interim review of the study data by the study’s Independent Data and Safety Monitoring Board (DSMB) recommended that results be released early.
Based on data up to March 2015, the DSMB found 41 instances of AIDS, serious non-AIDS events or death among those enrolled in the group starting ART early, compared to 86 events in those deferring it.
This translates to an tremendous reduction of 53% in the risk of developing serious illness or death. The risk reduction was even more pronounced for the AIDS-defining illnesses.
The most common AIDS-related illnesses among study participants were pulmonary tuberculosis, Kaposi’s sarcoma, and non-Hodgkins lymphoma. The most common serious non-AIDS-related illnesses were cancer, heart attack, and deaths due to various causes.
“We now have clear-cut proof that it is of significantly greater health benefit to an HIV-infected person to start antiretroviral therapy sooner rather than later,” said Anthony S. Fauci, Director of the US National Insititute of Allergy and Infectious Disease (NIAID).
He added: “Moreover, early therapy conveys a double benefit, not only improving the health of individuals but at the same time, by lowering their viral load, reducing the risk they will transmit HIV to others. These findings have global implications for the treatment of HIV.”
“This is an important milestone in HIV research,” said Jens Lundgren, M.D., of the University of Copenhagen and one of the co-chairs of the START study. “We now have strong evidence that early treatment is beneficial to the HIV-positive person. These results support treating everyone irrespective of CD4+ T-cell count.”
Commenting on the news, Gus Cairns, AIDSmap Editor, told KaleidoScot: “It’s an unexpectedly conclusive but very clear result: start HIV drugs before your CD4 count drops below 500 cells/mm3 and you have half the chance of getting sick compared with waiting. Simple as that.
“The only remaining debate is whether to recommend a new CD4 threshold of 500.
“Given the strength of the result, though, I think it’s reasonable to extrapolate that antiretroviral therapy has positive effects regardless of CD4 count and everyone diagnosed should be offered therapy immediately.”
George Valiotis of HIV Scotland called for treatment guidelines to be reviewed in Scotland.
He told KaleidoScot: “New research on treatment over the past decade has been very promising – it’s clear that getting on treatment early can improve health and reduce infectiousness.
“People living with HIV in Scotland have not told us that treatment is being withheld from them; but being on treatment can be a big commitment for many people, and so some prefer to wait. Treatment guidelines should be regularly reviewed to ensure they focus on the need of the patient and are never used to withhold treatment.”
Speaking with KaleidoScot, Alastair Rose Head of Operations for Gay Men’s Health (GMH) said.“GMH would always recommend discussing HIV care with their clinician to ensure they access the best possible treatment.
“This study represents interesting findings and highlights that early diagnoses provides the best treatment options. This is why regular testing for those at risk of HIV (and other STIs) is important in ensuring good sexual health.”
Current World Health Organization HIV treatment guidelines recommend that people living with HIV start ART when their CD4 counts fall to 500 cells/mm3, but some guidelines, including the current British HIV Association (BHIVA) guidelines, still recommend waiting until CD4 counts fall below 350 cells/mm3.